A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02929069
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 254
• Locations: 2
• Arms: 3
• Duration (Months): 45.5
• Patients Per Site: 127
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The intent of the proposed randomized controlled trial is to test the efficacy of a principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that addresses the pathways through which minority stress compromises young gay and bisexual men's (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual (e.g., condomless anal sex) health problems.

Condition or Disease	Intervention/Treatment	Phase
HIV; Acquired Immunodeficiency Syndrome	Behavioral: ESTEEM; Behavioral: CMHT; Behavioral: VCT	N/A

Detailed Description

ESTEEM (Effective Skills to Empower Effective Men) is a 10-session skills-building intervention designed to reduce young gay and bisexual men's (YGBM) co-occurring health risks by reducing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs YGBM's health. ESTEEM is based on the Unified Protocol, a cognitive-behavioral therapy (CBT) approach with efficacy across mental health and risk behaviors. In an initial study to create ESTEEM , the Unified Protocol was adapted by conducting interviews with 21 YGBM-expert mental health providers and 20 depressed, anxious YGBM at high risk for HIV infection. In a preliminary trial (NCT02448186), ESTEEM significantly reduced YGBM's spectrum of interrelated health threats, making it the first evidence-based intervention to simultaneously improve mental health, substance use, and sexual health outcomes among YGBM.

Important questions remain in order to validate the efficacy and potential cost-effectiveness of ESTEEM. Accordingly, we propose a 3-arm RCT that would examine (1) whether ESTEEM (arm 1) demonstrates significant improvements compared to existing LGBT-affirmative community mental health treatment (CMHT; arm 2) or standard HIV/STD voluntary counseling and testing (VCT; arm 3) for high-risk depressed and anxious YGBM and (2) whether it improves outcomes through reducing hypothesized cognitive, affective, and behavioral minority stress processes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 254 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jun 16, 2020
• Actual Study Completion Date: Jun 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESTEEM Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.	Behavioral: ESTEEM; ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.; Behavioral: VCT; Voluntary Counselling and Testing (VCT).
Active Comparator: Community Mental Health Treatment (CMHT) Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.	Behavioral: CMHT; CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.; Behavioral: VCT; Voluntary Counselling and Testing (VCT).
Active Comparator: Voluntary Counselling and Testing (VCT) Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM.	Behavioral: VCT; Voluntary Counselling and Testing (VCT).

Outcome Measures

Primary Outcome Measures

1. Any Condomless Anal Sex Acts [8 Months]

   Our primary outcome is the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.

Secondary Outcome Measures

1. Minority Stress: GRRS [Baseline]

   Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.

2. Minority Stress: GRRS [4 Months]

   Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.

3. Minority Stress: GRRS [8 Months]

   Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.

4. Minority Stress: GRRS [12 Months]

   Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.

5. Minority Stress: IHS [Baseline]

   Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.

6. Minority Stress: IHS [4 Months]

   Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.

7. Minority Stress: IHS [8 Months]

   Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.

8. Minority Stress: IHS [12 Months]

   Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.

9. Minority Stress: SOCS [Baseline]

   Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.

10. Minority Stress: SOCS [4 Months]

    Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.

11. Minority Stress: SOCS [8 Months]

    Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.

12. Minority Stress: SOCS [12 Months]

    Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.

13. Minority Stress: DERS [Baseline]

    Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.

14. Minority Stress: DERS [4 Months]

    Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.

15. Minority Stress: DERS [8 Months]

    Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.

16. Minority Stress: DERS [12 Months]

    Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.

17. Minority Stress: Brooding [Baseline]

    Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.

18. Minority Stress: Brooding [4 Months]

    Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.

19. Minority Stress: Brooding [8 Months]

    Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.

20. Minority Stress: Brooding [12 Months]

    Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.

21. Minority Stress: Rathus Assertiveness Schedule [Baseline]

    Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.

22. Minority Stress: Rathus Assertiveness Schedule [4 Months]

    Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.

23. Minority Stress: Rathus Assertiveness Schedule [8 Months]

    Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.

24. Minority Stress: Rathus Assertiveness Schedule [12 Months]

    Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.

25. Any Condomless Anal Sex Acts [Baseline]

    This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.

26. Any Condomless Anal Sex Acts [4 Months]

    This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.

27. Any Condomless Anal Sex Acts [12 Months]

    This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.

28. Safer Sex Self-Efficacy [Baseline]

    HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.

29. Safer Sex Self-Efficacy [4 Months]

    HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.

30. Safer Sex Self-Efficacy [8 Months]

    HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.

31. Safer Sex Self-Efficacy [12 Months]

    HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.

32. Decisional Balance [Baseline]

    HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.

33. Decisional Balance [4 Months]

    HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.

34. Decisional Balance [8 Months]

    HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.

35. Decisional Balance [12 Months]

    HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.

36. Depression: HAM-D [Baseline]

    To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.

37. Depression: HAM-D [4 Months]

    To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.

38. Depression: HAM-D [8 Months]

    To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.

39. Depression: HAM-D [12 Months]

    To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.

40. Depression: BSI GSI [Baseline]

    The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).

41. Depression: BSI GSI [4 Months]

    The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).

42. Depression: BSI GSI [8 Months]

    The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).

43. Depression: BSI GSI [12 Months]

    The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).

44. Substance Use: SIP-AD [Baseline]

    Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.

45. Substance Use: SIP-AD [4 months]

    Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.

46. Substance Use: SIP-AD [8 Months]

    Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.

47. Substance Use: SIP-AD [12 Months]

    Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.

48. Any Pre-Exposure Prophylaxis (PrEP) Use [Baseline]

    Participants will be asked if they had used PrEP in the last 3 months.

49. Any Pre-Exposure Prophylaxis (PrEP) Use [4 Months]

    Participants will be asked if they had used PrEP in the last 3 months.

50. Any Pre-Exposure Prophylaxis (PrEP) Use [8 Months]

    Participants will be asked if they had used PrEP in the last 3 months.

51. Any Pre-Exposure Prophylaxis (PrEP) Use [12 Months]

    Participants will be asked if they had used PrEP in the last 3 months.

Other Outcome Measures

1. HIV Test [Baseline]

   Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at Baseline.

2. HIV Test [12 Months]

   Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at 12 months.

3. Gonorrhea Test [Baseline]

   Oral, rectal and urine samples will be collected to test participants for Gonorrhea at Baseline.

4. Gonorrhea Test [12 Months]

   Oral, rectal and urine samples will be collected to test participants for Gonorrhea at 12 months.

5. Chlamydia Test [Baseline]

   Oral, rectal and urine samples will be collected to test participants for Chlamydia at Baseline.

6. Chlamydia Test [12 Months]

   Oral, rectal and urine samples will be collected to test participants for Chlamydia at 12 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• self-identification as a gay, bisexual or queer man;

• HIV-negative status confirmed through in-office testing;

• diagnosis of any DSM-5 depressive, anxiety, or trauma-/stress-related disorder;

• risk of HIV transmission through sexual activity (≥ 1 act of past-90-day-condomless anal sex involving a flesh penis with a partner with an unknown HIV status or an HIV-positive status, unless with an HIV-positive primary or main partner with known undetectable viral load or an HIV-negative primary or main partner who is known to be adherent to PrEP);

• not themselves currently adherent to PrEP (defined as taking PrEP on ≥ 4 days/week);

• NYC or Miami residential stability and planned availability for 12 months;

• English-language proficiency; and (9) provision of informed consent.

Exclusion Criteria:

• current active suicidality or homicidality (but not passive suicidality);

• evidence of active untreated mania, psychosis, or gross cognitive impairment;

• current enrollment in another intervention study;

• currently receiving 1 or more mental health treatment sessions/month or 8 or more CBT sessions within the past year;

• HIV-positive status (confirmed through in-office testing).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Public Health, Yale University	New Haven	Connecticut	United States	06520
2	Clinical Research Building, University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• Yale University
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: John Pachankis, PhD, MYSM School Of Medicine

Study Documents (Full-Text)

• Study Protocol - Aug 5, 2020
• Statistical Analysis Plan - Nov 15, 2020

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02929069
• Other Study ID Numbers: 1509016430; 1R01MH109413-01
• First Posted: Oct 10, 2016
• Last Update Posted: Jan 4, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Yale University: Minority Stress
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes

Study Results

Participant Flow

Arm/Group Title	ESTEEM	Community Mental Health Treatment (CMHT)	Voluntary Counselling and Testing (VCT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).
Period Title: Overall Study
STARTED	100	102	52
Completed 4 Month Follow Up	83	76	43
Completed 8 Month Follow Up	82	77	36
Assessed STI 12 Month	74	75	38
Assessed HIV 12 Month	76	76	39
Complete 12 Month Follow Up	81	81	42
COMPLETED	81	81	42
NOT COMPLETED	19	21	10

Baseline Characteristics

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)	Total
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).	Total of all reporting groups
Overall Participants	100	52	101	253
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.31 (4.47)	26.88 (3.43)	26.6 (4.23)	26.55 (4.17)
Sex: Female, Male (Count of Participants)
Female	2 2%	0 0%	1 1%	3 1.2%
Male	98 98%	52 100%	100 99%	250 98.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	43 43%	24 46.2%	41 40.6%	108 42.7%
Not Hispanic or Latino	57 57%	28 53.8%	60 59.4%	145 57.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
American Indian /Alaskan Native	1 1%	0 0%	0 0%	1 0.4%
Asian	5 5%	2 3.8%	3 3%	10 4%
Black/African American	20 20%	2 3.8%	21 20.8%	43 17%
Multiracial	12 12%	12 23.1%	14 13.9%	38 15%
Native Hawaiian/Pacific Islander	0 0%	1 1.9%	1 1%	2 0.8%
White	53 53%	32 61.5%	56 55.4%	141 55.7%
Other	9 9%	3 5.8%	6 5.9%	18 7.1%
Region of Enrollment (participants) [Number]
United States	100 100%	52 100%	101 100%	253 100%
Gender Identity (Count of Participants)
Man	100 100%	51 98.1%	99 98%	250 98.8%
Woman	2 2%	0 0%	0 0%	2 0.8%
Transgender Man	2 2%	0 0%	0 0%	2 0.8%
Genderqueer	2 2%	2 3.8%	2 2%	6 2.4%
Gender non-conforming/-binary	2 2%	0 0%	1 1%	3 1.2%
Two-spirit	3 3%	0 0%	0 0%	3 1.2%
Other	1 1%	0 0%	1 1%	2 0.8%
Sexual Orientation (Count of Participants)
Bisexual	25 25%	9 17.3%	19 18.8%	53 20.9%
Gay	69 69%	39 75%	78 77.2%	186 73.5%
Queer	6 6%	4 7.7%	3 3%	13 5.1%
Uncertain	0 0%	0 0%	1 1%	1 0.4%
Education (Count of Participants)
Less than College	6 6%	6 11.5%	10 9.9%	22 8.7%
College Degree	94 94%	46 88.5%	91 90.1%	231 91.3%
Diagnoses (Count of Participants)
Depression	79 79%	37 71.2%	79 78.2%	195 77.1%
Dysthymia	33 33%	9 17.3%	40 39.6%	82 32.4%
Panic Disorder	16 16%	12 23.1%	25 24.8%	53 20.9%
Agoraphobia	24 24%	11 21.2%	25 24.8%	60 23.7%
Social Anxiety Disorder	37 37%	20 38.5%	49 48.5%	106 41.9%
Obsessive Compulsive Disorder	23 23%	7 13.5%	20 19.8%	50 19.8%
Post-Traumatic Stress Disorder	18 18%	5 9.6%	14 13.9%	37 14.6%
Generalized Anxiety Disorder	53 53%	20 38.5%	51 50.5%	124 49%
Alcohol-Use Disorder	27 27%	13 25%	22 21.8%	62 24.5%
Substance-Use Disorder	55 55%	28 53.8%	53 52.5%	136 53.8%

Outcome Measures

1. Primary Outcome

Title	Any Condomless Anal Sex Acts
Description	Our primary outcome is the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat

Arm/Group Title	ESTEEM	Community Mental Health Treatment (CMHT)	Voluntary Counselling and Testing (VCT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	76	35
CAS = Yes	43 43%	47 90.4%	17 16.8%
CAS = No	38 38%	29 55.8%	18 17.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ESTEEM, Voluntary Counselling and Testing (VCT)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	.88
	Confidence Interval	(2-Sided) 95%; .52 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Minority Stress: GRRS
Description	Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [units on a scale]	13.34 (7.08)	14.34 (8.38)	14.48 (7.73)

3. Secondary Outcome

Title	Minority Stress: GRRS
Description	Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [units on a scale]	11.29 (7.05)	11.33 (7.20)	11.53 (6.94)

4. Secondary Outcome

Title	Minority Stress: GRRS
Description	Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [units on a scale]	10.14 (6.14)	10.51 (7.05)	11.58 (7.49)

5. Secondary Outcome

Title	Minority Stress: GRRS
Description	Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [units on a scale]	10.01 (6.79)	11.07 (7.29)	10.53 (7.32)

6. Secondary Outcome

Title	Minority Stress: IHS
Description	Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [units on a scale]	1.90 (0.78)	1.78 (0.75)	1.81 (0.70)

7. Secondary Outcome

Title	Minority Stress: IHS
Description	Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [units on a scale]	1.73 (0.72)	1.49 (0.46)	1.66 (0.62)

8. Secondary Outcome

Title	Minority Stress: IHS
Description	Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [units on a scale]	1.69 (0.67)	1.44 (0.44)	1.66 (0.66)

9. Secondary Outcome

Title	Minority Stress: IHS
Description	Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [units on a scale]	1.67 (0.75)	1.38 (0.42)	1.53 (0.59)

10. Secondary Outcome

Title	Minority Stress: SOCS
Description	Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [units on a scale]	1.84 (0.69)	1.73 (0.74)	1.83 (0.76)

11. Secondary Outcome

Title	Minority Stress: SOCS
Description	Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [units on a scale]	1.90 (0.70)	1.79 (0.75)	1.87 (0.74)

12. Secondary Outcome

Title	Minority Stress: SOCS
Description	Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [units on a scale]	1.94 (0.82)	1.73 (0.75)	1.83 (0.76)

13. Secondary Outcome

Title	Minority Stress: SOCS
Description	Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [units on a scale]	1.87 (0.79)	1.57 (0.73)	1.83 (0.81)

14. Secondary Outcome

Title	Minority Stress: DERS
Description	Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [units on a scale]	95.39 (20.53)	98.61 (21.20)	94.41 (25.20)

15. Secondary Outcome

Title	Minority Stress: DERS
Description	Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [units on a scale]	84.84 (21.48)	94.53 (24.16)	86.46 (19.62)

16. Secondary Outcome

Title	Minority Stress: DERS
Description	Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [units on a scale]	87.14 (24.29)	89.34 (21.89)	86.87 (21.91)

17. Secondary Outcome

Title	Minority Stress: DERS
Description	Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [units on a scale]	85.33 (20.75)	86.73 (21.21)	86.09 (20.94)

18. Secondary Outcome

Title	Minority Stress: Brooding
Description	Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [units on a scale]	13.91 (3.08)	14.25 (3.49)	13.47 (3.64)

19. Secondary Outcome

Title	Minority Stress: Brooding
Description	Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [units on a scale]	12.36 (3.21)	13.20 (3.57)	13.38 (3.15)

20. Secondary Outcome

Title	Minority Stress: Brooding
Description	Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [units on a scale]	12.02 (3.53)	12.19 (3.45)	13.14 (3.72)

21. Secondary Outcome

Title	Minority Stress: Brooding
Description	Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [units on a scale]	11.55 (3.36)	12.55 (3.44)	12.09 (3.50)

22. Secondary Outcome

Title	Minority Stress: Rathus Assertiveness Schedule
Description	Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [units on a scale]	99.44 (18.77)	101.39 (20.35)	99.98 (19.10)

23. Secondary Outcome

Title	Minority Stress: Rathus Assertiveness Schedule
Description	Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [units on a scale]	101.87 (15.31)	105.13 (16.94)	108.23 (19.62)

24. Secondary Outcome

Title	Minority Stress: Rathus Assertiveness Schedule
Description	Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [units on a scale]	104.02 (17.07)	106.85 (14.94)	106.47 (18.97)

25. Secondary Outcome

Title	Minority Stress: Rathus Assertiveness Schedule
Description	Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [units on a scale]	103.26 (15.32)	107.47 (15.81)	108.61 (16.01)

26. Secondary Outcome

Title	Any Condomless Anal Sex Acts
Description	This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Yes	100 100%	52 100%	101 100%
No	0 0%	0 0%	0 0%
MISSING	0 0%	0 0%	1 1%

27. Secondary Outcome

Title	Any Condomless Anal Sex Acts
Description	This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	43	76
Yes	47 47%	24 46.2%	53 52.5%
No	35 35%	17 32.7%	21 20.8%
MISSING ASSESSMENT	0 0%	2 3.8%	2 2%

28. Secondary Outcome

Title	Any Condomless Anal Sex Acts
Description	This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Participants with completed follow up visits.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Yes	39 39%	26 50%	44 43.6%
No	41 41%	15 28.8%	36 35.6%
MISSING ASSESSMENT	1 1%	1 1.9%	1 1%

29. Secondary Outcome

Title	Safer Sex Self-Efficacy
Description	HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [units on a scale]	38.92 (11.73)	36.69 (12.02)	38.72 (12.73)

30. Secondary Outcome

Title	Safer Sex Self-Efficacy
Description	HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [units on a scale]	42.83 (12.83)	37.4 (12.08)	41.8 (12.69)

31. Secondary Outcome

Title	Safer Sex Self-Efficacy
Description	HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [units on a scale]	42.73 (13.77)	36.44 (13.11)	40.32 (10.89)

32. Secondary Outcome

Title	Safer Sex Self-Efficacy
Description	HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [units on a scale]	44.68 (12.32)	38.55 (13.33)	41.53 (11.76)

33. Secondary Outcome

Title	Decisional Balance
Description	HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Pros Subscale	2.62 (0.81)	2.8 (0.74)	2.66 (0.77)
Cons Subscale	3.26 (0.81)	3.16 (0.81)	3.24 (0.8)

34. Secondary Outcome

Title	Decisional Balance
Description	HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Pros Subscale	2.45 (0.83)	2.71 (0.7)	2.65 (0.85)
Cons Subscale	3.17 (0.85)	3.19 (0.83)	3.19 (0.84)

35. Secondary Outcome

Title	Decisional Balance
Description	HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Pros Subscale	2.31 (0.83)	2.83 (0.65)	2.44 (0.68)
Cons Subscale	3.12 (0.9)	3.08 (0.82)	3.02 (0.84)

36. Secondary Outcome

Title	Decisional Balance
Description	HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Pros Subscale	2.46 (0.88)	2.71 (0.77)	2.46 (0.68)
Cons Subscale	3.17 (0.9)	3.26 (0.83)	3.0 (0.85)

37. Secondary Outcome

Title	Depression: HAM-D
Description	To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [units on a scale]	16.13 (6.26)	15.87 (6.75)	15.25 (6.83)

38. Secondary Outcome

Title	Depression: HAM-D
Description	To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [units on a scale]	10.20 (6.13)	9.93 (6.82)	10.51 (7.02)

39. Secondary Outcome

Title	Depression: HAM-D
Description	To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [units on a scale]	9.81 (6.04)	9.57 (6.20)	11.72 (6.39)

40. Secondary Outcome

Title	Depression: HAM-D
Description	To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [units on a scale]	9.95 (6.34)	11.49 (8.86)	10.73 (6.68)

41. Secondary Outcome

Title	Depression: BSI GSI
Description	The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [score on a scale]	1.23 (0.62)	1.29 (0.62)	1.31 (0.67)

42. Secondary Outcome

Title	Depression: BSI GSI
Description	The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [score on a scale]	0.66 (0.60)	0.86 (0.73)	0.77 (0.66)

43. Secondary Outcome

Title	Depression: BSI GSI
Description	The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [score on a scale]	0.60 (0.54)	0.69 (0.61)	0.80 (0.60)

44. Secondary Outcome

Title	Depression: BSI GSI
Description	The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [score on a scale]	0.65 (0.63)	0.70 (0.69)	0.76 (0.64)

45. Secondary Outcome

Title	Substance Use: SIP-AD
Description	Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Mean (Standard Deviation) [units on a scale]	4.95 (4.42)	4.71 (4.06)	4.52 (4.41)

46. Secondary Outcome

Title	Substance Use: SIP-AD
Description	Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	83	43	76
Mean (Standard Deviation) [units on a scale]	3.21 (4.19)	4.29 (3.98)	3.34 (3.94)

47. Secondary Outcome

Title	Substance Use: SIP-AD
Description	Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	36	77
Mean (Standard Deviation) [units on a scale]	2.72 (3.33)	3.75 (4.17)	3.38 (4.07)

48. Secondary Outcome

Title	Substance Use: SIP-AD
Description	Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	81	42	81
Mean (Standard Deviation) [units on a scale]	2.51 (3.54)	3.83 (4.18)	2.79 (3.61)

49. Secondary Outcome

Title	Any Pre-Exposure Prophylaxis (PrEP) Use
Description	Participants will be asked if they had used PrEP in the last 3 months.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Participants that either completed or partially completed the interview.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	101
No, I have never taken HIV PrEP	82 82%	41 78.8%	87 86.1%
Yes, I am currently taking HIV PrEP	0 0%	0 0%	1 1%
I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months	3 3%	3 5.8%	3 3%
I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago	15 15%	8 15.4%	10 9.9%

50. Secondary Outcome

Title	Any Pre-Exposure Prophylaxis (PrEP) Use
Description	Participants will be asked if they had used PrEP in the last 3 months.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

Participants that either completed or partially completed the interview, MISSING used for those that either dropped our or partially completed the interview.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	82	43	76
No, I have never taken HIV PrEP	63 63%	25 48.1%	54 53.5%
Yes, I am currently taking HIV PrEP	10 10%	13 25%	10 9.9%
I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months	2 2%	0 0%	1 1%
I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago	7 7%	4 7.7%	9 8.9%
MISSING ASSESSMENT	0 0%	1 1.9%	2 2%

51. Secondary Outcome

Title	Any Pre-Exposure Prophylaxis (PrEP) Use
Description	Participants will be asked if they had used PrEP in the last 3 months.
Time Frame	8 Months

Outcome Measure Data

Analysis Population Description

Participants that either completed or partially completed the interview, MISSING used for those that either dropped our or partially completed the interview.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	101
No, I have never taken HIV PrEP	56 56%	21 40.4%	44 43.6%
Yes, I am currently taking HIV PrEP	11 11%	9 17.3%	20 19.8%
I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months	7 7%	2 3.8%	2 2%
I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago	8 8%	4 7.7%	11 10.9%
MISSING	18 18%	16 30.8%	25 24.8%

52. Secondary Outcome

Title	Any Pre-Exposure Prophylaxis (PrEP) Use
Description	Participants will be asked if they had used PrEP in the last 3 months.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Participants that either completed or partially completed the interview, MISSING used for those that either dropped our or partially completed the interview.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	101
No, I have never taken HIV PrEP	50 50%	22 42.3%	44 43.6%
Yes, I am currently taking HIV PrEP	11 11%	7 13.5%	20 19.8%
I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months	7 7%	5 9.6%	3 3%
I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago	13 13%	8 15.4%	14 13.9%
MISSING	19 19%	10 19.2%	21 20.8%

53. Other Pre-specified Outcome

Title	HIV Test
Description	Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at Baseline.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Participants with complete and valid data.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Negative	100 100%	52 100%	102 101%
Preliminary Positive	0 0%	0 0%	0 0%

54. Other Pre-specified Outcome

Title	HIV Test
Description	Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at 12 months.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Participants with complete and valid data.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	76	39	76
Negative	73 73%	39 75%	75 74.3%
Preliminary Positive	3 3%	0 0%	1 1%

55. Other Pre-specified Outcome

Title	Gonorrhea Test
Description	Oral, rectal and urine samples will be collected to test participants for Gonorrhea at Baseline.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Participants with complete and valid data.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Non-reactive	94 94%	48 92.3%	97 96%
Reactive	5 5%	4 7.7%	4 4%
Inconclusive	0 0%	0 0%	1 1%
Not Assessed	1 1%	0 0%	0 0%
Non-reactive	95 95%	49 94.2%	99 98%
Reactive	5 5%	3 5.8%	1 1%
Inconclusive	0 0%	0 0%	1 1%
Not Assessed	0 0%	0 0%	1 1%
Non-reactive	100 100%	52 100%	102 101%
Reactive	0 0%	0 0%	0 0%
Inconclusive	0 0%	0 0%	0 0%
Not Assessed	0 0%	0 0%	0 0%

56. Other Pre-specified Outcome

Title	Gonorrhea Test
Description	Oral, rectal and urine samples will be collected to test participants for Gonorrhea at 12 months.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Participants with complete and valid data.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	74	38	75
Non-reactive	71 71%	36 69.2%	73 72.3%
Reactive	2 2%	2 3.8%	2 2%
Inconclusive	0 0%	0 0%	0 0%
Not assessed	1 1%	0 0%	0 0%
Non-reactive	67 67%	35 67.3%	73 72.3%
Reactive	5 5%	3 5.8%	2 2%
Inconclusive	0 0%	0 0%	0 0%
Not assessed	2 2%	0 0%	0 0%
Non-reactive	74 74%	38 73.1%	75 74.3%
Reactive	0 0%	0 0%	0 0%
Inconclusive	0 0%	0 0%	0 0%
Not assessed	0 0%	0 0%	0 0%

57. Other Pre-specified Outcome

Title	Chlamydia Test
Description	Oral, rectal and urine samples will be collected to test participants for Chlamydia at Baseline.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Participants with complete and valid data.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	100	52	102
Non-reactive	97 97%	50 96.2%	96 95%
Reactive	2 2%	2 3.8%	5 5%
Inconclusive	0 0%	0 0%	1 1%
Not assessed	1 1%	0 0%	0 0%
Non-reactive	97 97%	48 92.3%	90 89.1%
Reactive	3 3%	4 7.7%	10 9.9%
Inconclusive	0 0%	0 0%	1 1%
Not assessed	0 0%	0 0%	1 1%
Non-reactive	99 99%	51 98.1%	101 100%
Reactive	1 1%	1 1.9%	1 1%
Inconclusive	0 0%	0 0%	0 0%
Not assessed	0 0%	0 0%	0 0%

58. Other Pre-specified Outcome

Title	Chlamydia Test
Description	Oral, rectal and urine samples will be collected to test participants for Chlamydia at 12 months.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Participants with complete and valid data.

Arm/Group Title	ESTEEM	Voluntary Counselling and Testing (VCT)	Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).	Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
Measure Participants	74	38	75
Non-reactive	72 72%	38 73.1%	75 74.3%
Reactive	1 1%	0 0%	0 0%
Inconclusive	0 0%	0 0%	0 0%
Not assessed	1 1%	0 0%	0 0%
Non-reactive	69 69%	34 65.4%	74 73.3%
Reactive	3 3%	4 7.7%	1 1%
Inconclusive	0 0%	0 0%	0 0%
Not assessed	2 2%	0 0%	0 0%
Non-reactive	74 74%	38 73.1%	75 74.3%
Reactive	0 0%	0 0%	0 0%
Inconclusive	0 0%	0 0%	0 0%
Not assessed	0 0%	0 0%	0 0%

Adverse Events

Time Frame	12 Months
Adverse Event Reporting Description	Severe Adverse Events were assessed systematically using the Brief Symptom inventory (BSI) and Suicidal Ideation Attributes Scale (SIDAS) during in-office assessments at 4MFU, 8MFU and 12MFU. Active suicidality also assessed through participant self-disclosure during therapy or during semi-structured clinical interviews (HAMD) during follow-up visits.
Arm/Group Title	ESTEEM		Voluntary Counselling and Testing (VCT)		Community Mental Health Treatment (CMHT)
Arm/Group Description	Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT).		Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT).		Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT).
All Cause Mortality
	ESTEEM		Voluntary Counselling and Testing (VCT)		Community Mental Health Treatment (CMHT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/52 (0%)		0/102 (0%)
Serious Adverse Events
	ESTEEM		Voluntary Counselling and Testing (VCT)		Community Mental Health Treatment (CMHT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/100 (4%)		0/52 (0%)		1/102 (1%)
Psychiatric disorders
Active Suicidality	4/100 (4%)	4	0/52 (0%)	0	1/102 (1%)	1
Other (Not Including Serious) Adverse Events
	ESTEEM		Voluntary Counselling and Testing (VCT)		Community Mental Health Treatment (CMHT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/52 (0%)		0/102 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.