Aware: HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01154296
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), University of Pittsburgh (Other), University of California, San Francisco (Other), Oregon Health and Science University (Other), Medical University of South Carolina (Other), Research Foundation for Mental Hygiene, Inc. (Other), Duke University (Other), The Emmes Company, LLC (Industry), San Francisco Department of Public Health (Other), University of California (Other), Weill Medical College of Cornell University (Other)
• Enrollment: 5,012
• Locations: 9
• Arms: 2
• Duration (Months): 22
• Patients Per Site: 556.9
• Patients Per Site Per Month: 25.3

Study Details

Study Description

Brief Summary

Project Aware is a randomized controlled clinical trial in which individuals seeking medical or health services at sexually transmitted disease (STD) clinics are recruited to participate in a multi-center HIV testing and counseling study. The investigators will assess the relative effectiveness and cost-effectiveness of (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information only. The investigators will evaluate the effect of counseling on one primary outcome: STI incidence. Secondary outcomes will be reduction of sexual risk behaviors, substance use during sex (i.e., being under the influence during sex) and cost and cost effectiveness of counseling and testing. Participants will be assessed for sexually transmitted infections, HIV testing history and sexual and drug use risk behaviors at baseline and at 6-months follow-up. Approximately 5,000 individuals seeking medical or health services from approximately 9 STD clinics throughout the United States will be randomized. These individuals will be 18 years of age or older and efforts will be made to recruit a sample of study participants that reflects the proportion of minorities and gender in the STD clinic performance sites from which the investigators are recruiting.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS; Sexually Transmitted Infections	Behavioral: RESPECT-2 Counseling	N/A

Detailed Description

An estimated 56,300 Americans are newly infected with HIV every year. In addition, of the more than one million Americans living with HIV, approximately one-fifth do not know they are infected. Identifying these individuals is among the biggest challenges for HIV prevention in the United States. Early diagnosis of such individuals, combined with prevention counseling and provision of health care, could decrease the spread of HIV and improve the survival of HIV-infected persons.

The recent introduction of rapid HIV testing offers a critical public health screening approach for facilitating earlier diagnoses of HIV infection. Rapid tests permit a sensitive and specific, fast, simple, minimally invasive, and cost-effective method to screen for HIV.

Project Aware expands on the CDC's Project RESPECT-2 study that was an expansion of the RESPECT study (a randomized controlled trial conducted in STD clinics in the mid-1990s before the advent of highly active antiretroviral therapy and before the advent of rapid testing). Project RESPECT demonstrated that a 2-session, client centered counseling session based on behavioral theory with HIV testing was superior to a program with HIV testing and information only. This project showed that the counseling arm had significant reduction of STIs compared to those in the information arm. However, RESPECT did not include men who have sex with men (who account for 53% of all new HIV infections in the U.S.) and did not examine the cost effectiveness of the intervention. RESPECT-2 did include MSM, but it only compared a 1-session counseling session with rapid testing to 2-session counseling with traditional testing and did not address the question of whether counseling and testing is more effective than testing alone.

Project Aware combines the RESPECT-2 counseling approach by adapting the HIV Rapid Testing and Counseling in Drug Abuse Treatment Study (CTN 0032), a NIDA-sponsored randomized controlled clinical trial being conducted in the NIDA Clinical Trials Network (CTN) to sexually transmitted disease (STD) clinics to provide important and timely data on the effect of counseling in high-risk populations tested in health care settings. In this adaptation of CTN 0032, we will assess the relative effectiveness of (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information only (as recommended in the CDC guidelines). Secondary outcomes are reduction of sexual risk behaviors, substance use during sex (i.e., being under the influence during sex) and cost and cost effectiveness of counseling and testing. Participants (approximately 5,000 from 9 STD clinics) will be assessed for STIs, HIV testing history and sexual and drug use risk behaviors at baseline and at 6-months follow-up. The battery of STI tests will screen for Neisseria gonorrhea (GC), Chlamydia trachomatis (CT), Trichomonas vaginalis, Herpes Simplex 2 (HSV-2) and Treponema pallidum (syphilis). HIV test results that yield a reactive result will receive a confirmatory HIV blood test that day, with results delivered 5-10 days later. All participants will be randomized into one of two arms: Group 1- HIV testing and brief, client-centered counseling or Group 2- HIV testing and information only. Group 1 will receive a rapid HIV test with brief prevention counseling that addresses risk reduction based on an evidence-based counseling approach (RESPECT-2 counseling), while Group 2 will receive a rapid HIV test with information only.

The primary outcome will be analyzed using logistic regression for the binary outcome, new diagnoses of STIs (Yes/No). The logistic regression analysis will predict 6-month STI incidence as a function of randomization group controlling for the baseline incidence of STI. ANCOVA will be used for the secondary continuous outcomes, number of sexual risk behaviors and number of sexual episodes involving substance use. Costs will be compared based on study records supplemented by site-level data collection. Primary analyses will be performed under intent-to-treat (ITT) criteria.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5012 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Screening
• Official Title: Project Aware: HIV Rapid Testing & Counseling in STD Clinics in the U.S. -- an Adaptation of CTN 0032
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rapid HIV Testing w/ Counseling (Group 1) Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.	Behavioral: RESPECT-2 Counseling; Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.; Other Names: RESPECT-2 Protocol
No Intervention: Rapid HIV Testing & Information Only (Group 2) Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.

Outcome Measures

Primary Outcome Measures

1. STI Incidence [6 months post randomization]

   Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.

Secondary Outcome Measures

1. Sexual Risk Behavior -- # of Sex Acts [6 months post randomization]

   Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.

2. Sexual Risk Behavior -- # of Unprotected Sex Acts [6 months post randomization]

   Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts

3. Sexual Risk Behavior -- # of Partners [6 months post randomization]

   Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.

4. Sexual Risk Behavior -- # of Unprotected Partners [6 months post randomization]

   Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.

5. Sexual Risk Behavior -- # of Sex Acts With Substance Use [6 months post randomization]

   Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Site Eligibility:

1. high rates of STIs and HIV in their geographic target area,

2. sufficient number of patients so that they would be able to recruit the required 556 participants over the study time period,

3. prior participation in research and clinical studies, and

4. previous collaboration with investigators.

• Participant eligibility:

1. be seeking medical or health services at the participating STD clinic,

2. be at least 18 years old,

3. report being HIV-negative or status unknown,

4. provide informed consent,

5. provide locator information,

6. be able to communicate in English,

7. agree to be tested for STIs/STDs and HIV;

8. sign a HIPAA form and/or medical record release form to permit medical record abstraction of HIV and STI/STD tests, results and treatment; and

9. report living in the vicinity of the clinic and being able to return to the clinic for the 6-month follow-up visit.

Exclusion Criteria:

• Sites:

1. low rates of STIs and HIV in their geographic target area,

2. insufficient number of patients to meet study needs of 556 per site

3. no prior participation in research and clinical studies, and

4. no previous collaboration with investigators.

• Participants:

1. Not seeking medical or health services at the participating STD clinic,

2. under 18 years old,

3. HIV positive,

4. unwilling to provide Informed Consent,

5. refuse to provide locator information,

6. not able to communicate in English,

7. Disagree to be tested for STIs/STDs and/or HIV, and

8. unwilling to sign a HIPAA form and/or medical record release form to permit medical record abstraction of HIV and STI/STD tests, results and treatment,

9. report living out of the vicinity and unable to return to the clinic for the 6-month follow-up visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles Gay & Lesbian Center	Los Angeles	California	United States	90028
2	San Francisco Department of Public Health	San Francisco	California	United States	94102
3	Whitman-Walker Clinic	Washington	District of Columbia	United States	20009
4	Duval County Health Department	Jacksonville	Florida	United States	32206
5	Miami-Dade County Health Department	Miami	Florida	United States	33125
6	Multnomah County Health Department	Portland	Oregon	United States	97204
7	Allegheny County Health Department	Pittsburgh	Pennsylvania	United States	15213
8	Richland County Health Department	Colombia	South Carolina	United States	29204
9	Public Health Seattle & King County	Seattle	Washington	United States	98107

Sponsors and Collaborators

• Columbia University
• National Institute on Drug Abuse (NIDA)
• University of Pittsburgh
• University of California, San Francisco
• Oregon Health and Science University
• Medical University of South Carolina
• Research Foundation for Mental Hygiene, Inc.
• Duke University
• The Emmes Company, LLC
• San Francisco Department of Public Health
• University of California
• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Lisa R. Metsch, Ph.D., University of Miami
• Principal Investigator: Grant N Colfax, M.D., San Francisco Department of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lisa Metsch, Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences, Columbia University
• ClinicalTrials.gov Identifier: NCT01154296
• Other Study ID Numbers: AAAK3153; 1RC2DA028973-01
• First Posted: Jun 30, 2010
• Last Update Posted: Sep 29, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Lisa Metsch, Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences, Columbia University: HIV; Rapid Testing; Counseling; STD; U.S.
• Additional relevant MeSH terms: Sexually Transmitted Diseases

Study Results

Participant Flow

Recruitment Details	Individuals seeking services at 9 sexually transmitted disease (STD) clinics across the U.S. were recruited, screened and randomized between April 2010 - December 2010.
Pre-assignment Detail	Study personnel made 14,948 approaches to STD clinic patients; some were approached multiple times. Of the 6,239 consenting to be screened, 5028 were eligible (80.6%); 16 of these were not randomized due to: decision to decline (n=3), not returning (n=11), not testing with HIV/STD battery (n=1) and not completing baseline activities (n=1).

Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Period Title: Randomization and Intervention
STARTED	2505	2507
COMPLETED	2500	2505
NOT COMPLETED	5	2
Period Title: Randomization and Intervention
STARTED	2505	2507
COMPLETED	2177	2179
NOT COMPLETED	328	328

Baseline Characteristics

Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)	Total
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.	Total of all reporting groups
Overall Participants	2505	2507	5012
Age, Customized (participants) [Number]
<25 years	1705 68.1%	1727 68.9%	3432 68.5%
>=25 years	800 31.9%	780 31.1%	1580 31.5%
Sex/Gender, Customized (participants) [Number]
Male sex	1655 66.1%	1653 65.9%	3308 66%
Female sex	850 33.9%	854 34.1%	1704 34%
Race/Ethnicity, Customized (participants) [Number]
Black	1045 41.7%	1053 42%	2098 41.9%
Hispanic	382 15.2%	385 15.4%	767 15.3%
White	798 31.9%	794 31.7%	1592 31.8%
Other	280 11.2%	275 11%	555 11.1%
Region of Enrollment (participants) [Number]
United States	2505 100%	2507 100%	5012 100%
Men who have sex with men (MSM), # (participants) [Number]
Number [participants]	689 27.5%	711 28.4%	1400 27.9%
Any STI, # (participants) [Number]
Number [participants]	1049 41.9%	1092 43.6%	2141 42.7%
Any STI excluding trichomoniasis, # (participants) [Number]
Number [participants]	1016 40.6%	1070 42.7%	2086 41.6%
Gonorrhea, # (participants) [Number]
Number [participants]	137 5.5%	145 5.8%	282 5.6%
Chlamydia, # (participants) [Number]
Number [participants]	238 9.5%	254 10.1%	492 9.8%
Trichomoniasis, # (participants) [Number]
Number [participants]	126 5%	119 4.7%	245 4.9%
Syphilis, # (participants) [Number]
Number [participants]	28 1.1%	35 1.4%	63 1.3%
HSV-2, # (participants) [Number]
Number [participants]	758 30.3%	793 31.6%	1551 30.9%
HIV, # (participants) [Number]
Number [participants]	29 1.2%	24 1%	53 1.1%
# of sex acts (sex acts) [Least Squares Mean (Standard Deviation) ]
Least Squares Mean (Standard Deviation) [sex acts]	34.6 (1.0809)	33.4 (1.0431)	34.0 (0.751)
# of unprotected sex acts (unprotected sex acts) [Least Squares Mean (Standard Deviation) ]
Least Squares Mean (Standard Deviation) [unprotected sex acts]	23.9 (0.9578)	22.6 (0.9068)	23.3 (0.6594)
# of partners (partners) [Least Squares Mean (Standard Deviation) ]
Least Squares Mean (Standard Deviation) [partners]	4.7 (0.1141)	4.6 (0.1135)	4.6 (0.08047)
# of unprotected partners (unprotected partners) [Least Squares Mean (Standard Deviation) ]
Least Squares Mean (Standard Deviation) [unprotected partners]	2.1 (0.05812)	2.1 (0.05696)	2.1 (0.04069)

Outcome Measures

1. Primary Outcome

Title	STI Incidence
Description	Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Measure Participants	2039	2032
Number [participants]	250 10%	226 9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	A total of 2039/2505 participants randomized to the counseling group and 2032/2507 to the information-only group had complete follow-up STI data. Cumulative STI incidence was 250/2039 (12.3%) in the counseling group and 226/2032 (11.1%) in the information-only group (aRR, 1.12; 95%CI, 0.94-1.33).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	adjusted risk ratio (aRR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Sexual Risk Behavior -- # of Sex Acts
Description	Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Measure Participants	2505	2507
Least Squares Mean (Standard Error) [sex acts]	28.6 (1.1312)	29.1 (1.1553)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence rate ratio (IRR)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.

3. Secondary Outcome

Title	Sexual Risk Behavior -- # of Unprotected Sex Acts
Description	Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Measure Participants	2505	2507
Least Squares Mean (Standard Error) [unprotected sex acts]	17.4 (0.9791)	18.3 (1.0381)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence Rate Ratio (IRR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.

4. Secondary Outcome

Title	Sexual Risk Behavior -- # of Partners
Description	Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Measure Participants	2505	2507
Least Squares Mean (Standard Error) [partners]	2.7 (0.07454)	3.0 (0.08386)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence Rate Ratio (IRR)
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.82 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.

5. Secondary Outcome

Title	Sexual Risk Behavior -- # of Unprotected Partners
Description	Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Measure Participants	2505	2507
Least Squares Mean (Standard Error) [unprotected partners]	1.1 (0.03749)	1.1 (0.03845)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments	Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence Rate Ratio (IRR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.

6. Secondary Outcome

Title	Sexual Risk Behavior -- # of Sex Acts With Substance Use
Description	Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)	Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
Measure Participants	952	952
Number [sex acts with substance use]	115	106

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rapid HIV Testing w/ Counseling (Group 1), Rapid HIV Testing & Information Only (Group 2)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted Risk Ratio (aRR)
	Estimated Value	1.14
	Confidence Interval	() 95%; 0.89 to 1.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse events were captured post-randomization and were collected at each research visit. Other safety information is based on spontaneous reports and not specifically required by the study team.
Adverse Event Reporting Description	Only the following events were required for reporting as AEs: medical events that are directly related to the collection of the HIV and STI test samples (e.g. irritation at the testing site); additional AE were assessed based on report of untoward events that participant or investigator believes are a direct result of the study.
Arm/Group Title	Rapid HIV Testing w/ Counseling (Group 1)		Rapid HIV Testing & Information Only (Group 2)
Arm/Group Description	Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling. RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.		Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
All Cause Mortality
	Rapid HIV Testing w/ Counseling (Group 1)		Rapid HIV Testing & Information Only (Group 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Rapid HIV Testing w/ Counseling (Group 1)		Rapid HIV Testing & Information Only (Group 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/2505 (0.1%)		2/2507 (0.1%)
Cardiac disorders
Heart failure	0/2505 (0%)	0	1/2507 (0%)	1
General disorders
Death, cause unknown	1/2505 (0%)	1	0/2507 (0%)	0
victim of homicide, secondary to robbery	1/2505 (0%)	1	0/2507 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	1/2505 (0%)	1	0/2507 (0%)	0
Metastatic colon cancer	0/2505 (0%)	0	1/2507 (0%)	1
Other (Not Including Serious) Adverse Events
	Rapid HIV Testing w/ Counseling (Group 1)		Rapid HIV Testing & Information Only (Group 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2505 (0%)		0/2507 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.