KIU!: Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01836445
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), Emory University (Other), Hunter College of City University of New York (Other)
• Enrollment: 901
• Locations: 3
• Arms: 2
• Actual Duration (Months): 46
• Patients Per Site: 300.3
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections. Because YMSM are less likely to receive relevant sexual health education in traditional settings (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.

The purpose of this study is to compare two different versions of an online HIV prevention program for YMSM. The study is being conducted by researchers at Northwestern University in Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900 YMSM will be enrolled into this study from the clinics of community partners in Chicago, New York, and Atlanta.

Participants will be randomly assigned to one of two versions of the program. Some topics in the program include HIV facts and myths, sexually transmitted infections (STIs), and condom use. All participants, regardless of the program version they receive, will also take at-home urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program, participants will be contacted three more times over the course of a year for follow-up sessions and surveys.

The research team hypothesizes that the YMSM-specific prevention program will lead to a significant reduction in the frequency of unprotected anal sex acts and new STI infections compared to the HIV knowledge program that is for a general audience. The YMSM-specific program will also lead to improvements in secondary knowledge, motivation, and skills outcomes.

In order for the research team to measure the effectiveness of the YMSM-specific prevention program and determine if the study hypothesis is correct, participants will be asked questions about themselves, including questions about their sexual orientation, sexual experiences, health practices, including drug use, health knowledge, and questions about their feelings and emotions. Based on this information, the research team hopes to later change, improve, or expand the program to better address the needs of YMSM.

Condition or Disease	Intervention/Treatment	Phase
HIV; Gonorrhea; Chlamydia	Behavioral: Keep It Up!; Behavioral: HIV Knowledge Control	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 901 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Efficacy of Internet-based HIV Prevention
• Actual Study Start Date: May 1, 2013
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Keep It Up! Intervention The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete.	Behavioral: Keep It Up!; Other Names: KIU! KIU! 2.0 Keep It Up! 2.0
Active Comparator: HIV Knowledge Control The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days).	Behavioral: HIV Knowledge Control

Outcome Measures

Primary Outcome Measures

1. Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months [Baseline, 3 Months]

   Change in self-report of condomless anal sex acts at three months.

2. Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months [Baseline, 6 Months]

   Change in self-report of condomless anal sex acts at six months.

3. Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months [Baseline, 12 Months]

   Change in self-report of condomless anal sex acts at twelve months.

4. Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline [Baseline]

   The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.

5. Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months [12 months]

   The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.

Secondary Outcome Measures

1. Mean Score of Condom Errors at Baseline and 3 Months [Baseline, 3 Months]

   The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at three months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.

2. Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months [Baseline, 3 Months]

   The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at three months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.

3. Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months [Baseline, 3 Months]

   At three months, the change in: Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) Social Norms (for example, partners, friends, or family members opinions about condom use) Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4

4. Mean Score of Health Protective Communication Skills at Baseline and 3 Months [Baseline, 3 Months]

   The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at three months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).

5. Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months [Baseline, 12 Month]

   The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex.

6. Mean Score of Condom Errors at Baseline and 6 Months [Baseline, 6 Months]

   The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at six months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors

7. Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months [Baseline, 6 Months]

   The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at six months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.

8. Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months [Baseline, 6 Months]

   At six months, the change in: Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) Social Norms (for example, partners, friends, or family members opinions about condom use) Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4

9. Mean Score of Health Protective Communication Skills at Baseline and 6 Months [Baseline, 6 Months]

   The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at six months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).

10. Mean Score of Condom Errors at Baseline and 12 Months [Baseline, 12 Months]

    The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at twelve months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.

11. Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months [Baseline, 12 Months]

    The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at twelve months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.

12. Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months [Baseline, 12 Months]

    At twelve months, the change in: Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) Social Norms (for example, partners, friends, or family members opinions about condom use) Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4

13. Mean Score of Health Protective Communication Skills at Baseline and 12 Months [Baseline, 12 Months]

    The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at twelve months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).

14. Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months [Baseline, 12 Months]

    The change in effect that HIV testing has on health beliefs (for example, "I cannot get HIV") and sexual behaviors at twelve months. Range 1-5; higher scores = more feelings of invulnerability

Other Outcome Measures

1. Participant Rating of Intervention Acceptability and Tolerability [Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)]

   Participant rating of how much they enjoyed the intervention and participant feedback and suggestions for improvement. Range 1-4; higher scores indicate greater acceptability.

2. Participant Location [Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)]

   Log of where participants completed the intervention sessions (participants can select multiple locations).

3. Participant Experiences of Harm at 3 Month Follow-up [3 Months]

   Log of any negative experiences or harm experienced by participant at three months.

4. Participant Experiences of Harm at 6 Month Follow-up [6 Months]

   Log of any negative experiences or harm experienced by participant at six months.

5. Participant Experiences of Harm at 12 Month Follow-up [12 Months]

   Log of any negative experiences or harm experienced by participant at twelve months.

6. Occurrence of Sexually Transmitted Infections (STIs) at 3 Months [3 Months]

   The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 3 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.

7. Occurrence of Sexually Transmitted Infections (STIs) at 6 Months [6 Months]

   The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 6 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.

8. Level of Privacy [Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)]

   Log of the levels of privacy of the locations where participants completed intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Birth male who identifies as male and reports sexual contact with another male

• Received an HIV negative test result from a participating clinic/recruitment site

• Unprotected anal sex with another male in the last 6 months

• Ability to read English at 8th grade level

Exclusion Criteria:

• HIV positive

• Female or Transgender

• No email address for contact

• Currently in a monogamous relationship lasting longer than 6 months

• Participated in previous versions of KIU!

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322
2	Northwestern University	Chicago	Illinois	United States	60611
3	Hunter College	New York	New York	United States	10065

Sponsors and Collaborators

• Northwestern University
• National Institute on Drug Abuse (NIDA)
• Emory University
• Hunter College of City University of New York

Investigators

• Principal Investigator: Brian Mustanski, PhD, Northwestern University

Study Documents (Full-Text)

• Study Protocol - Dec 12, 2016
• Statistical Analysis Plan - Nov 9, 2016
• Informed Consent Form - Nov 24, 2014

More Information

Publications

• Centers for Disease Control and Prevention (CDC). HIV Surveillance in Adolescents and Young Adults. 2010.
• Centers for Disease Control and Prevention (CDC). Trends in HIV/AIDS diagnoses among men who have sex with men--33 states, 2001-2006. MMWR Morb Mortal Wkly Rep. 2008 Jun 27;57(25):681-6.
• Mustanski B, Lyons T, Garcia SC. Internet use and sexual health of young men who have sex with men: a mixed-methods study. Arch Sex Behav. 2011 Apr;40(2):289-300. doi: 10.1007/s10508-009-9596-1. Epub 2010 Feb 25.
• Prejean J, Song R, Hernandez A, Ziebell R, Green T, Walker F, Lin LS, An Q, Mermin J, Lansky A, Hall HI; HIV Incidence Surveillance Group. Estimated HIV incidence in the United States, 2006-2009. PLoS One. 2011;6(8):e17502. doi: 10.1371/journal.pone.0017502. Epub 2011 Aug 3.

• Responsible Party: Brian Mustanski, Associate Professor, Department of Medical Social Sciences; Director, IMPACT Program, Northwestern University
• ClinicalTrials.gov Identifier: NCT01836445
• Other Study ID Numbers: 1R01DA035145-01; 1R01DA035145-01
• First Posted: Apr 19, 2013
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Additional relevant MeSH terms: Gonorrhea

Study Results

Participant Flow

Recruitment Details	From May 2013 to December 2015, 901 participants were recruited and enrolled from (1) community-based HIV testing organizations in Atlanta, Chicago, and New York; (2) local health department clinics in Chicago; (3) street outreach in Atlanta, Chicago, and New York; and (4) local and national advertising.
Pre-assignment Detail	Participants were randomized after completing a baseline assessment and STI testing.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Period Title: Intervention Modules
STARTED	445	456
COMPLETED	375	434
NOT COMPLETED	70	22
Period Title: Intervention Modules
STARTED	445	456
COMPLETED	348	409
NOT COMPLETED	97	47
Period Title: Intervention Modules
STARTED	445	455
COMPLETED	342	380
NOT COMPLETED	103	75
Period Title: Intervention Modules
STARTED	445	455
COMPLETED	370	391
NOT COMPLETED	75	64
Period Title: Intervention Modules
STARTED	445	455
COMPLETED	365	378
NOT COMPLETED	80	77

Baseline Characteristics

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control	Total
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control	Total of all reporting groups
Overall Participants	445	456	901
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.27 (3.02)	24.15 (2.89)	24.21 (2.95)
Age, Customized (Count of Participants)
18 - 24	233 52.4%	244 53.5%	477 52.9%
25 - 29	211 47.4%	212 46.5%	423 46.9%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	445 100%	456 100%	901 100%
Race/Ethnicity, Customized (Count of Participants)
Native American	1 0.2%	4 0.9%	5 0.6%
Asian	15 3.4%	22 4.8%	37 4.1%
Black or African American	106 23.8%	113 24.8%	219 24.3%
Hispanic or Latino	135 30.3%	125 27.4%	260 28.9%
White	165 37.1%	165 36.2%	330 36.6%
More than one race	15 3.4%	17 3.7%	32 3.6%
Unknown or Not Reported	8 1.8%	10 2.2%	18 2%
Condomless Anal Sex (condomless anal sex acts) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [condomless anal sex acts]	4.3 (13.1)	3.4 (6.7)	3.9 (9.9)
Sexually Transmitted Infections (Count of Participants)
Urethral Chlamydia	15 3.4%	7 1.5%	22 2.4%
Urethral Gonorrhea	3 0.7%	4 0.9%	7 0.8%
Rectal Chlamydia	47 10.6%	30 6.6%	77 8.5%
Rectal Gonorrhea	29 6.5%	16 3.5%	45 5%
Any STI	82 18.4%	50 11%	132 14.7%
Education (Count of Participants)
Junior High School	0 0%	1 0.2%	1 0.1%
Partial High School	10 2.2%	7 1.5%	17 1.9%
High School Graduate/GED	60 13.5%	35 7.7%	95 10.5%
Partial College (at Least One Year)	116 26.1%	136 29.8%	252 28%
College Education	203 45.6%	215 47.1%	418 46.4%
Graduate Degree	56 12.6%	62 13.6%	118 13.1%
Employment (Count of Participants)
Full Time	223 50.1%	228 50%	451 50.1%
Part Time	115 25.8%	135 29.6%	250 27.7%

Outcome Measures

1. Primary Outcome

Title	Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months
Description	Change in self-report of condomless anal sex acts at three months.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 3 month follow-up.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	445	454
Baseline	304 68.3%	312 68.4%
3 Month Follow-up	148 33.3%	184 40.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Prevalence Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months
Description	Change in self-report of condomless anal sex acts at six months.
Time Frame	Baseline, 6 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 6 month follow-up.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	445	454
Baseline	304 68.3%	312 68.4%
6 Month Follow-up	133 29.9%	156 34.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Prevalence Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months
Description	Change in self-report of condomless anal sex acts at twelve months.
Time Frame	Baseline, 12 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 12 month follow-up.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	445	454
Baseline	304 68.3%	312 68.4%
12 Month Follow-up	136 30.6%	173 37.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Prevalence Ratio
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline
Description	The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Enrolled participants who returned STI test kits for analysis at baseline. Denominator varies by testing site and study arm: urethral (control - 452; intervention - 441) rectal (control - 449; intervention - 442)

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	443	453
Urethral Chlamydia	15 3.4%	7 1.5%
Urethral Gonorrhea	3 0.7%	4 0.9%
Rectal Chlamydia	47 10.6%	30 6.6%
Rectal Gonorrhea	29 6.5%	16 3.5%
Any STI	82 18.4%	50 11%

5. Primary Outcome

Title	Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months
Description	The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Enrolled participants who returned STI test kits for analysis at 12 month follow-up. Denominator varies by testing site and study arm: urethral (control - 374; intervention - 359) rectal (control - 374; intervention - 356)

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	359	374
Urethral Chlamydia	4 0.9%	7 1.5%
Urethral Gonorrhea	1 0.2%	3 0.7%
Rectal Chlamydia	22 4.9%	38 8.3%
Rectal Gonorrhea	13 2.9%	15 3.3%
Any STI	31 7%	54 11.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Z-test
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.38 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Mean Score of Condom Errors at Baseline and 3 Months
Description	The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at three months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on condom errors at baseline and 3 month follow-up.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	140	150
Baseline	4.28 (2.16)	4.05 (2.12)
3 Month Follow-up	3.23 (2.27)	3.45 (2.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.150
	Comments
	Method	Regression, Linear
	Comments

7. Secondary Outcome

Title	Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months
Description	The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at three months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on HIV knowledge at baseline and 3 month follow-up.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	348	409
Baseline	85.93 (13.00)	86.41 (11.64)
3 Month Follow-up	89.11 (11.22)	88.68 (11.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.374
	Comments
	Method	Regression, Linear
	Comments

8. Secondary Outcome

Title	Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months
Description	At three months, the change in: Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) Social Norms (for example, partners, friends, or family members opinions about condom use) Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 3 month.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	348	409
Baseline - Motivational Self-Rating	3.11 (0.80)	3.02 (0.87)
3 Month Follow-up - Motivational Self-Rating	3.11 (0.91)	3.03 (0.92)
Baseline - Social Norms	4.36 (0.54)	4.33 (0.53)
3 Month Follow-up - Social Norms	4.37 (0.62)	4.32 (0.62)
Baseline - Behavioral Skills	1.36 (0.39)	1.39 (0.39)
3 Month Follow-up - Behavioral Skills	1.28 (0.35)	1.38 (0.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Motivation items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.919
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Social Norms items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.493
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Behavioral Skills items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Linear
	Comments

9. Secondary Outcome

Title	Mean Score of Health Protective Communication Skills at Baseline and 3 Months
Description	The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at three months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).
Time Frame	Baseline, 3 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	236	292
Baseline - HPC Relationship Maintenance	1.34 (0.75)	1.36 (0.80)
3 Month Follow-up - HPC Relationship Maintenance	1.46 (0.89)	1.37 (0.83)
Baseline - HPC Condom Use	1.32 (0.86)	1.10 (0.81)
3 Month Follow-up - HPC Condom Use	1.38 (0.92)	1.22 (0.97)
Baseline - HPC HIV Testing	0.76 (0.75)	0.43 (0.63)
3 Month Follow-up - HPC HIV Testing	0.71 (0.73)	0.61 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Relationship Maintenance items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.067
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Condom Use items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.135
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for HIV Testing items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.025
	Comments
	Method	Regression, Linear
	Comments

10. Secondary Outcome

Title	Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months
Description	The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex.
Time Frame	Baseline, 12 Month

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on drug use before sex at baseline and 12 month.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	370	392
Baseline	100 22.5%	108 23.7%
12 Month Follow-up	92 20.7%	84 18.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.138
	Comments
	Method	Regression, Logistic
	Comments

11. Secondary Outcome

Title	Mean Score of Condom Errors at Baseline and 6 Months
Description	The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at six months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors
Time Frame	Baseline, 6 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on condom errors at baseline and 6 month.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	124	121
Baseline	4.29 (2.14)	3.96 (2.13)
6 Month Follow-up	3.09 (2.20)	3.12 (2.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.173
	Comments
	Method	Regression, Linear
	Comments

12. Secondary Outcome

Title	Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months
Description	The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at six months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.
Time Frame	Baseline, 6 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on HIV Knowledge at baseline and 6 month.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	342	380
Baseline	85.78 (13.21)	86.69 (11.59)
6 Month Follow-up	88.96 (12.52)	89.25 (12.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.567
	Comments
	Method	Regression, Linear
	Comments

13. Secondary Outcome

Title	Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months
Description	At six months, the change in: Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) Social Norms (for example, partners, friends, or family members opinions about condom use) Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4
Time Frame	Baseline, 6 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 6 month.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	342	380
Baseline - Motivational Self-Rating	3.13 (0.80)	3.03 (0.85)
6 Month Follow-up - Motivational Self-Rating	3.12 (0.90)	3.04 (0.93)
Baseline - Social Norms	4.35 (0.54)	4.34 (0.53)
6 Month Follow-up - Social Norms	4.31 (0.66)	4.27 (0.72)
Baseline - Behavioral Skills	1.36 (0.39)	1.39 (0.38)
6 Month Follow-up - Behavioral Skills	1.30 (0.40)	1.37 (0.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for motivation items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.861
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for social norms items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.628
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for behavioral skills items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.151
	Comments
	Method	Regression, Linear
	Comments

14. Secondary Outcome

Title	Mean Score of Health Protective Communication Skills at Baseline and 6 Months
Description	The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at six months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).
Time Frame	Baseline, 6 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	221	256
Baseline - HPC Relationship Maintenance	1.36 (0.75)	1.35 (0.78)
6 Month Follow-up - HPC Relationship Maintenance	1.65 (0.91)	1.39 (0.83)
Baseline - HPC Condom Use	1.35 (0.85)	1.06 (0.78)
6 Month Follow-up - HPC Condom Use	1.25 (0.95)	1.10 (0.96)
Baseline - HPC HIV Testing	0.61 (0.68)	0.48 (0.70)
6 Month Follow-up - HPC HIV Testing	0.74 (0.88)	0.69 (0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Relationship Maintenance items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Condom Use items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.067
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for HIV Testing items
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.637
	Comments
	Method	Regression, Linear
	Comments

15. Secondary Outcome

Title	Mean Score of Condom Errors at Baseline and 12 Months
Description	The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at twelve months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.
Time Frame	Baseline, 12 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on their condom errors at baseline and 12 month follow-up.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	112	115
Baseline	4.31 (2.31)	4.02 (2.23)
12 Month Follow-up	3.30 (2.49)	3.16 (2.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.862
	Comments
	Method	Regression, Linear
	Comments

16. Secondary Outcome

Title	Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months
Description	The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at twelve months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.
Time Frame	Baseline, 12 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on their HIV Knowledge at baseline and 12 month follow-up.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	370	392
Baseline	85.02 (13.67)	86.76 (10.88)
12 Month Follow-up	88.46 (13.15)	89.94 (10.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Other
	Comments	Generalized Linear Mixed Model statistical test used
Statistical Test of Hypothesis	p-Value	0.762
	Comments
	Method	Regression, Linear
	Comments

17. Secondary Outcome

Title	Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months
Description	At twelve months, the change in: Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) Social Norms (for example, partners, friends, or family members opinions about condom use) Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4
Time Frame	Baseline, 12 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 12 month.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	370	392
Baseline - Motivational Self-Rating	3.13 (0.80)	3.02 (0.87)
12 Month Follow-up - Motivational Self-Rating	2.93 (0.94)	2.97 (0.99)
Baseline - Social Norms	4.32 (0.58)	4.34 (0.53)
12 Month Follow-up - Social Norms	4.24 (0.65)	4.23 (0.67)
Baseline - Behavioral Skills	1.35 (0.39)	1.39 (0.38)
12 Month Follow-up - Behavioral Skills	1.38 (0.47)	1.39 (0.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Motivation items
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.043
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Social Norm items
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.617
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Behavioral Skills items
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.570
	Comments
	Method	Regression, Linear
	Comments

18. Secondary Outcome

Title	Mean Score of Health Protective Communication Skills at Baseline and 12 Months
Description	The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at twelve months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).
Time Frame	Baseline, 12 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points Higher score = less HPC skills; range 1-4

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	245	284
Baseline - HPC Relationship Maintenance	1.32 (0.79)	1.31 (0.80)
12 Month Follow-up - HPC Relationship Maintenance	1.65 (0.88)	1.45 (0.87)
Baseline - HPC Condom Use	1.32 (0.83)	1.09 (0.85)
12 Month Follow-up - HPC Condom Use	1.12 (0.95)	0.96 (0.89)
Baseline - HPC HIV Testing	0.57 (0.68)	0.48 (0.65)
12 Month Follow-up - HPC HIV Testing	0.64 (0.73)	0.56 (0.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Relationship Maintenance items
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.036
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for Condom Use items
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.837
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments	Analysis for HIV Testing items
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.953
	Comments
	Method	Regression, Linear
	Comments

19. Secondary Outcome

Title	Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months
Description	The change in effect that HIV testing has on health beliefs (for example, "I cannot get HIV") and sexual behaviors at twelve months. Range 1-5; higher scores = more feelings of invulnerability
Time Frame	Baseline, 12 Months

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on HIV invulnerability at baseline and 12 month.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	370	392
Baseline	1.92 (0.75)	1.84 (0.74)
12 Month Follow-up	2.05 (0.78)	1.95 (0.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Keep It Up! Intervention, HIV Knowledge Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.719
	Comments
	Method	Regression, Linear
	Comments

20. Other Pre-specified Outcome

Title	Participant Rating of Intervention Acceptability and Tolerability
Description	Participant rating of how much they enjoyed the intervention and participant feedback and suggestions for improvement. Range 1-4; higher scores indicate greater acceptability.
Time Frame	Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)

Outcome Measure Data

Analysis Population Description

Enrolled participants who completed assessments on intervention acceptability immediately following completion of intervention.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	375	434
Mean (Standard Deviation) [units on a scale]	3.52 (0.41)	3.50 (0.41)

21. Other Pre-specified Outcome

Title	Participant Location
Description	Log of where participants completed the intervention sessions (participants can select multiple locations).
Time Frame	Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)

Outcome Measure Data

Analysis Population Description

Participants who reported information about the locations where they completed the intervention sessions.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	375	434
At Home, Not in Bedroom	183 41.1%	213 46.7%
At Home, In Bedroom	231 51.9%	303 66.4%
Coffee Shop	21 4.7%	29 6.4%
Community Center	16 3.6%	13 2.9%
Library	25 5.6%	36 7.9%
Friend's House	32 7.2%	36 7.9%
Other	69 15.5%	105 23%

22. Other Pre-specified Outcome

Title	Participant Experiences of Harm at 3 Month Follow-up
Description	Log of any negative experiences or harm experienced by participant at three months.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

Number of participants who reported negative health experiences at 3 Month Follow-up

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	348	409
Count of Participants [Participants]	0 0%	0 0%

23. Other Pre-specified Outcome

Title	Participant Experiences of Harm at 6 Month Follow-up
Description	Log of any negative experiences or harm experienced by participant at six months.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Number of participants who reported negative health experiences at 6 Month Follow-up

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	342	380
Count of Participants [Participants]	0 0%	0 0%

24. Other Pre-specified Outcome

Title	Participant Experiences of Harm at 12 Month Follow-up
Description	Log of any negative experiences or harm experienced by participant at twelve months.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Number of participants who reported negative health experiences at 12 Month Follow-up as a result of participating in the study

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	370	392
Count of Participants [Participants]	0 0%	0 0%

25. Other Pre-specified Outcome

Title	Occurrence of Sexually Transmitted Infections (STIs) at 3 Months
Description	The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 3 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

Participants who were positive for an STI at baseline, were sent a follow-up test kit at 3 Month Follow-up, and tested positive again.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	55	32
Urethral Chlamydia	1 0.2%	1 0.2%
Urethral Gonorrhea	0 0%	0 0%
Rectal Chlamydia	12 2.7%	11 2.4%
Rectal Gonorrhea	6 1.3%	4 0.9%
Any STI	9 2%	5 1.1%

26. Other Pre-specified Outcome

Title	Occurrence of Sexually Transmitted Infections (STIs) at 6 Months
Description	The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 6 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Participants who were positive for an STI at baseline, were sent a follow-up test kit at 6 Month Follow-up, and tested positive again.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	50	26
Urethral Chlamydia	0 0%	0 0%
Urethral Gonorrhea	0 0%	0 0%
Rectal Chlamydia	7 1.6%	5 1.1%
Rectal Gonorrhea	2 0.4%	0 0%
Any STI	9 2%	5 1.1%

27. Other Pre-specified Outcome

Title	Level of Privacy
Description	Log of the levels of privacy of the locations where participants completed intervention.
Time Frame	Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)

Outcome Measure Data

Analysis Population Description

Participants who reported information about the locations where they completed the intervention sessions.

Arm/Group Title	Keep It Up! Intervention	HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!	The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
Measure Participants	373	433
Not Private At All	14 3.1%	28 6.1%
Somewhat Private	74 16.6%	100 21.9%
Moderately Private	81 18.2%	106 23.2%
Completely Private	204 45.8%	199 43.6%

Adverse Events

Time Frame	Adverse event data collected for nearly 4 years (May 2013 - March 2017)
Adverse Event Reporting Description	The adverse events that are reported differ from the clinicaltrials.gov definitions. Serious Non-compliance: Failure to follow the regulations, requirements and/or determinations of the IRB that adversely affects the rights or welfare of subjects. UPIRSO: Any incident that meets ALL of the following conditions: unexpected related or possibly related to participation in the research suggests that the research places human subjects or others at a greater risk of harm
Arm/Group Title	Keep It Up! Intervention		HIV Knowledge Control
Arm/Group Description	The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Keep It Up!		The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). HIV Knowledge Control
All Cause Mortality
	Keep It Up! Intervention		HIV Knowledge Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/445 (0%)		0/456 (0%)
Serious Adverse Events
	Keep It Up! Intervention		HIV Knowledge Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/445 (2.5%)		13/456 (2.9%)
Social circumstances
Confidentiality Breach 3.27.14	10/445 (2.2%)	10	12/456 (2.6%)	12
Confidentiality Breach 9.11.15	1/445 (0.2%)	1	1/456 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Keep It Up! Intervention		HIV Knowledge Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/445 (0%)		0/456 (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.