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

Primary Purpose

HIV, Gonorrhea, Chlamydia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Keep It Up!
HIV Knowledge Control
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

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!

Sites / Locations

  • Emory University
  • Northwestern University
  • Hunter College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Keep It Up! Intervention

HIV Knowledge Control

Arm 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.

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).

Outcomes

Primary Outcome Measures

Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months
Change in self-report of condomless anal sex acts at three months.
Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months
Change in self-report of condomless anal sex acts at six months.
Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months
Change in self-report of condomless anal sex acts at twelve months.
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.

Secondary Outcome Measures

Mean Score of Condom Errors at Baseline and 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.
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 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.
Mean Score of Motivation and Behavioral Skills at Baseline and 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
Mean Score of Health Protective Communication Skills at Baseline and 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).
Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months
The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex.
Mean Score of Condom Errors at Baseline and 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
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 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.
Mean Score of Motivation and Behavioral Skills at Baseline and 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
Mean Score of Health Protective Communication Skills at Baseline and 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).
Mean Score of Condom Errors at Baseline and 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.
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 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.
Mean Score of Motivation and Behavioral Skills at Baseline and 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
Mean Score of Health Protective Communication Skills at Baseline and 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).
Mean Score of Feelings of HIV Invulnerability at Baseline and 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

Full Information

First Posted
April 17, 2013
Last Updated
August 11, 2022
Sponsor
Northwestern University
Collaborators
National Institute on Drug Abuse (NIDA), Emory University, Hunter College of City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT01836445
Brief Title
Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men
Acronym
KIU!
Official Title
Efficacy of Internet-based HIV Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute on Drug Abuse (NIDA), Emory University, Hunter College of City University of New York

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Gonorrhea, Chlamydia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
901 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Keep It Up! Intervention
Arm Type
Experimental
Arm 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.
Arm Title
HIV Knowledge Control
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Keep It Up!
Other Intervention Name(s)
KIU!, KIU! 2.0, Keep It Up! 2.0
Intervention Type
Behavioral
Intervention Name(s)
HIV Knowledge Control
Primary Outcome Measure Information:
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
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
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
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
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Other Pre-specified Outcome Measures:
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)
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)
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
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
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
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
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
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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!
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Mustanski, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Hunter College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Centers for Disease Control and Prevention (CDC). HIV Surveillance in Adolescents and Young Adults. 2010.
Results Reference
background
PubMed Identifier
18583954
Citation
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.
Results Reference
background
PubMed Identifier
21826193
Citation
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.
Results Reference
background
PubMed Identifier
20182787
Citation
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.
Results Reference
background
PubMed Identifier
29937115
Citation
Mustanski B, Parsons JT, Sullivan PS, Madkins K, Rosenberg E, Swann G. Biomedical and Behavioral Outcomes of Keep It Up!: An eHealth HIV Prevention Program RCT. Am J Prev Med. 2018 Aug;55(2):151-158. doi: 10.1016/j.amepre.2018.04.026. Epub 2018 Jun 28.
Results Reference
derived
PubMed Identifier
28062389
Citation
Mustanski B, Madkins K, Greene GJ, Parsons JT, Johnson BA, Sullivan P, Bass M, Abel R. Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0. JMIR Res Protoc. 2017 Jan 7;6(1):e1. doi: 10.2196/resprot.5740.
Results Reference
derived

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

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