Clinical trial NCT01836445: Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men
Official title: Efficacy of Internet-based HIV Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Gonorrhea
Chlamydia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Emory University
name: Hunter College of City University of New York
First posted: 2013-04-19
Enrollment: 901
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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!

Primary outcomes:
measure: Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months
timeFrame: Baseline, 3 Months
measure: Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months
timeFrame: Baseline, 6 Months
measure: Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months
timeFrame: Baseline, 12 Months
measure: Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline
timeFrame: Baseline
measure: Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Mean Score of Condom Errors at Baseline and 3 Months
timeFrame: Baseline, 3 Months
measure: Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months
timeFrame: Baseline, 3 Months
measure: Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months
timeFrame: Baseline, 3 Months
measure: Mean Score of Health Protective Communication Skills at Baseline and 3 Months
timeFrame: Baseline, 3 Months
measure: Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months
timeFrame: Baseline, 12 Month
measure: Mean Score of Condom Errors at Baseline and 6 Months
timeFrame: Baseline, 6 Months
measure: Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months
timeFrame: Baseline, 6 Months
measure: Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months
timeFrame: Baseline, 6 Months
measure: Mean Score of Health Protective Communication Skills at Baseline and 6 Months
timeFrame: Baseline, 6 Months
measure: Mean Score of Condom Errors at Baseline and 12 Months
timeFrame: Baseline, 12 Months
measure: Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months
timeFrame: Baseline, 12 Months
measure: Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months
timeFrame: Baseline, 12 Months
measure: Mean Score of Health Protective Communication Skills at Baseline and 12 Months
timeFrame: Baseline, 12 Months
measure: Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months
timeFrame: Baseline, 12 Months
Other outcomes:
measure: Participant Rating of Intervention Acceptability and Tolerability
timeFrame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)
measure: Participant Location
timeFrame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)
measure: Participant Experiences of Harm at 3 Month Follow-up
timeFrame: 3 Months
measure: Participant Experiences of Harm at 6 Month Follow-up
timeFrame: 6 Months
measure: Participant Experiences of Harm at 12 Month Follow-up
timeFrame: 12 Months
measure: Occurrence of Sexually Transmitted Infections (STIs) at 3 Months
timeFrame: 3 Months
measure: Occurrence of Sexually Transmitted Infections (STIs) at 6 Months
timeFrame: 6 Months
measure: Level of Privacy
timeFrame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: Hunter College
state: New York
Study officials:
affiliation: Northwestern University
name: Brian Mustanski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Centers for Disease Control and Prevention (CDC). HIV Surveillance in Adolescents and Young Adults. 2010.
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.
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.
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.
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.
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.