Clinical trial NCT03551938: We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
Official title: ATN 157 -We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV, telehealth, HIV testing, YMSM, couples
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-06-11
Enrollment: 318
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: We Prevent seeks to develop and pilot test a developmentally-appropriate relationship skills session as an addition to the current Couples HIV Testing and Counseling (CHTC) intervention for young gay, bisexual and other men who have sex with men (YMSM). This project involves three phases to develop and pilot test the intervention. Phase I collected brief quantitative survey data, in-depth qualitative interview data, and cognitive interview data from YMSM and feedback from a technical expert group (TEG) to develop and refine the two-session intervention. Phase II involved conducting a one-arm pilot of the intervention condition to further refine the intervention content with a sample of 12 YMSM (6 dyads). Phase III involves conducting a randomized controlled trial (RCT) comparing the relationship-focused intervention to a control condition, which is HIV Testing, Counseling, and Referrals (CTR) alone with a sample of 320 YMSM.

Detailed description: Young (15-24 years old) gay, bisexual and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the US, despite stable or declining rates of infection among other groups. HIV prevention and research efforts in the US have continued to target MSM as individuals, largely focusing on messages that encourage the uptake of prevention efforts and reducing sexual risk. Recently, there has been growing interest in structural interventions to reduce HIV risk, tackling social, economic and cultural factors that place MSM in contexts of risk. However, despite socio-ecological theory postulating the importance of individual, dyadic and social influences on HIV risk, there has been a dearth of intervention efforts focused at the dyadic level.

We Prevent seeks to intervene on relationship communication skills as a pathway to HIV prevention during the critical period of adolescence. The proposed activities will develop and test a relationship skills focused HIV prevention intervention for young YMSM aged 15-24 as an addition to the current HIV Counseling, Testing, and Referrals (CTR) and Couples HIV Testing and Counseling (CHTC). At home STI test kits will also be sent in Phases II and III at baseline and one follow up.

Phase I of the project included collection of data from two groups of participants: 1) 30 YMSM in in-depth interviews and 8 YMSM in cognitive interviews and 2) 7 Technical Experts (TEG), for a total sample of 45 research participants.

Phase II consisted of a one-arm pilot test of the intervention condition with 6 YMSM dyads (total 12 participants). Participants completed a Baseline and 1-month follow-up assessment.

Phase III involves a pilot two-arm prospective RCT in which 320 YMSM will complete a Baseline assessment and then complete assessments every 3 months for 9 months.

Recruitment of all participants is in all 50 states and will be conducted through popular social media sites (e.g. Facebook). All interviews will be conducted through the HIPAA video-conferencing platforms, VSee and Zoom.

Specific Aims:

Phases I and II: To develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention for 15-19 year old YMSM and their partners.

Phase III: To conduct a randomized controlled trial (RCT) comparing the efficacy of the adapted intervention for 15-24 year old YMSM versus a control condition, which is CTR or CHTC alone.

Eligibility criteria: Inclusion Criteria:

* Ages 15 to 24 years (inclusive) at time of screening
* Current U.S. resident
* Sufficient age for sexual consent in the current state of residence (assessed at both the individual and dyadic level)
* Self-identify that they are in an emotional and sexual relationship with another male
* Cisgender men (assigned male sex at birth and currently identifies as male) OR transgender men (assigned female at birth and identifies as male or transgender man
* Self-reports that they engaged in any kind of sexual activity (oral, vaginal, anal) in their lifetime
* Has access to computer/personal device/smart phone with internet access
* Self-report being HIV negative or unknown serostatus
* Speak and read English

Exclusion Criteria:

* Younger than age for consent without parental permission in the current state of residence
* Assigned female sex at birth and currently identifies as something other than male or transgender man
* Assigned male sex at birth but identifies as gender other than male or transgender man
* Aged 14 years or younger or 25 or older at the time of screening
* HIV-positive
* Not currently in an emotional and/or sexual relationship with another male
* Does not speak or read English
* Reports intimate partner violence in the past 6 months

Primary outcomes:
measure: Sexual Risk Behavior
timeFrame: The number of participants who report sexual risk behavior at 3 months.
measure: Sexual Risk Behavior
timeFrame: The number of participants who report sexual risk behavior at 6 months.
measure: Sexual Risk Behavior
timeFrame: The number of participants who report sexual risk behavior at 9 months.
Secondary outcomes:
measure: HIV Communication
timeFrame: Mean at 3 months
measure: HIV Communication
timeFrame: Mean at 6 months
measure: HIV Communication
timeFrame: Mean at 9 months
measure: PrEP Use
timeFrame: The number of participants at 3 months
measure: PrEP Use
timeFrame: The number of participants at 6 months
measure: PrEP Use
timeFrame: The number of participants at 9 months
measure: HIV Testing
timeFrame: The number of participants at 3-months
measure: HIV Testing
timeFrame: The number of participants at 6 months
measure: HIV Testing
timeFrame: The number of participants at 9 months
measure: STI Testing
timeFrame: The number of participants at 3 months
measure: STI Testing
timeFrame: The number of participants at 6 months
measure: STI Testing
timeFrame: The number of participants at 9 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Center for Sexuality and Health Disparities
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rob Stephenson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Kristi Gamarel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gamarel KE, Darbes LA, Hightow-Weidman L, Sullivan P, Stephenson R. The Development and Testing of a Relationship Skills Intervention to Improve HIV Prevention Uptake Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Their Primary Partners (We Prevent): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 2;8(1):e10370. doi: 10.2196/10370.