ATN 157: WE PREVENT
ClinicalTrials.gov Number: NCT03551938
This project seeks to develop and refine a developmentally-appropriate relationship skills session as an addition to current HIV Counseling, Testing, and Referrals (CTR) and Couples HIV Testing and Counseling (CHTC) intervention for young gay, bisexual, and other men who have sex with men (YGBMSM). 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 YGBMSM and feedback from a technical expert group (TEG) to develop and refine the one or two session intervention. Phase II involved a one-arm pilot to further refine the intervention condition with YGBMSM and their partners. Phase III will involve a randomized controlled trial to examine the feasibility, acceptability, and efficacy of the We Prevent intervention (CTR and/or CHTC + a relationship skills component) to CTR alone, both delivered via telemedicine. For each phase of the proposal, participants will be recruited online by placing advertisements on social media sites.
In Phase I, we enrolled a total of 38 YGBMSM. For the first portion, a group of YGBMSM (n=30) were enrolled and completed a brief online survey which took approximately 15-20 minutes to complete. They were then invited to participate in an in-depth interview with a study staff member, which lasted 1-2 hours. A technical expert group (n=7) was identified and participated in virtual meetings to review and provide feedback on the intervention content. An additional group of YGBMSM (n=8) was recruited to completed cognitive interviews to further refine the intervention.
In Phase II, YGBMSM and their partners (6 dyads, n=12) enrolled in the We Prevent intervention to collect feasibility and acceptability data to further refine the intervention condition. Phase II participants completed Baseline and 1-month follow up assessments.
In Phase III, YGBMSM (n=320) will be randomly assigned to the We Prevent intervention condition (CTR and/or CHTC + a relationship skills component) or CTR alone, both delivered via telemedicine. Participants that are randomized to the intervention arm will have the option to participate alone or with their partner. Participants will complete Baseline, 3-month, 6-month, and 9-month follow up assessments.
The primary outcomes for Phase II and III include uptake of HIV prevention, defined as self-reported routine HIV and STI testing, increased PrEP knowledge and use, reductions in condomless sex, and relationship communication. We will also examine STI incidence as a secondary outcome, with biomarkers of STIs collected through self-samples that will be mailed to participants. Data on costs associated with the delivery of the intervention will be collected to allow a cost analysis and to inform the future scale up of the intervention.
The sample size for Phase I was 45 (38 YGBMSM and 7 technical experts). The sample size for Phase II was 12 individuals (6 dyads). The sample size for Phase III will be 320 individuals.
All index participants must be:
- Between the ages of 15 and 20 years
- Current U.S. resident
- Cisgender men (assigned male sex at birth and currently identifies as male) OR transgender men (assigned female sex at birth and identifies as male or transgender man)
- Have access to computer/personal device/smart phone with internet access
- Self-report being HIV negative or unknown serostatus
- More information about eligibility and exclusion criteria is available on ClinicalTrials.gov
The Technical Expert Group consisted of members who engage with diverse communities of TGBMSM, and have experience in the provision of HIV and LGBTQ clinical and social services. All participants will be recruited online by placing advertisements on social media sites.
Phase I data collection consisted of two separate parts. First, a group of 30 study participants completed a brief online survey in SurveyGizmo. After the completion of the brief online survey, participants completed an in-depth interview with a study staff member based at the University of Michigan. Second, an additional group of 8 study participants completed a cognitive interview with a study staff member who is based at the University of Michigan. Both the in-depth and cognitive interviews were conducted using VSee, which is a HIPAA-compliant video-conferencing program. Qualitative data were audio-recorded, with participants consent, and transcribed verbatim.
Phase II and III participants either completed or will complete all surveys using SurveyGizmo. They receive at-home STI testing kits at Baseline and one of the follow-up surveys. The HIV testing video-chat sessions (CTR, CTR + relationship skills, or CHTC + relationship skills) will all be conducted via Zoom, the HIPAA-compliant video-conferencing program.
- To develop and refine a developmentally-appropriate relationship skills session as an addition to the current CTR or CHTC intervention for 15-24-year-old YGBMSM
- To pilot test this relationship-skills-focused HIV prevention intervention for YGBMSM and their partners (only if they are randomized to the intervention arm and choose to participate with their partner) to increase the uptake of HIV prevention strategies, increase relationship communication skills, and reduce HIV transmission risk among 15-24-year-old YGBMSM.
Rob Stephenson, PhD, MSc, MA
Kristi Gamarel, PhD, EdM