We Prevent: a relationships skills intervention to improve HIV prevention uptake among young gay, bisexual and other men who have sex with men and their primary partners.
This project seeks to develop and refine 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 (YGBMSM). This project involves three phases to develop and pilot test the We Prevent intervention. Phase I will collect brief quantitative survey data, in-depth qualitative interview data, and cognitive interview data from YGBMSM and feedback from a technical experts group (TEG) to develop and refine the two session intervention that comprise the intervention. Phase II involves a one-arm pilot to further refine the intervention condition with YGBMSM and their partners. Phase III involves a randomized controlled trial to examine the feasibility, acceptability and efficacy of the We Prevent intervention compared to CHTC 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 will enroll a total of 50 YGBMSM. For this first portion, a group of YGBMSM (n = 40) will be enrolled to complete a brief online survey which will take approximately 15-20 minutes to complete. Participants will then be invited to participate in an in-depth interview with a study staff member which will take approximately 1-2 hours to complete. A technical expert group (TEG) will be identified to participate in virtual meetings to review and provide feedback on the intervention content. An additional group of YGBMSM (n = 10) will recruited to complete cognitive interviews which will last approximately 1 hour to further refine the intervention.
In Phase II, YGBMSM and their partners (30 dyads) will be enrolled in the We Prevent intervention to collect feasibility and acceptability data and further refine the intervention condition. Phase II participants will complete Baseline, 3- and 6-month assessments.
In Phase III, YGBMSM and their partners (160 dyads) will be randomly assigned to the We Prevent intervention condition or CHTC alone, both delivered via telemedicine. Participants will complete Baseline, 3-month, 6-month, and 9-month assessments.
The primary outcomes of Phase II and III include uptake of HIV prevention, defined as self-reported routine HIV and STI testing, increased PrEP knowledge and use, and reductions in condomless sex. We will also examine STI incidence as a secondary outcome, with biomarkers of STIs collected through self-samples that will mailed in by participants. Data on costs associated with the delivery of the intervention will collected, to allow a cost analysis to inform the future scale up of the intervention.
The sample size for Phase 1 is 50 YGBMSM. We plan to identify approximately 10 technical expert group members (TEG) to provide feedback on the intervention content. The sample size for Phase II is 60 individuals and Phase III is 320 individuals.
All index participants must be:
- Between the ages of 15 and 20 years
- Identify that they are in an emotional and/or sexual relationship with another male (assessed through multiple questions)
- Born male and identify as male
- Report that they engaged in condomless anal sex (CAS) with a man in the past 6 months
- Have access to computer with internet access within their home
- Self-report being HIV negative or unknown serostatus
- Speak or read English. Partners must meet the same requirement with the exception of the age criteria.
A Technical Expert Group will be formed and consist of members who engage with diverse communities of YGBMSM, 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 will consist of two separate parts. First, a group of 40 study participants will complete a brief online survey using Qualtrics. After the completion of the brief online survey, participants will complete an in-depth qualitative interview with a study staff member who is based at the University of Michigan. Second, an additional group of 10 study participants will complete a cognitive interview with a study staff member who is based at the University of Michigan. Both the in-depth qualitative interviews and cognitive interviews will be conducted using VSee, which is a HIPAA-secure video-conferencing program. Qualitative data will be audio-recorded, with participant consent, to allow for verbatim transcription of the interview and checked for accuracy and completion. Phase II and III participants will complete self-administered surveys using Qualtrics. Phase II and III participants will also mail in home STI collection kits at each of the follow-up assessments.
- To develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention for 15-20-year-old YGBMSM.
- To pilot test this relationship skills-focused HIV prevention intervention for YGBMSM and their partners to increase the uptake of HIV prevention strategies and reduce HIV transmission risk among 15-20-year-old YGBMSM.