N/A
N=318
We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT03551938 ↗Enrolled (actual)
318
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Sexual Risk Behavior — 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Relationship skills session for YMSM partnered-individuals and couples (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sexual Risk Behavior |
0; 1 | — |
| PRIMARY Sexual Risk Behavior |
0; 1 | — |
| PRIMARY Sexual Risk Behavior |
0; 1 | — |
| SECONDARY HIV Communication |
4.8; 5.0 | — |
| SECONDARY HIV Communication |
4.8; 5.0 | — |
| SECONDARY HIV Communication |
4.8; 5.0 | — |
| SECONDARY PrEP Use |
14; 10 | — |
| SECONDARY PrEP Use |
14; 10 | — |
| SECONDARY PrEP Use |
14; 10 | — |
| SECONDARY HIV Testing |
43; 42 | — |
| SECONDARY HIV Testing |
43; 42 | — |
| SECONDARY HIV Testing |
43; 42 | — |
| SECONDARY STI Testing |
28; 35 | — |
| SECONDARY STI Testing |
28; 35 | — |
| SECONDARY STI Testing |
28; 35 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03551938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.