Effectiveness of Relationship Education for Reducing HIV Incidence Among Men Who Have Sex With Men
Sponsored by Northwestern University
About this study
The purpose of this study is to upgrade an existing relationship education and HIV prevention program. This program is designed for gay, bisexual, queer, and transgender and non-binary people who partner with cisgender men. This means the program is designed for gay, bisexual and queer men, including both cisgender and transgender men. It is also designed for transgender and non-binary people who partner with cisgender men, including both transfeminine and transmasculine people. The investigators aim to test the effectiveness of this updated program among couples and single people. Participants will complete online surveys and get tested for Chlamydia and Gonorrhea. Participants will be tested for urethral and rectal Chlamydia and Gonorrhea. Participants will also complete at-home point-of-care HIV testing, with confirmatory testing for preliminary positive results. They will also participate in our program on relationship education and HIV prevention. Study staff will follow up with participants for up to 2 years. All participants will be randomized into one of two different conditions: the all2GETHER program or no program. "Randomized" means that it is completely up to chance which condition participants will be put into. Participants have a 50% chance of being assigned to either condition, similar to a coin toss. Participants should expect that they will be in this research study for 2 years. Participation in this study will be done remotely - participants will never need to come into a research lab.
The investigators will conduct a randomized controlled trial (RCT) with 5000 HIV-negative individuals, anticipating half of the individuals will have a serious partner, and half of those partnered individuals will enroll with their partner. After completing the baseline assessment, participants will be randomized to either the all2GETHER intervention package or follow-up only control, and they will be followed 24 months post-intervention. Only individuals participating with their partner will receive dyadic skills coaching sessions, while single and individual partnered MSM will receive the upgraded all2GETHER web app program only. all2GETHER web app delivers all core intervention content and uses diverse media (e.g., videos, interactive activities, quizzes) to deliver relationship educati…
Where this study is enrolling
- I'm interested
Northwestern University
Chicago, Illinois
Who can participate
Inclusion criteria
- ✓Cisgender men, transgender women and men, non-binary individuals
- ✓Had condomless anal sex with 2 or more serodiscordant/unknown-status cisgender male partners in the last 6 months
- ✓Aged 16-34 years
- ✓Lab-test confirmed HIV-negative
- ✓Read and speak English at 8th grade level or better
- ✓Internet access
- ✓Agree to audio recording of intervention sessions
- ✓Provides address to receive HIV/STI test supplies
- ✓For dyads, both partners may enroll if they meet the above criteria- partners who are aged 35+ and/or HIV-positive may enroll in a more limited capacity
Exclusion criteria
- ✕Participants assigned female at birth who identify as women are not eligible
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.