NCT05678556Recruiting
Effectiveness of Relationship Education for Reducing HIV Incidence Among Men Who Have Sex With Men
Effectiveness of Relationship Education for Reducing HIV Incidence in Men Who Have Sex With Men
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5000 (estimated)
- First submitted
- 12 Dec 2022
- Start date
- 15 Dec 2022
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Northwestern University
- Diseases
- HIV
- NCT number
- NCT05678556
What you commit to
- Study type: Interventional
- Planned participants: 5000
- From 15 Dec 2022 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- -Participants assigned female at birth who identify as women are not eligible
Who the study is looking for
- 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
Age in the registry: 16 years to 34 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.