Improving relationship education to reduce HIV rates among sexual and gender minorities
Official title: Effectiveness of Relationship Education for Reducing HIV Incidence in Men Who Have Sex With Men
Run by Northwestern University · NCT05678556 · Data updated 2026-11-12
This study is testing a new relationship education program to see if it can help reduce HIV rates among gay, bisexual, queer, and transgender individuals who are in relationships with cisgender men.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 34 Years |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | December 15, 2022 |
| Main results expected | August 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT05678556 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include HIV-negative cisgender men, transgender individuals, and non-binary people aged 16-34 who have had condomless anal sex with multiple partners.
✕Probably not a fit
Patients assigned female at birth who identify as women will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance an existing relationship education and HIV prevention program specifically for gay, bisexual, queer, and transgender individuals who partner with cisgender men. It will involve a randomized controlled trial with 5000 HIV-negative participants, half of whom will be partnered. Participants will complete online surveys, undergo testing for Chlamydia and Gonorrhea, and engage with an upgraded web app that provides relationship education and HIV prevention strategies. The study will follow participants for 24 months to assess the effectiveness of the intervention.
Why it matters
Potential benefit: If successful, this program could significantly reduce HIV incidence and improve relationship dynamics among sexual and gender minorities.
How similar studies have gone: Other studies have shown promise in using relationship education to improve health outcomes in similar populations, indicating a potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Northwestern University
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Michael E Newcomb, Ph.D — Northwestern University
- Study coordinator: Michael E Newcomb, Ph.D.
- Email: newcomb@northwestern.edu
- Phone: 312-503-0702
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.