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Effectiveness of Relationship Education for Reducing HIV Incidence Among Men Who Have Sex With Men

Northwestern University · with University of Cincinnati, Medical University of South Carolina · NCT05678556

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16–34 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
5000
US sites recruiting
1
Study start
December 15, 2022
Record last updated
May 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: all2GETHER

Conditions: Hiv; Chlamydia; Gonorrhea

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Northwestern University

    Chicago, IL 60611

    Site contact: Michael Newcomb, PhD · 8477128808 · newcomb@northwestern.edu

Study contacts (from the official record)

  • Michael E Newcomb, Ph.D. · 312-503-0702 · newcomb@northwestern.edu
  • Kathryn Macapagal, Ph.D. · 312-503-3605 · kathryn.macapagal@northwestern.edu
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Effectiveness of Relationship Education for Reducing HIV Incidence… (NCT05678556) | Bored Studies