Actively Recruiting

Phase Not Applicable
Age: 16Years - 34Years
All Genders
Healthy Volunteers
NCT05678556

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

Led by Northwestern University · Updated on 2026-05-08

5000

Participants Needed

1

Research Sites

298 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

U

University of Cincinnati

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 34Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 aged 35+ and/or HIV-positive may enroll in a limited capacity
Not Eligible

You will not qualify if you...

  • Participants assigned female at birth who identify as women are not eligible

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

Loading map...

Research Team

M

Michael E Newcomb, Ph.D.

CONTACT

K

Kathryn Macapagal, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here