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

Summary

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

• Hiv
• Chlamydia
• Gonorrhea

Interventions

BEHAVIORAL

all2GETHER

all2GETHER is an HIV prevention and relationship education program designed for young MSM and other individuals who have sex, date, and are in relationships with MSM. all2GEHTER consists of 3 online didactic skills modules that include videos, activities, and other self-paced education components and 2 videoconference-based skills coaching sessions The 3 online modules focus on developmental skills related to sexual health and relationship functioning, including HIV and STI prevention in couples, effective communication skills, coping skills for LGBTQ and relationship stress, problem-solving and acceptance. Individualized couple sessions led by facilitators focus on implementation of skills specific to the needs of each couple.

Sponsors & Collaborators

• University of Cincinnati

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Drexel University

  collaborator OTHER

• Northwestern University

  lead OTHER

Principal Investigators

• Michael E Newcomb, Ph.D · Northwestern University

• Kathryn Macapagal, Ph.D · Northwestern University

• Elissa Sarno, Ph.D · Northwestern University

• Brian Mustanski, Ph.D · Northwestern University

• Dennis Li, Ph.D · Northwestern University

• Jody Ciolino, Ph.D · Northwestern University

• Jim Carey, MPH · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

34 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-15

Primary Completion

2028-08-31

Completion

2028-08-31

Countries

• United States

Study Locations