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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 34
Healthy Volunteers: t
View:

• 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

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Michael E Newcomb, Ph.D.
newcomb@northwestern.edu
312-503-0702
Backup
Kathryn Macapagal, Ph.D.
kathryn.macapagal@northwestern.edu
312-503-3605
Time Frame
Start Date: 2022-12-15
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 5000
Treatments
Experimental: Experimental Arm
all2GETHER is an HIV prevention and relationship education program designed for young MSM. all2GEHTER consists of 3 online didactic skills modules and 2 videoconference-based skills coaching sessions The 3 online modules focus on developmental skills related to sexual health and relationship functioning, including HIV prevention in couples, communication skills, coping skills, problem-solving and acceptance. Individualized couple sessions focus on implementation of skills specific to the needs of each couple.
No_intervention: Control Arm
Participants will receive no intervention, but have access to HIV prevention resources from the CDC website and national databases. We will also assess exposure to other interventions that may be naturally occurring in participants' local context, which can be used to describe the sample and as a covariate (as necessary).
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of South Carolina, Drexel University, University of Cincinnati
Leads: Northwestern University

This content was sourced from clinicaltrials.gov