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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05678556
Status
Recruiting
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Conditions

  • Chlamydia
  • Gonorrhea
  • Hiv

Eligibility Criteria

Sex
ALL
Age
16 Years - 34 Years
Healthy Volunteers
Accepted

Interventions

  • all2GETHER — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 15, 2022
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
5,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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).

Primary Outcome Measure

HIV infection [ Time Frame: 24-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Michael Newcomb, PhD
[email protected]
8477128808

Find similar trials in Chicago, IL

By condition
HIV
By specialty
Infectious disease
By research site
Northwestern University· Chicago, IL

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