Recruiting

all2GETHER Program

Sponsor:

Northwestern University

Code:

NCT05678556

Conditions

Hiv

Chlamydia

Gonorrhea

Eligibility Criteria

Sex: All

Age: 16 - 34

Healthy Volunteers: Accepted

Interventions

all2GETHER

Study Details

Brief 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

Study ID

NCT05678556

Start date

Dec 15, 2022

Status verified date

May, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 34

Healthy Volunteers: Accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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).

Interventions

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.

Primary outcome measure

  • HIV infection [ Time Frame: 24-months ]

Central Contacts and Locations

Central contacts

Michael E Newcomb, Ph.D.

312-503-0702newcomb@northwestern.edu

Kathryn Macapagal, Ph.D.

312-503-3605kathryn.macapagal@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Michael Newcomb, PhD

8477128808newcomb@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-08.