About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
all2GETHER
Behavioralall2GETHER 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.
Treatment groups
Trial outcomes
Primary outcomes
HIV infection
Incidence of HIV confirmed via lab processed but self-administered collection
Secondary outcomes
Condomless Anal Sex
Incidence of Condomless Anal Sex
Pre-Exposure Prophylaxis Use
current use of HIV pre-exposure prophylaxis
Relationship Functioning
among partnered participants, we will assess change in relationship satisfaction and dyadic communication
Sexually transmitted infections
incidence of Chlamydia or Gonorrhea
Sponsors and contacts
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Northwestern University
Lead sponsor
University of Cincinnati
Collaborator
Medical University of South Carolina
Collaborator
Drexel University
Collaborator