Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities.
Patrick S Sullivan, Laura Salazar, Susan Buchbinder...
https://pubmed.ncbi.nlm.nih.gov/19417579Actively Recruiting
Phase Not Applicable
Age: 16Years - 34Years
All Genders
Healthy Volunteers
ID05678556
Effectiveness of Relationship Education for Reducing HIV Incidence in Men Who Have Sex With Men
Led by Northwestern University · Updated on 2026-05-08
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
U
University of Cincinnati
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an updated relationship education and HIV prevention program designed specifically for gay, bisexual, queer, transgender, and non-binary individuals who partner with cisgender men. This program aims to test its effectiveness in reducing HIV incidence among these groups by conducting a randomized controlled trial involving 5,000 HIV-negative participants, including couples and single individuals. The study will explore the impact of this program on HIV prevention and relationship functioning over a 24-month period. Participants are randomly assigned to one of two groups: the all2GETHER intervention or a control group receiving no intervention. The all2GETHER program includes a web app offering interactive multimedia modules on relationship skills and HIV prevention, and for couples, additional videoconference coaching sessions focusing on communication, conflict resolution, and sexual health. The control group receives access to standard HIV prevention resources but no formal intervention. Participants will complete online surveys and self-collect specimens for HIV and STI testing at multiple points during the study, including baseline, 12 months, and 24 months. Follow-up assessments will occur at 6, 12, 18, and 24 months, with questionnaires and biological testing to measure HIV infection rates and other health outcomes. The entire study is conducted remotely, allowing participants to remain at home while being monitored and supported for up to two years.
CONDITIONS
Brief Title
Effectiveness of Relationship Education for Reducing HIV Incidence Among Men Who Have Sex With Men
Who Can Participate
Age: 16Years - 34Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Identify as cisgender men, transgender women, men, or non-binary individuals
- Aged between 16 and 34 years
- Have had condomless anal sex with 2 or more cisgender male partners of unknown or different HIV status in the last 6 months
- Confirmed HIV-negative by lab test
- Able to read and speak English at an 8th grade level or better
- Have internet access
- Agree to audio recording of intervention sessions
- Provide address to receive HIV/STI testing supplies
- For couples, both partners may enroll if they meet the above criteria, with some exceptions for partners aged 35+ or HIV-positive who may participate in a limited way
You will not qualify if you...
- Participants assigned female at birth who identify as women are not eligible
AI-Screening
AI-Powered Screening
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1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Online screening via an eligibility questionnaire
Baseline Assessment and Enrollment
Duration - Approximately 1 week
Eligible participants complete an online informed consent and baseline self-report questionnaire, followed by self-collection of HIV/STI specimens using mailed testing kits.
1 baseline visit (online consent and survey) and specimen collection at home
Intervention
Duration - Varied; intervention delivery over several weeks post-baseline
Participants are randomized to either the all2GETHER intervention or follow-up only control. The all2GETHER intervention includes access to an online relationship education and HIV prevention web app. Participants enrolled as couples also receive two videoconference dyadic skills coaching sessions focused on communication and sexual health.
2 videoconference coaching sessions for couples; web app access is self-paced
Follow-up Assessments
Duration - 24 months post-intervention
Participants complete follow-up surveys and self-collection of HIV/STI specimens at multiple timepoints to monitor HIV incidence and other outcomes.
Assessments at 6, 12, 18, and 24 months; 12- and 24-month visits include specimen collection
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
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Research Team
M
Michael E Newcomb, Ph.D.
K
Kathryn Macapagal, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
"Is this normal? Is this not normal? There's no set example": Sexual Health Intervention Preferences of LGBT Youth in Romantic Relationships.
George J Greene, Kimberly A Fisher, Laura Kuper...
https://pubmed.ncbi.nlm.nih.gov/25678895Intimacy, monogamy, and condom problems drive unprotected sex among young men in serious relationships with other men: a mixed methods dyadic study.
George J Greene, Rebecca Andrews, Laura Kuper...
https://pubmed.ncbi.nlm.nih.gov/24202113Systematic review of couple-based HIV intervention and prevention studies: advantages, gaps, and future directions.
Tina Jiwatram-Negrón, Nabila El-Bassel
https://pubmed.ncbi.nlm.nih.gov/24980246Relationship education research: current status and future directions.
Howard J Markman, Galena K Rhoades
https://pubmed.ncbi.nlm.nih.gov/22283386Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention.
Michael E Newcomb, Kathryn R Macapagal, Brian A Feinstein...
https://pubmed.ncbi.nlm.nih.gov/28083833Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples.
Michael E Newcomb, Elissa L Sarno, Emily Bettin...
https://pubmed.ncbi.nlm.nih.gov/35725624Romantic relationships and sexual minority health: A review and description of the Dyadic Health Model.
Michael E Newcomb
https://pubmed.ncbi.nlm.nih.gov/33002795