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NCT03186534 · ClinicalTrials.gov registry record · Phase 2
Randomized Trial of an HIV Prevention and Relationship Education Program for Young Male Couples
A Phase 2 study of HIV and Gonorrhea, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
- 1
- Study location
NCT03186534: Completed Phase 2 study of HIV and Gonorrhea, sponsored by Northwestern University.
NCT03186534 is a Phase 2 study of HIV and Gonorrhea that has completed, run by Northwestern University. The registered enrollment target is 256 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03186534, a Phase 2 study of HIV and Gonorrhea, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
- 1
- Study location
Study Summary
Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise. There has been a relative dearth of research dedicated to understanding these health disparities between gay/bisexual and heterosexual youth, and even less has focused on identifying factors that might promote resilience against negative health outcomes. Understanding both risk factors and processes of resilience is critical in developing efficacious interventions to improve health in this population. Through a grant from the National Institutes of Health, the investigators completed formative research with young male couples. Qualitative interviews identified preferences for couples-based intervention format and content. While coupled YMSM expressed some interest in HIV prevention, participants were most interested in building relationship skills. Coupled YMSM preferred group-based interventions in order to meet and learn from other couples but had concerns about discussing personal topics in groups. Quantitative analyses found that the rate of condomless sex in couples increased from adolescence to young adulthood. Further, the influence of older partners, partner violence, and drinking before sex were strongest in emerging adulthood. Informed by these, the research team developed 2GETHER, which aims to reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a four session program. The first two sessions are group sessions aimed at skills building, and the second two sessions are individualized couple sessions aimed at skills implementation. Modules address communication skills, coping with stress (both general and sexual minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in couples regardless of HIV status; couples learn to use behavioral and biomedical appro
Primary Outcome
change in number of condomless anal sex acts with serodiscordant or unknown status partners
Conditions Studied
Interventions
- BEHAVIORAL 2GETHER
- BEHAVIORAL Positive Affect Enhancement
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2017-08-21 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 2 |
What the finished NCT03186534 record still lists
NCT03186534 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (42% lower).
The record links to 4 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which 2GETHER is the first listed.
NCT03186534 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03186534 about?
NCT03186534 is a clinical study titled "Randomized Trial of an HIV Prevention and Relationship Education Program for Young Male Couples". Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise. There has been a relative dearth of research dedicated to understanding these health disparities between gay/bisexual and heterosexual youth, and even less ha...
What is the current status of trial NCT03186534?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 256 participants. The study started on 2017-08-21. Estimated completion is 2022-06-30.
What conditions does trial NCT03186534 study?
This clinical trial studies the following conditions: HIV, Gonorrhea, Chlamydia, Relation, Interpersonal.
What interventions are being tested in trial NCT03186534?
The interventions under investigation include: 2GETHER (BEHAVIORAL), Positive Affect Enhancement (BEHAVIORAL).
Who is sponsoring clinical trial NCT03186534?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03186534 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03186534's enrollment target sits among peer trials
256 81st of 303 higher than 219 of 303 other HIV trials
participants (enrollment target), bucketed by value
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