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NCT03284541 · ClinicalTrials.gov registry record · Phase 2
Online HIV Prevention for Young Male Couples
A Phase 2 study of HIV and Gonorrhea, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT03284541 is a Phase 2 study of HIV and Gonorrhea that has completed, run by Northwestern University. The registered enrollment target is 400 participants, roughly in line with the 439-participant average among 303 other HIV trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT03284541, a Phase 2 study of HIV and Gonorrhea, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 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, they 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 investigators 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 approaches to
Interventions
- BEHAVIORAL 2GETHER
- BEHAVIORAL Existing Public Health Practice
Study Locations (1)
Illinois
- Northwestern University-Feinberg School of Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2022-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03284541
The ClinicalTrials.gov registry entry for NCT03284541 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 439-participant average among 303 other HIV trials with a reported enrollment target. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which 2GETHER is the first listed.
NCT03284541 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03284541 about?
NCT03284541 is a clinical study titled "Online HIV Prevention 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 NCT03284541?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2018-04-05. Estimated completion is 2022-04-01.
What conditions does trial NCT03284541 study?
This clinical trial studies the following conditions: HIV, Gonorrhea, Chlamydia.
What interventions are being tested in trial NCT03284541?
The interventions under investigation include: 2GETHER (BEHAVIORAL), Existing Public Health Practice (BEHAVIORAL).
Who is sponsoring clinical trial NCT03284541?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03284541 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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