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Completed Phase 2 Interventional Accepts healthy volunteers

Online HIV Prevention for Young Male Couples

ClinicalTrials.gov ID: NCT03284541

Public ClinicalTrials.gov record NCT03284541. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis on the health of the couple. The investigators completed a pilot trial of 2GETHER with funding from Northwestern University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility, acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized pre-/post-test design because the goal was to evaluate feasibility, acceptability and preliminary effects in a large number of diverse couples to inform a future efficacy RCT. Post-test occurred 2 weeks post-intervention, or \~2 months post-baseline. The pilot trial recruited a diverse sample of couples in less than one year and each program module receive high ratings of acceptability during post-sessions evaluation and an exit interview. At the 2-week post-test, the investigators observed significant decreases in HIV risk behavior, improvements in motivation to reduce HIV risk, and improvements in relationship investment. The current study will conduct a randomized controlled trial (RCT) to test the efficacy of 2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that aims to reduce HIV transmission risk by optimizing relationship functioning. This RCT will be implemented online; both the experimental and control condition will be administered via video-conferencing technology to couples across the United States. The investigators will conduct this RCT with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER intervention or existing public health practice (PHP). PHP differs depending on the HIV status of individuals in the dyad. Couples in which both members are HIV-negative will receive the single-session Couples-Based HIV Counseling and Testing (CHCT) protocol. Couples in which both members are HIV-positive will receive the single session Life-Steps medication adherence protocol. Couples with discordant HIV statuses will receive both interventions jointly.

Study identification

NCT ID
NCT03284541
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Northwestern University
Other
Enrollment
400 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 4, 2018
Primary completion
Mar 31, 2022
Completion
Mar 31, 2022
Last update posted
Jul 27, 2023

2018 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Northwestern University-Feinberg School of Medicine Chicago Illinois 60611

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03284541, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 27, 2023 · Synced Sep 8, 2026

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