NCT03186534: 2GETHER

Randomized Trial of an HIV Prevention and Relationship Education Program for Young Male Couples

Completed Phase 2 Last updated 8 February 2023

What this trial tests

Phase 2 trial testing 2GETHER in Hiv in 256 participants. Completed in 30 June 2022.

Timeline

21 August 2017

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	Northwestern University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	256
Start date	21 August 2017
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across United States

Drugs / interventions tested

• 2GETHER
• Positive Affect Enhancement

Conditions studied

• Hiv — all drugs for Hiv →
• Chlamydia — all drugs for Chlamydia →
• Gonorrhea — all drugs for Gonorrhea →
• Relation, Interpersonal — all drugs for Relation, Interpersonal →

Sponsor

Northwestern University

Who can join

18 and older, male only, with Hiv or Chlamydia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 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. The investigators will conduct an RCT with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER intervention or an attention-matched couples-based positive affect promotion program.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples.
   Newcomb ME, Sarno EL, Bettin E, Conway A, et al · · 2022 · cited 7× · PMID 35725624 · DOI 10.1186/s13063-022-06457-9
2. Substance Use and Relationship Functioning Among Young Male Couples.
   Smith MS, Newcomb ME. · · 2023 · cited 5× · PMID 37351709 · DOI 10.1007/s10508-023-02627-1
3. Randomized controlled trial of a relationship education and HIV prevention program for young male couples: Biomedical and behavioral outcomes.
   Newcomb ME, Swann G, Addington EL, Macapagal K, et al · · 2025 · cited 3× · PMID 39992776 · DOI 10.1037/hea0001448
4. Results of a positive affect intervention for male couples: Change over time and effects on mental health.
   Smith MS, Greenawalt I, Moskowitz JT, Addington EL, et al · · 2025 · PMID 40587318 · DOI 10.1037/ccp0000963