# Efficacy of Couples-Based HIV Prevention in Vulnerable Young Men

> **NIH NIH R01** · NORTHWESTERN UNIVERSITY · 2020 · $443,046

## Abstract

Project Summary
Adolescent and young adult men who have sex with men (YMSM) are the only group in the U.S. in which rates
of new HIV infections are increasing, which reflects a large disparity relative to heterosexuals. Steady or main
partner relationships account for a substantial proportion of new HIV infections in YMSM. Among YMSM a
serious relationship status is perhaps the strongest predictor of condomless anal intercourse (CAI), and pre-
exposure prophylaxis (PrEP) may be discontinued in a relationship. Romantic relationships also provide myriad
benefits, including promotion of mental, behavioral, and physical health. Despite the critical importance of
romantic relationship factors for HIV prevention, the vast majority of studies and interventions focus on
individuals. We conducted formative research on coupled YMSM through an NIH R21 from which we
developed an innovative couples-based intervention that addresses the continuum of HIV prevention and care
for YMSM couples. The 2GETHER program integrates couples- and group-based modalities and is innovative
in its design to address HIV transmission risk in couples regardless of serostatus; couples learn to utilize
behavioral and biomedical approaches to prevent both HIV acquisition and transmission, with an overarching
emphasis on improving relationship functioning. 2GETHER further encourages uptake of couples-based HIV
testing for HIV-/unknown YMSM and medication adherence and engagement in care for HIV+ YMSM. We
established feasibility, acceptability and preliminary efficacy of 2GETHER in a pilot trial of coupled YMSM
(N=60 couples; 120 individuals), including significant decreases in HIV transmission risk behavior. Based on
our highly successful pilot, we propose to test the efficacy of 2GETHER in large-scale randomized controlled
trial (RCT). We will: (a) enroll racially diverse coupled YMSM; (b) randomize couples to either the 2GETHER
intervention or attention-matched positive affect skills program for couples; (c) measure intervention outcomes
through 12 months post-intervention. Analysis of study outcomes will utilize both individual- and dyadic-level
data. Primary HIV risk behavioral outcome: an individual-level dichotomous variable indicating presence of CAI
with a serodiscordant or unknown status partner. Exploratory analysis will calculate an innovative variable that
accounts for the relative risk of sexual behaviors with partners of different serostatus, accounting for
biomedical prevention. Primary biomedical outcome: Chlamydia/Gonnorhea incidence in
individuals. Secondary dyadic-level HIV risk outcomes: concordance/discordance in relationship sexual
agreement type and presence of agreement breaks. Secondary individual-level engagement in care outcomes:
HIV testing uptake (HIV- men) and medication adherence (HIV+ men). In the context of increasing fatigue for
HIV prevention, a healthy relationships program for coupled YMSM presents an opportunity to reinvigorate HIV
prevention. Fu...

## Key facts

- **NIH application ID:** 9989734
- **Project number:** 5R01AA024065-05
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Michael E Newcomb
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $443,046
- **Award type:** 5
- **Project period:** 2016-09-20 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9989734

## Citation

> US National Institutes of Health, RePORTER application 9989734, Efficacy of Couples-Based HIV Prevention in Vulnerable Young Men (5R01AA024065-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9989734. Licensed CC0.

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