Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples

Michael E Newcomb, Elissa L Sarno, Emily Bettin, Adam Conway, James Carey, Christopher Garcia, Ricky Hill, Kyle Jozsa, Gregory Swann, Elizabeth L Addington, Jody D Ciolino, Kathryn Macapagal, Judith T Moskowitz, Brian Mustanski, Sarah W Whitton, Michael E Newcomb, Elissa L Sarno, Emily Bettin, Adam Conway, James Carey, Christopher Garcia, Ricky Hill, Kyle Jozsa, Gregory Swann, Elizabeth L Addington, Jody D Ciolino, Kathryn Macapagal, Judith T Moskowitz, Brian Mustanski, Sarah W Whitton

Abstract

Background: Young men who have sex with men (YMSM) are disproportionately impacted by the HIV epidemic in the USA, and a large number of new infections among YMSM occur in the context of main or primary partnerships. At the same time, healthy romantic relationships promote health and wellbeing by improving social support and encouraging healthy behaviors. Thus, we created 2GETHER: a relationship education and HIV prevention program for young male couples. 2GETHER is delivered face-to-face in a university setting and is composed of two group sessions and two individualized skills coaching sessions. We observed strong support of the feasibility, acceptability, and preliminary efficacy of 2GETHER in a pilot trial.

Methods: We are conducting an attention-matched randomized controlled trial (RCT) to test the efficacy of 2GETHER relative to a control condition based on a well-validated positive affect enhancement program. Enrollment occurred between August 2017 and March 2021 in Chicago and surrounding areas, and we enrolled and randomized 128 dyads (N = 256 individuals). Follow-up is ongoing and we will examine primary and secondary behavioral outcomes at 12 months post-intervention, with interim follow-up at 3, 6, and 9 months post-intervention. The primary biomedical outcome is sexually transmitted infection incidence at a 12-month follow-up.

Discussion: 2GETHER is innovative in that it places an equal emphasis on relationship skill building and HIV prevention. Thus, the program has the potential to impact numerous health-related outcomes. Despite challenges related to the recruitment of couples and the COVID-19 pandemic, we were able to enroll a robust sample of young male couples with sufficient power to detect effects on study outcomes.

Trial registration: ClinicalTrials.gov NCT03186534 .

Conflict of interest statement

The authors declare no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flowchart. Measures of primary and secondary outcomes and assessment schedule are displayed in Table 1

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