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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Human Immunodeficiency Virus | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2022

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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.
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Metadata
Title
Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples
Authors
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
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06457-9

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