Abstract
BACKGROUND: Young gay, bisexual, and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the United States. Substantial evidence indicates that up to two-thirds of new HIV infections occur in the context of a main partnership. Couples HIV testing and counseling (CHTC) has been shown to be a promising and effective strategy for increasing HIV prevention uptake among male couples; however, YMSM who are new to relationships may not have yet developed the efficacy, negotiation, and communication skills to navigate HIV testing in their relationship and communicate around developing a prevention plan. OBJECTIVE: This study aims to develop and test a relationship skills-focused HIV prevention intervention for YMSM and their partners. The intervention consists of two telehealth-delivered sessions: the first focuses on relationship skills and the second consists of CHTC and prevention planning. Both sessions are attended by both members of the dyad. METHODS: This protocol describes the development of the proposed intervention (We Prevent) and pilot test to examine its feasibility and preliminary efficacy. The intervention will include two motivational interviewing-based sessions: session one is a relationship skills-building session, focused on techniques to explore and build communication skills in a relationship, to help YMSM develop and enhance necessary skills for their current and future relationships; the second session is a CHTC session with YMSM and their partners, to help them develop an HIV prevention plan. Through qualitative data collection and a one-arm pilot with YMSM, we will develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention. We will then conduct a pilot randomized controlled trial (RCT), comparing the acceptability, feasibility, and preliminary efficacy of the adapted two-session telehealth intervention for YMSM versus a control group receiving one session only-a CHTC session delivered via telehealth. RESULTS: The We Prevent intervention is designed to increase uptake of HIV prevention, shown through self-reported reductions in condomless sex and increases in knowledge and uptake of pre-exposure prophylaxis. In addition, the intervention is designed to increase HIV and sexually transmitted infection (STI) testing. STI incidence is examined as a secondary outcome. A cost-input analysis will examine the costs associated with intervention delivery to inform future scale-up of the intervention. CONCLUSIONS: Drawing on theory and existing CHTC protocols delivered with video-based counseling, this proposed intervention affords the opportunity to empower YMSM with the skills necessary to communicate with their partners and protect themselves from HIV in their current and future relationships. TRIAL REGISTRATION: Clinicaltrials.gov NCT03551938; https://clinicaltrials.gov/ct2/show/NCT03551938 (Archived by WebCite at http://www.webcitation.org/73omJCz1a). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/10370.