Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial

Abstract

Background Young men who have sex with men (YMSM), particularly those who are partnered, are at unique risk for HIV. YMSM are among those at highest risk for HIV. Meanwhile, despite the fact that primary partners account for many—possibly most—new HIV infections, partnered men who have sex with men perceive themselves to be at much lower risk for HIV infection and therefore test less often than single men. In response to the risk of primary partner HIV transmission, couples HIV testing and counseling (CHTC) procedures have been developed for use in adult populations. Although promising, YMSM couples may require additional support to complete CHTC given their developmental context in which sexual and romantic relationships are relatively new, and communication skills are emergent. Objective The aim of this study was to test the additive benefit of adjunct treatment components tailored for YMSM, which enhance communication skills before the completion of CHTC. The intervention tests a continuum of prevention packages including assertive communication training videos and motivational interviewing focused on assisting with identification and development (MI-AID) before entering into the dyadic intervention components. This protocol is part of the Adolescent Medicine Trials Network (ATN) Scale It Up program described in this issue. Methods This is a comparative effectiveness trial that will be executed in 3 phases. Phase 1 will gather qualitative data related to intervention development and implementation from partnered YMSM at 4 subject recruitment venues (SRVs). Phase 2 will compare a continuum of these interventions in a pilot randomized controlled trial (RCT) at 2 SRVs. Phase 3 will compare the most successful adapted intervention package from phase 2 to CHTC as usual in a larger RCT at 4 SRVs. This phase is focused on implementation and sustainment phases of the Exploration, Preparation, Implementation, and Sustainment framework. Results Phase 1 data will be drawn from qualitative interviews with partnered YMSM (n=24) and staff from ATN sites (n=20). Baseline enrollment for phase 2 is expected to begin across 2 SRVs in June 2018 (n couples =36). In phase 2, survey data collection along with HIV and sexually transmitted infection (STI) testing will occur at baseline, and 1- and 3-month (postintervention) follow-ups. Phase 3 will begin enrollment across 4 SRVs in September 2019 (n couples =144) and follow-ups will occur at 1, 3, 6, and 9 months postintervention. Conclusions Although MI-AID, video-based assertive communication training, and CHTC have established efficacy when administered on their own, this study will be the first to evaluate the strongest adjunctive version of these interventions to address the specific developmental needs of partnered YMSM. Trial Registration ClinicalTrials.gov NCT03386...

Adolescent Trials Network for HIV-AIDS Scale It Up Program: Protocol for a Rational and Overview

“…ATN 156, Enhancing Sexual Safety: Couples’ Communication and HIV Testing Among YMSM (We Test), is a comparative effectiveness trial of couples HIV testing and counseling (CHTC) for adolescent age (15-19 years) same-sex male couples [18]. This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (CT) videos viewed by the couple together and individually delivered MI-based Communication Skills Training (MI-CST).…”

“…Participants complete the intervention session and an immediate posttest assessment 3 months after the baseline; they are then assessed every 3 months for 9 months postintervention. Details are provided in ATN 156 We Test [18].…”

“…SIU will achieve its aims through 4 primary study protocols (ATN 144 SMART: Sequential Multiple Assignment Randomized Trial; ATN 145 YMHP: Young Men’s Health Project; ATN 146 TMI: Tailored Motivational Interviewing Intervention; ATN 156 We Test: Couples' Communication and HIV Testing) [16-18], 2 center-wide protocols (ATN 153 EPIS and ATN 154 Cascade Monitoring; Carcone et al, under review, and Pennar et al, under review), and 3 cross-project initiatives. A substantial amount of literature underscores the importance of shortening the time from conceptualization of a research idea to service delivery.…”

Partners’ Consensus About Joint Effort and COVID-19 Prevention Among Sexual Minority Men

“…A number of dyadic interventions have been developed to reduce HIV risk among SMM in relationships (Gamarel et al, 2019 ; Newcomb et al, 2017 ; Starks et al, 2019a , 2019c ; Stephenson et al, 2016 , 2017 ). All these interventions in some way are predicated on the premise that the formation of joint goals—a shared plan to promote health behavior—leads to improved health outcomes.…”

Implementation Science Research Examining the Integration of Evidence-Based Practices Into HIV Prevention and Clinical Care: Protocol for a Mixed-Methods Study Using the Exploration, Preparation, Implementation, and Sustainment (EPIS) Model

“…The tailored motivational interviewing (MI) study (referred to as ATN 146 TMI) aims to scale up the use of an EBP, MI, in adolescent HIV clinical care settings (see the study by Naar et al [16] in this issue). Finally, a comparative effectiveness trial to assess the additive benefit of communication training during couples’ HIV testing and counseling (referred to as ATN 156 We Test; see the study by Starks et al [17] in this issue). The goal of the EPIS study is to describe the inner and outer contextual factors impacting the uptake of these 4 EBPs across 3 implementation phases.…”