Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure Prophylaxis (Project PARTNER): Randomized Controlled Trial Protocol

BACKGROUND: Men who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the United States and, among young MSM (YMSM) aged 20 to 29 years, as many as 79% to 84% of new infections occur between primary partners. Contributing to HIV risk, YMSM use drugs at comparatively high rates. To date, no interventions have been developed that specifically address the unique needs of partnered YMSM or incorporate a focus on relationship factors in addressing personal motivation for change. OBJECTIVE: The study’s primary aim is to evaluate the efficacy of the PARTNER intervention and evaluate potential moderators or mediators of intervention effects. The study’s secondary aims were to gather ideographic data to inform a future effectiveness implementation study and develop a novel biomarker for pre-exposure prophylaxis (PrEP) adherence by analyzing PrEP drug levels in fingernails. METHODS: PARTNER is a 4-session motivational interviewing–based intervention that integrates video-based communication training to address drug use and HIV prevention among partnered YMSM. This study utilizes a randomized controlled trial design to compare the PARTNER intervention with an attention-matched psychoeducation control arm that provides information about HIV-risk reduction, PrEP, and substance use. Participants are randomized in a 1-to-1 ratio stratified on age disparity between partners, racial composition of the couple, and relationship length. Follow-up assessments are conducted at 3-, 6-, 9-, and 12-months postbaseline. The study recruits and enrolls 240 partnered YMSM aged between 18 to 29 years at a research center in New York City. Participants will be HIV-negative and report recent (past 30-day) drug use and condomless anal sex with casual partners; a nonmonogamous primary partner (regardless of HIV status); or a serodiscordant primary partner (regardless of sexual agreement). Primary outcomes (drug use and HIV sexual transmission risk behavior) are assessed via a Timeline Follow-back interview. Biological markers of outcomes are collected for drug use (fingernail assay), sexual HIV transmission risk (rectal and urethral gonorrhea and chlamydia testing), and PrEP adherence (dried blood spots and fingernails for a novel PrEP drug level assay). RESULTS: The study opened for enrollment in February 2018. Anticipated completion of enrollment is October 2021. Primary outcome analyses will begin after final follow-up completion. CONCLUSIONS: Existing research on partnered YMSM within the framework of Couples Interdependence Theory (CIT) has suggested that relationship factors (eg, dyadic functioning and sexual agreements) are meaningfully related to drug use and HIV transmission risk. Results pertaining to the efficacy of the proposed intervention and the identification of putative moderators and mediators will substantially inform the tailoring of interventions for YMSM in relationships and contribute to a growing body of relationship science focused on enhancing health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03396367; https://clinicaltrials.gov/ct2/show/NCT03396367 (Archived by WebCite at http://www.webcitation.org/78ti7esTc. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13015