A protocol for a randomized controlled trial of couples motivational interviewing to reduce drug use and HIV transmission risk among male couples in the US: the Couples Health Project

Background: To reduce substance use and sexual HIV transmission risk among sexual minority men (SMM) requires the development of interventions tailored for those in relationships. In the past 5 years, there have been considerable advances in the development of motivational nterviewing (MI) with couples. The Couples Health Project (CHP) is the first multi-session risk reduction protocol built on this formative research. The purpose of this study is to evaluate the efficacy of CHP relative to a standard of care control - couples HIV testing and counseling (CHTC).

Methods: Eligibility includes couples where both partners are aged 18 or older, identify as cisgender male (assigned male sex at birth and identify as male gender), live in the US, and can communicate in English. Additionally, at least one partner has to be aged 18-34, HIV-negative, report recent drug use (excluding cannabis) and report condomless anal sex during the past 30 days. Couples are randomized post-baseline assessment to either CHP or CHTC. Follow-up assessments are completed at 3, 6, and 9-months post-randomization.

Discussion: Findings from this trial will inform the practice of MI with couples. If found efficacious, the CHP intervention would be the first multi-session MI with couples' risk reduction protocol designed for use by substance use treatment or HIV prevention service providers who wish to engage SMM and their relationship partners.

Protocol version: 1.0; April 1, 2024.

Trial registration: ClinicalTrials.gov Protocol Registration; NCT06307977; completed March 6, 2024; https://register.

Clinicaltrials: gov/ .