Acceptance and commitment therapy for people with HIV who drink at unhealthy levels: Protocol for the ACCEPT randomized controlled trial.

BACKGROUND: Alcohol consumption at unhealthy levels is associated with negative consequences at nearly every step of the HIV care continuum. We describe the rationale, aims, and study design for the ACCEPT Trial, a randomized controlled comparative efficacy trial for Acceptance and Commitment Therapy (ACT) compared to a standard brief alcohol intervention (BI) for people living with HIV (PWH) who drink at unhealthy levels. METHODS: A total of 300 PWH who report drinking at unhealthy levels will be randomly assigned 1:1 to the two treatments conditions and assessed, via self-report and an alcohol biomarker, for alcohol use and comorbid symptoms of depression, anxiety, and stress at baseline, post-treatment, and 3-, 6-, and 12-months later. Symptoms of experiential avoidance, a proposed mechanism of change in the ACT condition, will also be assessed at all timepoints. We hypothesize that the two treatments will have significant, and statistically equivalent, effects on alcohol use at the post-treatment and 3-month timepoints and the ACT condition will have superior outcomes, mediated by changes to experiential avoidance, at the 6- and 12-month timepoints. CONCLUSIONS: Confirmation of the ACCEPT trial's hypotheses will provide an important tool for HIV care, treating not only unhealthy alcohol use, but also other psychiatric comorbidities seen in this population. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06648629.