Trials volume 25 , Article number: Cite this article. Metrics details. However, it typically requires several in-person sessions at a health facility, which may limit its feasibility and effectiveness in remote settings.
This is a two-arm randomised open-label multicentre superiority trial. Participants allocated to mhGAP-Standard receive 4 in-person sessions using motivational interviewing, identifying triggers, and alternative behaviours, with the option of two additional booster sessions.
Participants in the mhGAP-Remote arm receive 1 in-person session covering the same content, followed by standardised SMSs over 8 weeks that reinforce intervention content. Non-specialist providers deliver the intervention and receive weekly supervision. Follow-up assessments occur at 8, 20, and 32 weeks post-randomisation. The primary outcome is change in self-reported alcohol use continuous AUDIT score , from baseline to 8 weeks follow-up.
Change in the biomarker phosphatidylethanol secondary , liver enzyme values in serum exploratory , and HIV viral load for people with HIV only; exploratory are also evaluated from baseline throughout the entire follow-up period. A linear regression model will be conducted for the primary analysis, adjusted for the stratification factors.
Three a priori sensitivity analyses for the primary outcome are planned based on per protocol treatment attendance, recovery from unhealthy alcohol use, and clinically significant and reliable change.
