A Brief Alcohol Intervention (BAI) to reduce alcohol use and improve PrEP outcomes among men who have sex with men in Vietnam: study protocol for a randomized controlled trial
Hao T. M. Bui,
Le Minh Giang,
Jane S. Chen,
Teerada Sripaipan,
Ha T. T. Nong,
Ngan T. K. Nguyen,
Sophia M. Bartels,
Sarah L. Rossi,
Heidi Hutton,
Geetanjali Chander,
Hojoon Sohn,
Olivia Ferguson,
Ha V. Tran,
Minh X. Nguyen,
Khanh D. Nguyen,
Sarah E. Rutstein,
Sara Levintow,
Irving F. Hoffman,
Byron J. Powell,
Brian W. Pence,
Vivian F. Go,
William C. Miller
Affiliations
Hao T. M. Bui
Center for Training and Research on Substance Abuse -HIV (CREATA-H), Hanoi Medical University
Le Minh Giang
Center for Training and Research on Substance Abuse -HIV (CREATA-H), Hanoi Medical University
Jane S. Chen
Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
Teerada Sripaipan
Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
Ha T. T. Nong
University of North Carolina Project Vietnam, Van Phuc Diplomatic Compound
Ngan T. K. Nguyen
University of North Carolina Project Vietnam, Van Phuc Diplomatic Compound
Sophia M. Bartels
Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
Sarah L. Rossi
Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
Heidi Hutton
Department of Psychiatry, School of Medicine, Johns Hopkins University
Geetanjali Chander
Division of General Internal Medicine, School of Medicine, University of Washington
Hojoon Sohn
Department of Preventive Medicine, College of Medicine, Seoul National University
Olivia Ferguson
Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
Ha V. Tran
University of North Carolina Project Vietnam, Van Phuc Diplomatic Compound
Minh X. Nguyen
Department of Epidemiology, School of Preventive Medicine and Public Health, Hanoi Medical University
Khanh D. Nguyen
Center for Training and Research on Substance Abuse -HIV (CREATA-H), Hanoi Medical University
Sarah E. Rutstein
Division of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill
Sara Levintow
Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
Irving F. Hoffman
Division of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill
Byron J. Powell
George Warren Brown School of Social Work, Washington University
Brian W. Pence
Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
Vivian F. Go
Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
William C. Miller
Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
Abstract Background In Vietnam and other global settings, men who have sex with men (MSM) have become the population at greatest risk of HIV infection. Although HIV pre-exposure prophylaxis (PrEP) has been implemented as a prevention strategy, PrEP outcomes may be affected by low persistence and adherence among MSM with unhealthy alcohol use. MSM have a high prevalence of unhealthy alcohol use in Vietnam, which may affect PrEP outcomes. Methods Design: We will conduct a two-arm hybrid type 1 effectiveness-implementation randomized controlled trial of a brief alcohol intervention (BAI) compared to the standard of care (SOC) at the Sexual Health Promotion (SHP) clinic Hanoi, Vietnam. Participants: Sexually active MSM (n=564) who are newly initiating PrEP or re-initiating PrEP and have unhealthy alcohol use will be recruited and randomized 1:1 to the SOC or BAI arm. A subgroup of participants (n=20) in each arm will be selected for longitudinal qualitative interviews; an additional subset (n=48) in the BAI arm will complete brief quantitative and qualitative interviews after completion of the BAI to assess the acceptability of the intervention. Additional implementation outcomes will be assessed through interviews with clinic staff and stakeholders (n=35). Intervention: Study participants in both arms will receive standard care for PrEP clients. In the BAI arm, each participant will receive two face-to-face intervention sessions and two brief booster phone sessions, based on cognitive behavioral therapy and delivered in motivational interviewing informed style, to address their unhealthy alcohol use. Outcomes: Effectiveness (PrEP and alcohol use) and cost-effectiveness outcomes will be compared between the two arms. Intervention implementation outcomes (acceptability, feasibility, adoption) will be assessed among MSM participants, clinic staff, and stakeholders. Discussion This proposed trial will assess an alcohol intervention for MSM with unhealthy alcohol use who initiate or re-initiate PrEP, while simultaneously preparing for subsequent implementation. The study will measure the effectiveness of the BAI for increasing PrEP persistence through reducing unhealthy alcohol use in a setting where excessive alcohol consumption is a normative behavior. If effective, implementation-focused results will inform future scale-up of the BAI in similar settings. Trial registration NCT06094634 on clinicaltrials.gov. Registered 16 October 2023.
