Center for Training and Research on Substance Abuse -HIV (CREATA-H), Hanoi Medical University, Hanoi, Vietnam.
Department of Epidemiology, School of Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam.
Trials. 2024 Aug 21;25(1):552. doi: 10.1186/s13063-024-08382-5.
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.
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.
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).
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.
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.
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.
NCT06094634 on clinicaltrials.gov. Registered 16 October 2023.
在越南和其他全球范围内，男男性行为者（MSM）已成为感染艾滋病毒风险最大的人群。尽管已将 HIV 暴露前预防（PrEP）作为一种预防策略实施，但 MSM 中不健康的酒精使用可能会影响 PrEP 的效果。越南 MSM 中存在较高的不健康酒精使用比例，这可能会影响 PrEP 的效果。
设计：我们将在越南河内性健康促进（SHP）诊所开展一项两臂混合 1 型有效性实施随机对照试验，比较简短酒精干预（BAI）与标准护理（SOC）的效果。
新开始 PrEP 或重新开始 PrEP 且有不健康酒精使用的活跃 MSM（n=564）将被招募并按 1:1 随机分配到 SOC 或 BAI 组。每组（n=20）的参与者将被选择进行纵向定性访谈；BAI 组中的另外一部分（n=48）参与者将在完成 BAI 后完成简短的定量和定性访谈，以评估干预措施的可接受性。通过对诊所工作人员和利益相关者（n=35）进行访谈，将评估其他实施结果。
两组研究参与者都将接受 PrEP 患者的标准护理。在 BAI 组中，每位参与者将接受两次面对面干预，以及两次简短的电话增能，基于认知行为疗法并以动机访谈为信息基础，以解决他们的不健康酒精使用问题。
将比较两组之间的有效性（PrEP 和酒精使用）和成本效益结果。将在 MSM 参与者、诊所工作人员和利益相关者中评估干预措施的实施结果（可接受性、可行性、采纳）。
这项拟议的试验将评估一种针对有不健康酒精使用的 MSM 的酒精干预措施，这些 MSM 开始或重新开始 PrEP，同时为随后的实施做准备。该研究将衡量 BAI 通过减少不健康酒精使用来提高 PrEP 持久性的效果，在这种情况下，过度饮酒是一种规范行为。如果有效，以实施为重点的结果将为在类似环境中推广 BAI 提供信息。
NCT06094634 在 clinicaltrials.gov 上注册。2023 年 10 月 16 日注册。
