A brief alcohol intervention to reduce alcohol use and improve PrEP ouctomes among men who have sex with men: A randomized controlled trial in Vietnam

项目总结 在男男性行为者(MSM)中使用不健康的酒精是很常见的。使用不健康的酒精是一种 从高风险/危险饮酒到酒精使用障碍。对于男男性接触者来说，不健康的饮酒可能会减少 准备坚持和坚持，这对预防艾滋病毒至关重要。减少不健康的饮酒可能会 改善PrEP结果。短暂的酒精干预(BAI)，它利用激励性访谈和 认知行为疗法：使用抗逆转录病毒药物增强HIV感染者的病毒抑制作用 心理治疗。这种影响是通过增加依从性来实现的。BAI可能对PrEP有类似的影响 不健康饮酒的男男性行为者的结局。我们提出了有效性-实现类型1的混合体 不健康饮酒男男性行为者BAI与标准护理的随机对照试验(RCT) 在越南使用启动或重新启动PrEP。我们假设BAI将改善a)PrEP持续性，b) 准备遵守，以及c)风险一致的PrEP使用(PrEP使用与当前风险一致，包括事件驱动 准备)。我们的具体目标是：1)评估BAI在增加PrEP持久性和 越南男男性接触者的饮酒依从性；2)评估BAI对男男性接触者饮酒的影响；3)估计 在越南各地的PrEP诊所扩大BAI的成本效益、可行性和可接受性。 这项试验和干预将在河内医科大学为越南MSM提供的PrEP诊所进行。 评估访问将在北卡罗来纳大学项目-越南进行。符合条件的参与者将包括男男性接触者(n=506) 到PrEP诊所进行PrEP启动或在6个月后再次启动PrEP。参赛者 还必须使用AUDIT-C Score≥4筛查不健康饮酒的阳性。在基线评估后， 参与者将随机接受标准护理或BAI，BAI包括两个面对面和两个 电话拜访。每个参与者将每季度接受访谈，包括使用时间线跟踪 诱导PrEP的使用、酒精使用和性行为，以及艾滋病毒感染、淋病、衣原体的检测 感染和梅毒。酒精使用和PrEP依从性也将通过生物标记物进行评估。初级阶段 有效结果为6个月和12个月的PrEP持续时间。次要结果包括PrEP坚持， 通过自我报告、药房记录和有效的生物测定进行评估；使用符合风险的PrEP；以及酒精 结果(大量饮酒天数(酗酒)，定义为每次饮用≥5的天数； 饮酒天数；每天饮酒量；以及磷脂酰乙醇值)。初级阶段 执行结果是增量成本效益比，以单位增量成本表示 质量调整后获得的寿命年，可行性和可接受性。如果成功，这项研究将被设置为确保 迅速扩大干预范围，通过减少不健康的饮酒和增加 为预防艾滋病毒使用做好准备。

PROJECT SUMMARY Unhealthy alcohol use is common among men who have sex with men (MSM). Unhealthy alcohol use is a spectrum from risky/hazardous drinking to alcohol use disorder. For MSM, unhealthy alcohol use may reduce PrEP persistence and adherence, which are critical for HIV prevention. Reducing unhealthy alcohol use may improve PrEP outcomes. The brief alcohol intervention (BAI), which draws on Motivational Interviewing and Cognitive Behavioral Therapy, increases viral suppression among people living with HIV on antiretroviral therapy. This effect is mediated through increased adherence. The BAI may have a similar effect on PrEP outcomes among MSM with unhealthy alcohol use. We propose an effectiveness-implementation type 1 hybrid randomized controlled trial (RCT) to compare the BAI to standard of care among MSM with unhealthy alcohol use initiating or re-initiating PrEP in Vietnam. We hypothesize that the BAI will improve a) PrEP persistence, b) PrEP adherence, and c) risk-aligned PrEP use (PrEP use consistent with current risk, including event-driven PrEP). Our specific aims are to: 1) Assess effectiveness of the BAI for increasing PrEP persistence and adherence among MSM in Vietnam; 2) Assess the impact of the BAI on alcohol use among MSM; 3) Estimate the cost-effectiveness, feasibility, and acceptability of scaling up the BAI in PrEP clinics throughout Vietnam. The trial and intervention will be conducted at the Hanoi Medical University PrEP clinic for MSM Vietnam. Evaluation visits will be conducted at UNC Project-Vietnam. Eligible participants will include MSM (n=506) presenting to the PrEP clinic for PrEP initiation or re-initiation after 6 months without PrEP. The participants must also screen positive for unhealthy alcohol use with an AUDIT-C score ≥ 4. After baseline evaluations, participants will be randomized to either standard of care or the BAI, which comprises two in-person and two telephone visits. Each participant will be followed quarterly with interviews, including use of timeline followback to elicit PrEP use, alcohol use, and sexual behavior, and tests for HIV infection, gonorrhea, chlamydial infection, and syphilis. Alcohol use and PrEP adherence will also be assessed with biomarkers. The primary effectiveness outcome is PrEP persistence at 6 and 12 months. Secondary outcomes include PrEP adherence, assessed by self-report, pharmacy records, and validated bioassays; risk-aligned PrEP use; and alcohol outcomes (heavy drinking days (binge drinking), defined as the number of days with ≥5 drinks per occasion; number of drinking days; and drinks per drinking day; and phosphatidylethanol level). The primary implementation outcomes are the incremental cost-effectiveness ratio, expressed as the incremental cost per quality-adjusted life-year gained, and feasibility and acceptability. If successful, this study will be set to ensure rapid scale up of an intervention to improve the lives of MSM by reducing unhealthy alcohol use and increasing PrEP use for HIV prevention.