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

简短的酒精干预措施可减少男男性行为者的饮酒并改善 PrEP 结果：越南的一项随机对照试验

• 批准号: 10542097
• 负责人: VIVIAN F. GO
• 金额: $ 65.42万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10542097
• 关键词: AIDS prevention; Address; Adherence; Affect; Alcohol consumption; Alcohols; Asia; Behavioral; Biological Assay; Biological Markers; Caring; Chlamydia Infections; Clinic; Clinical; Cognitive Therapy; Consolidated Framework for Implementation Research; Consumption; Effectiveness; Elements; Ensure; Epidemic; Evaluation; Event; Gonorrhea; HIV; HIV Infections; Health; Heavy Drinking; Human immunodeficiency virus test; Hybrids; Incidence; Individual; Injectable; Injecting drug user; Intervention; Interview; Measures; Mediating; Medical; Methods; Monitor; Oral; Outcome; Participant; Patient Self-Report; Persons; Pharmacy facility; Prevention; Public Health; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Records; Regimen; Reporting; Risk; Risk Behaviors; Sex Behavior; Sexual Health; Sexually Transmitted Diseases; Supervision; Syphilis; Telephone; Testing; Time; TimeLine; Universities; Vietnam; Viral; Visit; acceptability and feasibility; alcohol abstinence; alcohol misuse; alcohol use disorder; antiretroviral therapy; arm; base; binge drinking; brief alcohol intervention; cost; cost effectiveness; cost estimate; cost-effectiveness ratio; design; drinking; effectiveness evaluation; effectiveness outcome; eligible participant; experience; hazardous drinking; hybrid type 1 design; implementation outcomes; implementation process; improved; incremental cost-effectiveness; intervention cost; medication compliance; men; men who have sex with men; microcosting; motivational enhancement therapy; phosphatidylethanol; pre-exposure prophylaxis; pressure; prevent; primary outcome; programs; reduced alcohol use; scale up; secondary outcome; social stigma; standard of care; telephone session; therapy adherence; tool; treatment arm; uptake

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.

项目概要 不健康的饮酒在男男性行为者 (MSM) 中很常见。不健康的饮酒是 从危险/危险饮酒到酒精使用障碍。对于 MSM 来说，不健康的饮酒可能会减少 PrEP 的持久性和依从性对于艾滋病毒预防至关重要。减少不健康的饮酒可能 改善 PrEP 结果。简短的酒精干预（BAI），借鉴了动机访谈和 认知行为疗法可增加接受抗逆转录病毒治疗的艾滋病毒感染者的病毒抑制 治疗。这种效果是通过增加依从性来介导的。 BAI 可能对 PrEP 产生类似的影响 不健康饮酒的 MSM 的结果。我们提出了一种有效性-实施型 1 混合型 随机对照试验 (RCT)，比较患有不健康饮酒的 MSM 的 BAI 与护理标准 在越南使用启动或重新启动 PrEP。我们假设 BAI 将改善 a) PrEP 持久性，b) PrEP 依从性，以及 c) 与风险相关的 PrEP 使用（PrEP 使用与当前风险一致，包括事件驱动的风险） 暴露前预防）。我们的具体目标是： 1) 评估 BAI 对提高 PrEP 持久性的有效性，以及 越南 MSM 的遵守情况； 2) 评估 BAI 对 MSM 饮酒的影响； 3）估计 在越南各地 PrEP 诊所扩大 BAI 的成本效益、可行性和可接受性。 试验和干预将在河内医科大学越南 MSM 的 PrEP 诊所进行。 评估访问将在北卡罗来纳大学越南项目进行。符合资格的参与者将包括 MSM (n=506) 到 PrEP 诊所进行 PrEP 启动或在 6 个月未进行 PrEP 后重新启动。参加者 还必须对不健康饮酒筛查呈阳性且 AUDIT-C 评分≥ 4。基线评估后， 参与者将被随机分配到标准护理或 BAI，其中包括两名现场护理和两名 电话拜访。每个参与者将每季度接受一次采访，包括使用时间线回溯 引出 PrEP 使用、饮酒和性行为，以及 HIV 感染、淋病、衣原体检测 感染和梅毒。酒精使用和 PrEP 依从性也将通过生物标志物进行评估。初级 有效性结果是 PrEP 在 6 个月和 12 个月时的持续性。次要结果包括 PrEP 依从性、 通过自我报告、药房记录和经过验证的生物测定进行评估；风险匹配的 PrEP 使用；和酒精 结果（酗酒天数（酗酒），定义为每次饮酒 ≥5 次的天数； 饮酒天数；以及每个饮酒日的饮料；和磷脂酰乙醇水平）。初级 实施成果是增量成本效益比，表示为每项增量成本 获得的质量调整生命年以及可行性和可接受性。如果成功，这项研究将确保 快速扩大干预措施，通过减少不健康的饮酒和增加饮酒量来改善 MSM 的生活 PrEP 用于艾滋病毒预防。