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: 10705834
• 负责人: VIVIAN F. GO
• 金额: $ 58.93万
• 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/10705834
• 关键词: AIDS prevention; Address; Adherence; Affect; Alcohol consumption; Alcohols; Asia; Back; Behavioral; Biological Assay; Biological Markers; Caring; Chlamydia Infections; Clinic; Clinical; Cognitive Therapy; Consolidated Framework for Implementation Research; Consumption; 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; Policy Maker; Prevention; Public Health; Randomized; Randomized, Controlled Trials; Recommendation; Records; Regimen; Reporting; Risk; Risk Behaviors; Self Assessment; Sex Behavior; Sexual Health; Sexually Transmitted Diseases; Syphilis; Telephone; Testing; Time; Universities; Vietnam; Vietnamese; Viral; Visit; acceptability and feasibility; alcohol abstinence; alcohol misuse; alcohol use disorder; alcohol use initiation; antiretroviral therapy; arm; binge drinking; brief alcohol intervention; cost effective; cost effectiveness; cost estimate; cost per quality-adjusted life year; cost-effectiveness ratio; design; drinking; effectiveness evaluation; effectiveness outcome; eligible participant; experience; hazardous drinking; hybrid type 1 design; implementation outcomes; implementation process; implementation/effectiveness; improved; incremental cost; 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; timeline; tool; treatment arm; uptake; AIDS prevention; Address; Adherence; Affect; Alcohol consumption; Alcohols; Asia; Back; Behavioral; Biological Assay; Biological Markers; Caring; Chlamydia Infections; Clinic; Clinical; Cognitive Therapy; Consolidated Framework for Implementation Research; Consumption; 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; Policy Maker; Prevention; Public Health; Randomized; Randomized, Controlled Trials; Recommendation; Records; Regimen; Reporting; Risk; Risk Behaviors; Self Assessment; Sex Behavior; Sexual Health; Sexually Transmitted Diseases; Syphilis; Telephone; Testing; Time; Universities; Vietnam; Vietnamese; Viral; Visit; acceptability and feasibility; alcohol abstinence; alcohol misuse; alcohol use disorder; alcohol use initiation; antiretroviral therapy; arm; binge drinking; brief alcohol intervention; cost effective; cost effectiveness; cost estimate; cost per quality-adjusted life year; cost-effectiveness ratio; design; drinking; effectiveness evaluation; effectiveness outcome; eligible participant; experience; hazardous drinking; hybrid type 1 design; implementation outcomes; implementation process; implementation/effectiveness; improved; incremental cost; 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; timeline; 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.

项目摘要 在与男性发生性关系的男性中，不健康的饮酒很常见。不健康的酒精是 从危险/危险饮酒到酒精使用障碍的频谱。对于MSM，不健康的饮酒可能会减少 持久性和依从性，这对于预防艾滋病毒至关重要。减少不健康的饮酒可能 改善准备结果。简短的酒精干预（BAI），借鉴了动机面试和 认知行为疗法，增加抗逆转录病毒艾滋病毒患者的病毒抑制 治疗。通过提高依从性介导这种效果。 BAI可能对准备有类似的影响 MSM的结果与不健康的酒精使用。我们提出了一种有效性实施1型混合动力 随机对照试验（RCT）将BAI与MSM之间的护理标准与不健康的酒精进行比较 在越南使用或重新发射准备。我们假设BAI将改善a）准备持久性，b） 准备依从性，c）风险对准的准备使用（准备与当前风险一致，包括事件驱动 准备）。我们的具体目的是：1）评估BAI对增加持久性和 越南MSM之间的依从性； 2）评估BAI对MSM中饮酒的影响； 3）估计 在整个越南的预科诊所中扩大BAI的成本效益，可行性和可接受性。 该试验和干预措施将在MSM越南的河内医科大学预科诊所进行。 评估访问将在UNC项目 - 越南进行。合格的参与者将包括MSM（n = 506） 在6个月后，向Prep Clinic提出准备或重新启动。参与者 还必须筛选出不健康的酒精使用阳性的审计-C分数≥4。基线评估后， 参与者将被随机分配给护理标准或BAI，其中包括两个面对面和两个 电话访问。每个参与将每季度进行访谈，包括使用时间轴后卫 引起预备使用，饮酒和性行为，以及对艾滋病毒感染的测试，淋病，衣原体 感染和梅毒。饮酒和预遵循也将通过生物标志物进行评估。主要 有效性结果是在6个月和12个月时的持久性。次要结果包括准备依从性， 由自我报告，药房记录和经过验证的生物测定评估；风险一致的准备使用；和酒精 结果（大量饮酒日（暴饮暴食），定义为每次≥5饮料的天数； 饮酒天数；和每天喝酒；和磷脂酰乙醇水平）。主要 实施结果是增量成本效益比率，表示为每次增量成本 质量调整后的生活年度获得了，可行性和可接受性。如果成功，将设定这项研究以确保 快速扩大干预措施，以减少不健康的饮酒和增加，以改善MSM的生活 预防艾滋病毒的准备使用。