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.

项目摘要 不健康的饮酒在男男性行为者（MSM）中很常见。不健康的饮酒是一种 从危险/危险饮酒到酒精使用障碍。对于MSM，不健康的酒精使用可能会减少 PrEP的持久性和坚持性，这对艾滋病毒预防至关重要。减少不健康的酒精使用可能 改善PrEP结果。简短的酒精干预（BAI），它利用动机访谈， 认知行为疗法，增加抗逆转录病毒治疗的艾滋病毒感染者的病毒抑制 疗法这种效果是通过增加粘附介导的。BAI可能对PrEP有类似的影响 结果与不健康的酒精使用的男男性接触者。我们提出了一个有效性实现类型1混合 一项随机对照试验（RCT），在有不健康酒精的MSM中比较BAI与标准治疗 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） PrEP依从性，以及c）与风险一致的PrEP使用（PrEP使用与当前风险一致，包括事件驱动 PrEP）。我们的具体目标是：1）评估BAI对增加PrEP持久性的有效性， 2）评估BAI对MSM中酒精使用的影响; 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。 试验和干预将在河内医科大学越南MSM PrEP诊所进行。 评估访问将在越南项目中心进行。合格参与者将包括MSM（n=506） 在没有PrEP的6个月后，到PrEP诊所接受PrEP启动或重新启动。 还必须对不健康的酒精使用进行筛查，AUDIT-C评分≥ 4。在基线评估之后， 参与者将被随机分配到标准治疗组或BAI组，BAI组包括两个人和两个人。 电话访问。每季度将对每位参与者进行访谈，包括使用时间轴跟踪 引出PrEP使用，酒精使用和性行为，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。主 有效性结果是6个月和12个月的PrEP持续性。次要结局包括PrEP依从性， 通过自我报告、药房记录和经验证的生物测定进行评估;风险一致的PrEP使用;以及酒精 结果（重度饮酒日（暴饮），定义为每次饮酒≥5次的天数; 饮酒天数;和每天饮酒量;和磷脂酰乙醇水平）。主 执行成果是增量成本效益比，以每单位的增量成本表示。 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 通过减少不健康的酒精使用和增加 PrEP用于预防艾滋病毒。