Enhancing HIV Pre-Exposure Prophylaxis (PrEP) by Targeting Hazardous Alcohol Use and Concurrent Conditions

通过针对有害酒精使用和并发病症来加强 HIV 暴露前预防 (PrEP)

• 批准号: 10021534
• 负责人: PAUL SHUPER
• 金额: $ 24.62万
• 依托单位: CENTRE FOR ADDICTION AND MENTAL HEALTH
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10021534
• 关键词: AIDS prevention; Address; Adherence; Alcohol abuse; Alcohol consumption; Alcohol or Other Drugs use; Alcohols; Behavior; Biological Markers; Caring; Clinical; Effectiveness; Focus Groups; Future; HIV; Health behavior; Intervention; Lead; Link; Medical; Mental Depression; Participant; Patient Self-Report; Phase; Prevention strategy; Preventive; Randomized; Randomized Controlled Trials; Research; Resources; Role; Sexually Transmitted Diseases; Surveys; Tablets; Testing; Treatment Effectiveness; Unsafe Sex; Work; base; brief intervention; condoms; design; hazardous drinking; insight; men; men who have sex with men; pre-exposure prophylaxis; treatment adherence; treatment as usual

Although HIV pre-exposure prophylaxis (PrEP) constitutes a highly effective biomedical HIV prevention strategy, its effectiveness has been shown to be dependent on treatment adherence, retention in care, and the continued use of condoms. Identifying and addressing factors that detract from these PrEP-relevant behaviors is therefore imperative for maximizing the HIV preventive benefits of PrEP. Hazardous alcohol consumption, and concurrent conditions such as substance use and depression, have been shown to adversely impact a variety of health behaviors, and although these concerns are prevalent among PrEP-prescribed men who have sex with men (MSM), little work has been conducted to investigate their role in PrEP treatment. The present study involves a two-phased approach designed to 1) gain a better understanding of the associations among alcohol use, concurrent substance use and depression, and PrEP-related behaviors among PrEP-prescribed MSM (UH2 phase); and 2) explore whether addressing hazardous drinking and concurrent conditions can potentially lead to improvements in MSM’s PrEP-related behaviors (UH3 phase). The recently completed first phase of this research (UH2) involved 1) five focus groups with PrEP-prescribed MSM (N=35) to explore barriers to PrEP adherence, retention in PrEP-related care, and condom use; with an emphasis on alcohol consumption and concurrent conditions; 2) surveys with 141 PrEP-prescribed MSM to identify rates of, and associations among, PrEP adherence, condomless sex, hazardous drinking, and concurrent conditions; and 3) chart extraction of 501 PrEP-prescribed MSM to ascertain clinically-identified rates of, and associations among, hazardous drinking and concurrent conditions; PrEP adherence; retention in PrEP-related care; and sexually transmitted infections. Building on this initial work, the second phase of this research (UH3) will entail a pilot randomized controlled trial in which 120 hazardous drinking, PrEP-prescribed MSM will be randomly assigned to receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual. Participants assigned to the former condition for whom substance use- and/or depression-related concerns are identified will be provided with links to relevant resources. All trial participants will complete biomarker testing and self-report assessments at baseline, 3-months, and 6-months to assess the preliminary impact of the intervention on alcohol use, PrEP adherence, retention in care, and condomless sex. Feasibility and acceptability of the intervention will also be examined. Taken together, findings from both phases of this research will not only provide much needed insight into the possible impact of hazardous alcohol use and concurrent conditions on PrEP treatment, but they will also have the potential to guide future initiatives aimed at enhancing PrEP treatment effectiveness.

尽管艾滋病毒暴露前预防（PrEP）是一种非常有效的生物医学艾滋病毒预防方法， 策略，其有效性已被证明取决于治疗依从性，保留护理， 继续使用避孕套。识别和解决减损这些PrEP相关行为的因素 因此，为了最大限度地发挥PrEP的艾滋病毒预防效益， 和并发的条件，如物质使用和抑郁症，已被证明会对 各种各样的健康行为，虽然这些问题是普遍存在的PrEP规定的男子谁有 尽管与男性性行为者（MSM）的关系非常密切，但很少有工作调查他们在PrEP治疗中的作用。本 研究包括两个阶段的方法，旨在1）更好地了解 酒精使用，同时使用物质和抑郁症，以及PrEP处方中的PrEP相关行为 MSM（UH 2阶段）;以及2）探讨解决危险饮酒和并发症是否可以 可能导致MSM的PrEP相关行为（UH 3阶段）的改善。最近完成的第一个 本研究的第二阶段（UH 2）涉及1）五个焦点小组与PrEP处方MSM（N=35），以探索 坚持PrEP的障碍，PrEP相关护理的保留和避孕套的使用;重点是酒精 消费和并发症; 2）调查141 PrEP规定的MSM，以确定率， PrEP依从性、无避孕套性行为、危险饮酒和并发症之间的关联;以及3） 提取501例PrEP处方MSM的图表，以确定临床确定的 其中，危险饮酒和并发症; PrEP依从性;保留PrEP相关护理;以及 性传播感染在这项初步工作的基础上，这项研究的第二阶段（UH 3）将需要 一项试点随机对照试验，其中120名危险饮酒，PrEP处方MSM将随机 分配接受基于片剂的、减少酒精的短暂干预或常规治疗。 被分配到前一种情况的参与者，对他们来说，物质使用和/或抑郁相关的问题是 将提供相关资源的链接。所有试验参与者将完成生物标志物检测 在基线、3个月和6个月时进行自我报告评估，以评估 对酒精使用、PrEP依从性、保持护理和无避孕套性行为的干预。可行性和 还将审查干预措施的可接受性。总的来说，这两个阶段的调查结果 研究不仅将提供急需的深入了解危险酒精使用的可能影响， PrEP治疗的并发症，但它们也有可能指导未来的举措， 提高PrEP治疗效果。