Club drug use and PrEP adherence in vulnerable men

弱势男性俱乐部吸毒和 PrEP 依从性

• 批准号: 9110935
• 负责人: Christian Grov
• 金额: $ 0.02万
• 依托单位: BROOKLYN COLLEGE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2016-08-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9110935
• 关键词: Adherence; Adverse effects; Advertising; Age; Alcohol consumption; Alcohol or Other Drugs use; Anal Sex; Anus; Back; Behavioral; Biological; Biological Testing; Bisexual; Characteristics; Cities; Clinical; Cocaine; Contracts; Data; Decision Making; Demographic Factors; District of Columbia; Dose; Drug Combinations; Drug usage; Drug user; Enrollment; Event; Exploratory/Developmental Grant; Exposure to; FDA approved; Frequencies; Gap Junctions; Gays; General Population; Glean; HIV; HIV Infections; HIV Seropositivity; Health; Human immunodeficiency virus test; Incidence; Individual; Infection; Internet; Intervention; Interview; Ketamine; Literature; Measures; Methamphetamine; Methods; Monitor; Motivation; Participant; Patient Self-Report; Pharmaceutical Preparations; Play; Population; Prevention; Prophylactic treatment; Provider; Psychosocial Factor; Publishing; Regimen; Research; Research Personnel; Risk; Role; Sampling; San Francisco; Sex Behavior; Social Network; Tenofovir; Time; Urine; base; club drug; cohort; community based service; comparison group; condoms; cost; diaries; ecstasy; emtricitabine; experience; improved; medication compliance; men; men who have sex with men; monitoring device; oral HIV; prevent; prospective; protective behavior; psychosocial; sex; tool; transgender women; transmission process; truvada; uptake

 DESCRIPTION (provided by applicant): Men who have sex with men (MSM) are 44 times more likely to contract HIV than other men and they are among the only populations in which infections are on the rise. Pre-Exposure Prophylaxis (PrEP) in the form of once-daily Truvada (Emtricitabine/Tenofovir) is among the most promising biomedical prevention tool for MSM in the US. HIV-negative MSM who use club drugs (ketamine, MDMA/ecstasy, GHB, cocaine, methamphetamine) might benefit from the added protection of PrEP because our previous research found strong associations between club drug use and condomless anal sex among MSM. Further, there is substantial research, including that collected by our research team, suggesting that club drugs negatively impact HIV medication adherence for HIV-positive MSM. However, to date, there are no published equivalent studies on the role of club drugs in PrEP adherence among MSM who are taking PrEP. Instead, much data on barriers to PrEP adherence are based on hypothetical situations and/or with individuals who have never taken PrEP. The proposed study will follow two cohorts of MSM on PrEP: n = 50 who use club drugs and n = 50 who do not. Participants will be identified via our partnerships with providers who prescribe PrEP as well as those who provide other community-based services to MSM on PrEP, in addition to traditional venue-based recruitment and Internet social networking (e.g., advertising on Facebook, Grindr). AIM 1: Compare levels of PrEP adherence between MSM who use club drugs and those who do not (between-group analyses). AIM 2: Gather pilot data to identify the role that club drug use (frequency, drug type, drug combinations) plays in daily PrEP non-adherence among MSM who are drug users (within-group analyses). Measures will include self-report (retrospective via 30 day time-line follow back interview and prospective via twice-weekly online diaries for 10 weeks), biological (urine drug and oral HIV testing), objective (Wisepill Event Monitoring Device for 10 weeks), and qualitative assessments. Psychosocial and demographic measures will also be collected via ACASI at baseline, giving this study the added benefit of being able to identify other factors that are associated with PrEP non-adherence (Sub-aim 1). Given the role that club drugs play in condomless anal sex among MSM, HIV-negative MSM club drug might benefit from the added protection of PrEP. Meanwhile, there are no published studies on the role that club drugs play in PrEP non-adherence, in spite of compelling evidence that club drugs impact HIV medication adherence among HIV-positive MSM. The results of this study will be used to inform subsequent intervention strategies to reduce club drug use among MSM who take PrEP, as well as improve PrEP adherence. Consistent with the R21 mechanism, this study will generate the necessary formative pilot data for an R01 that will seek to reduce club drug use and improve PrEP adherence.

 描述（由申请人提供）：男男性行为者（MSM）感染艾滋病毒的可能性是其他男性的44倍，他们是感染率上升的唯一人群。暴露前预防（PrEP）以每日一次Truvada（恩曲他滨/替诺福韦）的形式是美国MSM最有前途的生物医学预防工具之一。使用俱乐部药物（氯胺酮，MDMA/摇头丸，GHB，可卡因，甲基苯丙胺）的HIV阴性MSM可能会受益于PrEP的额外保护，因为我们以前的研究发现俱乐部药物使用和MSM之间的无避孕套肛交之间存在很强的关联。此外，有大量的研究，包括我们的研究小组收集的研究，表明俱乐部药物对艾滋病毒阳性男男性行为者的艾滋病毒药物依从性产生负面影响。然而，迄今为止，有没有发表的等效研究俱乐部药物在PrEP坚持谁正在服用PrEP的MSM之间的作用。相反，很多数据的障碍PrEP坚持是基于假设的情况和/或与个人谁从来没有采取PrEP. The拟议的研究将遵循两个队列的MSM对PrEP：n = 50谁使用俱乐部药物和n = 50谁不。除了传统的基于场所的招聘和互联网社交网络（例如，Facebook、Grindr）。目的1：比较使用俱乐部药物的MSM和不使用俱乐部药物的MSM之间的PrEP依从性水平（组间分析）。目标2：收集试点数据，以确定俱乐部药物使用（频率，药物类型，药物组合）在吸毒的男男性行为者（组内分析）中每日PrEP非依从性中的作用。措施将包括自我报告（通过30天时间线随访访谈进行回顾性评估，通过每周两次在线日记进行前瞻性评估，持续10周）、生物学（尿液药物和口服HIV检测）、客观（Wisepill事件监测装置，持续10周）和定性评估。还将在基线时通过ACASI收集心理社会和人口统计学指标，使本研究能够识别与PrEP不依从性相关的其他因素（子目标1）。 考虑到俱乐部药物在男男性接触者无安全套肛交中的作用，HIV阴性男男性接触者俱乐部药物可能会受益于PrEP的额外保护。同时，尽管有令人信服的证据表明俱乐部药物会影响HIV阳性男男性接触者的HIV药物依从性，但目前还没有关于俱乐部药物在PrEP不依从性中所起作用的已发表研究。这项研究的结果将被用来告知后续的干预策略，以减少服用PrEP的MSM中俱乐部药物的使用，并提高PrEP的依从性。与R21机制一致，本研究将为R 01生成必要的形成性试点数据，以减少俱乐部药物使用并提高PrEP依从性。