Club drug use and PrEP adherence in vulnerable men

 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，他们是感染人数上升的唯一人群之一。暴露前预防(PrEP)每天一次的特鲁瓦达(恩曲他滨/替诺福韦)是美国最有前途的MSM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可能受益于PrEP的额外保护，因为我们之前的研究发现，在MSM中，俱乐部药物使用与无套肛交之间存在很强的相关性。此外，还有大量研究，包括我们研究团队收集的研究，表明俱乐部药物对HIV阳性MSM的HIV药物依从性有负面影响。然而，到目前为止，还没有发表过关于俱乐部药物在服用PrEP的MSM中遵守PrEP的作用的同等研究。相反，许多关于遵守PrEP的障碍的数据是基于假设的情况和/或从未服用PrEP的个人。这项拟议的研究将跟踪服用PrEP的两个MSM队列：n=50使用俱乐部药物的人和n=50不使用俱乐部药物的人。参与者将通过我们与开具PrEP处方的提供商以及那些在PrEP上为MSM提供其他基于社区的服务的提供商来确定，除了传统的基于场所的招聘和互联网社交网络(例如，在Facebook、Grindr上发布广告)。目标1：比较使用俱乐部药物和不使用俱乐部药物的MSM的PrEP依从性水平(组间分析)。目的2：收集试点数据以确定俱乐部吸毒(频率、药物类型、药物组合)在吸毒者MSM日常PrEP不依从性中所起的作用(组内分析)。措施将包括自我报告(通过30天时间线回访进行回顾，并通过每周两次的在线日记进行前瞻性评估，为期10周)、生物学(尿液药物和口服艾滋病毒检测)、目标(为期10周的Wisepill事件监测设备)和定性评估。心理社会和人口学测量也将通过ACASI在基线收集，使这项研究能够确定与PrEP不遵守有关的其他因素(次级目标1)。考虑到俱乐部药物在男男性行为中所起的作用，HIV阴性的MSM俱乐部药物可能受益于PrEP的额外保护。与此同时，尽管有令人信服的证据表明，俱乐部药物影响艾滋病毒阳性男男性接触者对艾滋病毒药物的依从性，但没有发表关于俱乐部药物在PrEP不遵守中所起作用的研究。这项研究的结果将被用来为后续的干预策略提供参考，以减少服用PrEP的MSM的俱乐部药物使用，以及提高PrEP的依从性。与R21机制一致，这项研究将为R01产生必要的形成性试点数据，寻求减少俱乐部药物使用并改善PrEP依从性。

 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.