Optimizing PrEP adherence in sexual minority men who use stimulants

摘要 在男男性行为者(MSM)中，迫切需要优化前所未有的临床 以及接触前预防(PrEP)对使用兴奋剂的人预防艾滋病毒的公共卫生益处 (即冰毒、可卡因和强效可卡因)。使用兴奋剂的男男性接触者感染艾滋病毒的速度快3-6倍 血清转换和新诊断的艾滋病毒感染的男男性行为者中有一人报告最近使用兴奋剂。发现 我们团队和其他人也证明了兴奋剂的使用是坚持PrEP的关键障碍 坚持不懈。使用兴奋剂的男男性接触者脱离PrEP护理的比率是前者的3倍，后者是后者的5倍 遵守次优PrEP的几率更大。拟议的多站点随机对照试验将 利用有前景的干预模式，在紧急情况下提供积极的情感干预 管理(CM)，我们最近展示了它实现了持久的和具有临床意义的 HIV+、使用甲基苯丙胺的男男性接触者中病毒载量的减少。在拟议的多站点RCT中，我们计划 测试实施情绪调节治疗是否能提高药物干预的成功率 (Artemis)对直接观察到的PrEP剂量进行智能手机CM期间的积极情绪干预 在12个月内更持久地降低艾滋病毒感染风险。艾滋病毒感染风险(主要 结果)将作为替诺福韦二磷酸(TFV-DP)水平和自身 报道了最近的无套肛交(CAS)。多达300名在PrEP上报告使用兴奋剂和CAS的MSM 过去3个月以及过去一个月内任何不遵守PrEP的行为将从社交网络中招募 在南佛罗里达州和旧金山的应用程序以及PrEP临床服务。符合以下条件的参与者 面对面基线评估中的纳入和排除标准将提供血迹斑点(DBS) 样本将被存储以测量TFV-DP水平，并开始为期3个月的基于智能手机的CM 包括每周最多完成四次直接观察的PrEP剂量(共48次)的财政奖励 在3个月内)。参赛者将完成磨合期(等待期)，在此期间他们将完成4 在随机化之前，直接观察到基于智能手机的CM PrEP剂量。在单独的随机访问中， 240名参与者(120名南佛罗里达州和120名旧金山)将被随机分配，以获得他们的第一个单独 交付阿耳特弥斯积极影响干预或注意力控制会议。全部5个单独交付 干预课程将在为期3个月的CM干预期内进行。后续评估将 在开始CM后3个月、6个月和12个月进行，收集DBS在6个月和12个月测量TFV-DP 月份。与NIH OAR的高度优先领域“减少艾滋病毒/艾滋病的发病率”相一致，这一临床 研究将为有针对性地部署有限的公共卫生资源提供有意义的信息，以优化 在使用兴奋剂的MSM中使用PrEP带来的前所未有的临床和公共卫生好处，这是最优先考虑的之一 减少艾滋病毒发病率的人口。

Abstract Among men who have sex with men (MSM), there is an urgent need to optimize the unprecedented clinical and public health benefits of pre-exposure prophylaxis (PrEP) to prevent HIV with those who use stimulants (i.e., methamphetamine, cocaine, and crack-cocaine). Stimulant-using MSM display 3-6 fold faster rates of HIV seroconversion, and one-in-ten MSM with newly diagnosed HIV infection report recent stimulant use. Findings from our team and others also demonstrate that stimulant use is a key obstacle to PrEP adherence and persistence. Stimulant-using MSM have a 3-fold greater rate of disengagement from PrEP care and 5-fold greater odds of sub-optimal PrEP adherence. The proposed multi-site randomized controlled trial (RCT) will leverage a promising intervention model of delivering a positive affect intervention during contingency management (CM), which we have recently demonstrated achieves durable and clinically meaningful reductions in viral load among HIV+, methamphetamine-using MSM. In the proposed multi-site RCT, we plan to test whether delivering an Affect Regulation Treatment to Enhance Medication Intervention Success (ARTEMIS) positive affect intervention during smartphone-based CM for directly observed PrEP doses achieves more durable reductions in HIV acquisition risk over 12 months. HIV acquisition risk (the primary outcome) will be operationalized as tenofovir diphosphate (TFV-DP) levels <700 fmol per punchand self- reported recent condomless anal sex (CAS). Up to 300 MSM on PrEP who report stimulant use and CAS in the past 3 months as well as any PrEP non-adherence in the past month will be recruited from social networking applications as well as PrEP clinical services in South Florida and San Francisco. Participants who meet the inclusion and exclusion criteria at an in-person baseline assessment will provide a dried blood spot (DBS) specimen that will be stored to measure TFV-DP levels and begin 3-months of smartphone-based CM that includes financial incentives for completing up to four directly observed PrEP doses per week (48 doses total over the 3 months). Participants will complete a run-in period (waiting period) where they will complete 4 directly observed smartphone-based CM PrEP doses prior to randomization. At a separate randomization visit, 240 participants (120 South Florida and 120 San Francisco) will be randomized to receive their first individually delivered ARTEMIS positive affect intervention or attention-control session. All 5 individually delivered intervention sessions will be delivered during the 3-month CM intervention period. Follow-up assessments will be conducted at 3, 6, and 12 months after beginning CM, with DBS collected to measure TFV-DP at 6 and 12 months. Consistent with the NIH OAR high priority area of “reducing the incidence of HIV/AIDS,” this clinical research will meaningfully inform the targeted deployment of limited public health resources to optimize the unprecedented clinical and public health benefits of PrEP in stimulant-using MSM, one of highest priority populations for decreasing HIV incidence.