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 以及暴露前预防（PrEP）对使用兴奋剂者预防艾滋病毒的公共卫生益处 (i.e.,甲基苯丙胺、可卡因和快克可卡因）。使用兴奋剂的MSM显示HIV感染率快3-6倍 血清转换，和一个新诊断的艾滋病毒感染的男男性接触者报告最近使用兴奋剂。结果 来自我们团队和其他人的研究也表明，兴奋剂的使用是PrEP依从性的关键障碍， 坚持不懈使用刺激剂的MSM从PrEP护理中脱离的比率高出3倍， 次优PrEP依从性的可能性更大。拟定的多中心随机对照试验（RCT）将 利用有希望的干预模式，在应急期间提供积极的情感干预 管理（CM），我们最近已经证明，实现持久和临床意义 HIV+、使用甲基苯丙胺的MSM中病毒载量的减少。在拟定的多中心RCT中，我们计划 测试是否提供情感调节治疗以提高药物干预的成功率 （ARTEMIS）在基于智能手机的CM期间对直接观察到的PrEP剂量进行积极影响干预 在12个月内实现更持久的艾滋病毒感染风险降低。艾滋病毒感染风险（主要 结果）将在替诺福韦二磷酸（TFV-DP）水平<700 fmol/punch和自身 报告了最近的无套肛交多达300名接受PrEP治疗的MSM报告兴奋剂使用和CAS 过去3个月以及过去一个月的任何PrEP不依从性将从社交网络招募 应用以及在南佛罗里达和旧金山弗朗西斯科的PrEP临床服务。满足以下条件的参与者 在现场基线评估时的入选和排除标准将提供干血斑（DBS） 样本将被储存以测量TFV-DP水平，并开始3个月的基于智能手机的CM， 包括每周完成最多4次直接观察的PrEP剂量（共48剂）的经济奖励 3个月）。参与者将完成一个磨合期（等待期），他们将完成4 在随机化之前直接观察基于智能手机的CM PrEP剂量。在单独的随机化访视时， 240名受试者（120名来自南佛罗里达和120名来自旧金山弗朗西斯科）将随机接受他们的第一次单独治疗 提供ARTEMIS积极情感干预或注意力控制课程。所有5个单独交付 将在3个月CM干预期间提供干预会话。后续评估将 在开始CM后3、6和12个月进行，收集DBS以测量6和12个月时的TFV-DP 个月与NIH OAR的“降低HIV/AIDS发病率”的高优先领域一致， 研究将为有限公共卫生资源的有针对性的部署提供有意义的信息， PrEP在使用兴奋剂的MSM中前所未有的临床和公共卫生益处， 降低艾滋病毒感染率。

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.