Optimizing PrEP adherence in sexual minority men who use stimulants

优化使用兴奋剂的性少数男性的 PrEP 依从性

基本信息

批准号：
10053835
负责人：
Adam Wayne Carrico
金额：
$ 95.17万
依托单位：
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10053835
关键词：
AIDS prevention AIDS/HIV problem Abstinence Adherence Affect Alcohol or Other Drugs use Area Attention Behavior Therapy Behavioral Blood Caring Cellular Phone Chronic stress Clinical Clinical Research Clinical Services Cocaine Coping Skills Crack Cocaine Diphosphates Dose Effectiveness Epidemic Evidence based intervention Exclusion Criteria Florida Funding Geographic Locations HIV HIV Infections HIV Seronegativity HIV Seropositivity Happiness Health Benefit Health Resources Health behavior change Human immunodeficiency virus test Incentives Incidence Individual Intervention Measures Mediator of activation protein Methamphetamine Modeling Newly Diagnosed Participant Patient Self-Report Persons Pharmaceutical Preparations Population Population Decreases Prevention Preventive Intervention Protocols documentation Psychological adjustment Public Health Randomized Randomized Controlled Trials Regulation Reporting Research Rewards Risk Running San Francisco Site Social Network Specimen Spottings Stress and Coping Substance Use Disorder Technology Tenofovir Testing Underserved Population United States National Institutes of Health Viral Load result Visit Withdrawal Work attentional control base condomless anal sex contingency management craving efficacy testing evidence base financial incentive follow up assessment gratitude improved inclusion criteria intervention effect men men who have sex with men methamphetamine use novel novel strategies open label pre-exposure prophylaxis prevent primary outcome psychologic recruit secondary outcome sexual minority stimulant use success systematic review theories

项目摘要

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.

抽象的在与男性发生性关系（MSM）的男性中，迫切需要优化前所未有的临床暴露前预防（PREP）的公共卫生益处，以防止使用兴奋剂的人艾滋病毒（即，甲基苯丙胺，可卡因和裂纹可卡因）。使用MSM刺激性显示3-6倍的艾滋病毒速率血清转化和新诊断的HIV感染报告最近使用的刺激性使用的一四分之一的MSM。发现来自我们的团队和其他人也表明，兴奋剂的使用是准备依从性和的关键障碍持久性。刺激性使用MSM的脱离率较高3倍次优的依从性的几率更大。拟议的多站点随机对照试验（RCT）将利用承诺的干预模型，即在意外事件中提供积极的影响干预管理（CM），我们最近证明了实现的耐用和临床意义艾滋病毒+甲基苯丙胺使用MSM的病毒载量减少。在拟议的多站点RCT中，我们计划测试是否提供影响调节治疗以增强药物干预成功（ARTEMIS）基于智能手机的CM期间的积极影响干预，以直接观察到的准备剂量在12个月内，艾滋病毒获取风险的降低更加持久。 HIV获取风险（主要结果）将作为替诺福韦二磷酸（TFV-DP）水平<700 fmol a Punchand and自我自我运行。报道了最近的无避孕套肛交（CAS）。最多300 msm的PREP谁报告了兴奋剂的使用和CAS 过去的3个月以及过去一个月的任何预备都将从社交网络中招募在南佛罗里达州和旧金山的应用以及临床服务。遇到的参与者在面对面评估中的包含和排除标准将提供干血点（DBS）将存储以测量TFV-DP水平并开始基于智能手机的CM的标本包括每周最多可直接观察到的预备剂量的经济激励措施（48剂在三个月中）。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，直接观察到基于智能手机的CM准备剂量。在单独的随机化访问中， 240名参与者（120个南佛罗里达州和120个旧金山）将被随机分别接收他们的第一个提供了Artemis积极影响干预或注意力控制会话。所有5个单独交付干预会议将在3个月的CM干预期内进行。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的TFV-DP 月份。与“减少艾滋病毒/艾滋病事件”的NIH高优先级一致，该临床研究将有意义地告知有限公共卫生资源的有针对性部署，以优化 PREP的前所未有的临床和公共卫生益处在使用刺激性的MSM中，这是优先级之一减少艾滋病毒事件的种群。