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：
10404091
负责人：
Adam Wayne Carrico
金额：
$ 104.29万
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 2023-07-03
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10404091
关键词：
AIDS prevention AIDS/HIV problem Abstinence Adherence Affect 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 Protocols documentation Psychological adjustment Public Health Randomized Randomized Controlled Trials Regulation Reporting Research Rewards Risk Running San Francisco Site Social Network Specimen Spottings Stimulant Stress and Coping Substance Use Disorder Technology Tenofovir Testing Underserved Population United States National Institutes of Health Viral Load result Visit 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 who have sex with men methamphetamine use novel novel strategies open label pre-exposure prophylaxis prevent preventive intervention primary outcome psychologic recruit secondary outcome sexual minority men stimulant use stimulant withdrawal substance 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.

抽象的在男男性行为者（MSM）中，迫切需要优化前所未有的临床暴露前预防 (PrEP) 对使用兴奋剂的人预防艾滋病毒的公共卫生益处（即甲基苯丙胺、可卡因和快克可卡因）使用兴奋剂的 MSM 的 HIV 感染率提高 3-6 倍。血清转化和新诊断出 HIV 感染的十分之一的 MSM 报告了最近的兴奋剂使用情况。我们团队和其他人的研究也表明，兴奋剂的使用是 PrEP 坚持的一个主要障碍，持续使用兴奋剂的 MSM 脱离 PrEP 护理的比率增加了 3 倍，增加了 5 倍。拟议的多中心随机对照试验 (RCT) 将提高 PrEP 依从性的可能性。利用一种有前景的干预模型，在突发事件期间提供积极的情感干预我们最近证明了管理（CM）实现了持久且具有临床意义的在拟议的多中心随机对照试验中，我们计划减少 HIV+、使用甲基苯丙胺的 MSM 中的病毒载量。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 期间对直接观察的 PrEP 剂量进行积极影响干预在 12 个月内实现更持久地降低 HIV 感染风险。结果）将在替诺福韦二磷酸盐（TFV-DP）水平<700 fmol/次和自我报告最近无套肛交 (CAS) 的 PrEP 中报告有使用兴奋剂和 CAS 的 MSM。过去 3 个月以及过去一个月内任何不遵守 PrEP 的人都将从社交网络中招募南佛罗里达州和旧金山的 PrEP 申请以及 PrEP 临床服务。现场基线评估的纳入和排除标准将提供干血斑 (DBS) 将存储样本以测量 TFV-DP 水平，并开始为期 3 个月的基于智能手机的 CM 包括每周完成最多四次直接观察的 PrEP 剂量的经济激励（总共 48 剂） 3 个月内），参与者将完成磨合期（等待期），在此期间他们将完成 4 项任务。在随机化之前直接观察基于智能手机的 CM PrEP 剂量。 240 名参与者（120 名南佛罗里达州和 120 名旧金山人）将被随机分配获得第一个单独的进行了 ARTEMIS 积极影响干预或注意力控制课程，所有 5 个课程均单独进行。干预课程将在 3 个月的 CM 干预期间进行。在开始 CM 后 3、6 和 12 个月进行，并在 6 和 12 个月收集 DBS 来测量 TFV-DP 与 NIH OAR 的“降低艾滋病毒/艾滋病发病率”的高度优先领域一致，该临床。研究将为有限的公共卫生资源的有针对性的部署提供有意义的信息，以优化 PrEP 对使用兴奋剂的 MSM 具有前所未有的临床和公共卫生益处，这是最优先考虑的问题之一人口减少艾滋病毒发病率。