PRIME: PrEP Intervention for people who Inject MEthamphetamine

PRIME：针对注射甲基苯丙胺患者的 PrEP 干预

• 批准号: 10424546
• 负责人: PHILLIP O COFFIN
• 金额: $ 82.89万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10424546
• 关键词: AIDS prevention; Address; Adherence; Adult; Affect; Attention; Blood; Bupropion; Car Phone; Centers for Disease Control and Prevention (U.S.); Client satisfaction; Clinical Trials; Contracts; Counseling; Data; Disease Outbreaks; Dose; Effectiveness; Enrollment; Ensure; Epidemic; Financial compensation; Future; HIV; HIV Infections; HIV Seronegativity; HIV risk; Habits; Health; Incentives; Infection; Injecting drug user; Injections; Intervention; Interview; Life Style; Location; Measures; Methamphetamine; Methamphetamine use disorder; Modeling; Oral; Outcome Measure; Participant; Pattern; Persons; Pharmacology; Population; Questionnaires; Randomized; Randomized Controlled Trials; Records; Reporting; Risk; Risk Behaviors; San Francisco; Sexual Transmission; Spottings; Standardization; Stimulant; Surveys; Syringes; System; Telephone; Tenofovir; Testing; Time; United States; Viral; Visit; adherence rate; aggressive therapy; arm; behavior change; condoms; contingency management; emtricitabine; follow-up; high risk; high risk population; implementation study; improved; injection drug use; interest; medication compliance; methamphetamine use; mobile application; opioid epidemic; pre-exposure prophylaxis; prevent; primary outcome; programs; recruit; sexual HIV transmission; sexual risk behavior; time use; tool; transmission process; trial comparing; two-arm trial; usability; willingness

Project Summary/Abstract Notwithstanding a substantial effort of “getting to zero”, new HIV infections among people who inject drugs are increasing. Methamphetamine is a primary driver of that increase, as methamphetamine use has been extensively demonstrated to increase both sexual and injection-related HIV transmission. Methamphetamine use is also associated with poor medication adherence, such that people with HIV who use methamphetamine are less likely to be virally suppressed. The most powerful tool for prevention of HIV available today, in addition to aggressive treatment of people living with HIV to ensure viral suppression, is pre-exposure prophylaxis (PrEP) with emtricitabine plus a tenofovir product (e.g. FTC/TAF). PrEP has been extensively demonstrated to reduce HIV infection when taken in sufficient amounts, generally defined as ≥4 doses per week. The Centers for Disease Control and other health agencies recommend PrEP for people who inject drugs, yet there has been precious little attention to this population in PrEP clinical trials, implementation studies, and demonstration projects. Two major reasons for this lack of attention are (1) that syringe access programs, where available, are powerful tools to lower HIV transmission by injection, and (2) that people who inject drugs – and in particular people who use methamphetamine – are likely to struggle with medication adherence. In the context of expanding methamphetamine use – as the next wave of the opioid crisis – and a national effort to eliminate HIV transmission, syringe access programs are unlikely to be sufficient to prevent the remaining infections that occur. In this study, “PrEP Intervention for people who Inject Methamphetamine” (PRIME), we propose to address the second concern by testing a combined adherence intervention. PRIME is a two-arm trial comparing standardized counseling to video directly-observed treatment with real-time contingency management (VDOT-CM) for adherence to once-daily emtricitabine/tenofovir alafenamide (FTC/TAF) PrEP among people who inject methamphetamine. We will randomize 140 adults who inject methamphetamine, are HIV-negative, and have recently engaged in HIV risk behaviors to VDOT-CM or counseling alone for 24 weeks. Both groups will receive PrEP and counseling to support PrEP adherence; the intervention condition will also receive a mobile phone app that video records daily PrEP use and a nominal contingency management incentive to complete the observed PrEP dosing. We will compare adherence to PrEP in both arms by testing dried blood spots for tenofovir disphosphate (TFV-DP) levels of ≥ 950 fmol/punch, corresponding to ≥4 doses per week. We will assess acceptability of PrEP in this population through qualitative interviews and survey items. Finally, we will compare injection and sexual risk behaviors prior to PrEP to those while on PrEP, to evaluate for risk compensation. Study results will provide critical data for intensive adherence support for PrEP among people who inject methamphetamine, a very high risk population for HIV transmission.

项目摘要/摘要 尽管做出了实质性的努力，但注射吸毒者中新的艾滋病毒感染人数仍在增加 越来越多。甲基苯丙胺是这一增长的主要驱动力，因为甲基苯丙胺的使用 广泛证明会增加性传播和与注射有关的艾滋病毒传播。甲基苯丙胺 使用也与服药依从性差有关，如艾滋病毒携带者使用甲基苯丙胺 不太可能受到病毒抑制。当今预防艾滋病毒最有力的工具，此外 对艾滋病毒携带者进行积极治疗以确保病毒抑制，是暴露前的预防措施 (PREP)恩曲他滨加替诺福韦产品(如FTC/TAF)。Prep已经被广泛地证明了 在服用足够量的情况下减少艾滋病毒感染，通常定义为每周服用≥4剂。《中心》 疾病控制和其他卫生机构建议注射毒品的人使用PrEP，但有 在PrEP临床试验、实施研究和 示范项目。这种缺乏关注的两个主要原因是(1)注射器访问程序， 在可用的情况下，有强大的工具来降低艾滋病毒通过注射的传播，以及(2)注射毒品的人 -尤其是使用甲基苯丙胺的人-可能会与服药依从性作斗争。在 扩大甲基苯丙胺使用的背景--作为阿片类药物危机的下一波--以及国家努力 消除艾滋病毒传播，获得注射器的方案不太可能足以预防剩余的 发生的感染。在这项名为《注射甲基苯丙胺者的PrEP干预》(Prime)的研究中，我们 建议通过测试联合依从性干预来解决第二个问题。擎天柱是一个双臂的 标准化咨询与实时应急视频直视治疗的试验比较 遵守每日一次恩曲他滨/替诺福韦丙氨酰胺(FTC/TAF)PrEP的管理(VDOT-CM) 注射甲基苯丙胺的人。我们将随机抽取140名注射甲基苯丙胺的成年人 HIV阴性，最近有从事HIV危险行为的VDOT-CM或单独咨询24周。 两组都将接受PrEP和咨询，以支持PrEP的遵守；干预条件还将 收到一个视频记录日常PrEP使用的手机应用程序和名义上的应急管理 完成观察到的PrEP剂量的激励。我们将通过测试来比较两个手臂对PrEP的依从性 替诺福韦二磷酸(TFV-DP)干血斑的≥为950fmol/Pick，对应于≥4剂量 每周。我们将通过定性访谈和调查来评估PrEP在这一人群中的可接受性 物品。最后，我们将比较PrEP之前和PrEP期间的注射和性危险行为，以 评估风险补偿。研究结果将为PrEP的强化坚持支持提供关键数据 在注射甲基苯丙胺的人群中，艾滋病毒传播的风险非常高。