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“达到零”的巨大努力，但注射毒品的人的新艾滋病毒感染是 增加。甲基苯丙胺是这种增加的主要驱动力，因为使用甲基苯丙胺 广泛的证明是增加了性和注射相关的HIV传播。甲基苯丙胺 使用也与较差的药物依从性有关，使使用甲基苯丙胺的艾滋病毒患者 实际上不太可能被抑制。当今可用的最强大的预防艾滋病毒的工具，此外 积极地治疗艾滋病毒携带者以确保病毒抑制，是预防前的预防 （PREP）与Emtritebine加替诺福韦产品（例如FTC/TAF）。准备已被广泛证明 减少足够量的艾滋病毒感染，通常定义为每周≥4剂。中心 对于疾病控制和其他卫生机构，建议注射药物的人做准备，但是有 在临床试验，实施研究和 示范项目。缺乏关注的两个主要原因是（1）注射器访问程序， 在可用的地方，是通过注射降低艾滋病毒传播的强大工具，以及（2）注入毒品的人 - 尤其是使用甲基苯丙胺的人 - 可能会在药物依从性上挣扎。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浪潮）以及全国性的努力 消除HIV传播，注射器访问程序不足以防止其余 在这项研究中，“注入甲基苯丙胺的人的准备干预”（Prime），我们 通过测试合并的依从性干预来解决第二个问题的建议。 Prime是两臂 试用将标准化咨询与直接观察的视频咨询与实时意外情况进行比较 管理（VDOT-CM），以遵守每日一次Emtricitabine/Tenofovir Alafenamide（FTC/TAF）准备 在注射甲基苯丙胺的人中。我们将随机注射甲基苯丙胺的140名成年人是 HIV阴性，最近一次对VDOT-CM或仅咨询持续24周就从事HIV风险行为。 这两个小组都将获得准备和咨询以支持准备依从性；干预条件也将 接收一个视频记录每日准备使用和标称应急管理的手机应用程序 激励完成观察到的准备剂量。我们将通过测试将依从性在两个武器中进行准备 替诺福韦过磷酸盐（TFV-DP）的干血点≥950fmol/punch，对应于≥4剂量 每周。我们将通过定性访谈和调查评估该人群中的PREP的可接受性 项目。最后，我们将在准备之前将注射和性风险行为与预备行为进行比较， 评估风险补偿。研究结果将为PREP提供密集依从性支持提供关键数据 在注射甲基苯丙胺的人中，艾滋病毒传播的风险很高。