PRIME: PrEP Intervention for people who Inject MEthamphetamine

项目总结/摘要 尽管在“实现零感染”方面作出了巨大努力，但注射吸毒者中新的艾滋病毒感染仍在继续。 增加。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一直是 已被广泛证实，这会增加性传播和注射相关的艾滋病毒传播。甲基苯丙胺 使用甲基苯丙胺还与药物依从性差有关，例如使用甲基苯丙胺的艾滋病毒感染者 不太可能被病毒抑制。此外，目前预防艾滋病毒最有力的工具 对艾滋病毒感染者进行积极治疗以确保病毒抑制的另一个途径是暴露前预防 （PrEP）与恩曲他滨加替诺福韦产品（例如FTC/TAF）。PrEP已被广泛证明， 当服用足量时，通常定义为每周≥4剂，可减少HIV感染。中心 疾病控制和其他卫生机构建议为注射毒品的人提供PrEP， 在PrEP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）注射器获取计划， 在可用的情况下，是降低注射艾滋病毒传播的有力工具，（2）注射毒品的人 - 特别是使用甲基苯丙胺的人-可能会与药物依从性作斗争。在 在扩大甲基苯丙胺使用的背景下-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，注射器获取计划不太可能足以防止剩余的 发生的感染。在这项研究中，“注射甲基苯丙胺的人的PrEP干预”（PRIME），我们 建议通过测试联合依从性干预来解决第二个问题。PRIME是一款双臂 标准化咨询与实时应急视频直接观察治疗的比较试验 管理（VDOT-CM），以遵守每日一次恩曲他滨/替诺福韦艾拉酚胺（FTC/TAF）PrEP 注射甲基苯丙胺的人群中我们将随机抽取140名注射甲基苯丙胺的成年人， HIV阴性，最近有HIV危险行为，接受VDOT-CM或单独咨询24周。 两组都将接受PrEP和咨询，以支持PrEP依从性;干预条件也将 接收一个移动的手机应用程序，该应用程序可以视频记录每日PrEP使用情况和名义应急管理 激励完成观察到的PrEP剂量。我们将通过测试比较两组患者对PrEP的依从性 二磷酸替诺福韦酯（TFV-DP）水平≥ 950 fmol/孔的干血斑，对应于≥4剂 的一年我们将通过定性访谈和调查评估PrEP在这一人群中的可接受性 项目.最后，我们将比较注射和性风险行为之前的准备，而对准备， 评估风险补偿。研究结果将为PrEP的强化依从性支持提供关键数据 在注射甲基苯丙胺的人群中，这是艾滋病毒传播的高危人群。

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.