Integrated rapid access to HIV prevention program for people who inject drugs (iRaPID)

项目摘要 艾滋病毒在注射吸毒者中的流行一直在下降，但在迅速增长的 随着阿片类药物的流行，社区现在越来越容易受到艾滋病毒传播的影响。最近的艾滋病毒爆发 与药物注射有关的艾滋病毒已进入PWID网络，因此可能扭转数十年的艾滋病毒 预防成功。虽然阿片类激动剂治疗（OAT）和注射器服务计划（SSP）可以减少艾滋病毒感染， 传播、获得和利用这些节目的机会不多或有限;性和 注射相关的艾滋病毒风险在许多PWID中持续存在。将暴露前预防（PrEP）纳入 现有的基于证据的方案（例如，OAT、SSPs）作为加强艾滋病毒 预防艾滋病的工作。然而，尽管PWID是理想的， 候选人和有兴趣开始PrEP。我们正在进行的PWID PrEP依从性试验的数据显示， 初始PrEP资格筛选访视和PrEP启动（通常为1-3周）之间的流失率（43.7%）。 此外，定性访谈表明PrEP交付的偏好，这将减少等待时间或 重复访问完全PrEP处方。这些早期的发现，在其他人的支持下，指导了快速 PrEP启动集成在现有的减少伤害服务中，减少或消除患者，临床医生， 结构性障碍。最近的试点研究结果表明， 快速（同一天）PrEP启动男性与男性发生性关系（MSM）和变性女性（TGW），但 其中没有一个包括PWID，这是一个在当前阿片类药物危机中特别需要的群体。快速PrEP启动 可能对PWID特别重要，因为它们更有可能在治疗开始前丢失。充分 优化艾滋病毒预防，PrEP护理应与OAT相结合。将OAT与ART相结合， 如果他们使用药物，医生将拒绝抗逆转录病毒治疗（ART）;如果患者 OAT、ART处方增加。鉴于研究结果，高级实践护士（APN）更有可能 以病人为中心的方式询问他们的药物使用情况，并提供更多的支持性咨询， 针对PWID的联合、当天PrEP/OAT的差异化护理模式非常适合从APN开始。我们， 因此，建议在一个执行科学框架内开发和试点测试这一模式。具体 目的是：1）目的1：研究PWID和临床利益相关者之间的可行性和可接受性， 针对PWID（iRaPID）的适应性APN交付的快速艾滋病毒预防计划，该计划整合了当天PrEP 和OAT;以及2）目的2：评估PrEP和OAT摄取在试点随机 iRaPID与常规治疗策略在无HIV的PWID中的对照试验。总之，这些目标将 通过消除当天混合药物分发的多层次障碍，弥补艾滋病毒预防方面的巨大差距 预防从成功的PWID当天PrEP/OAT模型中学到的元素可以指导未来的规模扩大 在资源有限的城市和非城市环境中，将APN和医生结合起来的模式。

PROJECT SUMMARY The HIV epidemic among people who inject drugs (PWID) has been on the decline, but amidst a burgeoning opioid epidemic, communities are now increasingly vulnerable to HIV transmission. Recent HIV outbreaks linked to drug injection has introduced HIV into PWID networks and thus, potentially reverse decades of HIV prevention successes. While opioid agonist therapy (OAT) and syringe services programs (SSPs) reduce HIV transmission, access to and utilization of such programs are unavailable or with limited availability; sexual and injection-related HIV risks persist in many PWID. The integration of pre-exposure prophylaxis (PrEP) into existing evidence-based programs (e.g., OAT, SSPs) has been presented as an opportunity to strengthen HIV prevention efforts in PWID. Uptake, however, remains stubbornly low in PWID despite them being ideal candidates and interested in starting PrEP. Data from our ongoing PrEP adherence trial in PWID show high rates of attrition (43.7%) between the initial PrEP eligibility screening visit and PrEP initiation (usually 1-3 weeks). Further, qualitative interviews indicate preferences for PrEP delivery that would decrease waiting times or repeated visits altogether PrEP prescription. These early findings, supported by others, guide the need for rapid PrEP initiation integrated within an existing harm reduction services that reduce or eliminates patient, clinician, and structural barriers. Results from recent pilot studies have shown early acceptability, feasibility, and safety of rapid (same-day) PrEP initiation in men who have sex with men (MSM) and transgender women (TGW), but none of them include PWID, a group with extraordinary need in the current opioid crisis. Rapid PrEP initiation may be particularly important for PWID as they are more likely to be lost before treatment initiation. To fully optimize HIV prevention, PrEP care should be combined with OAT. Combining OAT with ART evolved from physicians who would withhold antiretroviral therapy (ART) from PWID if they were using drugs; if patients were OAT, ART prescription increased. Given the findings that advanced practice nurses (APNs) are more likely to inquire in a patient-centered manner about their drug use and provide more supportive counseling, a new differentiated care model of combined, same-day PrEP/OAT for PWID is well-suited to start with APNs. We, therefore, propose to develop and pilot test this model within an implementation science framework. The specific aims are to: 1) Aim 1: examine feasibility and acceptability among PWID and clinical stakeholders for an adapted APN-delivered, rapid HIV prevention program for PWID (iRaPID) that integrates same-day PrEP and OAT; and 2) Aim 2: estimate the preliminary efficacy of PrEP and OAT uptake in a pilot randomized controlled trial of the iRaPID vs. treatment as usual strategy in PWID without HIV. Together, these aims will address a wide gap in HIV prevention by addressing multilevel barriers to dispensing same-day combination prevention. Elements learned from a successful same-day PrEP/OAT model for PWID can guide future scale-up models that incorporate both APNs and physicians in urban and non-urban settings where resources are limited.