In pursuit of a one-stop shop: a hybrid type 1 effectiveness-implementation trial of comprehensive tele-harm reduction for people who inject drugs

摘要 在结束艾滋病毒流行的计划下，注射吸毒者(PWID)仍然是高度优先的人群： 美国(EHE)有11%的新艾滋病毒感染可归因于注射吸毒(IDU)。IDU导致了多个 最近在美国爆发的艾滋病毒，主要是由持续的阿片类药物和兴奋剂危机推动的，造成了 实现到2030年通过四大支柱将艾滋病毒感染事件减少90%的目标的障碍- 诊断、治疗、预防和应对。EHE已经确定了这些支柱中的循证干预措施， 包括快速艾滋病毒检测、抗逆转录病毒药物、全面的注射器服务计划(SSP)和PrEP 需要在受艾滋病毒影响最严重的社区内实施、扩大和维持。要最大化和 扩大这些干预措施在PWID、差异化、简化、集成和 需要开发、测试和部署全面的医疗保健模式， 消除歧视的环境，同时解决艾滋病毒-物质使用障碍(SUD)的一个关键驱动因素。 除艾滋病毒外，PWID继续受到丙型肝炎等无数有害健康状况的影响 病毒(丙型肝炎病毒)、过量用药、细菌感染和性传播感染(STI)，原因是结构、经济、 社会和政策方面的限制。PWID经常经历歧视、耻辱和相当大的社会 劣势，导致几乎普遍的健康结果比不这样做的可比人群更差 注射毒品。需要创新、高效、可扩展和社区驱动的医疗保健模式 对PWID的去污名化设置至关重要。我们的团队领导了远程伤害的开发和测试 减少(THR)：一种基于远程健康的、多组件的适应性护理模式，适用于患有艾滋病毒的PWID患者。建房 在这项工作中，我们现在寻求快速适应和测试用于全面艾滋病毒的综合苏氨酸(C-Thr) 通过SSP提供的预防服务。我们提出了一种混合的I型有效性--实现随机化 对照试验(n=350)，以评估C-THR模式与异地转诊和同行导航的疗效 参与艾滋病毒预防(即PrEP或OUD的药物)。PWID将从一位学者那里招聘 佛罗里达州迈阿密(IDEA迈阿密)固定和移动医疗中心的注射器服务计划(SSP) SSP模式。拟议研究的总体目标有三个：(1)确定C-THR模型是否 与异地转诊和同行导航相比，提高对艾滋病毒预防的参与度，(2)检查 C-THR模式的长期临床和成本效益，以及(3)评估实施和 C-THR模型在不同的SSP设置中的可扩展性。共同的主要结果是替诺福韦在干血点上 或在随访3、6、9、12个月时进行尿药筛查。次要结果将包括 参与艾滋病毒/丙型肝炎病毒/性传播感染检测和丙型肝炎病毒持续病毒学应答(SVR，CURE)。成本-- 有效性分析、长期建模、混合方法实施和可伸缩性评估 提供令人信服的数据，说明C-THR在全面预防艾滋病毒方面的可持续性和可能产生的影响 在COVID时代及以后通过SSP交付。

ABSTRACT People who inject drugs (PWID) remain a high priority population under the Ending the HIV Epidemic: Plan for America (EHE) with 11% of new HIV infections attributable to injection drug use (IDU). IDU has led to multiple recent outbreaks of HIV in the US, driven primarily by the ongoing opioid and stimulant crises, creating an obstacle in meeting EHE goals of a 90% reduction in incident HIV infections by 2030 through the 4 pillars – diagnose, treat, prevent, and respond. EHE has identified evidence-based interventions within these pillars, including rapid HIV testing, antiretrovirals, comprehensive syringe services programs (SSPs), and PrEP that need to be implemented, scaled, and sustained within communities most affected by HIV. To maximize and extend the effectiveness of these interventions among PWID, differentiated, simplified, integrated, and comprehensive healthcare models need to be developed, tested, and deployed where they are in comfortable, destigmatizing environments that simultaneously address a key driver of HIV—substance use disorder (SUD). In addition to HIV, PWID continue to be impacted by a myriad of harmful health conditions such as hepatitis C virus (HCV), overdose, bacterial infections and sexually transmitted infections (STIs) due to structural, economic, social, and policy constraints. PWID often experience discrimination, stigma, and considerable social disadvantage, leading to almost universal poorer health outcomes than comparable populations who do not inject drugs. The need for innovative, efficacious, scalable, and community-driven models of healthcare in destigmatizing settings for PWID is crucial. Our team has led the development and testing of Tele-Harm Reduction (THR): a telehealth-based, multicomponent, adaptive care model for PWID living with HIV. Building on this work, we now seek to rapidly adapt and test Comprehensive-THR (C-THR) for comprehensive HIV prevention services delivered via an SSP. We propose a hybrid type I effectiveness-implementation randomized controlled trial (n=350) to evaluate the efficacy of the C-THR model vs. offsite referral and peer navigation for engagement in HIV prevention (i.e., PrEP or medications for OUD). PWID will be recruited from an academic medical center-based syringe services program (SSP) in Miami, FL (IDEA Miami) from both fixed and mobile SSP modalities. There are three overall aims of the proposed study: (1) to determine if the C-THR model increases engagement in HIV prevention compared to offsite referral and peer navigation, (2) to examine the long-term clinical and cost-effectiveness of the C-THR model, and (3) to assess the implementation and scalability of the C-THR model in diverse SSP settings. The co-primary outcome is tenofovir on dried blood spot or buprenorphine on urine drug screen across follow-up at 3,6,9 and 12 months. Secondary outcomes will include engagement in HIV/HCV/STI testing and sustained virologic response (SVR, cure) for HCV. The cost- effectiveness analysis, long-term modeling, and mixed-methods implementation and scalability evaluation will provide compelling data on the sustainability and possible impact of C-THR on comprehensive HIV prevention delivered via SSPs in the COVID era and beyond.