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

追求一站式服务：针对注射吸毒者的全面减少远程伤害的混合 1 型有效性实施试验

• 批准号: 10680988
• 负责人: Tyler Scott Bartholomew
• 金额: $ 65.99万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10680988
• 关键词: AIDS prevention; Academic Medical Centers; Address; Adherence; Adoption; Affect; Anti-Retroviral Agents; Award; Bacterial Infections; Blood; Buprenorphine; COVID-19 pandemic; Caring; Clinic; Clinical effectiveness; Communities; Comprehensive Health Care; Cost Effectiveness Analysis; Data; Development; Diagnosis; Discrimination; Disease Outbreaks; Drug Screening; Drug usage; Drug user; Dryness; Economics; Effectiveness; Effectiveness of Interventions; Enrollment; Environment; Epidemic; Evaluation; Evidence based intervention; Foundations; Future; Goals; HIV; HIV Infections; HIV risk; HIV/HCV; Harm Reduction; Health; Healthcare Systems; Hepatitis C; Hepatitis C virus; Human immunodeficiency virus test; Hybrids; Infection; Injecting drug user; Institution; Interdisciplinary Study; Intervention; Interview; Methods; Modality; Modeling; Naloxone; National Institute of Drug Abuse; Needle-Exchange Programs; Opioid; Overdose; Participant; Persons; Pharmaceutical Preparations; Policies; Population; Positioning Attribute; Practical Robust Implementation and Sustainability Model; Randomized; Randomized, Controlled Trials; Research; Services; Sexually Transmitted Diseases; Site; Spottings; Stimulant; Substance Use Disorder; Surveys; Syringes; Tenofovir; Testing; Trust; Urine; Viral; Work; acceptability and feasibility; antiretroviral therapy; care outcomes; care systems; coronavirus disease; cost effective; cost effectiveness; economic evaluation; effectiveness-implementation RCT; effectiveness/implementation trial; efficacy evaluation; efficacy testing; evidence base; experience; follow-up; health care model; implementation barriers; implementation evaluation; implementation process; implementation/effectiveness; injection drug use; innovation; medication for opioid use disorder; meetings; models and simulation; novel; opioid epidemic; overdose education; patient navigation; peer; perceived discrimination; pilot test; poor health outcome; pre-exposure prophylaxis; prevent; prevention service; primary outcome; process evaluation; recruit; response; scale up; screening; secondary outcome; social; social disparities; social stigma; standard of care; substance use; telehealth; uptake

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.

摘要 注射毒品者（PWID）仍然是《终止艾滋病毒流行： 美国（EHE），11%的新艾滋病毒感染可归因于注射毒品使用（IDU）。IDU导致了多个 最近在美国爆发的艾滋病毒，主要是由于持续的阿片类药物和兴奋剂危机， 通过以下4个支柱实现到2030年将艾滋病毒感染事件减少90%的EHE目标的障碍： 诊断、治疗、预防和应对。EHE已经确定了这些支柱内的循证干预措施， 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。最大化和 扩大这些干预措施在PWID中的有效性，区分，简化，整合， 需要开发、测试和部署全面的医疗保健模式， 消除污名化的环境，同时解决艾滋病毒药物使用障碍（SUD）的关键驱动因素。 除了艾滋病毒，PWID继续受到丙型肝炎等多种有害健康状况的影响 病毒（HCV），过量，细菌感染和性传播感染（STI），由于结构，经济， 社会和政策限制。残疾人经常遭受歧视、耻辱和相当大的社会影响。 不利因素，导致几乎普遍的健康结果比没有 注射毒品对创新、有效、可扩展和社区驱动的医疗保健模式的需求， 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）：一个基于远程保健的，多成分的，适应性的护理模式，为PWID艾滋病毒感染者。建筑 在这项工作中，我们现在寻求快速调整和测试综合THR（C-THR），以用于综合艾滋病毒 通过SSP提供预防服务。我们提出了一个混合型I型有效性实现随机 对照试验（n=350），评价C-THR模型与场外转诊和同行导航的有效性， 预防艾滋病毒（即，PrEP或OUD药物）。PWID将从学术界招募 佛罗里达州迈阿密（IDEA迈阿密）基于医疗中心的固定和移动的注射器服务计划（SSP SSP模式。本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，增加了对艾滋病毒预防的参与，（2）检查 C-THR模型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SSP设置中的可扩展性。共同的主要结果是替诺福韦对干血斑 或丁丙诺啡在随访3、6、9和12个月时的尿液药物筛查中。次要结局将包括 参与HIV/HCV/STI检测和HCV持续病毒学应答（SVR，治愈）。代价- 有效性分析、长期建模、混合方法实施和可扩展性评估将 提供关于C-THR对艾滋病毒综合预防的可持续性和可能影响的令人信服的数据 在COVID时代及以后通过SSP交付。