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.

抽象的 注射毒品（PWID）的人仍然是艾滋病毒流行病的高优先级人群：计划 美国（EHE）有11％的新艾滋病毒感染归因于注射药物使用（IDU）。 idu导致了多个 最近，美国艾滋病毒爆发的爆发主要是由正在进行的阿片类药物和兴奋性犯罪驱动的 到2030年通过4支支柱降低艾滋病毒感染的艾滋病毒感染的目标是达到90％的目标的障碍 - 诊断，治疗，预防和反应。 EHE确定了这些支柱中的循证干预措施， 包括快速艾滋病毒测试，抗逆转录病毒，全面注射器服务计划（SSP），并准备 需要在受艾滋病毒影响最大的社区内实施，缩放和维持。最大化和 将这些干预措施的有效性扩展到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型， 简单地解决艾滋病毒的关键驱动力的命运环境（SUD）。 除HIV外，PWID继续受到无数有害健康状况（例如丙型肝炎）的影响 病毒（HCV），过量，细菌感染和性传播感染（STIS），由于结构，经济，经济， 社会和政策限制。 PWID经常经历歧视，污名和相当大的社会 劣势，导致几乎普遍的健康状况比没有 注入药物。需要创新，高效，可扩展和社区驱动的医疗模型 对PWID的命运设置至关重要。我们的团队领导了Teletharm的开发和测试 减少（THR）：一种基于远程医疗的，多组分的自适应护理模型，用于艾滋病毒的生活。建筑 在这项工作中，我们现在寻求迅速适应和测试全面的艾滋病毒（C-THR） 通过SSP提供的预防服务。我们提出了随机的I型I型有效性实施 对照试验（n = 350）评估C-THR模型的效率与现场转介和同行导航的效率 参与预防艾滋病毒（即，OUD的药物或药物）。 PWID将从学术中招募 位于佛罗里达州迈阿密市的医疗中心注射器服务计划（SSP）（迈阿密的想法）和移动 SSP模式。拟议的研究有三个总体目标：（1）确定C-THR模型是否是否 与异地转介和同行导航相比，增加了预防艾滋病毒的参与度，（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 在潜水员SSP设置中C-THR模型的可伸缩性。联合主要结果是干血点上的替诺福韦 或尿液药物筛查上的丁丙诺啡在3、6、9和12个月的随访中。次要结果将包括 参与HCV的HIV/HCV/STI测试和持续的病毒学反应（SVR，治疗）。成本 - 有效分析，长期建模和混合方法的实施和可伸缩性评估将 提供有关C-THR对综合艾滋病毒预防的可持续性和可能影响的令人信服的数据 通过SSP在Covid时代及以后交付。