Integrating Long-Acting Injectable Treatment to Improve Medication Adherence among Persons Living with HIV and Opioid Use Disorder

摘要 艾滋病毒和OUD的治疗服务历来是在多个环境中提供的 导致护理分散和不协调。行为改变模型表明， 通过综合的、基于证据的、 干预措施有可能克服传统障碍，以优化参与， 改善临床结果。与这一观点相一致，许多研究 记录了在艾滋病毒护理背景下接受阿片类激动剂治疗与 坚持抗逆转录病毒疗法和降低艾滋病毒载量。药理学最新进展 已经导致了新的长效，注射，（LAI）药物的发展，艾滋病毒 （卡替拉韦与利匹韦林共同给药）和OUD（缓释丁丙诺啡）。 这些疗法有可能通过消除需要， 每天吃药尽管有广泛的证据基础支持LAI用于HIV和OUD， 和支持综合护理提供的临床指南，目前对1） 将HIV和OUD治疗结合到单一治疗点的可接受性/可行性/安全性 B）这些药物可能在哪些人群和哪些类型的环境中使用 （c）哪些因素可能阻碍或促进这些措施的未来实施 治疗。因此，拟议应用的目标是推进综合处理 通过对目标人群进行形成性研究， 利益相关者制定临床方案，以指导LAI联合治疗的实施; 评估这种综合交付模式的可行性、可接受性和安全性;并评估 优化可扩展性潜力的因素。这项研究将通过两个 主要目的：（1）制定临床方案，指导联合LAI治疗HIV， 通过对潜在患者、临床内容专家和 其他关键利益相关者。(2)对拟定的临床方案进行开放性试点测试， 在诊断为HIV和OUD的患者中评估可行性、可接受性和安全性。 在研究的所有阶段，我们将同时收集患者的信息， 供应商和组织层面的变量，以告知未来的实施。时发现的问题 研究将用于开发R 01应用程序，以进行全动力混合动力1型 可行性-实施研究设计。

ABSTRACT Treatment services for HIV and OUD have historically been delivered across multiple settings leading to fragmented and uncoordinated care. Models of behavior change suggest that addressing multiple health conditions simultaneously through integrated, evidence-based, interventions has the potential to overcome traditional barriers to optimize engagement and improve clinical outcomes. Consistent with this perspective, numerous studies have documented that receipt of opioid agonist treatment, in the context of HIV care, is associated with ART adherence and decreased HIV viral loads. Recent pharmacological advancements have led to the development of novel long-acting, injectable, (LAI) medications for both HIV (cabotegravir co-administered with rilpivirine) and OUD (extended-release buprenorphine). These therapies have the potential to dramatically improve adherence by eliminating the need for daily pill-taking. Despite the extensive evidence base supporting LAI for both HIV and OUD, and clinical guidelines supporting integrated care provision, currently little is known about 1) the perceived acceptability/feasibility/safety of combining HIV and OUD treatment into a single point of care; b) which populations and within which type of settings these medications may be optimally delivered; and c) what factors may impede or facilitate future implementation of these treatments. Therefore, the goal of the proposed application is to advance integrated treatment for HIV and OUD by conducting formative research with the target population and key stakeholders to develop a clinical protocol to guide the delivery of combined LAI treatment; evaluate the feasibility, acceptability, and safety of this integrated delivery model; and assess factors to optimize the potential for scalability. The study will be accomplished through two primary aims: (1) Develop a clinical protocol to guide the delivery of combined LAI for HIV and OUD by conducting in-depth interviews with prospective patients, clinical content experts, and other key stakeholders. (2) Conduct an open pilot test of the proposed clinical protocol to assess feasibility, acceptability, and safety among patients diagnosed with HIV and OUD. Throughout all phases of the study, we will simultaneously collect information on patient-, provider-, and organizational-level variables to inform future implementation. Findings from this study will be used to develop a R01 application to conduct a fully-powered Hybrid Type 1 Effectiveness-Implementation study design.