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

摘要 艾滋病毒和艾滋病的治疗服务历来是通过多种环境提供的。 导致零散和不协调的护理。行为改变的模型表明 通过综合的、基于证据的、 干预措施有可能克服传统障碍，以优化参与和 改善临床结果。与这一观点一致的是，许多研究都 有文件证明，在艾滋病毒护理方面接受阿片激动剂治疗与 随着抗逆转录病毒药物的坚持和艾滋病毒病毒载量的减少。最新药理研究进展 导致了针对HIV和HIV的新型长效、注射(LAI)药物的开发 (卡波替格韦与利培韦林联合应用)和OUD(丁丙诺啡缓释片)。 这些疗法有可能通过消除需要而显著提高依从性。 用于日常服药。尽管有广泛的证据支持LAI对HIV和OUD的作用， 和临床指南支持综合护理提供，目前对1)知之甚少 将艾滋病毒和OUD治疗合并为一个点的感知可接受性/可行性/安全性 护理；b)哪些人群和在什么类型的环境中可以使用这些药物 以最佳方式交付；以及c)哪些因素可能阻碍或促进今后执行这些措施 治疗。因此，拟议应用的目标是推进综合治疗 通过对目标人群和关键人群进行形成性研究 利益相关者制定临床方案，指导LAI联合治疗的实施； 评估此集成交付模式的可行性、可接受性和安全性；并评估 优化可伸缩性潜力的因素。这项研究将通过两个阶段完成 主要目标：(1)制定临床方案，指导艾滋病毒和艾滋病联合LAI的交付 通过对潜在患者、临床内容专家和 其他关键利益相关者。(2)对拟议的临床方案进行开放试点测试，以 评估诊断为HIV和OUD的患者的可行性、可接受性和安全性。 在研究的所有阶段，我们将同时收集关于患者的信息， 提供商和组织级别的变量，以通知未来的实施。由此得出的结论 这项研究将用于开发R01应用程序，以进行全动力混合动力类型1 有效性--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.