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

整合长效注射治疗以提高艾滋病毒感染者和阿片类药物使用障碍患者的用药依从性

• 批准号: 10592361
• 负责人: Kirsten Johnson Langdon
• 金额: $ 22.56万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10592361
• 关键词: AIDS prevention; Address; Adherence; Adverse event; Attitude; Behavior; Buprenorphine; Caring; Clinic; Clinical; Clinical Protocols; Criminal Justice; Development; Diagnosis; Disease Progression; Drug usage; Drug user; Effectiveness; Face; Goals; Guidelines; HIV; HIV Infections; HIV risk; Health; Hybrids; Incidence; Individual; Injectable; Intervention; Interview; Jail; Knowledge; Longevity; Measures; Medicine; Modeling; Oral; Outcome; Outpatients; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacy facility; Phase; Population; Prevention; Prisons; Provider; Quality of life; Research; Research Design; Risk; Risk Taking; Safety; Sampling; Services; Substance Use Disorder; System; Target Populations; Testing; Viral; Viral Load result; addiction; antiretroviral therapy; behavior change; community reentry; disorder risk; effectiveness/implementation study; evidence base; future implementation; high risk; implementation barriers; improved; injection drug use; integrated care; interest; medication compliance; medication for opioid use disorder; mortality; multiple chronic conditions; novel; opioid agonist therapy; opioid use; opioid use disorder; pharmacologic; pill; pilot test; point of care; prospective; resistant strain; safety and feasibility; satisfaction; secondary outcome; service utilization; substance use; therapy adherence; therapy development; transmission process; treatment services; uptake; viral resistance

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.

抽象的 HIV 和 OUD 的治疗服务历来在多个环境中提供 导致护理分散且不协调。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，优化参与和 改善临床结果。与这一观点相一致的是，许多研究表明 据记载，在艾滋病毒护理背景下接受阿片类激动剂治疗与 坚持 ART 并减少 HIV 病毒载量。最近的药理学进展 导致了针对艾滋病毒和艾滋病毒的新型长效注射（LAI）药物的开发 （卡博替拉韦与利匹韦林联合给药）和 OUD（缓释丁丙诺啡）。 这些疗法有可能通过消除需要来显着提高依从性 用于每日服药。尽管有大量证据支持 LAI 对 HIV 和 OUD 都有作用， 和支持综合护理提供的临床指南，目前对以下方面知之甚少：1) 将 HIV 和 OUD 治疗结合成一个点的可接受性/可行性/安全性 照顾； b) 这些药物可能适用于哪些人群以及哪种类型的环境 最佳交付； c) 哪些因素可能会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治疗 通过对目标人群和关键人群进行形成性研究，针对艾滋病毒和 OUD 利益相关者制定临床方案来指导 LAI 联合治疗的实施； 评估这种集成交付模式的可行性、可接受性和安全性；并评估 优化可扩展性潜力的因素。该研究将通过两个方面完成 主要目标：(1) 制定临床方案来指导针对 HIV 和艾滋病毒的联合 LAI 的实施 OUD 通过对潜在患者、临床内容专家进行深入访谈， 其他主要利益相关者。 (2) 对拟议的临床方案进行公开试点测试 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，我们将同时收集有关患者的信息， 提供者和组织级别的变量为未来的实施提供信息。由此得出的结论 研究将用于开发 R01 应用程序，以进行全动力混合动力 1 型 有效性-实施研究设计。