RFA-PS-23-004, Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home (INVITE-Home)

RFA-PS-23-004，长效注射剂的创新管理，用于在家加强艾滋病毒治疗（INVITE-Home）

• 批准号: 10795542
• 负责人: Parya Saberi
• 金额: $ 100万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2027-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10795542
• 关键词: RFA; PS; 23; 004; Innovative

ABSTRACT/PROJECT SUMMARY There is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with (PWH), with many conveniences for uptake and persistence. While LAI-ART eliminate the need for daily pill-taking and have the potential to help close critical gaps in HIV care, patients have expressed important barriers to effective implementation and concerns that frequent clinic visits can exacerbate stigma, increase the risk of unwanted disclosure, and lead to frequent disruptions in their daily lives. The need to travel to a clinic for injection visits multiple times throughout the year can also be financially and logistically prohibitive for many patients and can widen existing healthcare disparities. Similarly, clinicians worry that additional visits outside of routine care may lead to missed appointments, decreased engagement in care, and put further strain on limited clinic resources. Administration of LAI-ART by a trained layperson injector (such as family, friend, or partner of the patient) can help mitigate some of these patient- and clinician-identified barriers. This model of care has been used successfully in other contexts, but up to now it has not been evaluated for HIV treatment. Alternative LAI-ART delivery methods have the potential to increase the PWH and layperson injector’s confidence, empowerment, convenience, privacy, and self-management skills, and ultimately facilitate LAI-ART uptake and persistence. INVITE-Home (Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home) will support the expansion of LAI-ART in non-clinical settings by developing, implementing, and evaluating a comprehensive, theory-informed training to support the administration of LAI- ART by a trained layperson injector. In Aim 1, we will design and develop an innovative, theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings. We will qualitatively evaluate training barriers and needs of PWH, layperson injectors, and clinicians to develop the training. In Aim 2, we will enhance understanding of home-based LAI-ART using the training developed in Phase 1, by examining implementation and effectiveness of home-based LAI-ART injections. This study will address a critical need to develop alternative and decentralized LAI-ART delivery methods that can mitigate barriers to uptake and persistence, enhance the real-world LAI-ART effectiveness, reduce systemic and structural inequities, address clinical and policy challenges, and close key gaps in HIV care.

摘要/项目摘要 患有（PWH）的人对长效注射抗逆转录病毒疗法（LAI-ART）非常感兴趣， LAI-ART 消除了每天服药和坚持的需要。 有潜力帮助缩小艾滋病毒护理方面的关键差距，但患者表示了重要的障碍 有效实施，并担心频繁就诊会加剧耻辱感，增加患病风险 不必要的披露，并导致他们的日常生活频繁受到干扰。 对于许多人来说，全年多次注射就诊在经济和后勤方面也可能令人望而却步。 同样，信徒们担心，在其他地方进行额外的就诊可能会扩大现有的医疗保健差距。 常规护理可能会导致错过预约、参与护理，并给患者带来进一步的压力 诊所资源有限，由经过培训的非专业注射者（例如家人、朋友或 患者的伴侣）可以帮助减轻患者和临床医生发现的一些障碍。 护理已在其他情况下成功使用，但迄今为止尚未对艾滋病毒治疗进行评估。 替代性 LAI-ART 注射方法有可能提高 PWH 和非专业注射者的注射率 自信、赋权、便利、隐私和自我管理技能，最终促进 LAI-ART INVITE-Home（用于艾滋病毒治疗的长效注射剂的创新管理） 在家增强）将通过开发、支持 LAI-ART 在非临床环境中的扩展， 实施和评估全面的理论培训，以支持 LAI 的管理 由经过培训的外行注射器进行 ART 在目标 1 中，我们将设计和开发一种基于理论的创新型注射器。 我们将开展外行注射器培训，以提高 LAI-ART 在家庭环境中的接受度和采用率。 定性评估 PWH、非专业注射人员和退伍军人的培训障碍和需求，以开发 在目标 2 中，我们将利用 2017 年开发的培训来增强对家庭 LAI-ART 的理解。 第一阶段，通过检查和实施家庭 LAI-ART 注射的有效性。 满足开发替代性和分散式 LAI-ART 交付方法的迫切需求，该方法可以减轻 吸收和持久性的障碍，提高现实世界 LAI-ART 的有效性，减少系统性和 结构性不平等，解决临床和政策挑战，并缩小艾滋病毒护理方面的关键差距。