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/项目总结 在患有（PWH）的人群中，对长效注射抗逆转录病毒疗法（LAI-ART）的兴趣很高， 许多方便的吸收和持久性。虽然LAI-ART消除了每天服药的需要， 有可能帮助缩小艾滋病毒护理方面的关键差距，但患者表示， 有效执行，并关注频繁的诊所就诊可能加剧耻辱感，增加 不必要的披露，并导致他们的日常生活经常中断。需要前往诊所， 对于许多人来说，一年中多次进行注射访问在经济上和后勤上也是令人望而却步的。 患者，并可能扩大现有的医疗差距。同样，临床医生担心， 常规护理可能导致错过预约，减少护理参与，并进一步增加患者的压力。 有限的诊所资源。由受过训练的外行注射者（如家人、朋友或 患者的伴侣）可以帮助减轻这些患者和临床医生识别的障碍中的一些。这个型号的 在其他情况下也成功地使用了这种护理，但迄今为止尚未对艾滋病毒治疗进行评估。 替代LAI-ART输送方法有可能增加PWH和非专业注射者的 自信、授权、便利、隐私和自我管理技能，并最终促进LAI-ART 吸收和持久性。Invite-Home（艾滋病治疗长效注射剂的创新管理） 家庭增强）将通过开发， 实施和评估一个全面的，理论为基础的培训，以支持管理LAI- 由受过训练的外行注射器进行ART。在目标1中，我们将设计和开发一个创新的，基于理论的 对非专业注射者进行培训，以提高LAI-ART在家庭环境中的可接受性和吸收率。我们将 定性评估PWH、非专业注射者和临床医生的培训障碍和需求， 训练在目的2，我们会利用 第一阶段，通过检查家庭LAI-ART注射的实施和有效性。本研究将 满足开发替代和分散的LAI-ART提供方法的迫切需要， 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 我们的目标是消除结构性不平等，应对临床和政策挑战，缩小艾滋病毒护理方面的关键差距。