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

摘要/项目摘要 长效注射抗逆转录病毒疗法(LAI-ART)在患有(PWH)的人中有很高的兴趣， 对于理解和持之以恒有很多便利。而莱雅特则不再需要每天服药和 有可能帮助弥合艾滋病毒护理方面的关键差距，患者表示存在重要障碍 有效执行和担心频繁就诊会加剧耻辱，增加 不想要的披露，并导致他们的日常生活频繁中断。需要去诊所就诊 对于许多人来说，全年多次注射访问在财务和后勤上也是令人望而却步的 并可能扩大现有的医疗保健差距。同样，临床医生担心在国外额外的就诊 常规护理可能会导致错过预约，减少护理参与度，并给患者带来进一步的压力 临床资源有限。由训练有素的非专业注射者(如家人、朋友或 患者的伴侣)可以帮助缓解其中一些患者和临床医生识别的障碍。这一模式 CARE已被成功地用于其他情况，但到目前为止，尚未对其用于艾滋病毒治疗进行评估。 替代LAI-ART注射方法有可能增加PWH和外行注射器的 自信、赋权、便利、隐私和自我管理技能，最终促进莱雅 领悟和坚持。邀请之家(艾滋病毒治疗用长效注射剂的创新管理 在国内的增强)将通过开发， 实施和评估全面的理论培训，以支持LAI的管理-- 由训练有素的外行注射者进行的艺术。在目标1中，我们将设计和开发一种创新的、基于理论的 非专业人员注射者培训，以提高家庭环境中对LAI-ART的接受度和接受度。我们会 定性评估威尔斯亲王医院、非专业注射者和临床医生的培训障碍和需求，以制定 训练。在目标2中，我们将利用 第一阶段，通过检查以家庭为基础的LAART注射的实施和有效性。这项研究将 满足开发替代和分散的LAI-ART交付方法的迫切需求，以减少 吸收和坚持的障碍，增强现实世界的莱雅有效性，减少系统性和 消除结构性不平等，应对临床和政策挑战，弥合艾滋病毒护理方面的关键差距。

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.