Bourdeau Beth, Rebchook Greg, Shade Starley B, O'Shea Jesse, Buchacz Kate, Harris Orlando, Johnson Mallory O, Palomares Michelle, Bolton Alicia T, Van Nuys Jonathan, Moore Erin, Saberi Parya
Medicine, University of California San Francisco, San Francisco, California, USA
Medicine, University of California San Francisco, San Francisco, California, USA.
BMJ Open. 2025 Aug 5;15(8):e097921. doi: 10.1136/bmjopen-2024-097921.
There is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), with many conveniences for uptake and persistence. However, both patients and clinicians have expressed important barriers to effective implementation, including concerns about frequent clinic visits and strain on 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-identified and clinician-identified barriers. 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. First, INVITE-Home will design and develop an innovative, theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings, grounded in qualitative evaluation of training barriers and needs of PWH, layperson injectors and clinicians to develop the training. In Aim 2, INVITE-Home will enhance understanding of home-based LAI-ART using the training, by examining implementation and effectiveness of home-based LAI-ART injections.
This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board and the scientific staff of HIV Research Branch, Division of HIV Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, at the Centers for Disease Control and Prevention. Study staff will disseminate findings locally (eg, to partnering clinics, via the UCSF Center for AIDS Prevention Studies' Community Engagement Core), statewide (eg, the California Department of Public Health's Office of AIDS) and nationally at conferences related to HIV.
NCT06488846.
HIV感染者（PWH）对长效注射抗逆转录病毒疗法（LAI-ART）兴趣浓厚，该疗法在接受和持续治疗方面有诸多便利。然而，患者和临床医生都表示在有效实施方面存在重要障碍，包括对频繁门诊就诊的担忧以及门诊资源紧张的问题。由经过培训的非专业注射者（如患者的家人、朋友或伴侣）进行LAI-ART注射有助于缓解一些患者和临床医生所指出的障碍。替代性的LAI-ART给药方法有可能增强PWH和非专业注射者的信心、自主权、便利性、隐私性及自我管理技能，并最终促进LAI-ART的接受和持续治疗。
INVITE-Home（家庭中增强长效注射剂用于HIV治疗的创新给药方式）将通过开展、实施和评估一项全面的、基于理论的培训，以支持经过培训的非专业注射者进行LAI-ART注射，从而助力LAI-ART在非临床环境中的推广。首先，INVITE-Home将设计并开发一种创新的、基于理论的非专业注射者培训，以提高LAI-ART在家庭环境中的可接受性和使用率，该培训基于对PWH、非专业注射者和临床医生的培训障碍及需求的定性评估。在目标2中，INVITE-Home将通过检查家庭LAI-ART注射的实施情况和有效性，利用该培训加深对家庭LAI-ART的理解。
本研究及其方案已获得加利福尼亚大学旧金山分校（UCSF）机构审查委员会以及疾病控制与预防中心国家HIV/艾滋病、病毒性肝炎、性传播疾病和结核病预防中心HIV预防司HIV研究处科研人员的批准。研究人员将在当地（例如向合作诊所，通过UCSF艾滋病预防研究中心的社区参与核心）、全州范围（例如加利福尼亚州公共卫生部艾滋病办公室）以及全国范围内与HIV相关的会议上传播研究结果。
NCT06488846。
