PDF(Pubmed)
Abstract：
BACKGROUND: Approval of the first long-acting injectable antiretroviral therapy (LAI ART) medication heralded a new era of HIV treatment. However, the years since approval have been marked by implementation challenges. The \"Accelerating Implementation of Multilevel Strategies to Advance Long-Acting Injectable for Underserved Populations (ALAI UP Project)\" aims to accelerate the systematic and equitable delivery of LAI ART.
METHODS: We coded and analysed implementation barriers according to the Consolidated Framework for Implementation Research (CFIR) domains, desired resources and programme goals from questionnaire short-answer responses by clinics across the United States responding to ALAI UP\'s solicitation to participate in the project between November 2022 and January 2023.
RESULTS: Thirty-eight clinics responded to ALAI UP\'s solicitation. The characteristics of LAI ART as an innovation (cost, complexity of procurement, dosing interval, limited eligibility) precipitated and interacted with barriers in other CFIR domains. Barriers included obtaining coverage for the cost of medication (27/38 clinics) (outer setting); need for new workflows and staffing (12/38) and/or systems to support injection scheduling/coordination (16/38), transportation and expanded clinic hours (13/38) (inner setting); and patient (10/38) and provider (7/38) education (individuals). To support implementation, applicants sought: technical assistance to develop protocols and workflows (18/38), specifically strategies to address payor challenges (8/38); additional staff for care coordination and benefits navigation (17/38); opportunities to share experiences with other implementing clinics (12/38); patient-facing materials to educate and increase demand (7/38); and support engaging communities (6/38). Clinics\' LAI ART programme goals varied. Most prioritized delivering LAI ART to their most marginalized patients struggling to achieve viral suppression on oral therapy, despite awareness that current US Food and Drug Administration approval is only for virally suppressed patients. The goal for LAI ART reach after 1 year of implementation ranged from ≤10% of patients with HIV on LAI ART (17/38) to ≥50% of patients (2/38).
CONCLUSIONS: Diverse clinic types are interested in offering LAI ART and most aspire to use LAI ART to support their most vulnerable patients sustain viral suppression. Dedicated resources centred on equity and relevant to context and population are needed to support implementation. Otherwise, the introduction of LAI ART risks exacerbating, not ameliorating, health disparities.
METHODS: We coded and analysed implementation barriers according to the Consolidated Framework for Implementation Research (CFIR) domains, desired resources and programme goals from questionnaire short-answer responses by clinics across the United States responding to ALAI UP\'s solicitation to participate in the project between November 2022 and January 2023.
RESULTS: Thirty-eight clinics responded to ALAI UP\'s solicitation. The characteristics of LAI ART as an innovation (cost, complexity of procurement, dosing interval, limited eligibility) precipitated and interacted with barriers in other CFIR domains. Barriers included obtaining coverage for the cost of medication (27/38 clinics) (outer setting); need for new workflows and staffing (12/38) and/or systems to support injection scheduling/coordination (16/38), transportation and expanded clinic hours (13/38) (inner setting); and patient (10/38) and provider (7/38) education (individuals). To support implementation, applicants sought: technical assistance to develop protocols and workflows (18/38), specifically strategies to address payor challenges (8/38); additional staff for care coordination and benefits navigation (17/38); opportunities to share experiences with other implementing clinics (12/38); patient-facing materials to educate and increase demand (7/38); and support engaging communities (6/38). Clinics\' LAI ART programme goals varied. Most prioritized delivering LAI ART to their most marginalized patients struggling to achieve viral suppression on oral therapy, despite awareness that current US Food and Drug Administration approval is only for virally suppressed patients. The goal for LAI ART reach after 1 year of implementation ranged from ≤10% of patients with HIV on LAI ART (17/38) to ≥50% of patients (2/38).
CONCLUSIONS: Diverse clinic types are interested in offering LAI ART and most aspire to use LAI ART to support their most vulnerable patients sustain viral suppression. Dedicated resources centred on equity and relevant to context and population are needed to support implementation. Otherwise, the introduction of LAI ART risks exacerbating, not ameliorating, health disparities.
摘要：
背景：第一种长效注射抗逆转录病毒疗法（LAIART）药物的批准预示着HIV治疗的新纪元。然而,自批准以来的几年里，实施方面面临挑战。“加速实施多层次战略，为服务不足的人群推进长效注射（ALAIUP项目）”旨在加速LAIART的系统和公平交付。
方法：我们根据实施研究综合框架（CFIR）领域对实施障碍进行了编码和分析，所需的资源和计划目标来自美国各地诊所对ALAIUP在2022年11月至2023年1月期间参与该项目的邀请的问卷简答答复。
结果：38个诊所回应了ALAIUP的邀请。LAI艺术作为创新的特点(成本，采购的复杂性，给药间隔,有限的资格)沉淀并与其他CFIR领域的障碍相互作用。障碍包括获得药物费用的覆盖范围(27/38诊所)(外部环境)；需要新的工作流程和人员配备(12/38)和/或支持注射计划/协调的系统(16/38)，交通和扩大门诊时间（13/38）（内部设置）；以及患者（10/38）和提供者（7/38）教育（个人）。为了支持实施，申请人寻求:制定协议和工作流程的技术援助(18/38)，特别是应对付款人挑战的策略(8/38);增加护理协调和福利导航人员(17/38);与其他实施诊所分享经验的机会(12/38);面向患者的材料,以教育和增加需求(7/38);支持参与社区(6/38)。诊所\'LAIART计划目标各不相同。最优先为他们最边缘化的患者提供LAIART，这些患者努力通过口服治疗实现病毒抑制，尽管意识到目前美国食品和药物管理局的批准仅适用于病毒抑制的患者。实施1年后，LAIART的目标范围从≤10％的LAIART患者（17/38）到≥50％的患者（2/38）。
结论：不同类型的诊所对提供LAIART感兴趣，并且最渴望使用LAIART来支持其最脆弱的患者维持病毒抑制。需要以公平为中心并与环境和人口相关的专用资源来支持实施。否则,LAIART的引入风险加剧，没有改善，健康差异。
方法：我们根据实施研究综合框架（CFIR）领域对实施障碍进行了编码和分析，所需的资源和计划目标来自美国各地诊所对ALAIUP在2022年11月至2023年1月期间参与该项目的邀请的问卷简答答复。
结果：38个诊所回应了ALAIUP的邀请。LAI艺术作为创新的特点(成本，采购的复杂性，给药间隔,有限的资格)沉淀并与其他CFIR领域的障碍相互作用。障碍包括获得药物费用的覆盖范围(27/38诊所)(外部环境)；需要新的工作流程和人员配备(12/38)和/或支持注射计划/协调的系统(16/38)，交通和扩大门诊时间（13/38）（内部设置）；以及患者（10/38）和提供者（7/38）教育（个人）。为了支持实施，申请人寻求:制定协议和工作流程的技术援助(18/38)，特别是应对付款人挑战的策略(8/38);增加护理协调和福利导航人员(17/38);与其他实施诊所分享经验的机会(12/38);面向患者的材料,以教育和增加需求(7/38);支持参与社区(6/38)。诊所\'LAIART计划目标各不相同。最优先为他们最边缘化的患者提供LAIART，这些患者努力通过口服治疗实现病毒抑制，尽管意识到目前美国食品和药物管理局的批准仅适用于病毒抑制的患者。实施1年后，LAIART的目标范围从≤10％的LAIART患者（17/38）到≥50％的患者（2/38）。
结论：不同类型的诊所对提供LAIART感兴趣，并且最渴望使用LAIART来支持其最脆弱的患者维持病毒抑制。需要以公平为中心并与环境和人口相关的专用资源来支持实施。否则,LAIART的引入风险加剧，没有改善，健康差异。
