Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
BMJ Open. 2023 Oct 21;13(10):e079585. doi: 10.1136/bmjopen-2023-079585.
To end the HIV epidemic in Philadelphia, implementation of evidence-based practices (EBP) to increase viral suppression and retention in HIV care is critical. Managed problem solving (MAPS), an EBP for antiretroviral therapy adherence, follows a problem-solving approach to empower people living with HIV (PWH) to manage their health. To overcome barriers to care experienced by PWH in Philadelphia, the EBP was adapted to include a focus on care retention and delivery by community health workers (CHWs). The adapted intervention is MAPS+. To maximise the clinical impact and reach of the intervention, evaluation of the effectiveness and implementation of MAPS+ is necessary.
This manuscript describes the protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial in 10 clinics in Philadelphia. This research incorporates innovative approaches to accomplish three objectives: (1) to evaluate the effectiveness of the CHW-led MAPS+ intervention to improve viral suppression and retention in care 1 year after the individual implementation period (N=390 participants), (2) to examine the effect of the menu of implementation strategies on reach and implementation cost and (3) to examine processes, mechanisms, and sustainment of the implementation strategies for MAPS+ (N=56 participants). Due to various factors (eg, COVID-19), protocol modifications have occurred.
The institutional review board (IRB) at the city of Philadelphia serves as the primary IRB; initial approval was granted on 21 December 2020. The University of Pennsylvania and Northwestern University executed reliance agreements. A safety monitoring committee comprised experts in implementation science, biostatistics and infectious diseases oversee this study. This research will offer insights into achieving the goals to end the HIV epidemic in Philadelphia as well as implementation efforts of MAPS+ and other behavioural interventions aimed at increasing medication adherence and retention in care. Dissemination will include deliverables (eg, peer-reviewed manuscripts and lay publications) to reach multiple constituents.
NCT04560621.
要想在费城终结艾滋病疫情，实施提高艾滋病毒感染者抗病毒治疗成功率和保留率的循证实践（EBP）至关重要。管理式问题解决（MAPS）是一种用于提高抗逆转录病毒治疗依从性的 EBP，它采用问题解决方法，赋予艾滋病毒感染者（PLWH）管理自身健康的能力。为了克服费城 PLWH 所面临的各种护理障碍，该 EBP 进行了调整，纳入了重点关注社区卫生工作者（CHW）保留和提供护理的内容。调整后的干预措施称为 MAPS+。为了最大限度地提高干预措施的临床效果和覆盖面，有必要对 MAPS+ 的有效性和实施情况进行评估。
本研究描述了在费城 10 家诊所进行的一项基于 STEPWISE 楔形集群随机 2 型混合有效性实施试验的方案。该研究采用了创新方法来实现三个目标：（1）评估 CHW 主导的 MAPS+干预措施的有效性，以提高接受个人实施阶段后 1 年内的病毒抑制率和保留率（共 390 名参与者）；（2）研究实施策略菜单对覆盖范围和实施成本的影响；（3）检验 MAPS+实施策略的实施过程、机制和维持情况（共 56 名参与者）。由于各种因素（例如 COVID-19），方案进行了修改。
费城的机构审查委员会（IRB）作为主要的 IRB；最初的批准是在 2020 年 12 月 21 日授予的。宾夕法尼亚大学和西北大学签署了相互依赖协议。一个由实施科学、生物统计学和传染病学专家组成的安全监测委员会监督这项研究。这项研究将为实现终结费城艾滋病疫情的目标以及 MAPS+和其他旨在提高药物依从性和保留率的行为干预措施的实施工作提供参考。传播将包括可交付成果（例如，同行评议的论文和通俗出版物），以覆盖多个利益相关者。
NCT04560621。
