PDF(Pubmed)
Abstract：
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.
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.
摘要：
背景：为了结束费城的艾滋病毒流行，实施循证实践(EBP)以增加HIV治疗中的病毒抑制和保留至关重要.托管问题解决(MAPS)，抗逆转录病毒治疗依从性的EBP，遵循解决问题的方法，使艾滋病毒感染者（PWH）能够管理自己的健康。为了克服费城PWH所经历的护理障碍，对EBP进行了调整,将重点放在社区卫生工作者(CHW)的照护保留和分娩上.适应的干预是MAPS+。为了最大限度地提高临床影响和干预的范围，评估MAPS+的有效性和实施是必要的。
方法：本手稿描述了在费城10家诊所进行的阶梯式楔形集群随机2型混合有效性实施试验的方案。这项研究采用了创新的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，以改善个体实施期后1年的病毒抑制和保留（N=390名参与者），（2）检查实施策略菜单对覆盖范围和实施成本的影响；（3）检查过程，机制,和维持MAPS+的实施战略(N=56名参与者)。由于各种因素(例如，COVID-19），协议修改已经发生。
背景：费城的机构审查委员会（IRB）是主要的IRB；初步批准于2020年12月21日获得。宾夕法尼亚大学和西北大学签署了信赖协议。一个安全监控委员会由实施科学专家组成，生物统计学和传染病监督这项研究。这项研究将为实现费城结束艾滋病毒流行的目标以及实施MAPS+和其他行为干预措施提供见解，旨在提高药物依从性和护理保留率。传播将包括可交付物(例如，同行评审的手稿和出版物)，以达到多个组成部分。
背景：NCT04560621。
方法：本手稿描述了在费城10家诊所进行的阶梯式楔形集群随机2型混合有效性实施试验的方案。这项研究采用了创新的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，以改善个体实施期后1年的病毒抑制和保留（N=390名参与者），（2）检查实施策略菜单对覆盖范围和实施成本的影响；（3）检查过程，机制,和维持MAPS+的实施战略(N=56名参与者)。由于各种因素(例如，COVID-19），协议修改已经发生。
背景：费城的机构审查委员会（IRB）是主要的IRB；初步批准于2020年12月21日获得。宾夕法尼亚大学和西北大学签署了信赖协议。一个安全监控委员会由实施科学专家组成，生物统计学和传染病监督这项研究。这项研究将为实现费城结束艾滋病毒流行的目标以及实施MAPS+和其他行为干预措施提供见解，旨在提高药物依从性和护理保留率。传播将包括可交付物(例如，同行评审的手稿和出版物)，以达到多个组成部分。
背景：NCT04560621。
