Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers: A Stepped Wedge Hybrid Type II Effectiveness Implementation Trial

项目摘要/摘要 为了实现终止艾滋病毒流行的令人向往的目标(EHE)，循证做法(EBP)增加病毒 镇压必须在全国范围内有效实施。受管问题解决(映射)行为 干预是对HIV感染者(PLWH)行为改变的一种EBP。为了实现这一目标 应用程序，我们利用费城公共卫生部之间的数据到医疗合作伙伴关系 (PDPH)和参与诊所(n=12)，这增强了我们方法的可持续性。我们建议 地图可以由训练有素的社区卫生工作者(CHW)提供。使用CHW交付地图的方式是 根据他们与客户建立信任关系的能力以及在繁忙时转移任务的需要来证明是合理的 诊所。为了解决护理中的留存问题，我们将调整地图，使其也专注于解决问题的活动 为保留护理而量身定做(现在称为MAP+)。卫生福利院将设在诊所，以实施MAP+TO 改善PLWH的病毒抑制和护理保留。数据到护理允许识别哪些人是 失去了护理，并将这些患者与护理联系起来。目前，艾滋病毒护理中的用药依从性和保留率为 不针对数据到护理，因此我们将在此方法的基础上促进识别出院的PLWH 照顾他们，而不是病毒式地压制他们提供地图+。我们的一套实施策略包括以下任务： 将MAP+的交付转移到CHWS，提供CHWS培训和持续支持，并增加 通过标准化协议在CHW和医疗团队之间进行沟通。我们将进行一次混合动力 II型有效性--在12个诊所采用阶梯式楔形整群随机设计进行的实施试验 MAP+与通常护理相比，使用一套我们认为将最好地支持的实施战略 实施。每个诊所将被随机分配到三个实施开始时间中的一个。我们将收集基线 (通常护理)来自每个诊所6个月的数据，随后是MAP+和我们的实施方案 为期12个月的战略，在三个队列中，每个队列4个诊所。目标1将测试MAP+在临床上的有效性 有效性结果，包括病毒抑制(主要)和滞留(次要)。Aim 2将研究 一揽子实施战略对REACH的影响。我们还将衡量实施成本。目标3 将应用定性方法来了解我们实施的过程、机制和维持 接近。我们的结果将指导未来在整个艾滋病毒护理连续体中实施行为EBPS的努力， 与EHE的“治疗”支柱一致，并推动实施服务的科学性，与NIH一致 战略重点。

Project Summary/Abstract To achieve aspirational goals to end the HIV epidemic (EHE), evidence-based practices (EBPs) to increase viral suppression must be implemented effectively nationally. The Managed Problem Solving (MAPS) behavioral intervention is an EBP for behavior change in people living with HIV (PLWH). To accomplish the goals of this application, we leverage a data-to-care partnership between the Philadelphia Department of Public Health (PDPH) and participating clinics (n = 12), which enhances the sustainability of our approach. We propose that MAPS can be delivered by trained Community Health Workers (CHWs). The use of CHWs to deliver MAPS is justified by their ability to develop trusting relationships with their clients and the need for task shifting in busy clinics. In order to also address retention in care, we will adapt MAPS to also focus on problem solving activities tailored toward retention in care (now termed MAPS+). CHWs will be located in clinics to implement MAPS+ to improve viral suppression and care retention in PLWH. Data-to-care allows for identification of people who are lost to care and link these patients back to care. Currently, medication adherence and retention in HIV care are not targeted in data-to-care so we will build on this approach to facilitate the identification of PLWH who are out of care and not virally suppressed to offer them MAPS+. Our set of implementation strategies include task- shifting the delivery of MAPS+ to CHWs, providing the CHWs training and ongoing support, and increasing communication between the CHWs and medical care team via standardized protocols. We will conduct a hybrid type II effectiveness-implementation trial with a stepped-wedge cluster randomized design in 12 clinics to test MAPS+ compared to usual care using a set of implementation strategies that we believe will best support implementation. Each clinic will be randomized to one of three implementation start times. We will collect baseline (usual care) data from each clinic for 6 months, followed by MAPS+ and our package of implementation strategies for 12 months, in three cohorts of 4 clinics each. Aim 1 will test the effectiveness of MAPS+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary). Aim 2 will examine the effect of the package of implementation strategies on reach. We will also measure implementation cost. Aim 3 will apply a qualitative approach to understand processes, mechanisms, and sustainment of our implementation approach. Our results will guide future efforts to implement behavioral EBPs across the HIV care continuum, consistent with the “treat” pillar of EHE, and move the science of implementation services, consistent with NIH strategic priorities.