Application of Implementation Science approaches to assess the effectiveness of Task-shifted WHO-PEN to address cardio metabolic complications in people living with HIV in Zambia

标题：“应用执行科学方法评估 任务转移的WHO PEN处理心脏代谢性并发症的有效性 赞比亚的艾滋病毒“ 摘要 该项目的重点是整合以证据为基础的世卫组织基本非传染性疾病一揽子计划 干预(WHO-PEN)管理心血管疾病危险因素和心脏代谢的方法 在赞比亚卢萨卡，将艾滋病毒并发症纳入艾滋病毒感染者的常规护理环境。在形成过程中 在该项目的UG3阶段，我们成功地使WHO-PEN适应赞比亚的国家艾滋病毒方案 本地数据和实施科学理论，并创建了多组件、基于证据的干预 我们创造了“TASKPEN”一词。TASKPEN解决患有心脏代谢疾病的艾滋病毒患者面临的挑战 与艾滋病毒或其治疗有关的合并症或并发症，旨在改进检测和管理 心脏代谢性非传染性疾病(NCD)对艾滋病毒携带者的不成比例影响 赞比亚。TASKPEN循证要素包括：艾滋病毒和心脏代谢性疾病的一站式服务 保健；基于世卫组织PEN的卫生工作者指南、培训材料和治疗算法；实验室 提供心脏代谢性非传染性疾病筛查和诊断测试服务；以及加强非传染性疾病药物治疗 供应链。TASKPEN通过采用以下总体实施战略交付这些组件 临床服务整合和任务转移、实践促进、服务变更的子组件策略 适应高血压、糖尿病筛查和治疗的有形基础设施和设备 糖尿病和血脂异常。我们的总体策略和子组件策略将使护士和社区 卫生工作者在常规艾滋病毒临床环境中为这些疾病提供综合的循证护理 由实践促进者提供的支持和国家电子系统中嵌入的非传染性疾病决策支持工具 医疗记录。因为TASKPEN的各个组件已经被赞比亚国家推荐 根据指导方针，TASKPEN套餐将在常规艾滋病毒护理的主持下提供。我们假设 TASKPEN将导致对感兴趣的艾滋病毒和心脏代谢非传染性疾病的双重控制，并改善 次级临床终点，包括心血管疾病风险(由动脉粥样硬化决定 心血管疾病、ASCVD、风险评分)和艾滋病毒携带者的艾滋病毒抑制 作为我们在赞比亚卢萨卡的研究地点的艾滋病毒诊所。为了验证这一假设，我们计划进行一项第二类- 混合有效性-实施阶梯式楔形试验，这是一种准实验设计，允许 在评估实施结果和战略的同时，衡量临床效果。这个 试验结合了几项临床和方法创新，包括首次使用护理点 赞比亚非传染性疾病的诊断，一种全面的临床抽样方法，以对其影响进行概括性的洞察 TASKPEN对整个艾滋病毒护理人群的影响，以及成本效益模型。此外，这项审判还作为 为5名博士后、博士后和博士后实施科学研究员提供实践培训平台 来自赞比亚大学，包括一名从NHLBI获得一项小型研究项目拨款的人。资金 通过本补编申请将支持对UH3成功至关重要的以下领域的战略投资，并 在发生意外费用的情况下：1)建立基本的医疗系统构建块， TASKPEN介绍；2)通过留住现有的、受过培训的研究人员确保高质量的数据收集；以及3) 为通过该项目指导的五名博士前/博士后研究员提供持续资金。我们希望到2019年年底 在该项目中，卫生部将考虑更广泛地扩大TASKPEN对赞比亚卫生的干预 我们的研究员将处于有利地位，可以申请独立的NIH D43或K43资金。

TITLE: Administrative Supplement for “Application of implementation science approaches to assess the effectiveness of task-shifted WHO PEN to address cardiometabolic complications in people living with HIV in Zambia” ABSTRACT This project focuses on integrating the evidence-based WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach to managing cardiovascular disease risk factors and cardiometabolic complications of HIV into routine care settings for persons living with HIV in Lusaka, Zambia. During the formative UG3 phase of the project, we successfully adapted WHO-PEN for the national HIV program in Zambia using local data and implementation science theory and created a multi-component, evidence-based intervention that we have coined “TASKPEN”. TASKPEN addresses challenges faced by HIV patients who have cardiometabolic comorbidities or complications related to HIV or its treatment, and aims to improve detection and management of cardiometabolic non-communicable diseases (NCDs) that disproportionately affect people living with HIV in Zambia. TASKPEN evidence-based components include: a “one-stop shop” for HIV and cardiometabolic disease care; guidelines, training materials, and treatment algorithms for health workers based on WHO PEN; laboratory services for screening and diagnostic testing of cardiometabolic NCDs; and a strengthened NCD medication supply chain. TASKPEN delivers these components by employing an overarching implementation strategy of clinical service integration and sub-component strategies of task-shifting, practice facilitation, and changing of physical infrastructure and equipment to accommodate screening and treatment of hypertension, diabetes mellitus, and dyslipidemia. Our overarching and sub-component strategies will enable nurses and community health workers to deliver integrated, evidence-based care for these conditions in routine HIV clinical settings with support provided by practice facilitators and NCD decision support tools imbedded in the national electronic medical record. As the individual components of TASKPEN are already recommended by Zambia national guidelines, the TASKPEN package will be delivered under the auspices of routine HIV care. We hypothesize that TASKPEN will result in dual control of both HIV and cardiometabolic NCDs of interest, and improve secondary clinical endpoints, including cardiovascular disease risk (as determined by the Atherosclerotic Cardiovascular Disease, ASCVD, risk score) and HIV viral suppression for persons living with HIV attending 12 HIV clinics serving as our study sites in Lusaka, Zambia. To test this hypothesis, we plan to conduct a type 2- hybrid effectiveness-implementation stepped-wedge trial, which is a quasi-experimental design that allows for measurement of clinical effectiveness alongside assessment of implementation outcomes and strategies. The trial incorporates several clinical and methodological innovations, including the first use of point-of-care diagnostics for NCDs in Zambia, a total clinic sampling approach to make generalizable insights into the impact of TASKPEN on the entire HIV care population, and cost-effectiveness modeling. In addition, the trial serves as a hands-on training platform for five pre-doctoral, doctoral, and post-doctoral implementation science fellows from the University of Zambia, including a recipient of a small research program grant from NHLBI. The funding requested via this supplement will support strategic investment in the following areas critical to UH3 success and where unexpected expenses were incurred: 1) putting in place basic health system building blocks required for TASKPEN introduction; 2) ensuring quality data collection by retaining existing, trained study staff; and 3) sustaining funding for five pre/post/doctoral fellows mentored through the project. Our hope is that by the end of the project, the Ministry of Health will consider wider scale-up of the TASKPEN intervention in the Zambian health system, and that our fellows will be well-positioned to apply for independent NIH D43 or K43 funding.