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

应用实施科学方法来评估任务转移的 WHO-PEN 解决赞比亚艾滋病毒感染者心脏代谢并发症的有效性

• 批准号: 10817964
• 负责人: Michael Emmanuel Herce
• 金额: $ 17.65万
• 依托单位: CENTRE FOR INFECTIOUS DISEASE RESEARCH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-10 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10817964
• 关键词: Acceleration; Address; Administrative Supplement; Adoption; Affect; Africa South of the Sahara; Algorithms; Anti-Retroviral Agents; Area; Atherosclerosis; Blood Pressure; Cardiometabolic Disease; Cardiovascular Diseases; Caring; Chronic; Clinic; Clinical; Clinical Services; Clinical effectiveness; Coin; Community Health Aides; Complex; Computerized Medical Record; Cost Effectiveness Analysis; Counseling; Data; Data Collection; Data Science; Detection; Diabetes Mellitus; Diagnostic tests; Diastolic blood pressure; Disease; Dyslipidemias; Effectiveness; Ensure; Epidemic; Equipment; Evidence based intervention; Feedback; Focus Groups; Funding; Genetic; Glycosylated hemoglobin A; Grant; Guidelines; HIV; Health; Health Personnel; Health system; Healthcare; Human Resources; Hybrids; Hypertension; Individual; Infection; Infrastructure; Intervention; Interview; Investments; Knowledge; Laboratories; Life Style; Malignant Neoplasms; Maternal and Child Health; Measurement; Measures; Mental Health; Mentors; Metabolic; Methodology; Modeling; Modification; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Nurses; Opportunistic Infections; Outcome; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physicians; Pilot Projects; Population; Positioning Attribute; Postdoctoral Fellow; Primary Care; Primary Prevention; Quasi-experiment; Randomized; Recommendation; Research; Resources; Risk; Risk Factors; Sampling; Scientist; Secondary Prevention; Self Management; Services; Site; Testing; Tobacco use; Training; Treatment Protocols; United States National Institutes of Health; Universities; Viral; Zambia; burden of illness; cardiometabolism; cardiovascular disorder risk; cardiovascular risk factor; clinical decision support; comorbidity; cost; cost effective; cost effectiveness; design; disorder risk; eHealth; effectiveness evaluation; effectiveness/implementation hybrid; evidence base; human centered design; hypertension treatment; implementation evaluation; implementation outcomes; implementation science; implementation strategy; implementation/effectiveness; improved; innovation; insight; interest; low and middle-income countries; modifiable risk; mortality; next generation; novel; pandemic disease; point-of-care diagnostics; pre-doctoral; prevent; programs; routine care; scale up; screening; service delivery; skills; standard of care; stem; success; supply chain; support tools; synergism; systemic inflammatory response; theories; treatment guidelines; trial design; virtual

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.

标题：“应用执行科学方法评估 世卫组织PEN任务转移对解决患有心脏病患者心脏代谢并发症的有效性 赞比亚的艾滋病毒” 摘要 该项目的重点是整合世卫组织循证的基本非传染性疾病一揽子计划 管理心血管疾病风险因素和心血管代谢的干预（WHO-PEN）方法 在赞比亚的卢萨卡，艾滋病毒感染者将艾滋病毒并发症纳入常规护理环境。在形成 在项目的UG 3阶段，我们成功地将世卫组织笔会用于赞比亚的国家艾滋病毒方案， 本地数据和实施科学理论，并创建了一个多组件，基于证据的干预措施， 我们创造了“任务笔”TASKPEN解决了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，旨在改善检测和管理 对艾滋病毒感染者影响尤为严重的心血管代谢性非传染性疾病（非传染性疾病）， 赞比亚. TASKPEN的循证组成部分包括：艾滋病毒和心脏代谢疾病的“一站式服务” 护理;基于WHO PEN的卫生工作者指南、培训材料和治疗算法;实验室 心脏代谢性非传染性疾病筛查和诊断检测服务;以及强化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来提供这些组件： 临床服务整合和任务转移，实践促进和改变的子组成部分的战略， 为筛查和治疗高血压、糖尿病和糖尿病提供物质基础设施和设备 糖尿病和血脂异常。我们的总体和子组件战略将使护士和社区 卫生工作者在常规的艾滋病毒临床环境中为这些疾病提供综合的循证护理， 实践促进者提供的支持和国家电子信息系统中嵌入的非传染性疾病决策支持工具 病历由于赞比亚国家人权委员会已经建议了TASKPEN的各个组成部分， 根据艾滋病毒/艾滋病预防和治疗指导方针，TASKPEN方案将在常规艾滋病毒护理的主持下提供。我们假设 TASKPEN将导致对艾滋病毒和感兴趣的心脏代谢性非传染性疾病的双重控制， 次要临床终点，包括心血管疾病风险（由动脉粥样硬化研究所确定） 心血管疾病，ASCVD，风险评分）和艾滋病毒抑制的艾滋病毒感染者参加12 艾滋病诊所作为我们在赞比亚卢萨卡的研究地点。为了验证这一假设，我们计划进行2型- 混合有效性-实施阶梯楔形试验，这是一种准实验设计， 临床有效性的测量以及实施结果和策略的评估。的 试验融合了多项临床和方法创新，包括首次使用即时护理 赞比亚非传染性疾病的诊断，一种全面的诊所抽样方法， TASKPEN对整个艾滋病护理人群的影响，以及成本效益模型。此外，该试验还作为 为五位博士前、博士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NHLBI的小型研究计划赠款的接受者。资金 通过本补充申请的资金将支持对UH 3成功至关重要的以下领域的战略投资， 在发生意外费用的情况下：（1）建立必要的基本卫生系统构件， TASKPEN介绍; 2）通过保留现有的、经过培训的研究人员，确保数据收集的质量;以及3） 为通过该项目得到指导的5名博士前/博士后研究员提供持续资金。我们的希望是， 根据该项目，卫生部将考虑更广泛地扩大TASKPEN在赞比亚卫生领域的干预措施， 我们的研究员将有能力申请独立的NIH D43或K43资金。