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: 10508973
• 负责人: Michael Emmanuel Herce
• 金额: $ 69.7万
• 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/10508973
• 关键词: Address; Adverse effects; Advocate; Africa South of the Sahara; Algorithms; Anti-HIV Agents; Cardiovascular Diseases; Cardiovascular system; Caring; Chronic; Clinic; Clinical; Clinical effectiveness; Coin; Community Health Aides; Complex; Complication; Cost Effectiveness Analysis; Counseling; Data; Data Collection; Data Science; Detection; Diabetes Mellitus; Disease; Dyslipidemias; Effectiveness; Epidemic; Equipment; Evidence based intervention; Feedback; Focus Groups; Funding; Future; Genetic; Guidelines; HIV; HIV Seropositivity; HIV antiretroviral; Health; Health Personnel; Health Professional; Health system; Healthcare; Human Resources; Hybrids; Hypertension; Individual; Infection; Institutes; Interactive Systems Framework; Intervention; Interview; Investments; Knowledge; Lead; Life Style; Malignant Neoplasms; Maternal and Child Health; Measurement; Mental Health; Metabolic; Modeling; Modification; Morbidity - disease rate; Nurses; Nursing Services; Opportunistic Infections; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physicians; Pilot Projects; Primary Health Care; Primary Prevention; Protocols documentation; Quality of life; Quasi-experiment; Randomized; Research; Resources; Risk; Risk Factors; Secondary Prevention; Self Management; Tobacco use; Training; Training Support; Treatment Protocols; United States National Institutes of Health; Viral; Viral Load result; Zambia; antiretroviral therapy; base; burden of illness; cardiometabolic risk; cardiometabolism; cardiovascular disorder risk; cardiovascular risk factor; clinical decision support; clinical implementation; clinical outcome measures; comorbidity; cost; cost effective; cost effectiveness; design; eHealth; effectiveness evaluation; effectiveness implementation study; evidence base; experience; implementation evaluation; implementation framework; implementation outcomes; implementation science; implementation strategy; improved; low and middle-income countries; modifiable risk; mortality; multidisciplinary; novel; pandemic disease; personalized management; prevent; programs; routine care; scale up; screening; secondary endpoint; service delivery; skills; standard of care; stem; support tools; systemic inflammatory response; task analysis; theories; treatment guidelines; trial design; virtual

PROJECT SUMMARY This project focuses on task shifting and integrating the evidence-based WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach to managing cardiovascular disease risk factors and cardiometabolic complication of HIV into routine care settings for persons living with HIV in Lusaka, Zambia. Using local data and implementation science theories, we will adapt WHO-PEN for the national HIV program in Zambia, and create a streamlined, task-shifted evidence-based intervention that we have coined “TASKPEN”. TASKPEN will focus on addressing challenges faced by HIV patients who have cardio-metabolic complications related to HIV or its treatment, but in the future could be expanded to address other noncommunicable diseases. TASKPEN aims to improve detection and management of these complications. We hypothesize that the TASKPEN intervention will result in reduced cardiovascular disease risk as determined by the Data-collection on Adverse Effects of Anti-HIV Drugs (D:A:D) risk score, as well as clinical improvement in a number of secondary end-points, including HIV viral suppression, for HIV- positive patients attending PEPFAR-supported HIV clinics in the urban Lusaka district of Zambia. The implementation strategies used will enable productive interactions between activated, informed patients and proactive, prepared health care professionals by task shifting most of the care to nurses and community health workers who will be supported by the training and adapted screening and treatment algorithms based on WHO-PEN protocols. TASKPEN will be integrated into routine primary care HIV services where nurses and community health workers lead the intervention. As the individual components of TASKPEN are already recommended by Zambia national HIV guidelines, screening of participants to take part in the study will be done as part of routine HIV care. For those eligible, the screening for metabolic complications will be done at baseline, and 6, 12, and 24 months. Those found with any cardiometabolic complications will receive an individualized management plan, which will combine usual HIV care plus the adapted protocol for management of cardiovascular disease risk factors and cardiometabolic complications. To advocate for scale-up of TASKPEN in Zambia, we plan to evaluate its clinical impact using a cross- sectional type 2-hybrid effectiveness-implementation stepped-wedge design, which is a quasi-experimental design that allows for measurement of clinical effectiveness alongside assessment of implementation outcomes and strategies. Our hope is that by the end of the study, the Zambian Ministry of Health will maintain TASKPEN at all study facilities and would consider wider scale-up in the Zambian health system.

项目概要 该项目的重点是任务转移和整合基于证据的世卫组织基本一揽子计划 管理心血管疾病风险的非传染性疾病干预措施 (WHO-PEN) 方法 将艾滋病毒因素和心脏代谢并发症纳入艾滋病毒感染者的常规护理环境 赞比亚卢萨卡，我们将利用当地数据和科学实施理论，调整 WHO-PEN 以适应 赞比亚国家艾滋病毒规划，并制定精简的、任务转移的循证干预措施 我们创造了“TASKPEN”，TASKPEN 将专注于解决艾滋病毒患者所面临的挑战。 患有与艾滋病毒或其治疗相关的心脏代谢并发症，但未来可能会扩大到 TASKPEN 旨在改善这些疾病的检测和管理。 我们探索 TASKPEN 干预将减少心血管疾病。 由抗 HIV 药物不良反应数据收集 (D:A:D) 风险评分确定的风险，以及 作为许多次要终点的临床改善，包括 HIV 病毒抑制， 在赞比亚卢萨卡市区，艾滋病毒紧急救援计划支持的艾滋病毒诊所就诊的阳性患者。 所使用的实施策略将使活跃的、知情的患者之间能够进行富有成效的互动 积极主动、准备充分的医疗保健专业人员，将大部分护理任务转移给护士和 社区卫生工作者将获得培训和适应性筛查和治疗的支持 基于 WHO-PEN 协议的算法将被纳入艾滋病毒日常初级保健中。 护士和社区卫生工作者主导干预的服务。 TASKPEN 已得到赞比亚国家艾滋病毒指南的推荐，对参与者进行筛查 参加这项研究将作为常规艾滋病毒护理的一部分，对符合条件的人进行代谢筛查。 并发症将在基线以及 6、12 和 24 个月时进行。 并发症将接受个性化的管理计划，该计划将结合常规的艾滋病毒护理和 用于管理心血管疾病危险因素和心脏代谢并发症的适应方案。 为了倡导在赞比亚扩大 TASKPEN 的规模，我们计划使用跨领域评估其临床影响 截面型2-混合有效性-实施阶梯楔形设计，这是一种准实验 允许在评估实施的同时衡量临床有效性的设计 我们希望，在研究结束时，赞比亚卫生部将能够 在所有研究机构维持 TASKPEN，并将考虑在赞比亚卫生系统中更广泛地扩大规模。