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.

项目摘要 该项目着重于任务转移和整合基于证据的人物。 非通讯疾病干预措施（WHO-PEN）用于管理心血管疾病风险的方法 艾滋病毒的因素和心脏代谢并发症进入艾滋病毒患者的常规护理环境 赞比亚卢萨卡。使用本地数据和实施科学理论，我们将适应WHO-PEN 赞比亚的国家艾滋病毒计划，并创建一种简化的，任务迁移的基于循证的干预措施 我们创造了“ Taskpen”。任务彭将专注于解决艾滋病毒患者面临的挑战 患有与艾滋病毒或治疗有关的有氧代谢并发症，但将来可以扩展到 解决其他非通信疾病。 Taskpen旨在改善对这些的检测和管理 并发症。我们假设任务培养干预将导致心血管疾病减少 由抗HIV药物的不良影响（D：A：D）风险评分的数据收集确定的风险 随着许多次要终点（包括HIV病毒抑制）的临床改善，用于HIV- 在赞比亚城市卢萨卡地区参加PEPFAR支持的HIV诊所的积极患者。 所使用的实施策略将使激活的知情患者之间的生产互动 通过将大部分护理转移给护士和 社区卫生工作者将得到培训和改编的筛查和治疗的支持 基于WHO-pen协议的算法。 TaskPen将被整合到常规的初级保健艾滋病毒中 护士和社区卫生工作者领导干预的服务。作为单个组件 Zambia国家HIV指南已经推荐了Taskpen的 参加研究将作为常规艾滋病毒护理的一部分进行。对于那些符合条件的人，筛查代谢 并发症将在基线，6、12和24个月进行。那些带有任何心脏代谢的人 并发症将获得个性化的管理计划，该计划将结合常规的艾滋病毒护理以及 用于管理心血管疾病危险因素和心脏代谢并发症的改编方案。 为了提倡在赞比亚进行任务板的扩大规模，我们计划使用交叉评估其临床影响 截面类型2杂交有效性 - 实现阶梯式钢丝设计，这是一种准实验 设计允许测量临床有效性以及实施评估 结果和策略。我们的希望是，到研究结束时，赞比亚卫生部将 在所有研究设施中维护任务围栏，并考虑在赞比亚卫生系统中进行更广泛的规模。