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: 10705143
• 负责人: Michael Emmanuel Herce
• 金额: $ 59.66万
• 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/10705143
• 关键词: Acceleration; Address; Adverse effects; Advocate; Africa South of the Sahara; Algorithms; Anti-HIV Agents; Anti-Retroviral 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; Eligibility Determination; Epidemic; Equipment; Evidence based intervention; Feedback; Focus Groups; Funding; Future; Genetic; Guidelines; HIV; HIV Seropositivity; Health; Health Personnel; Health Professional; Health system; Healthcare; Human Resources; Hybrids; Hypertension; Individual; Infection; Interactive Systems Framework; Intervention; Interview; Investments; Knowledge; Lead; Life Style; Malignant Neoplasms; Maternal and Child Health; Measurement; Measures; 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 Care; Primary Prevention; Productivity; Protocols documentation; Quality of life; Quasi-experiment; Randomized; Recommendation; 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; burden of illness; cardiometabolic risk; 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; experience; implementation evaluation; implementation framework; implementation outcomes; implementation science; implementation strategy; implementation/effectiveness; 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; synergism; 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 该项目的重点是任务转移和整合世卫组织循证的基本 非传染性疾病干预（WHO-PEN）管理心血管疾病风险的方法 将艾滋病毒感染者纳入常规护理环境， 赞比亚的卢萨卡。利用当地数据和实施科学理论，我们将调整世卫组织笔会， 赞比亚的国家艾滋病毒方案，并建立一个精简的、任务转移的循证干预措施， 我们创造了“任务笔”TASKPEN将重点解决艾滋病毒患者面临的挑战， 患有与艾滋病毒或其治疗有关的心脏代谢并发症，但在未来可能会扩大到 防治其他非传染性疾病。TASKPEN旨在改善这些问题的检测和管理。 并发症我们假设TASKPEN干预将减少心血管疾病 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 作为一些次要终点的临床改善，包括HIV病毒抑制， 在赞比亚城市卢萨卡地区，艾滋病紧急救援计划支持的艾滋病毒诊所就诊的阳性患者。的 所使用的实施策略将使活跃的、知情的患者之间进行富有成效的互动 和积极主动，准备好的医疗保健专业人员的任务转移到护士的大部分照顾， 社区卫生工作者将得到培训和适应性筛查和治疗的支持， 基于WHO-PEN协议的算法。TASKPEN将被纳入常规初级保健艾滋病毒 由护士和社区卫生工作者领导干预的服务。作为单个组件， 赞比亚国家艾滋病毒指南已经推荐了TASKPEN，对参与者进行筛查， 参加研究的人将作为常规HIV护理的一部分。对于那些符合条件的人， 将在基线、6个月、12个月和24个月时进行并发症检查。那些发现有任何心脏代谢 并发症将接受个性化的管理计划，该计划将结合联合收割机通常的艾滋病毒护理和 调整了心血管疾病风险因素和心脏代谢并发症管理方案。 为了倡导在赞比亚扩大TASKPEN的规模，我们计划使用交叉评估其临床影响， 分段型2-混合有效性-实施阶梯楔形设计，这是一个准实验 允许测量临床有效性以及评估实施情况的设计 成果和战略。我们希望在研究结束时，赞比亚卫生部将 在所有研究机构保持TASKPEN，并考虑在赞比亚卫生系统中更广泛地推广。