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

项目总结 该项目的重点是任务转移和整合以证据为基础的世卫组织一揽子基本 非传染性疾病干预措施(WHO-PEN)管理心血管疾病风险的方法 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。利用当地数据和执行科学理论，我们将使世卫组织-PEN适应 赞比亚的国家艾滋病毒计划，并创建简化的、任务转移的循证干预措施 我们创造了“TASKPEN”一词。TASKPEN将专注于解决艾滋病毒患者面临的挑战 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 解决其他非传染性疾病。TASKPEN的目标是改进对这些问题的检测和管理 并发症。我们假设TASKPEN干预将导致心血管疾病的减少 由抗艾滋病毒药物不良反应数据收集(D：A：D)风险评分确定的风险 随着一些次要终点的临床改善，包括艾滋病毒病毒抑制，艾滋病毒- 在赞比亚城市卢萨卡区，阳性患者前往由PEPFAR支持的艾滋病毒诊所就诊。这个 使用的实施策略将使活跃、知情的患者之间能够进行富有成效的互动 和主动、有准备的医疗保健专业人员通过将大部分护理转移到护士和 将得到培训和适应的筛查和治疗支持的社区卫生工作者 基于WHO-PEN协议的算法。TASKPEN将纳入常规初级保健艾滋病毒 护士和社区卫生工作者主导干预的服务。作为单独的组件 已经被赞比亚国家艾滋病毒指南推荐，对参与者进行筛查以 参加这项研究将作为常规艾滋病毒护理的一部分。对于符合条件的人，新陈代谢筛查 并发症将在基线、6个月、12个月和24个月进行。那些被发现有心脏代谢异常的人 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 适用于心血管疾病危险因素和心脏代谢并发症的管理方案。 为了倡导在赞比亚扩大TASKPEN的规模，我们计划使用交叉试验来评估其临床影响。 分段类型2-混合有效性-实施阶梯式楔形设计，这是一种准实验 允许在评估实施情况的同时测量临床有效性的设计 结果和战略。我们希望在研究结束时，赞比亚卫生部将 在所有研究设施维持TASKPEN，并将考虑扩大赞比亚卫生系统的规模。

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.