BACKGROUND Across sub-Saharan Africa, evidence-based clinical guidelines to screen and manage hypertension exist; however, country level application is low due to lack of service readiness, uneven health worker motivation, weak accountability of health worker performance, and poor integration of hypertension screening and management with chronic care services. The systems analysis and improvement approach (SAIA) is an evidence-based implementation strategy that combines systems engineering tools into a five-step, facility-level package to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). As hypertension screening and management are integrated into chronic care services in sub-Saharan Africa, an opportunity exists to test whether SAIA interventions shown to be effective in improving efficiency and coverage of HIV services can be effective when applied to the non-communicable disease services that leverage the same platform. We hypothesize that SAIA-hypertension (SAIA-HTN) will be effective as an adaptable, scalable model for broad implementation. METHODS We will deploy a hybrid type III cluster randomized trial to evaluate the impact of SAIA-HTN on hypertension management in eight intervention and eight control facilities in central Mozambique. Effectiveness outcomes include hypertension cascade flow measures (screening, diagnosis, management, control), as well as hypertension and HIV clinical outcomes among people living with HIV. Cost-effectiveness will be estimated as the incremental costs per additional patient passing through the hypertension cascade steps and the cost per additional disability-adjusted life year averted, from the payer perspective (Ministry of Health). SAIA-HTN implementation fidelity will be measured, and the Consolidated Framework for Implementation Research will guide qualitative evaluation of the implementation process in high- and low-performing facilities to identify determinants of intervention success and failure, and define core and adaptable components of the SAIA-HTN intervention. The Organizational Readiness for Implementing Change scale will measure facility-level readiness for adopting SAIA-HTN. DISCUSSION SAIA packages user-friendly systems engineering tools to guide decision-making by front-line health workers to identify low-cost, contextually appropriate chronic care improvement strategies. By integrating SAIA into routine hypertension screening and management structures, this pragmatic trial is designed to test a model for national scale-up. TRIAL REGISTRATION ClinicalTrials.gov NCT04088656 (registered 09/13/2019; https://clinicaltrials.gov/ct2/show/NCT04088656).

中文翻译：

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系统分析和改进方法，以优化PLHIV个体的高血压诊断和治疗级联（SAIA-HTN）：一项III型混合杂种随机试验。

背景技术在整个撒哈拉以南非洲地区，存在以证据为基础的筛查和管理高血压的临床指南。但是，由于缺乏服务就绪性，卫生工作者的积极性不均衡，卫生工作者绩效的问责制薄弱以及高血压筛查和管理与慢性病护理服务结合不佳，因此在国家一级的申请率很低。系统分析和改进方法（SAIA）是基于证据的实施策略，将系统工程工具组合为五步，设备级别的程序包，以提高对差距的理解（级联分析），指导识别和确定低成本工作流程的优先级修改（过程映射），并反复测试和重新设计这些修改（持续改进质量）。由于高血压筛查和管理已纳入撒哈拉以南非洲的慢性病护理服务中，因此有机会测试显示出有效地提高SAIA干预效果的SAIA干预措施在应用于非传染性疾病服务时是否有效。利用相同的平台。我们假设SAIA高血压（SAIA-HTN）作为一种适应性强，可扩展的模型，可以广泛实施。方法我们将在莫桑比克中部的8个干预和8个控制设施中部署一项混合的III型聚类随机试验，以评估SAIA-HTN对高血压管理的影响。有效性结果包括高血压的级联流量测量（筛查，诊断，管理，控制），以及艾滋病毒感染者中的高血压和艾滋病毒临床结果。从付款人的角度（卫生部），成本效益将被估算为每增加一名患者通过高血压分级步骤所增加的成本，以及每增加一名残疾调整生命年所避免的成本。将评估SAIA-HTN的实施保真度，并且《实施研究合并框架》将指导对高绩效和低绩效机构中实施过程的定性评估，以确定干预成功与失败的决定因素，并定义SAIA的核心和适应性组成部分-HTN干预。实施变更的组织准备程度将衡量采用SAIA-HTN的设施级别的准备情况。讨论SAIA打包了用户友好的系统工程工具，以指导一线卫生工作者的决策，从而确定低成本，因地制宜的长期护理改善策略。通过将SAIA纳入常规的高血压筛查和管理结构中，该实用试验旨在测试全国范围内的模型推广。试用注册ClinicalTrials.gov NCT04088656（注册时间09/13/2019; https://clinicaltrials.gov/ct2/show/NCT04088656）。