SAIA-TB: Using the Systems Analysis and Improvement Approach (SAIA) to prevent TB in rural South Africa

项目摘要 结核病(TB)仍然是全球主要的传染病杀手之一，尽管有 强大的诊断、有效的预防和治疗。全面结核病规划执行不力 在南非等高负担国家，艾滋病毒感染仍然是结核病发病率居高不下的驱动因素。在……里面 南非在结核病护理方面有许多损失；据估计，有95%的结核病患者 然而，只有82%的人确诊，70%的人开始治疗，53%的人成功完成治疗。 然而，还必须筛查和治疗亚临床结核病感染，以减少巨大的结核病宿主。 有可能发展为结核病的人，特别是最近与结核病患者和艾滋病毒携带者有过接触的人 (PLH)。使用执行科学方法并在艾滋病毒改进的成功基础上再接再厉 医疗级联“90-90-90”目标，我们的团队最近试行了两个结核病级联治疗耐药和 对药物敏感的结核病以及试点的结核病预防计划，包括对304多个家庭进行家访， 对922名结核病患者家庭接触者进行筛查。 该R01奖项将采用系统分析和改进方法(SAIA)，这是一种基于证据的方法 实施科学战略将系统工程工具结合到临床层面的结核病一揽子计划中(SAIA- TB)，扩展了成功的SAIA模型，在撒哈拉以南非洲的一系列临床环境中进行了试验，并 美国，并利用PI在南非的初步结核病级联分析数据。SAIA-TB将评估六个 全面的结核病指标(筛查、评估、诊断、与护理、治疗和无结核病的联系 生存)，以帮助一线医护人员和管理人员通过使用 结核病级联分析工具、过程流程图和持续质量改进周期。 我们的具体目标是：(1)评估SAIA-TB在患者级联优化中的有效性 患有结核病和高危接触者(特别是PLH)。我们将使用阶梯楔形交叉试验来评估 SAIA-TB对12个乡村卫生室结核病综合保健的影响我们假设SAIA-TB的实施 将导致结核病筛查和结核病预防治疗或结核病治疗启动期间增加20% 干预期为2年。(2)确定不同诊所实施SAIA-TB的驱动因素。 将使用焦点小组讨论和关键线人访谈来描述实施过程 诊所工作人员，使用执行研究综合框架进行了分析，并提供了其他数据 从研究日志中收集来描述对SAIA-TB的忠诚度。(3)评估全面结核病护理的可接受性 在获得诊所护理的患者中，在结核病级联的每一步实施SAIA-TB。我们将使用 可接受性的理论框架和定义可接受性和比较的社会生态学模型 在患者中完成结核病级联步骤的个人、家庭和系统层面的障碍和促进者 无论有没有感染艾滋病毒。

Project Summary Tuberculosis (TB) remains one of the leading infectious disease killers globally despite the availability of robust diagnostics, effective prevention, and treatment. Poor implementation of comprehensive TB programs and HIV infection remain drivers of ongoing high TB rates in high burden countries such as South Africa. In South Africa there are many losses in the TB care cascade; an estimated 95% of individuals with TB access evaluation, yet only 82% are diagnosed, 70% initiate treatment, and 53% successfully complete treatment. However, it is also imperative to also screen and treat subclinical TB infection to lessen the vast reservoir of people at risk of progressing to TB disease, especially recent contacts of TB patients and people living with HIV (PLH). Using implementation science methods and building on the success of the improvements in the HIV care cascade “90-90-90” targets, our team has recently piloted two TB care cascades for drug-resistant and drug-sensitive TB as well as piloted a TB prevention program including home visits to over 304 families, screening 922 household contacts of patients with TB. This R01 award will adapt the Systems Analysis and Improvement Approach (SAIA), an evidence-based implementation science strategy combining systems engineering tools into a clinic-level package for TB (SAIA- TB), expanding upon successful SAIA models trialed across a range of clinical settings in sub-Saharan Africa and the USA, and leveraging the PI’s preliminary TB cascade analysis data in South Africa. SAIA-TB will evaluate six comprehensive TB indicators (screening, evaluation, diagnosis, linkage to care, treatment, and TB-free survival) to aid frontline healthcare workers and managers to optimize cascade performance through the use of a TB cascade analysis tool, process flow mapping, and continuous quality improvement cycles. Our specific aims are to: (1) Evaluate the effectiveness of SAIA-TB on cascade optimization for patients with TB and high-risk contacts (specifically PLH). We will use a stepped-wedge crossover trial to evaluate the impact of SAIA-TB on comprehensive TB care in 12 rural clinics. We hypothesize that SAIA-TB implementation will lead to a 20% increase in TB screening and TB preventive therapy or TB disease treatment initiation during the 2-year intervention period. (2) Determine the drivers of SAIA-TB implementation variability across clinics. The implementation process will be described using focus group discussions and key informant interviews with clinic staff, analyzed using the consolidated framework for implementation research, with additional data gathered from study logs to describe fidelity to SAIA-TB. (3) Assess the acceptability of comprehensive TB care among patients accessing care at clinics implementing SAIA-TB at each step of the TB cascade. We will use the theoretical framework for acceptability and the socioecological model to define acceptability and compare individual-, family- and system-level barriers and facilitators to completing TB cascade steps among patients with and without HIV infection.