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

SAIA-TB：使用系统分析和改进方法 (SAIA) 预防南非农村地区的结核病

• 批准号: 10699071
• 负责人: Brittney Jayne van de Water
• 金额: $ 65.54万
• 依托单位: BOSTON COLLEGE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-12 至 2028-02-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10699071
• 关键词: Affect; Africa South of the Sahara; Area; Attitude; Award; Belief; Caring; Clinic; Clinical; Cluster randomized trial; Collaborations; Communicable Diseases; Consolidated Framework for Implementation Research; Country; Cross-Over Trials; Data; Data Analyses; Development; Diagnosis; Diagnostic; Disease; Drug resistance; Effectiveness; Eligibility Determination; Engineering; Evaluation; Family; Focus Groups; HIV; HIV Infections; HIV/TB; Health; Health Personnel; Health Services Accessibility; Home; Home visitation; Household; Immunocompromised Host; Individual; Infection; Intervention; Interview; Knowledge; Literature; Maps; Mentored Patient-Oriented Research Career Development Award; Methods; Modeling; Patient-Focused Outcomes; Patients; Performance; Persons; Policies; Population; Populations at Risk; Positioning Attribute; Prevention; Prevention program; Preventive therapy; Process; Reporting; Research; Resource-limited setting; Rural; Site; South Africa; South African; System; Systems Analysis; Thoracic Radiography; Translating; Tuberculosis; Update; Viral; Visit; Work; acceptability and feasibility; clinical care; cost; design; drug-sensitive; effectiveness evaluation; evidence base; evidence based guidelines; follow-up; global health; high risk; implementation process; implementation science; implementation strategy; improved; informant; innovation; insight; patient engagement; prevent; programs; progression risk; rural South Africa; rural area; rural health clinic; scale up; screening; success; system-level barriers; testing access; tool; treatment guidelines; tuberculosis treatment; uptake

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.

项目摘要 结核病（TB）仍然是全球主要的传染病杀手之一，尽管有可用的 强大的诊断，有效的预防和治疗。全面结核病规划执行不力 和艾滋病毒感染仍然是南非等高负担国家结核病发病率持续高企的驱动因素。在 南非在结核病护理级联中有许多损失;估计95%的结核病患者可以获得结核病治疗 然而，只有82%的人被诊断出来，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感染，以减少结核病的巨大储存库。 有发展成结核病风险的人，特别是最近接触过结核病患者和艾滋病毒感染者 （PLH）.利用科学方法实施，在艾滋病毒/艾滋病领域取得的成功基础上， 为了实现结核病护理级联“90-90-90”目标，我们的团队最近试点了两个结核病护理级联， 对药物敏感的结核病以及结核病预防项目的试点，包括对304个家庭进行家访， 筛查922名结核病患者的家庭接触者。 该R 01奖项将采用系统分析和改进方法（SAIA），这是一种基于证据的 实施科学战略，将系统工程工具结合到结核病的临床级包中（SAIA- 结核病），扩大了在撒哈拉以南非洲的一系列临床环境中试用的成功SAIA模型， 美国，并利用PI在南非的初步结核级联分析数据。SAIA-TB将评估六个 全面的结核病指标（筛查、评估、诊断、与护理的联系、治疗和无结核病） 生存），以帮助一线医护人员和管理人员通过使用 TB级联分析工具、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对患者级联优化的有效性 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个农村诊所结核病综合治疗影响我们假设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的开始增加20%， 2年干预期。(2)确定各诊所SAIA-TB实施差异性的驱动因素。 实施过程将通过焦点小组讨论和关键知情人访谈进行描述， 诊所工作人员，使用实施研究的综合框架进行分析，并提供额外数据 从研究日志中收集来描述对SAIA-TB的保真度。(3)评估全面结核病护理的可接受性 在结核病级联的每一步，在实施SAIA-TB的诊所接受治疗的患者中。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因素 无论是否感染艾滋病毒。