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

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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.