ABSTRACT
BACKGROUND: The use of systems engineering tools, including the development and use of care cascades using routinely collected data, process mapping, and continuous quality improvement, is used for frontline healthcare workers to devise systems level change. South Africa experiences high rates of tuberculosis (TB) infection and disease as well as HIV co-infection. The Department of Health has made significant gains in HIV services over the last two decades, reaching their set "90-90-90" targets for HIV. However, TB services, although robust, have lagged in comparison for both disease and infection. The Systems Analysis and Improvement Approach (SAIA) is a five-step implementation science method, drawn from systems engineering, to identify, define, and implement workflow modifications using cascade analysis, process mapping, and repeated quality improvement cycles within healthcare facilities. METHODS: This stepped-wedge cluster randomized trial will evaluate the effectiveness of SAIA on TB (SAIA-TB) cascade optimization for patients with TB and high-risk contacts across 16 clinics in four local municipalities in the Sarah Baartman district, Eastern Cape, South Africa. We hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period. Focus group discussions and key informant interviews with clinic staff will also be conducted to determine drivers of implementation variability across clinics. DISCUSSION: This study has the potential to improve TB screening, treatment initiation, and completion for both active disease and preventive measures among individuals with and without HIV in a high burden setting. SAIA-TB provides frontline health care workers with a systems-level view of their care delivery system with the aim of sustainable systems-level improvements. TRIAL REGISTRATION: Clinicaltrials.gov, NCT06314386. Registered 18 March 2024, https://clinicaltrials.gov/study/NCT06314386 . NCT06314386.
ABSTRACT
INTRODUCTION: South Africa is among countries with the highest burden of drug resistant tuberculosis (DR-TB). The Eastern Cape Province reported the highest MDR-TB mortality rates in South Africa for the 2010 treatment cohorts. This study aimed to determine risk factors for mortality among adult patients registered for DR-TB treatment in the province. METHODS: We conducted a retrospective cohort study of adult patients treated for laboratory confirmed DR-TB between January 2011 and December 2013. Demographic and clinical characteristics of the patients were obtained from a web-based electronic database of patients treated for DR-TB. We applied modified Poisson regression with robust standard errors to identify risk factors for DR-TB mortality. We also stratified the analyses into multi-drug resistant TB (MDR-TB) and extensively drug resistant (XDR-TB). RESULTS: Among 3,729 patients that met the inclusion criteria, 39% (n = 1,445) died. Of the patients that died, 53% (n = 766) were male, 68% (n = 982) had MDR-TB, 72% (n = 1,038) were HIV co-infected, and median age was 37 years (Interquartile Range [IQR] 30-46). Patients were at higher risk of mortality during DR-TB treatment if they were HIV co-infected not on antiretroviral treatment (ART) (adjusted incidence risk ratio [aIRR] 3.3, 95% confidence interval [CI] 2.9-3.8), were 60 years or older (aIRR 1.7, 95%CI 1.5-2.0), had a diagnosis of XDR-TB (aIRR 1.6, 95%CI 1.5-1.7), or had been hospitalised at treatment start (aIRR 1.7, 95%CI 1.5-1.8). Among MDR-TB patients, risk of mortality was higher if patients were HIV co-infected not on ART (aIRR 3.9, 95%CI 3.3-4.6), were 60 years or older (aIRR 1.9, 95%CI 1.6-2.3), or had been hospitalised at start of MDR-TB treatment (aIRR 1.7, 95%CI 1.5-1.9). Among XDR-TB patients, risk of mortality was higher in patients who were HIV co-infected not on ART (aIRR 1.8, 95%CI 1.5-2.2), or had been hospitalised at the start of XDR-TB treatment (aIRR 1.5, 95%CI 1.3-1.8). CONCLUSION: HIV co-infected not on ART, older age, XDR-TB and hospital admission for DR-TB treatment were independent risk factors for DR-TB mortality. Integration of TB and HIV services, with focus on voluntary HIV testing and counselling of DR-TB patients with unknown HIV status, and provision of ART for all co-infected patients may reduce DR-TB mortality in the Eastern Cape.
