RESUMO
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.
RESUMO
BACKGROUND: Bangladesh is a highly populous country where the prevalence of drug-resistant tuberculosis (DR-TB) is growing. With the rapid increase in DR-TB notifications through GeneXpert technology, it was imperative to come up with a new treatment strategy that could keep up with the increase of patients diagnosed. INTERVENTION: Intervention was designed to support national transition of DR-TB management of World Health Organization-approved long course (20-to-24-month regimen) treatment from a hospital-based approach to the decentralized model of community-based programmatic management of DR-TB (cPMDT). In close coordination with the Ministry of Health and Family Welfare and National TB Program, patients were initiated into treatment at hospitals and then transferred to community-based care. A cadre of directly observed therapy providers supported treatment at the household level, supervised by the outpatient DR-TB teams. METHODS: We conducted a descriptive pre- and post-intervention study of all 1,946 DR-TB patients enrolled in treatment nationwide between May 2012 and June 2015. Data were collected from hospitals, patient cards, district records, and diagnostic laboratories through the National TB Program. Intervention results were assessed in comparison with the baseline (2011) indicators. RESULTS: During the intervention period, treatment enrollment of 1,946 diagnosed DR-TB patients through the national program increased from 50% in 2011 to 100% in 2015. The delay between diagnosis and treatment initiation decreased from 69 days in 2011 to 6 days in 2014. Most (95%) of the patients completed all scheduled follow-up smear and culture tests. By the sixth month of treatment, 99% of patients had negative smear conversion and 98% had negative culture conversion. The treatment success rate increased from 70% in 2011 to 76% in 2015 at the end of the intervention period. The results also indicate a decline between baseline and end line from 14% to 9% for patients died, 14% to 10% for loss to follow-up, and 1.7% to 0% for treatment failure. CONCLUSIONS: Community-based management is an effective approach for increasing access to quality-assured DR-TB treatment. Using existing structures and resources, the intervention demonstrated that favorable treatment outcomes can be achieved and sustained by treating patients with DR-TB at their homes.
