Chirundu

Researchers are evaluating a comprehensive Treatment Decision Algorithms (TDA) based approach for tuberculosis (TB) in children under 15 years old living in high TB burden and resource-limited areas of Mozambique and Zambia. This study aims to provide evidence for implementing this approach at District Hospitals and Primary Health Centres to improve TB screening, diagnosis, treatment decisions, and disease severity assessments. The trial uses a pragmatic cluster-randomized stepped wedge design to assess effectiveness, feasibility, acceptability, costs, and policy adoption of the TDA-based method under real-world programmatic conditions. The intervention involves using a Clinical Decision Support System (CDSS) to operationalize the TDA-based approach, which includes TB screening, diagnosis, treatment decision-making, and shorter treatment eligibility for non-severe TB in children. Children with presumptive TB, including high-risk groups such as those younger than 2 years, children living with HIV, and those with severe acute malnutrition, are assessed using specific TDAs with or without chest X-ray depending on the healthcare level. The CDSS incorporates clinical and microbiological data, guiding treatment decisions and duration based on disease severity and risk factors. Participants include all sick children under 15 years who enter selected health facilities, either outpatient or inpatient, including those identified through household contact tracing. Data collection involves monitoring TB treatment initiation over an average of 24 months, and assessments cover diagnostic accuracy, user acceptability, implementation feasibility, health economics, and policy impact. The study also strengthens health information systems and supports clinical mentoring and supervision by national TB programs to ensure comprehensive monitoring and evaluation throughout the trial period.