Study of a New TB Diagnosis and Treatment Approach for Children Under 15 at District and Primary Health Centers in Mozambique and Zambia

What this Trial Is About

The trial investigates a comprehensive Treatment Decision Algorithms TDA-based approach for tuberculosis TB screening, diagnosis, and treatment decision-making in children under 15 years old living in high TB burden and resource-limited settings in Mozambique and Zambia. This pragmatic cluster-randomized stepped wedge study aims to provide evidence on the effectiveness, feasibility, acceptability, costs, and adoption of this approach at district hospitals and primary health centers. It also seeks to support integration of findings into local health policies and practices. The intervention involves implementing a comprehensive TDA-based approach supported by a Clinical Decision Support System CDSS and strengthened health information systems. This approach integrates TB screening, diagnosis, treatment decisions, and severity assessment to identify eligibility for shorter treatment regimens, especially in high-risk groups such as children living with HIV and those with severe acute malnutrition. The study compares this intervention to the current Standard of Care SOC used in each country, which includes symptom screening, HIV testing, Xpert testing, and other diagnostic procedures. Participants include all sick children under 15 years attending selected district hospitals and primary health centers who have presumptive TB or belong to high-risk groups. Data on TB diagnosis, treatment decisions, time to treatment, and treatment outcomes will be collected over about 24 months. Researchers will assess effectiveness, acceptability, implementation feasibility, health economics, and policy impact. The study also monitors diagnostic accuracy, user preferences, and cost-effectiveness, with follow-up extending through intervention delivery and six months post-intervention for sustained delivery.

The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis