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

Who May Qualify: The effectiveness assessment will be conducted using aggregated or individual data from direct beneficiaries of the intervention: - All sick children aged below 15 years entering the selected health facilities (DH and PHC) at either outpatient (OPD) or inpatient (IPD) departments, including children from high-risk groups, as well as children identified as contact of TB cases through community- or facility-based household contact tracing. - Children with presumptive TB. The WHO definition of presumptive TB will be used, as defined in the 2022 WHO Operational Handbook, namely: children are classified as having presumptive TB if they have unremitting symptoms lasting more than 2 weeks (any one of cough, fever, not eating well or anorexia, weight loss or failure to thrive, fatigue, reduced playfulness or decreased activity) . The definitions of presumptive TB have been adapted locally for the programmatic pilot. All children with presumptive TB as defined locally will be considered in the intervention and in secondary effectiveness and sub-group analyses. High-risk group will be defined using the definition in WHO-suggested TDAs A\&B as children younger than 2 years, CLHIV or children with SAM. CLHIV will be defined per national testing strategy including positive PCR test for children below the age of 18 months. Children will be considered to have SAM (and thereby be eligible for the TB-Speed SAM algorithm) using WHO criteria. These include being \<5 years with a weight-for-height Z score (WHZ) \< -3 SDs or mid-upper arm circumference (MUAC) \< 115 mm (in children over 6 months) or clinical signs of bilateral pitting oedema, and being aged ≥5 years with a body mass index (BMI) for age Z-score \< -3SD. Who Should NOT Join This Trial: There will be no exclusion criteria for the programmatic pilot: all children will be offered the intervention. Always talk to your doctor about whether this trial is right for you.