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Validation of Treatment Decision Algorithms for Childhood Tuberculosis

Validation of Treatment Decision Algorithms for Childhood Tuberculosis at District Health Care Levels in Mozambique and Zambia - the Decide-TB Cluster-randomized Pragmatic Trial

Not applicable Interventional University of Zambia · NCT06593080

This study is testing a new way to help doctors in Zambia and Mozambique make better decisions for screening and treating tuberculosis in children under 15 years old.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment30240 (estimated)
AgesN/A to 14 Years
SexAll
SponsorUniversity of Zambia Academic / other
Locations29 sites (Chingola, Copperbelt and 28 other locations)
Trial IDNCT06593080 on ClinicalTrials.gov

What this trial studies

The DECIDE-TB project aims to implement and evaluate a comprehensive Treatment Decision Algorithms (TDA) approach for screening, diagnosing, and treating tuberculosis in children under 15 years in Zambia and Mozambique. This pragmatic cluster-randomized trial will assess the effectiveness, feasibility, and acceptability of the TDA-based approach at district hospitals and primary health centers. The study will involve symptomatic children entering selected health facilities, focusing on improving TB case detection and treatment decision-making in resource-limited settings.

Who should consider this trial

Good fit: Ideal candidates for this study are symptomatic children under 16 years who are entering selected health facilities and may have presumptive TB.

Not a fit: Patients who are adults or those not presenting with presumptive TB cases will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve TB detection and treatment outcomes in children living in high-burden areas.

How similar studies have performed: Other studies have shown success with similar TDA-based approaches in improving TB management, indicating potential for this trial's success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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.

Exclusion Criteria:

There will be no exclusion criteria for the programmatic pilot: all children will be offered the intervention.

Where this trial is running

Chingola, Copperbelt and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions TuberculosisChild HealthHIVSevere Acute Malnutrition
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.