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

Recruiting now · Not applicable

Conditions studied: Tuberculosis, Child Health, HIV, Severe Acute Malnutrition

In brief

The Decide-TB project aims to generate evidence for the implementation of a comprehensive Treatment Decision Algorithms (TDA) based approach for TB in children living in high TB burden and resource-limited countries, at District Hospital (DH) and Primary Health Centre (PHC) levels, and to facilitate the integration of this evidence within practices and policies. This programmatic pilot led by the National TB Programs (NTP) will test a TDA-based approach integrating TB screening, diagnosis, treatment decision-making, and disease severity assessment for shorter treatment eligibility, for use at a lower level of healthcare. This TDA-based approach will be evaluated in a hybrid effectiveness implementation study based on a pragmatic stepped wedge cluster-randomized trial. The Decide TB project will be implemented at the district level, targeting five districts in each country. Each cluster in a district will be made up of one district hospital and six primary health centers. The study will develop a Clinical Decision Support System (CDSS) to operationalize the use of TDAs, and strengthen District Health Information Systems (DHIS2) to collect individual data, which will contribute to monitoring and evaluation, clinical mentoring, and supervision by the country's NTPs.

Key facts

Study ID

NCT06593080

Run by

Chishala Chabala

People needed

30240

Starts

2024-06-01

Expected to finish

2027-08-31

Last updated by the study team

2026-03-24

Who can join

Age: any, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Chawama Urban Health Centre — Chingola, Copperbelt, Zambia (enrolling)
• Chiwempala Urban Health Centre — Chingola, Copperbelt, Zambia (enrolling)
• Kabundi East Urban Health Clinic — Chingola, Copperbelt, Zambia (enrolling)
• Kasompe Urban Health Centre — Chingola, Copperbelt, Zambia (enrolling)
• Muchinshi Rural Health Centre — Chingola, Copperbelt, Zambia (enrolling)
• Nchanga 1 Urban Health Centre — Chingola, Copperbelt, Zambia (enrolling)
• Nchanga North Referal Hospital — Chingola, Copperbelt, Zambia (enrolling)
• Allessandras Urban Health Centre — Luanshya, Copperbelt, Zambia (enrolling)
• Chaisa Urban Health Centre — Luanshya, Copperbelt, Zambia (enrolling)
• Fisenge Urban Health Centre — Luanshya, Copperbelt, Zambia (enrolling)
• Kawama Urban Health Centre — Luanshya, Copperbelt, Zambia (enrolling)
• Malaika Urban Health Centre — Luanshya, Copperbelt, Zambia (enrolling)
• Mikomfwa Urban Health Centre — Luanshya, Copperbelt, Zambia (enrolling)
• Roan Antelope General Hospital — Luanshya, Copperbelt, Zambia (enrolling)
• Thomson District Hospital — Luanshya, Copperbelt, Zambia (enrolling)
• Chipepo Rural Health Centre — Chirundu, Southern Province, Zambia (enrolling)
• Hachipilika Rural Health Centre — Chirundu, Southern Province, Zambia (enrolling)
• Jamba Rural Health Centre — Chirundu, Southern Province, Zambia (enrolling)
• Kapululira Rural Health Centre — Chirundu, Southern Province, Zambia (enrolling)
• Lusitu Rural Health Centre — Chirundu, Southern Province, Zambia (enrolling)
• Mtendere Mission Referal hospital — Chirundu, Southern Province, Zambia (enrolling)
• Sikoongo Rural Health Centre — Chirundu, Southern Province, Zambia (enrolling)
• Habulile Rural Health Centre — Kalomo, Southern Province, Zambia (enrolling)
• Kalomo District Hospital — Kalomo, Southern Province, Zambia (enrolling)
• Kalomo Urban Health Centre — Kalomo, Southern Province, Zambia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.