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The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis
Sponsor: Chishala Chabala
Summary
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.
Official title: Validation of Treatment Decision Algorithms for Childhood Tuberculosis at District Health Care Levels in Mozambique and Zambia - the Decide-TB Cluster-randomized Pragmatic Trial
Key Details
Gender
All
Age Range
Any - 14 Years
Study Type
INTERVENTIONAL
Enrollment
30240
Start Date
2024-06-01
Completion Date
2027-08-31
Last Updated
2026-03-24
Healthy Volunteers
Yes
Interventions
The comprehensive TDA based approach
The intervention consists of implementing a comprehensive TDA-based approach for TB diagnosis and treatment decision-making, including shorter treatment for non-severe TB in children identified as TB presumptive cases through a CDSS. It will also include the management of high-risk groups. In practice, all sick children will be assessed using the WHO-suggested TDAs A with CXR (DH) and B without CXR (PHC). CLHIV and those hospitalised with SAM at DH will have further assessment and treatment decisions based on the PAANTHER and TB-Speed SAM TDAs, respectively. Clinical and microbiological assessment data will be incorporated into a CDSS to help with the clinical decision to initiate TB treatment. The CDSS will incorporate specific features and test results for high-risk group children based on the PAANTHER TDA and the TB-Speed SAM TDA and will incorporate the results of the severity assessment to guide the choice of TB treatment duration once children are diagnosed with TB.
Locations (29)
Chawama Urban Health Centre
Chingola, Copperbelt, Zambia
Chiwempala Urban Health Centre
Chingola, Copperbelt, Zambia
Kabundi East Urban Health Clinic
Chingola, Copperbelt, Zambia
Kasompe Urban Health Centre
Chingola, Copperbelt, Zambia
Muchinshi Rural Health Centre
Chingola, Copperbelt, Zambia
Nchanga 1 Urban Health Centre
Chingola, Copperbelt, Zambia
Nchanga North Referal Hospital
Chingola, Copperbelt, Zambia
Allessandras Urban Health Centre
Luanshya, Copperbelt, Zambia
Chaisa Urban Health Centre
Luanshya, Copperbelt, Zambia
Fisenge Urban Health Centre
Luanshya, Copperbelt, Zambia
Kawama Urban Health Centre
Luanshya, Copperbelt, Zambia
Malaika Urban Health Centre
Luanshya, Copperbelt, Zambia
Mikomfwa Urban Health Centre
Luanshya, Copperbelt, Zambia
Roan Antelope General Hospital
Luanshya, Copperbelt, Zambia
Thomson District Hospital
Luanshya, Copperbelt, Zambia
Chipepo Rural Health Centre
Chirundu, Southern Province, Zambia
Hachipilika Rural Health Centre
Chirundu, Southern Province, Zambia
Jamba Rural Health Centre
Chirundu, Southern Province, Zambia
Kapululira Rural Health Centre
Chirundu, Southern Province, Zambia
Lusitu Rural Health Centre
Chirundu, Southern Province, Zambia
Mtendere Mission Referal hospital
Chirundu, Southern Province, Zambia
Sikoongo Rural Health Centre
Chirundu, Southern Province, Zambia
Habulile Rural Health Centre
Kalomo, Southern Province, Zambia
Kalomo District Hospital
Kalomo, Southern Province, Zambia
Kalomo Urban Health Centre
Kalomo, Southern Province, Zambia
Mawaya Urban Health Centre
Kalomo, Southern Province, Zambia
Namwianga Urban Health Centre
Kalomo, Southern Province, Zambia
Nkandanzovu Rural Health Centre
Kalomo, Southern Province, Zambia
Siachitema Rural Health Centre
Kalomo, Southern Province, Zambia