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RECRUITING
NCT06593080
NA

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

Sponsor: Chishala Chabala

View on ClinicalTrials.gov

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

OTHER

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