Validation of Treatment Decision Algorithms for Childhood Tuberculosis At District Health Care Levels in Mozambique and Zambia - the Decide-TB Cluster-randomized Pragmatic Trial
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.
• For TB screening, all symptomatic children \<16 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.
• For access to TB diagnostic services and TDAs, children aged below 16 years identified with presumptive TB, i.e. those with ≥1 systematic screening criteria, among the following:
‣ Cough with a duration of \>2 weeks,
⁃ Fever with a duration of \>2 weeks,
⁃ Documented weight loss,
⁃ History of TB contact with any duration of cough, OR identified by the site clinician irrespective of the above criteria, especially presumed extra-pulmonary TB cases.