Validation of treatment decision algorithms for childhood tuberculosis at district healthcare levels in Mozambique and Zambia: the Decide TB cluster-randomised pragmatic trial - a study protocol

Introduction: Of 1.2 million children and young adolescents (<15 years) developing tuberculosis (TB) yearly, more than 50% are undiagnosed and unreported to national TB programmes (NTPs) and the World Health Organization (WHO). This is mainly due to poor performance of microbiological tests, limited clinical skills and structural barriers for childhood TB diagnosis at decentralised levels of care. Treatment decision algorithms (TDAs) could improve child TB outcomes but require external validation. We aim to evaluate a comprehensive TDA-based approach for childhood TB screening, diagnosis and treatment decision-making at district hospital (DH) and primary health centre (PHC) levels in Mozambique and Zambia.

Methods and analysis: Decide TB is a pragmatic, hybrid effectiveness-implementation type 2 cluster-randomised trial with a stepped wedge design. The comprehensive TDA-based approach (intervention) will be implemented under programmatic conditions in four districts in each country (each comprising one DH and six PHCs), randomly selected to switch sequentially from the standard of care to the intervention. Evaluations will assess epidemiological, clinical, economic, social sciences, implementation and health policy endpoints. Aggregated and individual data from children with presumptive TB will be extracted from facility registers and individual data will be collected using an electronic medical record (EMR), both data sources will be entered in national Demographic Health Information System 2 databases. Questionnaires and individual/group interviews (among healthcare workers (HCWs), parents/caregivers and key informants), supervision and mentoring reports and quantitative cost tools will be used.

Ethics and dissemination: Ethics approval was obtained from national ethics committees in Mozambique (Instituto Nacional de Saúde review board and National Committee for Bioethics in Health) and Zambia (University of Zambia ethical review board and National Health Research Authority); this includes a waiver for analysing data collected by NTPs (no identifiable information reported, intervention with minimal risk) without individual consent from children’s parents/caregivers. Informed consent will be obtained from HCWs, parents/caregivers and key informants. Results will be openly shared with the scientific community, WHO and national and international stakeholders for translation into policy and practice. Procedures for requesting further use of Decide TB data will be publicly available.

Trial registration number: NCT06593080; PACTR202407866544155.