![]() This randomized trial is meant to provide high-quality evidence to inform WHO recommendations on investigation of household contacts, as currently these are based on very low-quality evidence. Findings will be submitted for publication in major medical journals and presented in conferences, to WHO and National and municipal TB programs of the involved countries. The study was approved by the Research Ethic Board of the Research Institute of the McGill University Health Centre, the Brazilian National Ethical Board CONEP, and the “Comité Local d’Éthique Pour la Recherche Biomédicale (CLERB) de l’Université de Parakou,” Benin. Stratified analyses by age (under versus over 5) and by index patient microbiological status will be conducted.Īll participants provide signed informed consent. Societal costs, incidence of severe adverse events, and prevalence of TBD are among secondary outcomes. The main outcome is the proportion of HHC that are TPT eligible who start TPT within 3 months of the index TB patient starting TBD treatment. Clusters are defined as HHC members of the same index patients with newly diagnosed pulmonary TBD. ![]() All strategies start with symptom screening. CXR for all if CXR is normal, TPT is recommended. This superiority cluster-randomized multicenter trial with three arms of equal size compares, in Benin and Brazil, three strategies for HHC investigation aged 0–50: (i) tuberculin skin testing (TST) or interferon gamma release assay (IGRA) for TBI and if positive, chest X-Ray (CXR) to rule out TBD in persons with positive TST or IGRA (ii) same as (i) but GeneXpert (GX) replaces CXR and (iii) no TBI testing. There is equipoise on the need for these tests in different risk populations, especially HHC aged over 5. Tests for TB infection (TBI) or to rule out TB disease (TBD) are preferred, but if not available, this should not be a barrier if access to these tests is limited for high-risk people, such as PLH and HHC under 5 years old. The World Health Organization recommends tuberculosis (TB) preventive treatment (TPT) for all people living with HIV (PLH) and household contacts (HHC) of index TB patients. ![]()
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