Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia

The goal of this cluster-randomised controlled trial (CRCT) is to learn whether the use of new non-sputum-based diagnostic tests and other intervention components for tuberculosis (TB) diagnosis in healthcare facilities (HCF) can increase TB notifications. The main questions it aims to answer are: (1) Does the diagnostic intervention package raise TB notifications by HCF?; (2) Does the diagnostic intervention package raise the proportion of patients with TB who are diagnosed with microbiological tests, lower the time needed for TB diagnosis, lower the number of visits to HCF before TB diagnosis, raise the use of TB tests by healthcare providers, and lower the costs for TB diagnosis? Researchers will compare the diagnostic intervention package provided to HCFs and the community in the intervention arm with the standard of care in the control arm to assess the intervention's effect. Healthcare providers will be trained to provide diagnostic interventions to patients visiting their HCFs and to community residents in the areas surrounding HCFs.

NCT Number	NCT07293455
Lead Sponsor	Universitas Padjadjaran Collaborators: Bill and Melinda Gates Foundation, University of Otago, University of Melbourne, Radboud University Medical Center, Universitas Sebelas Maret
Conditions	Tuberculosis
Enrollment	40,000 participants
Start Date	2026-03
Primary Completion	2027-02 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2026-02-10