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Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia
Sponsor: Universitas Padjadjaran
Summary
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.
Official title: Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia; Work Package 3: Cluster Randomised Controlled Trial of A Diagnostic Package to Increase the Number of Tuberculosis Cases Notified
Key Details
Gender
All
Age Range
29 Days - Any
Study Type
INTERVENTIONAL
Enrollment
40000
Start Date
2026-03
Completion Date
2027-10
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
nPOC Testing Intervention Package
The intervention package will comprise: 1. Introduction of a new-generation diagnostic test (nPOC test) into the HCFs; 2. Optimisation of clinical algorithms with the incorporation of the new test; 3. Promotional package to encourage patient attendance and utilisation of tests at HCFs by practitioners in the intervention areas; 4. TB household contact investigation using the new test according to an algorithm with community health volunteers (cadres) involvement in the intervention areas.
Locations (1)
Bandung District Health Office
Bandung, West Java, Indonesia