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NOT YET RECRUITING
NCT07293455
NA

Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia

Sponsor: Universitas Padjadjaran

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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