NCT07293455

Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40,000 (estimated)
• Sponsor: Universitas Padjadjaran · Academic / Other
• Sex: All
• Age: 29 Days
• Healthy volunteers: Not accepted

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.

Detailed description

TB remains a critical public health problem worldwide. Most of the patients with TB were from low- and middle-income countries with limited resources. A large proportion of them visited HCFs without sufficient laboratory services to diagnose TB, causing a delay in TB diagnosis and treatment. In addition, while up to half of patients with presumptive TB cannot produce adequate sputum specimens, current TB diagnostics rely on sputum-based tests. Therefore, the use of near point-of-care (nPOC) or point-of-care (POC) non-sputum-based tests can potentially provide more accessible TB diagnosis and reduce delays. This CRCT is part of a larger series of studies within the EVIDENT Research Project in Indonesia. Based on a clinical validation study (EVIDENT work package 1) and a diagnostic yield, feasibility, and cost study (EVIDENT work package 2), the CRCT (EVIDENT work package 3) will provide evidence of the effects of implementation of a multi-component public health intervention in the intervention arm, compared to the control arm. Carefully designed clinical algorithms will be employed to incorporate the new diagnostic test, using sputum and/or tongue swab specimens, into the health services. To increase patients' attendance and utilisation of the new diagnostic test, a promotional package will be provided to clinics unable to host it and to selected pharmacies. Finally, a household contact investigation will be conducted, involving community health volunteers. Clusters are the community health centre (CHC) catchment areas, defined as geographical areas surrounding a CHC where the TB programme is expected to be implemented. The interventions will be administered in HCFs and the community in the intervention arm, while the control arm will continue standard of care with no intervention, except for refresher training on TB case notification into the National TB Information System (locally known as Sistem Informasi Tuberkulosis or SITB) before the intervention roll-out. The primary and secondary endpoints will be assessed over the 12-month post-intervention roll-out (follow-up period), with adjustment for baseline (12-month pre-randomisation period). TB case notification data will be obtained from the National TB Information System. In addition to the main study, several sub-studies will be conducted to assess the secondary objectives: the Patient Pathway \& Patient Costing Sub-study, the Standardised Patient Sub-study, and the Health System Costing Sub-study. The Patient Pathway \& Patient Costing study is a cross-sectional study of patients recently diagnosed with TB at the selected HCF in the intervention and control arms. In the Standardised Patient Sub-study, trained standardised patients will visit selected HCFs to present a clinical scenario and record their experiences regarding examinations, diagnostic testing, and referrals. The health system costing study will gather information on the costs of diagnosing TB in HCFs and communities in the intervention and control arms.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-02-01
• Completion: 2027-10-01
• First posted: 2025-12-19
• Last updated: 2026-02-10

Locations

1 site across 1 country: Indonesia