Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia

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.

Conditions

• Tuberculosis

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.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of Otago

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Universitas Sebelas Maret

  collaborator OTHER

• Universitas Padjadjaran

  lead OTHER

Principal Investigators

• Bachti Alisjahbana, Professor, MD, PhD · Research Center for Care and Control of Infectious Diseases Universitas Padjadjaran

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

29 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2027-02-28

Completion

2027-10-31

Countries

• Indonesia

Study Locations