Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia

ConditionTuberculosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29+
SponsorUniversitas Padjadjaran

About this trial

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.

Eligibility criteria

Qualifiers

Cough ≥2 weeks

Acute malnutrition

Weight loss or weight faltering during the past 3 months among those who had contact history with patients with TB in the past 12 months.

Cough with/without sputum

Disqualifiers

Have started TB treatment or TB prophylaxis therapy.

Trial design

Treatments tested in this trial

  • nPOC Testing Intervention Package

Treatment groups

40,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universitas Padjadjaran

Lead sponsor

Bill and Melinda Gates Foundation

Collaborator

University of Otago

Collaborator

University of Melbourne

Collaborator

Radboud University Medical Center

Collaborator

Universitas Sebelas Maret

Collaborator