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
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