Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia

Study acronym: EVIDENT
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 31 days later Feb 2027 → Mar 31, 2027
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Record History

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  1. Recruitment opened Show 8 more changesShow less
    • Primary completion pushed from Feb 2027 to Mar 31, 2027
    • Study completion date: Oct 2027 to Oct 31, 2027
    • Start date changed from estimate of Mar 2026 to Apr 1, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 5 of 5 entries
  2. Interventions: Multi-component public health intervention (Other) to nPOC Testing Intervention Package (Diagnostic Test)
    • Collaborators: 1 to 5
    • Publications: details revised at 5 of 5 entries
    • Study description expanded, about 1 word
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07293455
Lead Sponsor Universitas Padjadjaran
Collaborators: Bill and Melinda Gates Foundation, University of Otago, University of Melbourne, Radboud University Medical Center, Universitas Sebelas Maret
Conditions
(from sponsor)		 Tuberculosis
Related terms Disease, Tuberculosis
Enrollment 40,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov