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Recruiting
NCT07293455
Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia
Conditions: Tuberculosis
Sex: All
Ages: 29 Days – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40000
Sponsor: Universitas Padjadjaran
Location: Bandung District Health Office Bandung West Java
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.
Eligibility Criteria
Inclusion Criteria:
1. Aged between \>28 days and 14 years old with the following symptoms:
* 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.
2. Aged ≥15 years old who had a cough for ≥2 weeks or bloody cough, with or without the following symptoms:
* Cough with/without sputum
* Fever
* Weight loss
* Night sweat
* Fatigue
* Chest pain/discomfort
* Breathlessness
* Loss of appetite
* Shivering
Exclusion Criteria:
* Have started TB treatment or TB prophylaxis therapy.
Source: ClinicalTrials.gov (NCT07293455). StuddyBuddy aggregates publicly available trial information.