Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia
ConditionTuberculosis
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
nPOC Testing Intervention Package
Diagnostic testThe 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.
Treatment groups
40,000 Participants
are divided into 2 treatment groupsGroup A: Near Point-of-Care (nPOC) TestingActive comparator 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in TB case notifications per population attending healthcare facilities
Difference in average TB notification rate per population attending healthcare facilities in intervention and control arms.
Time frame
The outcome is measured for the 12 months before the commencement of any study procedures and over the 12-month follow-up period, starting 6 months after the start of the intervention roll-out.Secondary outcomes
1
Change in TB case notifications in CHC areas, who live in the area, per CHC area population
Difference in average TB notification rate among those who live in the CHC area, per CHC area population, in the intervention and control arms.
Time frame
The outcome is measured for the 12 months before the commencement of any study procedures and over the 12-month follow-up period, starting 6 months after the start of the intervention roll-out.2
Change in proportion of microbiologically confirmed TB cases over all diagnosed TB cases
The proportion of microbiologically confirmed TB cases among all diagnosed cases in healthcare facilities in the intervention and control arms.
Time frame
The outcome is measured over the 12 months before the commencement of any study procedures and over a 12-month follow-up period starting 6 months after the start of intervention roll-out.3
Difference in time to TB diagnosis from the beginning of symptoms (Patient Pathway and Patient Costing Sub-study)
The mean difference in days from symptom onset to TB diagnosis between the intervention and control arms.
Time frame
Up to 10 months during the follow-up period4
Difference in time to TB diagnosis from the first visit to a formal HCF (Patient Pathway and Patient Costing Sub-study)
The mean difference in days from the first visit to a formal HCF to TB diagnosis between the intervention and control arms.
Time frame
Up to 10 months during the follow-up period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov