Testing Health Workers At Risk to Advance Our Understanding of TB Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorBeth Israel Deaconess Medical Center
About this trial
It has been estimated that 1.7 billion people have tuberculosis (TB) infection; yet current tests are unable to predict which people are at highest risk of developing TB disease, which can be life-threatening. THWART-TB is a prospective longitudinal cohort study of health workers (HWs) in Cape Town, South Africa, where our preliminary data reveals HWs have a high annual TB infection risk (34%). This cohort, who will undergo frequent serial evaluation (every 3 months) with a combination of novel assays never previously evaluated together, presents a unique opportunity to evaluate immune responses at the time of initial infection and to characterize the dynamic profile of these immune responses over time in a high-risk population. The knowledge generated will improve our understanding of TB infection and help to identify which people exposed to TB may remain at risk, enabling us to better target preventive strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Health worker
Able to provide informed consent
Disqualifiers
Prior history of TB or known prior positive IGRA
Current or prior history of taking anti-TB treatment
Trial population
The study population will be health workers (primarily clinical but may include support staff) who are \>18 years of age.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TB infection testing
Diagnostic testDiagnostic testing with existing and novel tests to evaluate for TB infection and disease
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Health workers1 intervention
Trial outcomes
Primary outcomes
1
Interferon gamma release assay conversion
IGRA conversion using Quantiferon-Plus
Time frame
Tested at months 0, 3, 6, 9, 12, 24Secondary outcomes
1
TB disease
Development of active TB disease, defined by positive Xpert Ultra or defined clinically based on clinician starting treatment for active TB disease with combination of suggestive symptoms and/or abnormalities on chest x-ray in the absence of bacteriological confirmation.
Time frame
Assessed at months 0, 3, 6, 9, 12, 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
University of Stellenbosch
Collaborator
Source ClinicalTrials.gov