Testing Health Workers At Risk to Advance Our Understanding of TB Infection

NCT06221488 | Recruiting

• 1 other identifier: DP2AI176896
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tuberculosis; Tuberculosis Infection

Keywords

Tuberculosis; TB; TB infection; Health worker

Outcome Measures

Primary Outcomes (1)

• Interferon gamma release assay conversion

  IGRA conversion using Quantiferon-Plus

  Tested at months 0, 3, 6, 9, 12, 24

Secondary Outcomes (1)

• TB disease

  Assessed at months 0, 3, 6, 9, 12, 24

Study Arms (1)

Health workers

Health workers with baseline negative interferon gamma release assays

Diagnostic Test: TB infection testing

Interventions

TB infection testing DIAGNOSTIC_TEST

Diagnostic testing with existing and novel tests to evaluate for TB infection and disease

Health workers

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be health workers (primarily clinical but may include support staff) who are \>18 years of age.

You may qualify if:

• ≥18 years old
• Health worker
• Able to provide informed consent

You may not qualify if:

• Prior history of TB or known prior positive IGRA
• Current or prior history of taking anti-TB treatment

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• University of Stellenbosch: collaborator

Study Sites (1)

Stellenbosch University

Cape Town, South Africa

RECRUITING

Related Publications (1)

• Nathavitharana RR, Mishra H, Sullivan A, Hurwitz S, Lederer P, Meintjes J, Nardell E, Theron G. Predicting Airborne Infection Risk: Association Between Personal Ambient Carbon Dioxide Level Monitoring and Incidence of Tuberculosis Infection in South African Health Workers. Clin Infect Dis. 2022 Oct 12;75(8):1297-1306. doi: 10.1093/cid/ciac183.

  PMID: 35348657 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will collect blood (whole blood, plasma, serum, PBMCs), sputum, and nasopharyngeal swab specimens. Specimens will be stored for future use, which will remain in South Africa for future research and training.

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Ruvandhi Nathavitharana, MBBS MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruvandhi Nathavitharana, MBBS MPH

CONTACT

+16467152601; rnathavi@bidmc.harvard.edu

Grant Theron, PhD

CONTACT

+27 21 9389693; gtheron@sun.ac.za

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

ZA (1)