Actively Recruiting
Led by Beth Israel Deaconess Medical Center · Updated on 2025-05-23
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
B
Beth Israel Deaconess Medical Center
Lead Sponsor
U
University of Stellenbosch
Collaborating Sponsor
Researchers are studying tuberculosis (TB) infection in health workers in Cape Town, South Africa, where the risk of TB infection is notably high. The study aims to better understand immune responses to TB infection, especially early after exposure, using new and established tests. This research hopes to improve how we identify those at greatest risk of developing active TB disease, which can be life-threatening, and to inform better prevention strategies. Health workers will be tested every three months over one year using a combination of established and novel diagnostic tests, including interferon gamma release assays (IGRAs), blood RNA biosignatures, antibody responses, and tests detecting TB DNA. This approach allows researchers to observe changes in immune and pathogen markers over time and to see if early positive test results are temporary or persistent. The study will also collect samples for future research. Participants will undergo serial testing at months 0, 3, 6, 9, 12, and 24. Researchers will monitor TB infection status and the occurrence of active TB disease through these visits. Data from these tests will help understand the timing and nature of immune responses and pathogen presence during early TB infection. The study duration for each participant extends to two years, with ongoing assessments to evaluate risk and protection against TB.
CONDITIONS
Testing Health Workers At Risk to Advance Our Understanding of TB Infection
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants undergo serial testing every 3 months for one year using established and novel tests to evaluate for TB infection and disease.
Visits every 3 months for a total of 5 visits during the first year
Duration - Additional 12 months after initial monitoring
Participants continue to be assessed for TB infection and disease at 24 months to understand longer-term outcomes.
1 visit at 24 months
Total: 1 location
1
Stellenbosch University
Cape Town, South Africa
Actively Recruiting
R
Ruvandhi Nathavitharana, MBBS MPH
G
Grant Theron, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Ruvandhi R Nathavitharana, Hridesh Mishra, Amanda Sullivan...
https://pubmed.ncbi.nlm.nih.gov/35348657