RID-TB:Dx
Research type
Research Study
Full title
Research to Improve the Detection and Treatment of Latent Tuberculosis Infection: Diagnostics (RID-TB:Dx) A randomised controlled trial to evaluate the effectiveness of using the RD-1 based C Tb skin test as a replacement for blood-based interferon-γ release assay for detection of latent TB infection and initiation of TB preventive treatment in the UK
IRAS ID
269485
Contact name
Ellen Owen-Powell
Contact email
Sponsor organisation
University College London
Eudract number
2019-002592-34
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Title: A randomised controlled trial to evaluate the effectiveness of using the RD-1 based C Tb skin test as a replacement for blood-based interferon-γ release assay for detection of latent TB infection and initiation of TB preventive treatment in the UK
Summary: Latent TB infection (LTBI) testing and treatment reduces TB incidence by preventing reactivation, and is expected to be cost-saving to the health system. However, high rates of testing, treatment uptake and treatment completion are essential to achieve these benefits. In 2011 TB guidelines stated that a blood test for LTBI provided good value for money. However, more recent analysis suggests that a skin test (tuberculin skin test, TST) may be better value. The LTBI screening programme conveniently uses blood tests, called interferon-gamma release assays (IGRA). The TST may not always correctly identify who has LTBI as reliably as IGRA. This can lead to unnecessary treatment if results are falsely positive. There is now a new skin test available, called C-Tb, which research suggests is as good as IGRA in correctly identifying LTBI. In a three-year randomised study, we propose to compare the C-Tb test to usual care using IGRA to see whether it is more accurate, easier to obtain a diagnosis, and offers better value for money for the NHS. We will also do research to understand what people think of C-Tb, and their experience of testing for LTBI. We will invite people who have a high risk of developing TB disease to take part. People will be invited from the community, general practice or hospitals.
The study is part of a 5-year NIHR-funded programme of research to improve access to diagnosis and enhance treatment uptake and completion in individuals with or at risk of LTBI in England.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/1624
Date of REC Opinion
3 Jan 2020
REC opinion
Further Information Favourable Opinion