Research to Improve the Detection and Treatment of Latent Tuberculosis Infection: Treatment
Can new short-course regimens and additional support help patients stick to latent tuberculosis treatment regimens?
What is this study about?
Following declines in the incidence of tuberculosis (TB) during the 20th century, there was a resurgence of the disease in England from the late 1980s to 2005. Consequently, NHS England and Public Health England (PHE) launched a strategy in 2015 to bring about a sustained decline with screening for latent TB infection (LTBI) as a funded element of the plan. LTBI testing and treatment reduces tuberculosis incidence by preventing reactivation and is expected to create a cost saving to the NHS after about five years (NHS England). However, high rates of treatment uptake and treatment completion are essential prerequisites to accrue these benefits.
Improving LTBI treatment adherence is critical to achieving reductions in TB incidence. Standard LTBI treatment in the UK involves 12 weeks of self-administered daily treatment. Whilst this regimen is successful at preventing disease, its effectiveness is limited by low treatment completion rates.
The RID-TB: Treat trial aims to assess the effect of newly shortened LTBI treatment regimens and additional adherence support on treatment adherence.
Routine support consists of an animated video and leaflet with information about latent TB infection and the importance of completing treatment. On top of this, the additional support groups will get reminders in the form of audio alarms or text messages if they do not take their medication on time.
Researchers will randomise participants across four arms:
- three months of daily isoniazid plus rifampicin (3HR), with routine treatment support (current standard-of-care),
- three months of daily isoniazid plus rifampicin (3HR), with additional support,
- three months of weekly isoniazid plus rifapentine (3HP), with additional adherence support,
- one month of daily isoniazid plus rifapentine (1HP), with routine treatment support.
The trial is open-label, meaning both the researchers and participants will know which drug regimen and level of support each patient receives.
Type of study
Who is funding the study?
RID-TB: Treat is a part of a 5-year programme of work, RID-TB, which is funded by the National Institute of Health and Care Research (NIHR).
When is it taking place?
Where is it taking place?
Who is included?
Adults aged 16-65 who have been referred for treatment for LTBI.