RID-TB:Treat
Research type
Research Study
Full title
An open-label, multi-centre, randomised controlled trial evaluating the effects of short-course rifapentine-based regimens and additional adherence support on LTBI treatment adherence and completion among adults in the UK
IRAS ID
282304
Contact name
Ibrahim Abubakar
Contact email
Sponsor organisation
University College London
Eudract number
2020-004444-29
ISRCTN Number
ISRCTN18128181
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The RID-TB programme aims to contribute to a substantial reduction in the incidence of tuberculosis (TB) in England by evaluating complementary interventions targeted at different stages in the diagnosis, treatment and prevention of latent TB infection (LTBI). The interventions are designed to improve access to diagnosis, increase uptake of testing and enhance treatment completion in individuals with or at risk of LTBI. We hypothesise that this approach will enable the NHS to more effectively address the burden of LTBI and consequently decrease the incidence of active TB in the UK. Improving LTBI treatment adherence is critical to achieving the goals of the national TB strategy. Research to understand barriers and enablers of adherence as well as the evaluation of promising technology and drug regimens in the NHS, may provide the tools to reduce tuberculosis rates.
Specific promising interventions in active tuberculosis adherence studies include the use of mobile/digital technology (mHealth) and evaluation of shorter regimens. Published systematic reviews of mHealth interventions for treatment of active tuberculosis concluded that data are limited. A recent study in China found electronic reminders using specially designed medication monitors improved adherence in active tuberculosis patients, but text messaging reminders did not.1 Most of the evidence available is on active tuberculosis with little research on mHealth interventions to improve LTBI treatment adherence. Motivation to complete treatment may differ between patients with active disease and LTBI due to different severity and outcome of the two conditions. In addition, decreasing the complexity of current regimens may promote better adherence. A regimen that is shorter or administered only weekly may result in better treatment completion than the current daily 3-month regimen. Additionally, in the settingface of the COVID-19 epidemic, shorter regimens can reduce the number of clinic visits, and hence reduce risk of infection and pressure on the health care. Therefore, a 1-month regimen that is now newly recommended by the World Health Organization (WHO) has a great potential to help continue LTBI care at this challenging moment due to COVID-19.
We aim to conduct a randomised controlled trial to assess the effect of novel short-course rifapentine-based regimens for TB prevention and additional adherence support on LTBI treatment completion against standard-of-care (SOC). Regimens of interest are a one-month daily rifapentine plus isoniazid (1HP) and a 3-month weekly rifapentine plus isoniazid (3HP); standard-of-care is a 3-month daily rifampicin plus isoniazid (3HR). Additional adherence support will include a reminder using an electronic pill box and educational interventions informed by behavioural theory. The main hypotheses are that the novel regimens will improve treatment adherence compared to 3HR, and additional support will improve adherence to each regimen compared to routine support.
The primary outcome is adequate treatment adherence, defined as taking ≥ 90% of allotted doses within the treatment period. Patients aged between 16 and 65, with a positive LTBI test result and no evidence of active TB and eligible to start TB preventive therapy will be recruited from primary and secondary care. A total of 920 participants will be randomised to three treatment regimens, with or without additional adherence support.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/1097
Date of REC Opinion
25 Nov 2020
REC opinion
Further Information Favourable Opinion