IMPACT
Research type
Research Study
Full title
Intervening with a Manualised Package to AChieve treatment adherence in people with Tuberculosis: the IMPACT study
IRAS ID
231542
Contact name
Marc Lipman
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/05/135, UCL Data Protection Registration
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Compared to the rest of the UK and Western Europe, England has a big problem with the infectious disease tuberculosis (TB). The large amount of TB in the country has led Public Health England and NHS England to develop a national TB control plan. Treatment for TB lasts a long time (at least six months and even more in people with drug resistant TB). Finding ways to make sure that people are able to take all the doses of their medication is one of the plan’s priorities. If people miss doses (described as being ‘non -adherent’), their TB can develop resistance to the usual drugs, risking both their health and that of the population.
At present we don’t have good ways of knowing if someone will struggle with their medication. In this study, we will use high quality social and clinical science research methods to find out why taking treatment may be difficult for some people, and how health services can work with them to improve this, or even avoid it happening.
Our proposal is split into four stages:
1) Finding examples in the TB literature of good practise to figure out who will not adhere and how this can be avoided;
2) Working with social and behavioural scientists, doctors, nurses, people with TB and the public in different parts of the UK, decide what could go into a guide for clinicians to enable them to more successfully identify adherence problems and then assist people to avoid or manage these;
3) Putting the guide together, so that it is easy to use and understand;
4) Testing out the guide with real patients in a small study. The guide will include a tool to judge someone’s risk of not taking all their drugs and then provide solutions for their exact needs. We will first of all test it in London with the help of 80 patients. The cost of the guide to the NHS will be calculated.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
18/LO/1359
Date of REC Opinion
29 Aug 2018
REC opinion
Unfavourable Opinion