Title: Intervening with a Manualised Package to achieve treatment adherence in people with Tuberculosis: the IMPACT study
Funder: Department of Health and Social Care

Abstract: Tuberculosis (TB) rates in the UK are high compared to similarly-resourced countries, prompting a multi-agency National Strategy to control TB in England. This, and the 2016 NICE guidelines, identified the need to ensure patients maximise their adherence to therapy by reducing the barriers to starting and continuing treatment - an area where there is insufficient research. We aim to improve treatment adherence among people with TB in England by developing and piloting a risk- and behavioural theory-based manualised intervention package to identify those at risk of poor adherence and offer pragmatic solutions to manage the underlying factors. DESIGN: A mixed-methods work programme comprising: 1) scoping review of the social sciences and health literature; 2) refinement of a conceptual framework based on qualitative and quantitative service user and health care worker interviews; 3) construction of a manualised intervention package; 4) pilot study; and 5) process evaluation of the intervention. SCOPING REVIEW: Reviews of the grey and peer-reviewed literature will identify barriers to adherence with treatment for TB, and interventions that can mitigate these. We will retrieve articles using a comprehensive search strategy, extract and summarise data, and assess quality. REFINEMENT OF CONCEPTUAL FRAMEWORK: Derived from interviews with patients, communities and healthcare professionals from different TB services (Southampton, London and Edinburgh) representative of the national TB picture. MANUALISED INTERVENTION PACKAGE: Will consist of two components 1) to identify individuals at risk of non-adherence with anti-TB treatment & 2) to promote adherence through specific supportive measures. The package will be developed using evidence from the scoping review plus formative methods. It will contain social and behavioural management components covering personal (including psychological), socio-cultural and health systems-structural factors that can be applied and assessed together or separately. PILOT STUDY: Cluster randomised controlled trial of the manualised intervention package versus usual NHS care in 80 patients starting treatment for TB. Usual care comprises more ad hoc, largely unevidenced efforts to promote adherence by clinicians. Setting: four NHS TB clinics in North and East London (which manage 20% of English TB cases). Target population: all adults attending NHS TB clinics for treatment of active TB, including those with drug resistance. The intervention must be suitable for all patients receiving treatment for TB. Medication adherence will be determined using pill counts as the primary measure. OUTCOMES: Proportion completing treatment randomised to the intervention versus usual care. Process evaluation to determine how components work separately and together. Results will inform a definitive cluster randomised controlled trial of the refined intervention COST: The cost of implementing the intervention, determined from an NHS perspective TIMETABLE: Study duration 3 years RESEARCH TEAM: Our collaborative team of TB experts, social and behavioural scientists, clinicians, epidemiologists, nurses, policy experts and trialists are highly skilled and globally recognised in the relevant fields (social sciences, medication adherence, literature reviews, operational research, service user engagement, clinical trials and care) needed to successfully complete this work.

Lay abstract: 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. Poor adherence to treatment can occur for a number of reasons. These include someone not knowing much about their disease condition and why they need to take their treatment, side effects from the drugs, or people choosing to stop their treatment as soon as they feel better, rather than taking the entire course. Wider psychological, social, cultural and economic issues, including stigma due to having TB, lack of support from family members or friends, homelessness, drug and alcohol misuse and barriers to good access to NHS services also play a part. 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. Involving people with TB, their communities, and NHS staff will be critical throughout this project to ensure that the guide is acceptable, helpful, and useful. This will occur through interviews, meetings and consultation. Our collaborative TB team of social and behavioural scientists, clinicians, clinical trial specialists, epidemiologists and policy experts are highly skilled and have a long history of successful working with people and communities with TB. We hope that our study will provide new and useful information which will help others in future. We will make sure that the results of the study are reported to people with TB and their carers, clinicians, scientists, and policy makers. This will be achieved by using social media, presentations at conferences and local meetings, and publishing the results in health and social care scientific journals. This will increase the impact of our work for the whole of the NHS.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: INFECTION