Protocol for the mixed-methods process and context evaluation of theTB & Tobaccorandomised controlled trial in Bangladesh and Pakistan: a hybrid effectiveness–implementation study

Abstract

IntroductionTuberculosis (TB) remains a significant public health problem in South Asia. Tobacco use increases the risks of TB infection and TB progression. The TB& Tobacco placebo-controlled randomised trial aims to (1) assess the effectiveness of the tobacco cessation medication cytisine versus placebo when combined with behavioural support and (2) implement tobacco cessation medication and behavioural support as part of general TB care in Bangladesh and Pakistan. This paper summarises the process and context evaluation protocol embedded in the effectiveness–implementation hybrid design.Methods and analysisWe are conducting a mixed-methods process and context evaluation informed by an intervention logic model that draws on the UK Medical Research Council’s Process Evaluation Guidance. Our approach includes quantitative and qualitative data collection on context, recruitment, reach, dose delivered, dose received and fidelity. Quantitative data include patient characteristics, reach of recruitment among eligible patients, routine trial data on dose delivered and dose received, and a COM-B (‘capability’, ‘opportunity’, ‘motivation’ and ‘behaviour’) questionnaire filled in by participating health workers. Qualitative data include semistructured interviews with TB health workers and patients, and with policy-makers at district and central levels in each country. Interviews will be analysed using the framework approach. The behavioural intervention delivery is audio recorded and assessed using a predefined fidelity coding index based on behavioural change technique taxonomy.Ethics and disseminationThe study complies with the guidelines of the Declaration of Helsinki. Ethics approval for the study and process evaluation was granted by the University of Leeds (qualitative components), University of York (trial data and fidelity assessment), Bangladesh Medical Research Council and Bangladesh Drug Administration (trial data and qualitative components) and Pakistan Medical Research Council (trial data and qualitative components). Results of this research will be disseminated through reports to stakeholders and peer-reviewed publications and conference presentations.Trial registration numberISRCTN43811467; Pre-results.

Health worker and patient views on implementation of smoking cessation in routine tuberculosis care

“…Different project work packages, such as a quantitative process evaluation component and the context evaluation, will help fill in potential gaps left by this interview study. 29…”

“…Details of the behaviour support intervention, the cytisine trial and the process evaluation are published in the process evaluation and the trial protocols. 11,29 In short, regarding the behaviour support intervention, we aimed to systematically assess the implementation process at clinic level and to discover mechanisms of interaction between participants and the intervention by observing and interviewing patients and health workers. For the qualitative process evaluation components, we chose a multi-site case study design 30,31 to gain an understanding of the multi-faceted and complex real-life contexts at the clinic level.…”

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“…Since previous studies have shown smoking is associated with an increased risk of TB (Boeckmann et al, 2018;Perriot et al, 2018;Zhang et al, 2019), six questions were asked about patients' smoking behaviour. In general, most of the respondents were not smokers (n=300, 69.9%) but admitted that they quit smoking after being diagnosed with or infected by TB.…”

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“…We will disseminate results via conferences, scientific forums, and publications as well as via reports and workshops targeted towards stakeholders. In reporting this protocol and the results of the process evaluation, we followed the MRC framework and previous study protocols and process evaluations with comparable approaches [34,35]. In addition, the complex intervention is reported based on the Criteria for Reporting the Development and Evaluation of Complex Interventions (CReDECI 2) [36] (Additional file 1).…”