INTRODUCTION: Tuberculosis (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 ANALYSIS: We 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 DISSEMINATION: The 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 NUMBER: ISRCTN43811467; Pre-results.

ARK Foundation Dhaka Bangladesh

Department of Family Medicine CAPHRI School for Public Health and Primary Care Maastricht University Maastricht The Netherlands

Department of Health Sciences University of York York UK

Institute of General Practice Addiction Research and Clinical Epidemiology Unit Medical Faculty of the Heinrich Heine University Düsseldorf Germany

Leeds Institute of Health Sciences University of Leeds Leeds UK

National Tuberculosis Control Programme Islamabad Pakistan

The Initiative Islamabad Pakistan

University Hospital Prague VFN v PRAZE Prague Czech Republic

Usher Institute of Population Health Sciences and Informatics University of Edinburgh Edinburgh UK

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World Health Organization. Global Tuberculosis Report 2017: Leave no one behind - Unite to end TB. Geneva: World Health Organization, 2017.

Dye C. Global epidemiology of tuberculosis. Lancet 2006;367:938–40. 10.1016/S0140-6736(06)68384-0 PubMed DOI

Bates MN, Khalakdina A, Pai M, et al. . Risk of tuberculosis from exposure to tobacco smoke: a systematic review and meta-analysis. Arch Intern Med 2007;167:335–42. 10.1001/archinte.167.4.335 PubMed DOI

World Health Organization. Tuberculosis & Tobacco: a strong association. TB Tob. Factsheet. 2009. http://www.who.int/tobacco/resources/publications/factsheet_tb_tobacco_sep09.pdf (accessed 30 May 2017).

Pai M, Mohan A, Dheda K, et al. . Lethal interaction: the colliding epidemics of tobacco and tuberculosis. Expert Rev Anti Infect Ther 2007;5:385–91. 10.1586/14787210.5.3.385 PubMed DOI

Slama K, Chiang CY, Enarson DA, et al. . Tobacco and tuberculosis: a qualitative systematic review and meta-analysis. Int J Tuberc Lung Dis 2007;11:1049–61. PubMed

World Health Organization. Global Health Observatory (GHO) data on tobacco control. Preval. Tob. Smok. 2016. http://www.who.int/gho/tobacco/use/en/ (accessed 13 Oct 2016).

Reitsma MB, Fullman N, Ng M, et al. . Smoking prevalence and attributable disease burden in 195 countries and territories, 1990-2015: a systematic analysis from the Global Burden of Disease Study 2015. Lancet 2017;389:1885–906. 10.1016/S0140-6736(17)30819-X PubMed DOI PMC

Stead LF, Koilpillai P, Fanshawe TR, et al. . Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database Syst Rev 2016;3:CD008286 10.1002/14651858.CD008286.pub3 PubMed DOI PMC

Stead LF, Koilpillai P, Lancaster T. Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation. Cochrane Database Syst Rev 2015;10:CD009670 10.1002/14651858.CD009670.pub3 PubMed DOI

Piné-Abata H, McNeill A, Murray R, et al. . A survey of tobacco dependence treatment services in 121 countries. Addiction 2013;108:1476–84. 10.1111/add.12172 PubMed DOI PMC

Jeyashree K, Kathirvel S, Shewade HD, et al. . Smoking cessation interventions for pulmonary tuberculosis treatment outcomes. Cochrane Database Syst Rev 2016;1:CD011125 10.1002/14651858.CD011125.pub2 PubMed DOI PMC

Hajek P, McRobbie H, Myers K. Efficacy of cytisine in helping smokers quit: systematic review and meta-analysis. Thorax 2013;68:1037–42. 10.1136/thoraxjnl-2012-203035 PubMed DOI

Walker N, Howe C, Glover M, et al. . Cytisine versus nicotine for smoking cessation. N Engl J Med 2014;371:2353–62. 10.1056/NEJMoa1407764 PubMed DOI

Siddiqi K, Khan A, Ahmad M, et al. . Action to Stop Smoking in Suspected Tuberculosis (ASSIST) in Pakistan. Ann Intern Med 2013;158:667 10.7326/0003-4819-158-9-201305070-00006 PubMed DOI

Elsey H, Khanal S, Manandhar S, et al. . Understanding implementation and feasibility of tobacco cessation in routine primary care in Nepal: a mixed methods study. Implement Sci 2016;11:104 10.1186/s13012-016-0466-7 PubMed DOI PMC

Michie S, Richardson M, Johnston M, et al. . The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med 2013;46:81–95. 10.1007/s12160-013-9486-6 PubMed DOI

Michie S, Hyder N, Walia A, et al. . Development of a taxonomy of behaviour change techniques used in individual behavioural support for smoking cessation. Addict Behav 2011;36:315–9. 10.1016/j.addbeh.2010.11.016 PubMed DOI

Dogar O. Understanding variations in the outcome of a smoking cessation programme in Tuberculosis patients in Pakistan - the role of fidelity? 2016.

Moore GF, Audrey S, Barker M, et al. . Process evaluation of complex interventions: Medical Research Council guidance. BMJ 2015;350:h1258 10.1136/bmj.h1258 PubMed DOI PMC

Linnan L, Steckler A. Process evaluation for public health interventions and research: an overview : Steckler A, Linnan L, Process evaluation for public health interventions and research. San Francisco: Jossey-Bass, 2002:1–23.

Moore GF, Audrey S, Barker M, et al. . Process evaluation of complex interventions: Glasgow, 2014.

Hickey G, McGilloway S, Furlong M, et al. . Understanding the implementation and effectiveness of a group-based early parenting intervention: a process evaluation protocol. BMC Health Serv Res 2016;16:490 10.1186/s12913-016-1737-3 PubMed DOI PMC

Carroll C, Patterson M, Wood S, et al. . A conceptual framework for implementation fidelity. Implement Sci 2007;2:40 10.1186/1748-5908-2-40 PubMed DOI PMC

Hasson H. Systematic evaluation of implementation fidelity of complex interventions in health and social care. Implement Sci 2010;5:67 10.1186/1748-5908-5-67 PubMed DOI PMC

Suri H. Purposeful Sampling in Qualitative Research Synthesis. Qual Res J 2011;11:63–75. 10.3316/QRJ1102063 DOI

Lorencatto F, West R, Christopherson C, et al. . Assessing fidelity of delivery of smoking cessation behavioural support in practice. Implement Sci 2013;8:40 10.1186/1748-5908-8-40 PubMed DOI PMC

IBM Corp. IBM SPSS Statistics for Windows, 2016. Version 24.0.

SAS Institute (Cary N.C.). SAS 9.4.

R Core Team. R: A language and environment for statistical computing. 2016. http://www.r-project.org/

Bricon-Souf N, Newman CR. Context awareness in health care: a review. Int J Med Inform 2007;76:2–12. 10.1016/j.ijmedinf.2006.01.003 PubMed DOI

Bergström A, Skeen S, Duc DM, et al. . Health system context and implementation of evidence-based practices-development and validation of the Context Assessment for Community Health (COACH) tool for low- and middle-income settings. Implement Sci 2015;10:120 10.1186/s13012-015-0305-2 PubMed DOI PMC

Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci 2011;6:42 10.1186/1748-5908-6-42 PubMed DOI PMC

Silverman D. Doing qualitative research. 3rd edn Los Angeles: SAGE Publ, 2011.

QSR International Pty Ltd. NVivo qualitative data analysis Software. Version 11 2015.

Damschroder LJ, Lowery JC. Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR). Implement Sci 2013;8:51 10.1186/1748-5908-8-51 PubMed DOI PMC

Damschroder LJ, Aron DC, Keith RE, et al. . Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009;4:50 10.1186/1748-5908-4-50 PubMed DOI PMC

Cane J, O’Connor D, Michie S, et al. . Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci 2012;7:37 10.1186/1748-5908-7-37 PubMed DOI PMC

Cane J, Richardson M, Johnston M, et al. . From lists of behaviour change techniques (BCTs) to structured hierarchies: comparison of two methods of developing a hierarchy of BCTs. Br J Health Psychol 2015;20:130–50. 10.1111/bjhp.12102 PubMed DOI

English M, Nzinga J, Mbindyo P, et al. . Explaining the effects of a multifaceted intervention to improve inpatient care in rural Kenyan hospitals--interpretation based on retrospective examination of data from participant observation, quantitative and qualitative studies. Implement Sci 2011;6:124 10.1186/1748-5908-6-124 PubMed DOI PMC

West R, Walia A, Hyder N, et al. . Behavior change techniques used by the English Stop Smoking Services and their associations with short-term quit outcomes. Nicotine Tob Res 2010;12:742–7. 10.1093/ntr/ntq074 PubMed DOI

Birken SA, Powell BJ, Presseau J, et al. . Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review. Implement Sci 2017;12 2:2 10.1186/s13012-016-0534-z PubMed DOI PMC

Flick U. Triangulation. 3rd edn Wiesbaden: VS Verlag für Sozialwissenschaften, 2011.

Denzin NK. The Research Act. 3rd edn: Englewood Cliffs, N. J: Prentice Hall, 1989.

Zahid R, Dogar O, Mansoor S, et al. . The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers - study protocol for a randomized controlled trial. Trials 2017;18:14 10.1186/s13063-016-1761-y PubMed DOI PMC

Karkee R, Lee AH. Birth spacing of pregnant women in Nepal: a community-based study. Front Public Health 2016;4:205 10.3389/fpubh.2016.00205 PubMed DOI PMC

Osrin D, Azad K, Fernandez A, et al. . Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. Bull World Health Organ 2009;87:772–9. 10.2471/BLT.08.051060 PubMed DOI PMC

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ISRCTN
ISRCTN43811467