A mHealth intervention (mTB-Tobacco) for smoking cessation in people with drug-sensitive pulmonary tuberculosis: protocol for an adaptive design, clusterrandomised controlled trial (Quit4TB)

IntroductionPeople with tuberculosis (TB) who continue to smoke are more likely to have poor health outcomes than those who quit. Established smoking cessation approaches such as mHealth may help TB patients quit smoking. This paper summarises the methodology proposed to assess the effectiveness and cost-effectiveness of mTB-Tobacco (an mHealth intervention) in helping TB patients stop smoking and have improved health outcomes. Methods and analysisA two-arm, parallel, open-label, multi-centre, cluster randomised, two-stage adaptive design trial is proposed to first evaluate the superiority of mTB-Tobacco, compared with usual care and then the non-inferiority of mTB-tobacco compared with face-to-face behaviour support. Study settings include TB treatment centres in Bangladesh and Pakistan. The study population includes adult patients, newly diagnosed (within four weeks) with pulmonary TB disease, daily smokers, willing to quit, and have access to mobile phones. The primary outcome includes biochemically verified continuous smoking abstinence assessed at 6 months per Russell Standard. A generalised linear mixed-effects model will be used to assess the impact of mTB-Tobacco intervention on continuous outcomes, incorporating fixed effects for the intervention, random effects for clusters, and relevant covariates. Cost-effectiveness analysis will be done to estimate the cost per quitter and cost per QALY gained, calculate the incremental cost-effectiveness ratios (ICER) to establish the value for money for mTB-Tobacco. Ethics and disseminationThis trial will be conducted in compliance with ICH-GCP guidelines and the Declaration of Helsinki. The study has been approved by the ethics committees of the University of Edinburgh Medical School Research Ethics Committee (EMREC) of UK, the Bangladesh Medical Research Council (BMRC) and the National Bioethics Committee (PMRC) of Pakistan. FundingThe study is funded by the National Institute of Health Research (NIHR) UK under a research award named NIHR Global Health Research Unit on Respiratory Health (RESPIRE) (Award ID: NIHR132826) Trial registration numberISRCTN86971818 (https://doi.org/10.1186/ISRCTN86971818); Submission date:29/08/2023; Registration date:11/09/2023; Last edited:30/04/2024 Strengths and limitations of this studyO_LIThis trial will be the first one to test the effectiveness of mHealth based intervention to help TB patients quit smoking at 6 months. C_LIO_LIAn effective mTB-Tobacco intervention could be transformational for TB patients who smoke. It will not only benefit the TB patients but will also allow the national TB control programmes to have a less resource-intensive and effective intervention for smoking cessation that can be easily integrated into their system. C_LIO_LIThe web portal that will be developed under this project can be used by TB programmes with no to minimal extra cost to only account for the SMS text message delivery. C_LIO_LITB disease is more prevalent in vulnerable populations e.g. lower socioeconomic groups, and such population is more likely to have poor literacy as compared to the general population. This can be a challenge as TB patients ability to read and understand SMS messages may be a barrier. C_LI