METHODS AND ANALYSIS: A two-arm, parallel, open-label, multicentre, 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 4 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 quality-adjusted life year gained, calculate the incremental cost-effectiveness ratios to establish the value for money for mTB-Tobacco.
ETHICS AND DISSEMINATION: This trial will be conducted in compliance with International Council on Harmonisation - Good Clinical Practice 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. The results of this trial will be disseminated in peer-reviewed journals and presented in academic conferences.
TRIAL REGISTRATION NUMBER: ISRCTN86971818 (https://doi.org/10.1186/ISRCTN86971818); pre-enrolment, submission date: 29 August 2023; registration date: 11 September 2023.
METHODS: We adopted the Joanna Briggs Institute's scoping review protocol and followed the Cochrane Rapid Review method to accelerate the review process, using the Implementation and Operation of Mobile Health projects framework and The Extended Technology Acceptance Model of Mobile Telephony to categorise the results. We conducted the review in four stages: (1) establishing value, (2) identifying digital health policy, (3) searching for evidence of infrastructure, design, and end-user adoption, (4) local input to interpret relevance and adoption factors. We used open-source national/international statistics such as the World Health Organization, International Telecommunication Union, Groupe Speciale Mobile, and local news/articles/government statistics to scope the current status, and systematically searched five databases for locally relevant exemplars.
RESULTS: We found 118 studies (2015-2021) and 114 supplementary online news articles and national statistics. Digital health policy was available in all countries, but scarce skilled labour, lack of legislation/interoperability support, and interrupted electricity and internet services were limitations. Older patients, women and those living in rural areas were least likely to have access to ICT infrastructure. Renewable energy has potential in enabling digital health care. Low usage mobile data and voice service packages are relatively affordable options for mHealth in the five countries.
CONCLUSIONS: Effective implementation of digital health technologies requires a supportive policy, stable electricity infrastructures, affordable mobile internet service, and good understanding of the socio-economic context in order to tailor the intervention such that it functional, accessible, feasible, user-friendly and trusted by the target users. We suggest a checklist of contextual factors that developers of digital health initiatives in LMICs should consider at an early stage in the development process.