Behaviour change intervention for smokeless tobacco (ST) cessation delivered through dentists within a dental setting: a feasibility study protocol

OBJECTIVES/AIM: To adapt a structured behavioural support intervention for smokeless tobacco (ST) cessation and to assess the feasibility and acceptability of delivering the intervention via dentists within dental settings in Pakistan. MATERIAL AND METHODS: The study will have 3 phases: (1) Adapt a previously developed intervention to make it suitable for delivery in a clinical/dental setting through qualitative interviews with dental patients and dentists; (2) A multi-centre, pilot randomised control trial in two teaching dental hospitals in Pakistan. Participants (dental patients) will be randomly assigned to intervention or control group in a 1:1 allocation ratio to receive either a structured behavioural support intervention involving face to face counselling or self-help material plus usual care. Each participant will be in the study for approximately 6 months and the overall study is expected to run for 12 months; (3) An embedded qualitative process evaluation. All trial participants will be followed up at 3 and 6 months to assess self-reported ST use. Outcome measures will include: rates of eligibility, recruitment and retention, randomisation group cross-over rates, the provision of data on ST use behaviour, fidelity to the intervention and qualitative assessment of acceptability and feasibility. DISCUSSION: Despite the high use of ST in Pakistan, users are offered negligible cessation support. The findings of this multi-centre, mixed-method feasibility study will inform the scope for a larger trial on ST cessation delivered through the existing dental health system.