We Can Quit2 (WCQ2): a community-based programme to help women living in disadvantaged areas of Ireland to stop smoking

INTERVENTION: Four matched pairs of districts (eight clusters), will be randomised with each matched pair of clusters randomised to intervention or controls in a 1:1 allocation ratio. The randomisation will follow a pragmatic approach whereby paired districts ready for the intervention will be randomised first, followed by the next available matched pair; this accounts for temporal changes over time and will provide a balanced design. The randomisation will be conducted remotely by the Wellcome Trust Clinical Research Facility (CRF) independent of the Trial Management Team, who will have developed a Standard Operating Procedure (SOP) for this process. The code for each matched pair of districts will have been concealed and securely stored by the Wellcome‐CRF. It will be revealed to the WCQ2 trial team once sufficient numbers have been recruited (or by agreement with the Trial Management Group (TMG)) if recruitment is insufficient prior to intervention delivery). Practitioners will be informed of their allocation by the research team and and participants will be informed of their allocation by the practitioners. Participants randomised to the intervention will receive 12 weekly behavioural support group sessions and Nicotine Replacement Therapy (NRT). The group sessions are designed to enhance positive social support systems among peers. NRT is made available without cost to all intervention participants. Each programme will be delivered in a local community facility by two trained Community Facilitators (CFs) who tend to be ex‐smokers themselves. Each session will last approximately 90 minutes. The CF’s will make proactive personal contact both during and between sessions with participants using their own language and cultural style and provide opportunity to share testimonials and personal experiences. They also carry out regular Carbon Monoxide (CO) monitoring. Participants will be followed up at e CONDITION: Smoking cessation ; Mental and Behavioural Disorders ; Smoking cessation PRIMARY OUTCOME: Feasibility of recruitment, assessed by the number of women enrolled in the study as a proportion of the recruitment target of 194 women from eight randomised districts within 18 months during four 12 week periods INCLUSION CRITERIA: 1. Female 2. Aged 18 or over 3. English speaker 4. Self‐reported as a daily smoker with an interest in quitting 5. Deemed to live/work within easy travel distance of the trial catchment areas Women taking Nicotine Replacement Therapy (NRT) or who are have been prescribed bupropion/varenicline by the doctor at time of recruitment are eligible to take part, as are women using e‐cigarettes. SECONDARY OUTCOME: ; 1. Retention and data completion rates in each trial arm at 12 weeks and 6 months post quit date as a follow‐up timepoint in the full trial. Retention will be measured as the number of women retained in the study by 12 weeks and six months post quit date as a proportion of the number of women enrolled.; Data completion will be measured as the proportion of valid sets of outcome measures completed by women at 12 weeks and six months post quit date.; 2. Proportion of participants who are continuously abstinent from smoking (as per Russell Standard), at 12 weeks. This will be measured by self‐report corroborated by salivary cotinine and anabasine.; 3. Proportion of participants who are continuously abstinent from smoking, at 6 months after their quit date, corroborated by salivary cotinine and anabasine.; 4. Proportion of enrolled smokers who engage with smoking cessation services in each trial arm (engagement is defined as arrival for a first with a smoking cessation adviser and having set a quit date). This will be measured by the proportion of women who have set a quit date up to and including the second session with a smoking cessation advisor as a proportion of those who enrolled in the study; 5. Proportion of participants who report improvement in health status measured at baseline (week 1) and 12 weeks and 6 months. This will be measured by calculating the number and percentage of responses for each item of the 12‐item short‐form health survey (SF‐12) at week 1, week 12 and 6 months. Means, standard deviations (or their non‐parametric alternative) will be estimated together with the corresponding change scores and effect sizes.; 6. Fidelity to and adaptation of the intervention as established by Community Facilitator checklist and diary assessed at time of focus group interview at week 12.; 7. Acceptability of trial processes by participants and practitioners involved in service delivery as established by interviews at week 12.; 8. Assessment of the trial design across a range of pre‐designed measures PRECIS 2 during intervention delivery and at the end of the intervention and ADePT (A process for Decision‐making after Pilot and feasibility Trials) decision aid will be used at the end of the intervention to aid the decision‐making process around progression to the full trial.;