Design: Multi-centre two-arm cluster randomised controlled trial with mixed-method embedded process and economic evaluation.
Setting: Homeless centres in England, Scotland and Wales.
Participants: Adult smokers (18+ years; n= 480) accessing homeless centres and who are known to centre staff and willing to consent.
Intervention and comparator: Clusters (n=32) will be randomised to either an e-cigarette starter pack with weekly allocations of nicotine containing e-liquid for 4-weeks (choice of flavours (menthol, fruit and tobacco) and strengths 12 mg/mL and 18mg/mL), or the usual care intervention which comprises very brief advice and a leaflet signposting to the local stop smoking service.
Measurements: The primary outcome is 24-week sustained CO validated smoking cessation (Russell Standard defined, intention-to-treat analysis). Secondary outcomes: i) Fifty percent smoking reduction (cigarettes per day) from baseline to 24 weeks; ii) 7-day point prevalence quit rates at 4-, 12- and 24-week follow-up; iii) changes in risky smoking practices (e.g. sharing cigarettes, smoking discarded cigarettes) from baseline to 4-, 12- and 24-weeks; iv) cost-effectiveness of the intervention; v) fidelity of intervention implementation; mechanisms of change; contextual influences and sustainability.
Comments: This is the first study to randomly assign smokers experiencing homelessness to an e-cigarette and usual care intervention to measure smoking abstinence with embedded process and economic evaluations. If effective, the results will be used to inform the larger scale implementation of offering e-cigarettes across homeless centres to aid smoking cessation.
Keywords: Smoking; homelessness; tobacco; e-cigarettes; vaping; ENDS; cessation; harm reduction; very brief advice; usual care
- harm reduction
- usual care
- very brief advice