Title: Exploring the uptake and use of electronic cigarettes provided to smokers accessing homeless centres: a feasibility study
Funder: Department of Health and Social Care

Abstract: Smoking rates in the UK are at an all-time low, at 15.8% of the adult population. However, this masks considerable inequalities; prevalence amongst adults who are homeless, for example, remains four times higher than the national average. Homeless smokers make fewer quit attempts, are less likely to stop smoking, and are at risk of poor physical and mental health outcomes including other addictions. As such, this is a difficult to engage population, however, not tackling smoking in this population will only increase health inequalities. E-cigarettes (EC) are now the most common method of stopping smoking in the UK, used in over one third of quit attempts. There is emerging evidence of cessation efficacy but initial start-up costs may deter those on lower incomes from purchasing. Supplying free e-cigarette starter kits at a location already being accessed by homeless smokers may therefore facilitate behaviour change and smoking cessation. Our aim is to undertake a feasibility cluster randomised controlled trial to evaluate the effectiveness of supplying free e-cigarette starter kits for smoking cessation to smokers accessing homeless centres. The study will take place in four homeless centres (who will serve as clusters) across the UK: two in the intervention (e-cigarette) and two in the control (usual care) arm; each control and intervention centre matched for accommodation provision. 120 participants (30 at each centre) will complete questionnaires measuring smoking behaviour and general health and provide a breath carbon monoxide (CO) sample at baseline. Those in the e-cigarette arm will be provided with an e-cigarette starter kit including 4 weeks supply of e-liquids and support to use them. Follow up assessments including smoking behaviour, quit rates, CO levels, health-related quality of life and e-cigarette usage patterns will be conducted at 4, 12 and 24 weeks. Centres in the control group will be provided with information on smoking cessation and how to access their local stop smoking service and will be followed up at the same time points. Qualitative interviews with 24 participants (12 in each arm) including completers and non-completers, and 12 service centre staff (6 in each arm) will be conducted between weeks 4 and 8. The feasibility study will inform the design of a future trial. Specifically, we will assess: willingness of smokers to participate; retention in the intervention and control groups and the percentage that are still using e-cigarettes at each follow up time point; unintended consequences; preliminary evidence of the effectiveness of supplying free e-cigarette starter kits; the feasibility of collecting data on contacts with health care services within this population as an input to an economic evaluation in a full RCT; the cost of providing free e-cigarettes on a per person basis. We will monitor engagement with the study through quantitative measures and qualitative interviews with completers, non-completers and staff to assess facilitators and barriers to comply with the study. If successful, findings from this feasibility study will be used to inform the design of a fully powered cluster randomised controlled trial to evaluate the effectiveness of providing free e-cigarette starter kits to homeless smokers for smoking cessation. If the main trial is effective, the service delivery model has the potential to be rolled out nationally across homeless centres.

Lay abstract: Smoking rates in the UK are now the second lowest in Europe (after Sweden) but homeless smokers are still 4 times more likely to smoke. They are also less likely to try to stop smoking and if they do, are less likely to succeed. E-cigarettes are now the most popular method of quitting with some studies suggesting they may help people to stop smoking. For those on low incomes, however, the price for a starter kit may put people off. Supplying free e-cigarette starter kits at centres that homeless smokers already go to may help smokers to reduce the number of cigarettes they smoke and eventually stop. This study will explore whether supplying free e-cigarette starter kits to smokers accessing homeless centres is a good idea and look at the best ways to do this. If enough people sign up for the study, continue to use the e-cigarette and cut down their smoking or quit completely, we can be confident that it would be worthwhile running a larger study to explore whether e-cigarettes help homeless smokers to stop smoking. Our study will take place in four homeless centres across the UK: two in the e-cigarette group and two in a control group ('usual care' - advice to quit and signposting to the stop smoking service). At the start of the study, 120 smokers (30 at each centre) will complete questionnaires about their current smoking and their health and will breathe into a breathalyser which measures carbon monoxide (CO) – a harmful toxicant caused by smoking. Those in the e-cigarette group will be given a starter kit and 4 weeks supply of e-liquid and support to use it. We will see everyone in the study again at 4, 12 and 24 weeks to ask them about their quit attempts, current smoking, e-cigarette use, health and CO level. Those in the control group will be given information about quitting smoking and how to access their local stop smoking service and will be seen at the same time points but will not receive the free e-cigarette. We will interview 24 participants (12 in each group) including some who completed and some who did not complete the study, and 12 service centre staff (6 in each group) between weeks 4 and 8. We will use the information from this study to decide whether a larger trial is possible and worthwhile. To do this we will measure: willingness of smokers to take part; whether they complete study measures; if they are still using e-cigarettes at each follow up time point; how many quit smoking or reduce the number of cigarettes they smoke; and the cost of providing free e-cigarettes to smokers. We will gather information to see how smokers and staff at homeless centres engage with the study and will interview some smokers who complete and some who drop out as well as staff to explore their views on using, and supporting the use of, e-cigarettes. We will share our findings with the smokers who took part and the homeless centres we work with, as well as making our findings available online and via social media and press releases. The main goal of the study is to make a decision as to whether to proceed to a larger trial and how best to run this trial. If we do run a full trial we will assess whether providing free e-cigarette starter kits to homeless smokers is a good way of helping smokers to quit. If this is the case, homeless centres may consider adopting this approach to reduce inequalities and the impact of diseases caused by smoking in this vulnerable group.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;RESPIRATORY;STROKE