Title: Effects of e-cigarettes vs usual care for smoking cessation when offered at homeless centres: A cluster randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Around 60% of people who are homeless smoke tobacco; far higher than the UK average of 14.1%. E-cigarettes (EC) are the most popular method of quitting smoking, with some studies suggesting they are more helpful than nicotine gum or patches and are less harmful than smoking. For people on low or no income however, the price of a starter kit is relatively high. Supplying free EC starter kits at centres for people experiencing homelessness may overcome this problem. In our earlier smaller study, we found that EC starter kits were well received by participants, staff at homeless centres were able to support the study, and we could collect data needed for a full trial. A larger study is now needed to explore whether supplying EC to smokers at homeless centres can help with quitting and whether it offers value for money. This will be the first study in the world to look at this._x000D_ _x000D_ Our study will take place in 32 centres across five areas in Great Britain (GB): Scotland; Wales; London; South-East England and East England. Sixteen of these will be in the EC group and 16 will be in a usual care (UC) group. Before collecting information from those taking part, we will inform staff at centres about smoking vs. EC use and how to support the study. We will also introduce the study to smokers attending the centres. Once people have agreed to take part, we will ask them to complete questionnaires asking about their smoking and health. They will also breathe into a breathalyser which measures carbon monoxide (CO), a harmful chemical produced by smoking. This will tell us whether the person has recently smoked. Those in the EC group will be given a starter kit, 4 weeks supply of e-liquids and support to use it. Those in the UC group will be given information and advice about stopping smoking and signposted to the local Stop Smoking Service (SSS). We will see everyone again at 4, 12 and 24 weeks to ask them about their quit attempts, current smoking, EC use, health and CO level._x000D_ _x000D_ First, we will run a pilot study with 120 participants across eight centres to check that we can recruit enough people in our scheduled time-frame. If we have problems with recruitment we will talk to a group of independent experts (our Trial Steering Committee) and consider stopping the study. If recruitment goes to plan, we will continue as a full trial with 480 participants; 240 in each group, 15 from each centre. To look at people’s experience of taking part we will speak with 32 participants and 16 service centre staff from the EC group and from different areas of GB. We will look at how delivery of the intervention worked and which parts of the intervention led to a change in participants’ smoking. If we find that EC help people to stop smoking, we will also speak with six decision makers in England, Scotland and Wales (18 in total) who will be responsible for deciding whether EC could be provided in homeless centres in future and how this might happen. An economic evaluation will also be done to see if the intervention is cost-effective compared with UC._x000D_ _x000D_ We will share our findings with the participants and the homeless centres involved. We will make our findings available online and via social media and press releases. If we find that providing free EC starter kits to people accessing homeless services works well for helping people to quit smoking, homeless centres may consider taking up this approach to reduce inequalities and the impact of diseases caused by smoking in this population.

Lay abstract: Adult smoking rates in the UK are at a historic low, at 14.1%. However, this masks considerable inequalities. Prevalence amongst adults who are homeless, is four times higher than the national average. Homeless smokers make fewer quit attempts, are less likely to stop smoking but show desire to quit. The harms of tobacco smoking are exacerbated in this population because of concurrent smoking of illicit substances which compromise lung function. There is therefore an urgent need to explore the efficacy of novel approaches for smoking cessation in one of the most vulnerable and hard to treat groups in society._x000D_ _x000D_ E-cigarettes (EC) are the most common method used in a quit attempt in the UK and evidence for their efficacy is accumulating. However, initial start-up costs may deter those on lower incomes from buying one. Our feasibility study (NIHR ref.17-55-29) in 4 homeless centres in England and Scotland in 2019 demonstrated that providing a free EC starter kit was acceptable to staff and clients. We met our overall minimum recruitment and retention targets and collected most of the information needed for economic evaluation. We now propose a full trial which aims to determine the efficacy and cost-effectiveness of providing free EC starter kits to smokers accessing homeless centres compared with usual care (UC)._x000D_ _x000D_ The trial will take place in 32 homeless centres (who will serve as clusters) across GB, allocated either to an EC or UC arm. Allocation will be stratified by region (n=5: Scotland, Wales, London, East England, and South East) using stratified permuted blocks to ensure balance. 480 participants (15 smokers in each centre) will complete questionnaires about general health and smoking behaviour and provide a breath carbon monoxide (CO) sample at baseline. Those in the EC arm (N=240) will be provided with an EC starter kit, 4-weeks supply of e-liquids and support from trained centre staff to use them. Follow up assessments including smoking behaviour, quit rates, CO levels, health-related quality of life, health-care service utilisation will be conducted at 4, 12 and 24 weeks. Participants in the UC group (N=240) 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. An inbuilt pilot study with 120 participants (8 centres) will monitor recruitment with green/amber/red stop/go criteria._x000D_ _x000D_ An embedded mixed methods process evaluation using both quantitative (e.g. questionnaires) and qualitative (e.g. interviews) approaches will explore treatment context, fidelity of implementation, mechanisms of change and sustainability. Mechanisms of change and context will be explored through in-depth qualitative interviews with 32 participants (weeks 12-24) and 16 staff members (weeks 4-8) in 8 centres (4 England, 2 Wales, 2 Scotland) in the EC arm. An economic evaluation (an incremental cost-effectiveness of the EC intervention over and above UC) will also be conducted._x000D_ _x000D_ We will share our findings with the participants and the homeless centres involved and will make our findings available online and via social media and press releases. Pathways to implementation across homeless centres in GB will be explored through workshops with key decision makers in each country

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