Motivating Smokers at Outdoor Public Smoking Hotspots to Have Quit Attempt With Nicotine Replacement Therapy Sampling: A Randomized Controlled Trial

Trial design The study aims at motivating smokers to have quit attempt using nicotine replacement therapy (NRT) sampling. We will firstly train nurses and university undergraduate students as outreach smoking cessation ambassadors. These trained ambassadors will proactively approach the smokers at outdoor smoking hotspots, where rubbish bins with a collector of cigarette butts are nearby, and invite them to participate in the RCT.

Subjects Smokers with the following inclusion criteria will be invited to participate in our RCT: (1) Aged 18 years or above; (2) Smoke 10 cigarettes or more per day in the past week; (3) Able to read and speak Chinese; (4) Have not used NRT for the past 3 months; (5) Have no severe angina and serious cardiac arrhythmias; (6) Have not suffered from acute myocardial event in the past 4 weeks; and (7) Not pregnant and breastfeeding The recruitments of subjects will take place at 9 outdoor urban places where smokers stayed and smoked from July 2015 to September 2015 (To be confirmed) Procedures We target to train nurses and smoking cessation ambassadors for the recruitment and providing intervention to the subjects. Recruitment of outreach smoking cessation ambassadors will be conducted through sending mass mails to students of the University of Hong Kong. Retired nurses who are now providing counselling services in our existing smoking cessation projects will be recruited. They will be invited to participate in a training programme which provides them an overview of the smoking cessation counselling and pharmacotherapy in helping smokers quit smoking. Our research team (comprised of physicians and nurses) will develop the training material and intervention guide based on the principles of the US Agency for Health Care Policy and Research (AHCPR) guidelines in the US [28], the guidelines of the National Institutes of Health [29] and World Health Organization [30]. The training content will cover (1) smoking trend in Hong Kong; (2) health hazards of smoking, (3) basic skills in assessing smoking dependence and quitting readiness; (4) knowledge of smoking cessation medication (types of NRT, adherence and side effects etc.) and (5) brief counseling skills. At the end of the training, participants should be capable of delivering brief intervention of smoking cessation including the advice on using NRT.

Smoking cessation ambassadors will approach the smokers and distribute souvenirs with smoking cessation messages at the outdoor smoking hotspots. The souvenir will be a small pack of tissue paper, with motivational messages (e.g. 1 in 2 smokers will be killed by smoking), quitline number (e.g. Quitline of Tobacco Control Office 1833183) and other resources for quitting printed on the tissue pack. If the smoker is willing to accept the souvenir and talk to the ambassador, the ambassador will ask further questions related to the eligibility through an informal conversation. If the subject is eligible, the ambassador will seek his/her consent to receive further intervention and provide his/her mobile phone number.

Interventions The intervention group will receive a free pack of one-week NRT. The nurse will help the subject to decide which NRT product (patch, gum and lozenge) he/she can use and advise how to use the NRT based on his/her smoking habit and amount of cigarette consumption, followed by the delivery of the sampling, instructions of using the NRT sampling, an education card about NRT and a 12-page smoking cessation booklet (Figure 1). Based on the experience in the previous trials, the choice of NRT (either patch, lozenge or gum) will be made according to subject's preference, and the counsellors will provide medication counselling [25-27]. If the subject is willing to continue the counselling at recruitment, the ambassador will further introduce the NRT's side effects, adherence and effectiveness (Table 1). Otherwise, the ambassador will contact the subject for providing these details and enquiring the usage through telephone within 2 days.

Some subjects may not be interested to use NRT sampling or some may not use them for quitting it. An envelope with a return address and pre-paid postage will be given with the NRT sampling, so that subjects can send back any unused NRT sampling to us to avoid wastage.