Use of Nicotine Replacement Therapy (NRT) Sample and Brief Smoking Cessation Advice for Recruiting Smokers
Use of Nicotine Replacement Therapy (NRT) Sample and Brief Smoking Cessation Advice for Recruiting Smokers
Background More than 60% of the daily smokers in Hong Kong have never tried and have no
 intention to quit smoking. About 30.8% of daily smokers attempted to quit but failed.
 Nicotine replacement therapy (NRT) is a safe and effective pharmacotherapy to reduce
 withdrawal symptoms during early stage of tobacco abstinence and increase quit rate. However,
 the prevalence of using NRT in Hong Kong is lower than most of the developed countries. The
 proposed project aims to test if providing free NRT sampling to smokers can increase quit
 attempt, the use of smoking cessation (SC) services and abstinence.

 Methods University undergraduate students will be trained, and will invite smokers at outdoor
 smoking hotspots to quit smoking and enroll into SC services. Eligible smokers will be
 randomized to experimental or control group according to a cluster randomization, using
 recruitment session as the randomization unit. The experimental group will be provided with
 1-week free NRT sampling and medication counselling, whereas the control group will be
 provided medication counselling. Both groups are advised to enroll in the SC services. The
 two primary outcomes include (1) the proportion of smokers who enroll in any SC service in
 Hong Kong within 1 month of the recruitment; and (2) the proportion of smokers who report
 quit attempts at 1 month follow-up

 Discussions The findings will inform the feasibility and effectiveness of delivering free NRT
 sampling to increase quit attempt, the use of smoking cessation services and abstinence. It
 will yield more information on smokers' adherence to the NRT sampling, side effect and safety
 issue of the usage.
Study design

 The proposed project has 4 phases: (1) Training of SC ambassadors (SCAs) for the SC
 promotion; (2) SC promotion sessions to deliver the medication counselling and NRT sampling
 (experimental group), or the advice to use NRT only (control group); (3) Follow-up of the
 recruited smokers; (4) Evaluation of the effectiveness of training, promotions, and use of
 NRT sampling. To examine the effectiveness of NRT sampling for recruitment and quitting, a
 multi-site cluster RCT (allocation ratio 2:1) will be used. All promotion sessions will be
 randomly allocated to either the experimental or the control group. The experimental group
 will receive medication counselling and NRT samples, while the control group only receive the
 advice to use NRT. Because smokers who receive NRT sampling will be more likely to
 participate in the study, the experimental sessions will then recruit more smokers than the
 control sessions. Hence, the allocation ratio of participants is arbitrarily set at 2:1. To
 increase comparability between the two groups, the promotion sessions of one hotspot will be
 randomly allocated to either group. All recruitment and quitting outcomes in the smokers
 between the experimental and control group will be compared.

 Subjects

 Smokers with the following inclusion criteria will be invited to participate in our RCT: (1)
 Hong Kong residents, (2) aged 18 to 65 years, (3) have used any tobacco products in the past
 month, (4) able to read and speak Chinese, (5) have not used NRT for the past month, (6) no
 severe angina, serious cardiac arrhythmias and hypertension, (7) have not suffered acute
 myocardial event in the past 4 weeks, (8) neither pregnant nor breastfeeding, (9) not under
 medication and treatment due to mental illness. To confirm the smoking status, in those who
 use conventional cigarettes, smokers' exhaled carbon monoxide will be measured on-site.
 Nurses will measure the blood pressure if smoker is aged over 50 years old, obese by
 observation, or upon patient requests.

 The inclusion criterion no. 3 was "smoke 10 cigarettes or more per day in the past week" and
 is amended to "have used any tobacco products in the past month". The initial intention of
 setting the inclusion criteria of at least 10 cigarettes per day (CPD) is to recruit smokers
 who have moderate to strong level of craving and a greater need for NRT. However, we also
 recognize that one of the objectives of the research is to promote the use of NRT for quit
 attempts with NRT sampling. In fact, smokers who smoke less than 10 CPD can also benefit from
 using NRT gums. Therefore, the change in the inclusion criteria does not deviate from our
 research aim. In contrast, with the removal of the criterion for CPD, we will be able to
 reach out to a larger group of smoking population and encourage more smokers to use NRT to
 quit smoking.

 Procedures

 In the experimental sessions, the SCAs will approach and distribute souvenirs (e.g. a pen) or
 leaflets to the smokers at outdoor smoking hotspots for 3-4 hours. The souvenirs and leaflets
 will have SC messages, quitline number and other SC services. If a smoker is willing to
 accept them and talk to the SCAs, the SCAs will advise the smoker to quit using the AWARD
 protocol. The AWARD protocol includes (1) Ask the smoking history, (2) Warn about the high
 risk (i.e., half of the smokers will die of smoking-related diseases), (3) Advise to quit,
 (4) Refer to the SC clinics of TWGHs and (5) Repeat the above advice (Do-it-again) [4]. Our
 previous studies have shown that the AWARD protocol is a feasible and appropriate tool used
 by non-healthcare professionals to promote smoking cessation [4-6]. If the smoker is
 interested in smoking cessation, the SCAs will introduce NRT to the smoker and conduct a
 preliminary assessment of his/her eligibility for enrolling in the "NRT sampling" programme.
 The SCAs will invite him/her to go to the smoking cessation truck nearby to receive
 counselling by an onsite nurse. If the smoker is not eligible, he/she can still enroll in the
 cessation service provided by the SC clinics.

 Intervention: NRT sampling and medication counselling

 In the experimental sessions, an onsite nurse will assess whether each participant is fit for
 using NRT with further assessment on his/her current physical status, medication and blood
 pressure. If the participant is willing to use NRT to quit smoking and pass the nurse's
 assessment, he/she will be prescribed the NRT sample, regardless of whether they use NRT for
 smoking reduction and when the quit day is. The nurse will help the participant decide which
 type of NRT product (gum: 2mg, patch: 14mg or 21mg) that he/she can use and advise him/her on
 how to use the NRT based on his/her smoking habit and daily cigarette consumption. In
 addition, the nurse will deliver medication counselling which addresses five main components:
 (1) the benefits for using NRT in quitting, (2) withdrawal symptoms due to smoking cessation,
 (3) side effects of NRT, (4) instructions for using NRT, and (5) making appointments for
 TWGHs SC clinics. Afterwards, the participant will receive 1-week free NRT.

 In the control sessions, all the above procedures for the experimental group will be applied,
 except that they will not receive an NRT sample and an instruction card about the use of NRT.
 Instead, they will be advised to obtain free NRT by enrolling in the SC clinics. Both groups
 will receive a one-page leaflet provided by the SC clinics, and encouraged to make service
 appointments with the SC clinics.

 When the participant has finished the above procedures, the research assistant or trained
 ambassadors (under supervision of the research staff) or the nurse will introduce the trial
 of evaluating the effect of NRT sample and the outreach service and screen the eligibility of
 participating in the trial. If the participant is eligible, the research assistant will seek
 his/her consent to participate in the trial, and complete a baseline questionnaire.

 Some smokers are willing to participate in the RCT, but they have no time to receive all
 intervention or complete all recruitment procedures at the hotspots. In these cases, the SCAs
 will only briefly introduce the RCT, ask the participants to give written consent. A nurse
 will contact these participants to complete the baseline questionnaire and deliver the
 intervention (counselling and NRT prescription) within the same day. If the participants are
 in the experimental group, after the telephone counselling by the nurse, our research staff
 will send the NRT sample via mail within 2 days.

 Randomization

 We will use cluster randomization based on promotion session as the cluster unit because the
 procedures of individual randomization are difficult in outdoor areas as found in our pilot
 RCT. The PI will randomly allocate the promotion sessions within a hotspot to the 2 groups by
 a list of group allocation which is based on a list of random numbers from Excel programme.
 Each hotspot will have 2 or more promotion sessions, and each session will last for about 3-4
 hours. If a hotspot has 2 promotion sessions on 1 single day, the 2 sessions will be
 allocated into the same RCT group, and we will organize 2 more promotion sessions in this
 hotspot on another day.

 Allocation concealment

 All recruitment staff will know the group allocation before each promotion session, so no
 group concealment can be done.

 Blinding

 Participants cannot and will not be blinded to the intervention. Assessors of the follow-up
 outcomes and the research analysts will not be involved in the recruitment and intervention
 delivery, and will be blinded to the group allocation (single blindness).

 Follow-up

 All the smokers who consent to the follow-up will be contacted via telephone or WhatsApp
 around one week by a nurse or a trained research staff after recruitment. The aim of this
 follow-up is (1) to enquire if there is any progress towards smoking cessation and (2)
 encourage the use of NRT for a quit attempt and/or enrollment in SC services as soon as
 possible. If participants show no interest to quit, the nurse/research staff will use the
 "5R" approach to re-motivate the quitting intention. The "5R" approach is being adopted by
 the local and international smoking cessation guideline including the discussion on why
 quitting is important (relevance), hazards of smoking (risk), benefits of quitting (rewards),
 difficulties (roadblocks) and repeated quit attempts (repetition). If participants report any
 contra-indication(s) to NRT, the nurse/research staff will discuss the reasons with them,
 and, if necessary, refer the participants to the physician in the smoking cessation clinic.

 At 1-, 3- and 6-month follow-up, the quitting outcomes will be assessed by a trained
 interviewer through telephone who is blinded to the subject's group status.
Inclusion Criteria:

 -  Hong Kong residents

 -  aged 18 to 65 years

 -  have used any tobacco products in the past month

 -  able to read and speak Chinese

 -  have not used NRT for the past month

 Exclusion Criteria:

 -  Have severe angina, serious cardiac arrhythmias and hypertension

 -  Have suffered from acute myocardial event in the past 4 weeks

 -  Pregnant nor breastfeeding

 -  Under medication and treatment due to mental illness

 One of the inclusion criteria was "smoke 10 cigarettes or more per day in the past week"
 and is amended to "have used any tobacco products in the past month". The initial intention
 of setting the inclusion criteria of at least 10 cigarettes per day (CPD) is to recruit
 smokers who have moderate to strong level of craving and a greater need for NRT. However,
 we also recognize that one of the objectives of the research is to promote the use of NRT
 for quit attempts with NRT sampling. In fact, smokers who smoke less than 10 CPD can also
 benefit from using NRT gums. Therefore, the change in the inclusion criteria does not
 deviate from our research aim. In contrast, with the removal of the criterion for CPD, we
 will be able to reach out to a larger group of smoking population and encourage more
 smokers to use NRT to quit smoking