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Protocol
Effectiveness of nicotine replacement therapy sample at outdoor smoking hotspots for initiating quit attempts and use of smoking cessation services: a protocol for a cluster randomised controlled trial
  1. Yee Tak Derek Cheung1,
  2. Ching Han Helen Chan2,
  3. Kin Sang Ho2,
  4. Celeste Tang2,
  5. Chloe Wing Hei Lau1,
  6. William Ho Cheung Li1,
  7. Man Ping Wang1,
  8. Tai Hing Lam3
  1. 1School of Nursing, The University of Hong Kong, Hong Kong, Hong Kong
  2. 2Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong, Hong Kong
  3. 3School of Public Health, The University of Hong Kong, Hong Kong, Hong Kong
  1. Correspondence to Dr Yee Tak Derek Cheung; derekcheung{at}hku.hk

Abstract

Introduction More than half of the smoking population in Hong Kong are unmotivated to quit. Only about 2% of tobacco users in the territory have ever used cessation aids such as nicotine replacement therapy (NRT). The present study aims to assess the effectiveness of delivering 1-week free NRT sample plus brief intervention to smokers at outdoor smoking hotspots on quit attempts and use of smoking cessation services.

Methods and analysis This is a two-arm, pragmatic, multisite, cluster randomised controlled trial (RCT) on the effectiveness of increasing quit attempts, use of cessation service and recruitment outcomes. Trained smoking cessation ambassadors will approach smokers at outdoor smoking hotspots, and deliver brief smoking cessation advice. Recruitment sessions are randomised to intervention or control group (allocation ratio 1:1). Participants in the intervention group (n=550) will receive 1-week free NRT sample (either patch or gum), brief medication advice from an onsite nurse and cessation service referral, whereas participants in control group (n=275) will only receive the brief advice and service referral. The primary outcomes are the proportion of participants who enrol in any cessation service in Hong Kong within 1 month of the recruitment, and the proportion of participants who report quit attempts at 1-month follow-up. Secondary outcomes include self-reported use of NRT, self-reported 7-day tobacco abstinence, 30-day abstinence at 3 months and 6 months, biochemically validated abstinence at 6 months, perceived importance, difficulty and confidence to quit (scale 0–10), and Incremental Behavior Change towards Smoking Cessation. Process outcomes include number of smokers who will be approached, will accept the brief smoking cessation advice or be recruited to participate in the RCT.

Ethics and dissemination The Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster approved the trial (UW 18-118). Findings will be disseminated through funding website, publication and conference presentations.

Trial registration number NCT03717051

  • smoking cessation
  • nicotine replacement therapy
  • brief intervention
  • smoking hotpsots
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Footnotes

  • Contributors The corresponding author confirms that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. YTDC and CWHL were responsible for literature search, data analysis, data interpretation, and manuscript writing. YTDC, CHHC, KSH, CT, WHCL, MPW and THL were responsible for the staff training and intervention design. CT and CWHL were responsible for fieldwork supervision, data collection. All authors reviewed the manuscript and approved for submission.

  • Funding This work was supported by Health Care and Promotion Scheme of the Health Medical Research Fund, Food and Health Bureau, the Hong Kong SAR Government (grant number 01170418). The funder has no roles in study design, collection, management, analysis and interpretation of data.

  • Competing interests THL is the principal investigator of two-family well-being projects, and MPW is the coinvestigator of one of the two projects funded by Hong Kong Jockey Club Charities Trust. All other authors have no connection with tobacco, alcohol, pharmaceutical or gaming industries or anybody substantially funded by these organisations.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Not required

  • Provenance and peer review Not commissioned; externally peer reviewed.

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