Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): The Study Protocol of an Uncontrolled Feasibility Study of Novel Nicotine Replacement Products among People Living with HIV Who Smoke
2. Materials and Methods
2.1. Trial Aim and Objectives
- Measuring quit attempts.
- Measuring cigarettes smoked per day.
- Evaluating short-term (7-day) abstinence from cigarette smoking (at 4, 8, 12 and 24 weeks post treatment initiation).
- Evaluating medium-term abstinence from cigarette smoking (continuous, abstinence from tobacco smoking for at least 8 weeks), measured at 12 and 24 weeks post treatment initiation.
- Obtaining feedback on the intervention (including, printed information, investigational devices and medicine).
- Obtaining data to accurately describe the sample (e.g., demographic features, history of smoking and quitting), knowledge of health impacts, their level of quitting motivation, quit self-efficacy and level of nicotine dependence.
- Monitoring adverse events and contribute to the literature on the safety of vaping as a method to quit smoking.
2.3. Research Ethics
2.4.2. Eligibility Criteria
- Inclusion criteria: diagnosis of HIV; aged 18 years, or over; smoke ≥5 cigarettes per day at the time of enrolment into the trial; have been smoking for at least 12 months; have capacity to consent and able to understand study instructions and procedures (e.g., sufficient English language ability); willing to attempt to quit tobacco smoking after study enrolment.
- Exclusion criteria: participating in a smoking-cessation program; pregnant (measured by self-report, with confirmation by self-administered pregnancy test where there is doubt) or planning to become pregnant during trial participation period; breast-feeding (measured by self-report) or planning to be during trial participation period; experienced chest pain, or another cardiovascular event or procedure (e.g., heart attack, stroke, insertion of stent, bypass surgery) in the last month; being treated with oxygen therapy.
2.5. Intervention Description
- Printed information
- Information and instruction booklet. The booklet outlines instructions on how to use, store and handle the investigational products, information of vaping instead of quitting and information and links on quitting smoking resources supports (such as Quitline) and tips from vapers.
- A “Positively Quitting” booklet. A booklet developed by Queensland Positive People to help PLHIV to quit smoking containing information such as the benefits of quitting and suggestions for managing cigarette cravings.
- Copies of device user manuals.
- A study wallet card confirming participation in the trial.
- Investigational devices
- One Innokin Endura T18® vaporiser kit
- One Innokin Endura T22® vaporiser kit
- Four spare coils
- One wall charger
- Investigational medicine
- Ten 10 mL bottles of Nicophar® 12 mg nicotine e-liquid
2.6. Data Collection Points and Outcome Measures
2.6.1. Primary Outcome Measures
- Familiarity and experience with VNPs
- Attitudes toward VNPs
- Acceptability of trial products and associated reasons (e.g., impact on cravings, assisting with quitting, ease of use)
- Comparison of perceptions and use of trial products with traditional smoking cessation pharmacotherapy (e.g., varenicline, bupropion and NRT).
- Level of interest in short and long-term use of VNPs
- Nature of product use
- Quantity of e-liquid and coils used
- Locations, when used and how often, reasons for use, ease of use
- Barriers and facilitators to VNP use, such as adequacy for reducing withdrawal
2.6.2. Secondary Outcome Measures
- Number of quit attempts
- Tobacco cigarettes smoked per day (CPD)
- Abstinence measures:
- Short-term abstinence or 7 days point prevalence (defined as having not smoked any tobacco in the previous 7 days at assessment) at weeks 4, 8, 12 and 24.
- Medium-term abstinence from tobacco smoking measured by continuous abstinence from tobacco smoking for at least 8 weeks post quit date, with no more than five (tobacco) cigarettes from the start of the abstinence period (measured at weeks 12 and 24).
- Descriptive measures of the sample:
- History of tobacco smoking and quitting
- Knowledge of health effects of smoking and nicotine
- Motivation to quit
- Quitting self-efficacy
- Fagerstrom Test for Nicotine Dependence (FTND) 
- A measure of behavioural dependence, using the Glover-Nilsson Smoking Behavioural Questionnaire (GN-SBQ) 
- Measures of adverse events.
2.6.3. Participant Reimbursement
- Baseline survey and interview: $50
- Week 4 survey: $20
- Week 8 survey: $20
- Week 12 (end of treatment) survey and interview: $50
- Week 24 (final follow-up) survey: $20
2.7. Safety and Adverse Events
2.8. Participant Attrition
2.9. Data Management and Analysis
3.1. Strengths/Usefulness of Findings
3.2. Innovation/Novelty and Strengths
Conflicts of Interest
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|Week (month)||0||1 (1)||4 (1)||8 (2)||12 (3)||24 (6)|
|Treatment Period (12 weeks)||X||X||X||X|
|1 week check in||X|
|Measures: Primary Objectives|
|Familiarity with vaporized nicotine products (VNPs)—survey||X|
|Attitudes and use of VNPs—survey||X||X||X||X||X|
|Attitudes towards smoking, quitting and VNPs—interview||X||X|
|Measures: Secondary Objectives|
|Cigarettes per day (CPD)||X||X||X||X||X|
|Smoking and quitting||X|
|Knowledge of harms||X||X|
|Fagerstrom Test for Nicotine Dependence (FTND)||X||X|
|Glover Nilsson Smoking Behavioural Questionnaire (GNSBQ)||X||X|
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Bell, S.; Dean, J.; Gilks, C.; Boyd, M.A.; Fitzgerald, L.; Mutch, A.; Baker, P.; Neilsen, G.; Gartner, C.E. Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): The Study Protocol of an Uncontrolled Feasibility Study of Novel Nicotine Replacement Products among People Living with HIV Who Smoke. Int. J. Environ. Res. Public Health 2017, 14, 799. https://doi.org/10.3390/ijerph14070799
Bell S, Dean J, Gilks C, Boyd MA, Fitzgerald L, Mutch A, Baker P, Neilsen G, Gartner CE. Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): The Study Protocol of an Uncontrolled Feasibility Study of Novel Nicotine Replacement Products among People Living with HIV Who Smoke. International Journal of Environmental Research and Public Health. 2017; 14(7):799. https://doi.org/10.3390/ijerph14070799Chicago/Turabian Style
Bell, Stephanie, Judith Dean, Charles Gilks, Mark A. Boyd, Lisa Fitzgerald, Allyson Mutch, Peter Baker, Graham Neilsen, and Coral E. Gartner. 2017. "Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): The Study Protocol of an Uncontrolled Feasibility Study of Novel Nicotine Replacement Products among People Living with HIV Who Smoke" International Journal of Environmental Research and Public Health 14, no. 7: 799. https://doi.org/10.3390/ijerph14070799