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Trial registered on ANZCTR


Registration number
ACTRN12616001641482
Ethics application status
Approved
Date submitted
23/11/2016
Date registered
28/11/2016
Date last updated
29/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): Feasibility Study
Scientific title
Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): An uncontrolled feasibility study of novel nicotine replacement products among people living with HIV (PLHIV) who smoke
Secondary ID [1] 290150 0
NONE
Universal Trial Number (UTN)
U1111-1179-4374
Trial acronym
THRiVe: Feasibility Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Addiction 300268 0
Smoking 300269 0
Condition category
Condition code
Mental Health 300136 300136 0 0
Addiction
Infection 300137 300137 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is an uncontrolled study of a harm reduction intervention, using vaporised nicotine in people living with HIV who smoke cigarettes.
Participants will receive two study devices (Innokin Endura T18, and Innokin Endura T22) each device is a type of vaporised nicotine product that deliver the study medicine (Nicophar brand nicotine liquid, containing; 1.2% nicotine, 82.8% glycerol and water 16%) to use over a 12 week treatment period and asked to replace as many cigarettes as possible (if not all) with use of the vaporised nicotine products (VNPs). Participants are free to use both devices interchangeably or only one based on their own own personal preference over the 12 week treatment period. The study will investigate they way people use the VNPs and what they think of the devices and people use the VNPs based on their needs and preferences, adherence is therefore not measured in this study.

Participants will receive 10 x 10mL bottles of e-liquid for every four-week period to use. This concentration is in common use and recommended by the manufacturer as the most appropriate strength to be used with the Innokin Endura devices.

The device administers the liquid nicotine to reduce tobacco withdrawal symptoms, such as craving cigarettes (similar to other fast acting NRT products). The frequency with which the device (and its liquid nicotine) is used is therefore dependent on the user's level of nicotine dependence. Literature suggests people who use vaporised nicotine self-titrate, similar to their self-titration of tobacco cigarettes or NRT products.

Participants will also receive an 'intervention pack' containing;
a. A list of participant instructions
b. A “Positively Quitting” booklet designed to help people living with HIV to quit smoking (this booklet was developed by and available from Queensland Positive People, a peer-based advocacy organisation for people living with HIV.
c. Information on using the devices instead of smoking instructions on how to use, store and handle the investigational products
d. Copies of device user manuals
e. Links and information on quitting supports (such as Quitline)
f. A study wallet card to confirm participation in trial

Intervention code [1] 295899 0
Behaviour
Intervention code [2] 295900 0
Treatment: Other
Intervention code [3] 296501 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299619 0
Acceptability of the novel vaporised nicotine products (Innokin Endura T18 and Innokin Endura T22) and an e-liquid (containing 12mg/mL of nicotine in vegetable glycerol and water) for quitting smoking or reducing the number of cigarettes smoked per day, among people living with HIV who smoke 5 or more cigarettes per day.

Acceptability will be measured using a combination of both quantitative survey items (using a number of formats such as yes/no, multiple choice and likert scales) and semi-structured interviews.
Timepoint [1] 299619 0
Quantitative survey items: Baseline and weeks; 4, 8, 12, 24
Interviews: Baseline and week 12
Primary outcome [2] 300306 0
Participant use of novel vaporised nicotine products (Innokin Endura T18 and Innokin Endura T22) and an e-liquid (containing 12mg/mL of nicotine in vegetable glycerol and water) for quitting smoking or reducing the number of cigarettes smoked per day, among people living with HIV who smoke 5 or more cigarettes per day.
Use (i.e. which product/s were used and details of use, for example where use occurred) will be measured using a combination of both quantitative survey items (using a number of formats such as yes/no, multiple choice and likert scales) and semi-structured interviews.
Timepoint [2] 300306 0
Quantitative survey items: Baseline and weeks; 4, 8, 12, 24
Interview: Baseline and week 12
Secondary outcome [1] 327695 0
Number of quit attempts.
The number of quit attempts made between each major contact point will be measured using participant self report, to forced choice survey items (for example "Since you completed the week 4 survey for us, have you made a quit attempt"). The number of quit attempts and length of the longest quit attempt will also be measured in participants who report having made a quit attempt.
Timepoint [1] 327695 0
Week 4, 8, 12, 24 post treatment initiation.
Secondary outcome [2] 327698 0
Short-term abstinence (7-day abstinence) from tobacco cigarettes will be measured using a series of self-report survey items designed for the study.
Timepoint [2] 327698 0
Baseline and weeks 4, 8, 12 and 24 post treatment initiation.
Secondary outcome [3] 327699 0
Medium-term abstinence (continuous, abstinence from tobacco smoking for at least 8 weeks) will be measured using a series of self-report survey items designed for the study.
Timepoint [3] 327699 0
12 and 24 weeks post treatment initiation
Secondary outcome [4] 327700 0
Feedback on the information packs (which included information on the nicotine vaporisers) provided to participants will be collected during the semi-structured interview at week 12.
Timepoint [4] 327700 0
12 weeks (end of treatment).
Secondary outcome [5] 327701 0
Whether participation influences quitting motivation, measured using quantitative survey items designed for the study.


Timepoint [5] 327701 0
Baseline and week 12 post treatment initiation.
Secondary outcome [6] 329614 0
Whether participants using the study devices and medicine can reduce tobacco smoking will be measured using the self-reported average of number of cigarettes smoked per day at each survey point.
Timepoint [6] 329614 0
Baseline and weeks 4, 8, 12 and 24 post treatment initiation.
Secondary outcome [7] 329659 0
Whether participation influences level of knowledge of health impacts of smoking, measured using quantitative survey items designed for the study to measure participants' knowledge of harm from smoking.
Timepoint [7] 329659 0
Baseline and week 12 post treatment initiation.
Secondary outcome [8] 329660 0
Whether participation influences quit self-efficacy, measured using quantitative survey items designed for the study.

Timepoint [8] 329660 0
Baseline and week 12 post treatment initiation.
Secondary outcome [9] 329661 0
Whether participation influences level of nicotine dependence measured using the Fagerstrom Test for Nicotine Dependence and the Glover-Nilsson Smoking Behavioural Questionnaire.
Timepoint [9] 329661 0
Baseline and week 12 post treatment initiation.

Eligibility
Key inclusion criteria
1. A diagnosis of HIV
2. Aged 18 years (or over)
3. Smoke 5 (or more) cigarettes per day, at the time of enrolment into the trial
4. Have been smoking for at least 12 months
5. Have capacity to consent and able to understand study instructions and procedures (e.g. sufficient English language ability).
6. Willing to attempt to quit tobacco smoking within 1 week of enrolment
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently participating in a smoking-cessation program
2. Aged <18 years
3. Currently 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
4. Currently breast-feeding (measured by self-report) or planning to be during trial participation period
5. Insufficient capacity to provide informed consent or complete the study requirements (e.g. completing surveys in English)
6. Has experienced chest pain, or another cardiovascular event or procedure (e.g. heart attack, stroke, insertion of stent, bypass surgery) in the last month
7. Being treated with oxygen therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis
Survey data will be analysed using descriptive statistics (counts and percentages).

Interview data will be analysed qualitatively using thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6977 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 14687 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 14693 0
4000 - Brisbane City
Recruitment postcode(s) [3] 14694 0
4169 - East Brisbane

Funding & Sponsors
Funding source category [1] 294517 0
Charities/Societies/Foundations
Name [1] 294517 0
HIV Foundation Queensland
Address [1] 294517 0
Level 1
725 Ann Street
Fortitude Valley
Brisbane QLD 4006
Country [1] 294517 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 293381 0
None
Name [1] 293381 0
Address [1] 293381 0
Country [1] 293381 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295951 0
Metro South HREC
Ethics committee address [1] 295951 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 295951 0
Australia
Date submitted for ethics approval [1] 295951 0
12/10/2016
Approval date [1] 295951 0
17/11/2016
Ethics approval number [1] 295951 0
HREC/16/QPAH/693
Ethics committee name [2] 297657 0
University of Queensland’s Human Research Ethics Committees A & B
Ethics committee address [2] 297657 0
Cumbrae-Stewart Building #72
The University of Queensland
St Lucia, QLD 4072
Ethics committee country [2] 297657 0
Australia
Date submitted for ethics approval [2] 297657 0
Approval date [2] 297657 0
11/01/2017
Ethics approval number [2] 297657 0
2016001749 / HREC/16/QPAH/693

Summary
Brief summary
There is mounting evidence of widespread use of vaporised nicotine products (VNPs) among the general population of smokers. There is also evidence of their effectiveness at achieving short-term cessation with few reported side effects, although limited long term efficacy and safety data is available. VNPs may offer a harm reduction approach to tobacco in populations such as people living with HIV who have high rates of smoking and experience significant associated health consequences. This study will examine whether such products that deliver liquid nicotine are acceptable to people living with HIV who smoke and whether a larger, randomised controlled trial to assess long-term cessation outcomes and relapse prevention would be feasible.
Trial website
Nil
Trial related presentations / publications
Public notes
Recruitment to the study includes both self-referring participants and via three study site:
1. Princess Alexandra Sexual Health at the Princess Alexandra Hospital ( Metro South Hospital and Health Service)
2. Metro North Sexual Health and HIV Service based at the Biala City Community Health Centre (Metro North Hospital and Health Service)
3. Queensland Positive People at East Brisbane

Contacts
Principal investigator
Name 63470 0
Dr Coral Gartner
Address 63470 0
School of Public Health The University of Queensland Public Health Building
Herston Road Herston Qld 4006
Country 63470 0
Australia
Phone 63470 0
+61 7 3346 5478
Fax 63470 0
+61 7 3365 5442
Email 63470 0
c.gartner@uq.edu.au
Contact person for public queries
Name 63471 0
Ms Stephanie Bell
Address 63471 0
School of Public Health The University of Queensland Public Health Building
Herston Road Herston Qld 4006
Country 63471 0
Australia
Phone 63471 0
+61 7 3346 5473
Fax 63471 0
Email 63471 0
s.bell@uq.edu.au
Contact person for scientific queries
Name 63472 0
Ms Stephanie Bell
Address 63472 0
School of Public Health The University of Queensland Public Health Building
Herston Road Herston Qld 4006
Country 63472 0
Australia
Phone 63472 0
+61 7 3346 5473
Fax 63472 0
Email 63472 0
s.bell@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary