Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000297426
Ethics application status
Approved
Date submitted
3/06/2015
Date registered
7/03/2016
Date last updated
7/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The HAA (Herehere and Aukati) Trial: A traditional Maori method of restriction repurposed for indigenous smoking cessation.
Scientific title
The HAA Trial: A pilot randomised controlled trial to test the efficacy of an Intervention that has repurposed traditional Maori tools to increase quit attempts in Maori who smoke
Secondary ID [1] 286741 0
none
Universal Trial Number (UTN)
1111-1169-1973
Trial acronym
The HAA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Use 295104 0
Condition category
Condition code
Public Health 295348 295348 0 0
Health service research
Mental Health 295584 295584 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve attending a single half day Herehere Aukati training hui (meeting).

The training, which will be facilitated by expert traditional weavers, kaumatua (elders) and the Trial research team, will provide participants with a background to the Aukati “restriction” ritual – its traditional use, cultural application and how Aukati will be used to aid stopping smoking. In the Aukati session, a brief Aukati karakia (incantation) will be taught to participants. These karakia when recited on their target quit day will commence the Aukati for intervention participants. The karakia will also be used as cessation tools to overcome urges. The intervention per participant will be three months.

Within these hui a background to the wristbands and their connection to symbolising not smoking will be given to participants. Cultural considerations in weaving will be introduced and participants will learn to weave their own wristband to wear once they commence their Aukati.

Treatment participants will be required to set a quit date no longer than 3 days following the training. The ability to set a quit date within this timeframe will be a requirement of registration.

Monitoring of the intervention will be briefly (less than 15 minutes) kanohi ki te kanohi (face to face) for weeks 4 & 12. This will involve a one to one session with a member of the research team in which Carbon Monoxide monitoring will occur and a series of questions about their smoking status. At 7 days from quit day and then fortnightly the research team will contact participants for followup by their nominated best method of contact . The Trial will have an active Facebook page where participants will be able to also ask questions and provide support to each other.

The Treatment described here will, with improvement from process evaluation tasks undertaken in the Pilot be utilised in the Transferability testing.
Intervention code [1] 291895 0
Behaviour
Comparator / control treatment
Usual Care consisting of any service that Maori who smoke access to receive support to stop smoking
Control group
Active

Outcomes
Primary outcome [1] 295100 0
The primary outcome for the trial is the proportion of smokers with self- reported and verified biochemical continuous abstinence at 12 weeks from the quit date. Abstinence will be defined by using the Russell Standard (that is: intention to treat analysis, only have smoked (if any) a total of five cigarettes from the quit date and biochemical verification of self-reported abstinence through an exhaled carbon monoxide device with a reading of less than 10 ppm (parts per million)
Timepoint [1] 295100 0
12 weeks abstinence
Secondary outcome [1] 314767 0
Abstinence 1 week following quit date using exhaled carbon monoxide testing device
Timepoint [1] 314767 0
7 days from quit day
Secondary outcome [2] 315869 0
Abstinence 4 weeks following quit date using exhaled carbon monoxide testing device
Timepoint [2] 315869 0
4 weeks from Quit day
Secondary outcome [3] 316873 0
Verbal Confirmation of Continued abstinence in Pilot participants beyond three month followed up intervention through either a telephone call follow-up or visit to the participant.
Timepoint [3] 316873 0
6 months
Secondary outcome [4] 316874 0
Participant perceptions of Resource (weaving and karakia) will be assessed by a face to face semi structured interview.
Timepoint [4] 316874 0
Fortnightly from Quit Day up to three months.
Secondary outcome [5] 316875 0
Adverse events will be self reported by participants through a follow up interview by either telephone or face to face visit.
Timepoint [5] 316875 0
Fortnightly from Quit Day up to three months
Secondary outcome [6] 316876 0
Treatment Failure information will be collected through follow up telephone call or face to face visit. The composite of treatment failure information will include: 1. the number of cigarette per day since the last follow up 2. the use of other treatments since the last follow up. This information will be collected by a questionnaire designed specifically for this study.
Timepoint [6] 316876 0
Fortnightly from Quit Day up to three months.

Eligibility
Key inclusion criteria
In this trial, the inclusion criteria will include self-identified Maaori who self- identify as current smokers with an inhaled carbon monoxide machine reading of greater than or equal to 4ppm , aged 16 years or over (Perkins, Karlitz & Jao, 2013). Participants will be required to also complete the Fagerstrom Test for Dependence (Heatherton, et al., 1991). The score must be equal to or greater than 5 for enrolement. Smokers must be seeking support to stop smoking and agree to the set a quit date as per their allocated group guidelines.
Pregnant and breastfeeding women can and will be included in this study as will people with severe illness, mental health, and drug and alcohol addictions. Participants must be willing and able to provide consent, understand their role as a participant in the study and willing to comply with study procedures
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People that were unable or unwilling to provide their own informed consent for their participation, non-smokers with a reading of less than 4 ppm, under the age of 16 years old and non-Maaori will be excluded from participating in the trial. People unable to agree to setting a target quit day according to whatever group they are allocated to will be excluded also.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All potential participants that contact the research team to register will be assessed by the research assistant to see if they meet the inclusion criteria for the trial (age, smoking status, Fagerstrom Test for Dependence {FTFD} (Heatherton, Kozlowski, Frecker, Fagerstrom, 1991)). Eligible participants will be asked to fill a demographic data survey (if not in person met, the research assistant will do this over the phone). All participants that meet the inclusion
criteria will then be enrolled in the study. and will be allocated a number on with 001 and ending at 150.
Participants will be randomised as soon as they are registered. Participants randomised to control will be referred immediately to a provider of “usual care”. The staggering of participants will ensure that services are able to logistically cope with the referrals.
The intervention group will receive a panui (notice) no more than 3 days following their randomisation inviting them to attend the next available Herehere Aukati training hui.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)


Opaque sealed envelopes containing equal numbers of intervention and control have been created. Envelopes contain no markings and will be shuffled by the research assistant prior to their use. For each participant registration, the research assistant will open one envelope to reveal whether or not that participant will be allocated to either control or treatment. Randomisation will be stratified minimally by sex and level of nicotine dependence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The intention-to-treat principle will be followed for statistical analyses and the imputation method for missing data will be conservative whereby non-responders will be classified as smokers.
Characteristics will be compared between the groups at baseline, 7 day point prevalence, fortnightly follow-up and testing at 4 and 12 weeks from quit day using independent t tests for continuous variables, or chi- square tests for categorical variables as appropriate.
Preliminary analyses using models appropriate for the distribution of the variables will be undertaken to determine variables that differ between treatment groups, and between those with complete and incomplete follow-up data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/05/2015
Date of last participant enrolment
Anticipated
Actual
3/12/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
227
Accrual to date
Final
227
Recruitment outside Australia
Country [1] 6951 0
New Zealand
State/province [1] 6951 0
Waikato, Tamaki Makaurau

Funding & Sponsors
Funding source category [1] 291407 0
University
Name [1] 291407 0
Auckland UniServices
Country [1] 291407 0
New Zealand
Primary sponsor type
Other
Name
Tuakana Teina Insight
Address
PO Box 24077
Hillcrest
Hamilton 3286
Country
New Zealand
Secondary sponsor category [1] 290081 0
None
Name [1] 290081 0
Address [1] 290081 0
Country [1] 290081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292955 0
Health Disability Ethics Committee
Ethics committee address [1] 292955 0
Ethics committee country [1] 292955 0
New Zealand
Date submitted for ethics approval [1] 292955 0
14/05/2015
Approval date [1] 292955 0
27/05/2015
Ethics approval number [1] 292955 0
15/STH/78

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57362 0
Mrs Te Pora Thompson-Evans
Address 57362 0
Tuakana Teina Insight
PO Box 24077
Hillcrest
Hamilton 3253
Country 57362 0
New Zealand
Phone 57362 0
+64 2102708805
Fax 57362 0
Email 57362 0
[email protected]
Contact person for public queries
Name 57363 0
Te Pora Thompson-Evans
Address 57363 0
Tuakana Teina Insight
PO Box 24077
Hillcrest
Hamilton 3253
Country 57363 0
New Zealand
Phone 57363 0
+64 7 8241054
Fax 57363 0
Email 57363 0
[email protected]
Contact person for scientific queries
Name 57364 0
Te Pora Thompson-Evans
Address 57364 0
Tuakana Teina Insight
PO Box 24077
Hillcrest
Hamilton
3253
Country 57364 0
New Zealand
Phone 57364 0
+642102708805
Fax 57364 0
Email 57364 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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