ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000972224

Ethics application status

Approved

Date submitted

20/03/2018

Date registered

8/06/2018

Date last updated

6/06/2019

Date data sharing statement initially provided

6/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

SISTAQUIT (Supporting Indigenous Smokers to Assist Quitting)

The SISTAQUIT trial compares usual care to health provider training in culturally-appropriate smoking cessation care for pregnant Aboriginal and/or Torres Strait Islander women.

Scientific title

SISTAQUIT (Supporting Indigenous Smokers to Assist Quitting)
A Cluster Randomised Controlled Trial to Improve Strategies for the Management of Smoking Cessation in Pregnant Aboriginal and/or Torres Strait Islander Women

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1210-3753

Trial acronym

SISTAQUIT

Linked study record

ACTRN 12616001603404 (ICAN QUIT in Pregnancy pilot study)

Health condition

Health condition(s) or problem(s) studied:

Management of smoking during pregnancy for Aboriginal and Torres Strait Islander women

Tobacco smoking during pregnancy

Respiratory health of babies from birth to 6 months of age

Condition category

Condition code

Public Health

Health promotion/education

Reproductive Health and Childbirth

Antenatal care

Mental Health

Addiction

Public Health

Health service research

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

SISTAQUIT is a cluster randomised controlled trial (RCT) at 30 Aboriginal Community Controlled Health Services (ACCHSs), Aboriginal Medical Services (AMS) and General Practitioner (GP) practices across Australia.

Each health service/GP practice will be randomly assigned to continue usual care (15 Control sites) or receive the SISTAQUIT health provider training in culturally appropriate smoking cessation care + resources at the start of the study (15 Intervention sites).

The 15 Control sites will receive the SISTAQUIT training + resources at the end of the study (Intervention-later group)..

The SISTAQUIT Intervention comprises::
- culturally appropriate training in smoking cessation care for health providers (2 hours)
Health providers include GPs, midwives, nurses, Tobacco & Aboriginal Health Workers
Ideally, all health providers at each service/GP practice (especially those who provide
care for pregnant women) will undertake the training
- targeted educational resources: participant booklet & flip chart, health provider manual
- oral nicotine replacement therapy (oral NRT)
- participant smoking cessation information video loop

All sites (Intervention + Control) receive:
- trial implementation training & support throughout the study
- reimbursement for trial activities

The Intervention training comprises two approximately 1-hour sessions presented onsite by an Aboriginal member of the SISTAQUIT team. The sessions centre on two pre-recorded training videos of culturally-appropriate smoking cessation care, presented by both a GP specialiasing in smoking cessation care and an Aboriginal Health Educator.

Participants at study sites will be followed for the smoking cessation care they receive via surveys at trial follow up time points. Health providers may optionally participate in pre-study, post-training and end of study surveys to assess their skills and confidence in providing smoking cessation care for pregnant Indigenous women.

Intervention code [1]

Behaviour

Intervention code [2]

Prevention

Comparator / control treatment

Control centres (15) will continue usual care for their pregnant participants, but will receive the SISTAQUIT Intervention + resources at the end of the study.

The control group is therefore a 'delayed' Intervention group.

Control sites have the option of undertaking the training + resources after their last participant (e.g. the 15th woman who agrees to participate at that particular Control site) gives birth.

Control sites will receive training in trial methods at the start of the study and implementation support throughout the study, as well as reimbursement for trial activities.

Control group

Active

Outcomes

Primary outcome [1]

Smoking cessation status self report
(participants at Intervention centres vs participants at usual care (Control) centres)

Timepoint [1]

4 weeks after recruitment to the trial

Primary outcome [2]

Carbon monoxide (CO) validated smoking cessation status

Timepoint [2]

4 weeks after recruitment to the trial

Secondary outcome [1]

Smoking cessation status self report
(participants at Intervention centres vs participants at usual care (Control) centres)

Timepoint [1]

- 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth) - 6 months post partum (after giving birth)

Secondary outcome [2]

Carbon monoxide (CO) validated smoking cessation status
(participants at Intervention centres vs participants at usual care (Control) centres)

Timepoint [2]

- 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth) - 6 months post partum (after giving birth)

Secondary outcome [3]

Reduction of episodes of respiratory illness among babies followed for 6 months
(babies of participants at Intervention centres vs babies at Control centres)

Pregnant participants can optionally consent for their babies to be followed from birth to 6 months

Babies' respiratory illness outcomes will be collected via a custom survey designed for the trial

Timepoint [3]

- monthly from birth through 6 months of age
- at 6 months

Secondary outcome [4]

Perinatal outcomes of babies
(babies of participants at Intervention centres vs babies at Control centres)

Pregnant participants can optionally consent for their babies to be followed from birth to 6 months

Data to be collected via birth discharge summary (deidentified & relabelled with study ID) and related health records

Timepoint [4]

- at birth
- at 6 months

Secondary outcome [5]

Health outcomes of participating mothers during pregnancy and at birth
(such as use of medical services, pre-eclampsia and associated symptoms (e.g. hypertension, proteinuria, cerebral edema)

Data to be collected via birth discharge summary, and possibly via other health record extracts

(participants at Intervention centres vs participants at usual care (Control) centres)

Timepoint [5]

Throughout pregnancy and at birth

Secondary outcome [6]

The economic evaluation will utilise the primary outcome measure and the outcome measure of respiratory illness among babies for the effectiveness component of the CEA.

Resource utilisation (the costs) for the economic evaluation will include the marginal cost of the intervention compared to usual care. Health care utilisation for both mother and baby for both trial groups will be assessed from trial participation through to 6 months following birth of the child. The health care resource utilisation of mothers will be derived from AMS/GP data, hospital records and the health diary. The health care utilisation of participating babies born to participating mothers in both groups will also be assessed, where available, using: the audit of babies’ records from AMS/GP practices, hospital records, birth records/ discharge summary, the babies’ personal health record and the mother’s health diary.

Timepoint [6]

Some of the information used in the economic analysis will be provided by surveys undertaken by trial participants at baseline (recruitment), 4 & 12 weeks on-study, 36 weeks gestation and 4 weeks post-partum. The remainder will be collected throughout the study by participating sites from the sources described above.

Secondary outcome [7]

Measurement of quit attempts as recorded on the participant follow up surveys (designed specifically for this study)
(participants at Intervention centres vs participants at usual care (Control) centres)

Timepoint [7]

- 4 weeks on study (4 weeks after recruitment) - 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth) - 6 months post partum (after giving birth)

Secondary outcome [8]

The baseline and follow up characteristics of the participants (e.g. demographic, smoking characteristics, attitudes, and depression scores, and self-reported empowerment & wellbeing via the GEM (Growth and Empowerment) survey) among mothers in the intervention vs the control group will be compared to determine the predictors of smoking behaviour changes

Timepoint [8]

- at recruitment to the study (baseline) - 4 weeks on study (4 weeks after recruitment) - 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth - 6 months post partum (after giving birth)

Secondary outcome [9]

Proportion of Health Providers (HPs) offering NRT (Nicotine Replacement Therapy) to trial participants as part of their smoking cessation care, as recorded on the trial oral NRT record and oral NRT vouchers (provided to each participating centre), as well as prescriptions for (patch) NRT.

(HPs at Intervention centres vs HPs at usual care (Control) centres)

NB: Oral NRT is currently not available on the PBS. If oral NRT becomes listed on the PBS, then scripts (for both oral NRT and NRT patches) may be the sole measure.

Timepoint [9]

Secondary outcome [10]

Proportion of HPs offering smoking cessation care to trial participants, as recorded on a checklist which is part of the participant baseline and follow up visit surveys.

(HPs at Intervention centres vs HPs at usual care (Control) centres)

Timepoint [10]

- at recruitment to the study (baseline)
- 4 weeks on study (4 weeks after recruitment)
- 12 weeks on study (12 weeks after recruitment)
- 36 weeks gestation
- 4 weeks post partum (after giving birth)

Secondary outcome [11]

Proportion of HPs offering smoking cessation care to all pregnant women attending participating centres up to 12 months prior to the start of the study at that centre, as extracted from the electronic records of participating sites.

Timepoint [11]

- Up to 12 months prior to activation of the trial at each participating centre

Secondary outcome [12]

Proportion of HPs offering smoking cessation care to trial participants, as recorded on extracts from participants' health records (de-identified & relabelled with participant ID)

(HPs at Intervention centres vs HPs at usual care (Control) centres)

Timepoint [12]

- from recruitment through the 4-week post-partum visit for each participant

Secondary outcome [13]

HP self- reported knowledge, attitudes and skills in managing smoking cessation for Aboriginal and Torres Strait Islander pregnant women.

(HPs at Intervention centres vs HPs at usual care (Control) centres)

Timepoint [13]

at the start of the study at each participating centre, - 2 months after the start of the study at each centre - 12 months after the start of the study at each centre

Secondary outcome [14]

Comparison of the Behaviour Change Techniques (BCT) and decision-making processes regarding smoking cessation care at Intervention vs Control centres, as transcribed from audio-recordings of HP and participant consultations (with consent from both the HP and participant)

Timepoint [14]

- at any time from recruitment through the 6 month post-partum visit for each participant

Secondary outcome [15]

Participant self-reported use and adherence to NRT, as recorded on participant surveys
(participants at Intervention centres vs participants at usual care (Control) centres)

Timepoint [15]

Eligibility

Key inclusion criteria

Participants:
• Pregnant
• Up to and including 32 weeks gestation
• Aboriginal and/or Torres Strait Islander (or expectant mothers of an Aboriginal and/or Torres Strait Islander baby)
• Smoke tobacco (any amount)
• Able to provide informed consent
• Attending antenatal care at one of the 30 AMS/GP practices participating in SISTAQUIT

Centres (Aboriginal Community Controlled Health Services (ACCHS)/Aboriginal Medical Services (AMS), GP practices):
1. A health service confirming pregnancy or providing antenatal or routine care for pregnant
mothers of Aboriginal or Torres Strait Islander babies.
2. Employ at least one GP who can participate in the training.
Participation of centres without a GP onsite will be reviewed on a case by case basis, e.g.
to determine if another health professional is available to undertake a prescribing role (for
NRT), or if a memorandum of understanding can be made with a local GP to undertake
this role. These alternative responsible parties will need to undertake the full webinar
training and study briefing in trial methods to ensure compatibility with the SISTAQUIT
Intervention and trial procedures.
3. Have contact with at least 20 pregnant mothers of Aboriginal babies who smoke/year
(ideally at one location (i.e. ‘clinic’) within each Service, and at most two clinics within any
ACCHS/AMS/GP practice)
4. Are able to recruit and follow patients as required
5. At least 30 km radius from other sites recruited to the study

Minimum age

16 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Participants:
• Women who are not able to give informed consent.
Please note that women may still participate in the study even if they do not wish their
baby’s outcomes to be followed. (This is not an exclusion criteria.)
• Non-smoker

Centres (Aboriginal Community Controlled Health Services, AMS, GP practices):
Centres not meeting the above Centre Inclusion Criteria may still be eligible to participate if certain minimum requirements are met (e.g. as described above, the centre has access to a local GP who can undertake the training and prescribe NRT)

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)

The AMS/GP practice manager/s, research facilitator/s, and health providers will not be blind to their allocation group. Women participating in the study will not be informed of the service allocation and providers will be asked not to disclose this information. However if this information is disclosed it does not jeopardise the trial as the health providers are not blind to the allocation. Statistical analysis will be done with a statistician blinded to the allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Sites will be randomised to receive either the webinar training or the control group using standard practice. Stratified by the Australian Standard Geographical Classification – Remoteness Area, block randomisation will be employed using independent statisticians and a computer generated random number sequence method. Services in intervention and control groups will be isolated from one another by at least 30kms to avoid cross-contamination between groups

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Participating sites are the unit of randomisation (Cluster randomised controlled trial)

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size & Power Calculation
Based on standard Randomised Controlled Trial (RCT) of provider training.
Primary outcome 4-weeks: Assuming an Intra Class Correlation (ICC) of 0.01 (median for primary care research), it is calculated that a sample size of approximately 30 Aboriginal Medical Services (AMS) and/or General Practioner (GP) practices (15 in each arm) with an average of 13 women per practice will give the study 80% power to detect an increase in the primary outcome from 3% in the control group to 11% in the intervention group at the primary endpoint of 12-weeks with a 5% type 1 error rate. Allowing for a 15% loss to follow-up, at 12- weeks, we would need to recruit 450 women at baseline (225 per arm). A non-significant assisted quit rate of 11% was achieved in previous study (control 5%). Because of study arm contamination, and in reference to the literature, a baseline rate of 3% is more likely, with an absolute difference of 7% being achievable in our trial at 4-weeks. Other time-points: A sample of this size will enable detectable increases of 8% at 12-weeks, and 75% power to detect sustained 8 % increase at 36-weeks gestation and 4-weeks post-partum. Feasibility of patient sample: With 30 AMSs/GP practices, each seeing at least 20 eligible pregnant Aboriginal smokers per year, there will be a pool of 600 eligible participants available. Assuming approximately 70% of these will consent, we will have access to 450 participants in the first year.

DATA ANALYSIS
Primary Outcome
The primary analysis will compare smoking cessation rates of pregnant smokers at 4-weeks (also 12-weeks, 36-weeks gestation and 4-weeks post-partum) between treatment groups and will follow the intent-to-treat principle with multiple imputation the primary method of dealing with missing data (assuming missing at random). Missing data will be filled-in using logic where possible (e.g. if smoking at previous time-point then not possible to have continued abstinence at the current time point) and otherwise the method of chained equations will be used, where the imputation model will include a range of covariates believed to be associated with either the missing outcome or the outcome itself (e.g. previous quit attempts, consultations about quitting and self-efficacy). Intervention efficacy will be assessed by fitting a mixed effects logistic regression model to each of the imputed datasets, where the outcome variable will be carbon monoxide (CO) validated continuous abstinence or not, and 7-day abstinence or not (for sensitivity analysis). Separate models will be fit at each time point. The models will include a fixed effect for treatment group (Intervention vs Control), and stratification variable (location) and a random treatment centre effect to account for clustering of participants within practices. Variables prognostic of the outcome variable (previous quit attempts, consultations about quitting, and self-efficacy) will be included in the model as covariates to improve power. Regression coefficients and standard errors from all imputed data sets will be pooled. Sensitivity analysis will be performed by fitting models that make different assumptions about the missing data mechanism (e.g. Missing Not at Random). A secondary longitudinal analysis will utilise data from each follow-up, including a random subject level intercept to model serial correlations.
Patient characteristics (e.g. dependence levels, smoking status, home smoking, depression scores from Patient Health Questionnaire 9 (PHQ9)) will be compared between time periods using chi-square tests for categorical variables and t-tests for continuous variables; factors found to be different between time periods will be included in the regression as covariates.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

2/07/2018

Actual

5/10/2018

Date of last participant enrolment

Anticipated

30/06/2020

Actual

Date of last data collection

Anticipated

31/12/2020

Actual

Sample size

Target

450

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,NT,QLD,SA,WA

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Global Alliance for Chronic Diseases (GACD)

Address [2]

Wellcome Trust
215 Euston Road
London NW1 2BE
United Kingdom

Country [2]

United Kingdom

Funding source category [3]

Government body

Name [3]

Cancer Institute New South Wales (CINSW)

Address [3]

Level 9, 8 Central Ave,
Australian Technology Park,
Eveleigh NSW 2015

Country [3]

Australia

Funding source category [4]

Government body

Name [4]

Cancer Australia

Address [4]

Level 14
300 Elizabeth Street
Surry Hills NSW 2010

Country [4]

Australia

Funding source category [5]

Charities/Societies/Foundations

Name [5]

Cure Cancer Australia Foundation

Address [5]

422 Kent St
Sydney NSW 2000

Country [5]

Australia

Funding source category [6]

University

Name [6]

University of Newcastle

Address [6]

University Drive
Callaghan NSW 2308

Country [6]

Australia

Funding source category [7]

University

Name [7]

Centre for Brain and Mental Health Research (CBMHR)

Address [7]

The University of Newcastle
University Drive
Callaghan NSW 2308

Country [7]

Australia

Primary sponsor type

University

Name

The University of Newcastle

Address

University Drive
Callaghan NSW 2308
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee (UON HREC)

Ethics committee address [1]

University Drive
Callaghan NSW 2308
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/02/2018

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

The Aboriginal Health and Medical Research Council Human Research Ethics Committee (AHMRC HREC)

Ethics committee address [2]

PO Box 1565
Strawberry Hills, NSW 2012

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

06/02/2018

Approval date [2]

07/03/2018

Ethics approval number [2]

1140/15

Ethics committee name [3]

Western Australian Aboriginal Health Ethics Committee (WAAHEC)

Ethics committee address [3]

PO Box Stirling St
Perth WA 6849

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

15/09/2017

Approval date [3]

Ethics approval number [3]

Ethics committee name [4]

The Human Research Ethics Committee of the Northern Territory Dept of Health and Menzies School of Health Research (Menzies HREC)

Ethics committee address [4]

PO Box 41096
Casuarina NT 0811

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

07/11/2017

Approval date [4]

Ethics approval number [4]

Ethics committee name [5]

Darling Downs Hospital and Health Service Human Research Ethics Committee (Darling Downs HREC)

Ethics committee address [5]

Locked Mail Bag 2
Toowoomba QLD 4350

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

22/01/2018

Approval date [5]

Ethics approval number [5]

Ethics committee name [6]

Far North Queensland Human Research Ethics Committee (FNQ HREC)

Ethics committee address [6]

PO Box 902
Cairns QLD 4870

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

06/03/2018

Approval date [6]

Ethics approval number [6]

Ethics committee name [7]

ABORIGINAL HEALTH RESEARCH ETHICS COMMITTEE (AHREC)

Ethics committee address [7]

Aboriginal Health Council of South Australia Inc,
220 Franklin Street, Adelaide, SA, 5000

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

22/11/2018

Approval date [7]

03/12/2018

Ethics approval number [7]

AHREC Protocol 04-16-652

Summary

Brief summary

The SISTAQUIT™ trial provides training to health providers (HP) at Aboriginal Medical Services (AMS) and GP practices in culturally appropriate smoking cessation care for pregnant Aboriginal and Torres Strait Islander women.

Almost 1 in 2 Aboriginal and Torres Strait Islander women smoke during pregnancy. Tobacco smoking in pregnancy is the most important preventable risk factor for poor maternal and infant health outcomes, including chronic lung problems and respiratory infections. Pregnancy is an important window of opportunity for health providers to help smokers quit, however they often lack the confidence and skills to address their patients’ smoking.

The SISTAQUIT intervention has been developed over many years of research including an extensive Aboriginal community consultation and co-development phase, pre-testing of resources in three states, and the recent Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy pilot study in 6 Aboriginal Medical Services (AMS) in three states (SA, NSW, QLD).

The primary aim of SISTAQUIT is to assess the effectiveness of the HP training intervention at increasing smoking cessation among pregnant Indigenous smokers at 4 weeks post-baseline, compared to standard care. Secondary aims include: 1.) to increase the proportion of health providers offering assistance to pregnant Indigenous smokers; 2.) Reduce the episodes of respiratory illness and adverse perinatal outcomes in their babies (to 6 months); 3.) Conduct an economic evaluation of the intervention which includes cost-effective and cost-benefit analyses.

We aim to recruit 30 AMS; 15 will be randomised to receive the intervention and 15 will be randomised to continue usual care (cluster Randomised Controlled Trial (cRCT)). The 15 AMS randomised to continue usual care will receive the intervention and SISTAQUIT resources at the end of data collection (i.e. the cluster RCT uses a ‘wait list’ control group). Each site that is formally recruited will receive reimbursement for the research activities undertaken for the trial.

Ideally, all HP at each centre randomised to the intervention group will receive the SISTAQUIT smoking cessation training (as a whole of service approach). Pregnant women up to 32 weeks gestation will be invited to participate in the project; women will be followed at recruitment, 4 & 12 weeks post-recruitment, 36 weeks gestation (4 weeks before their due date), and 4 weeks & 6 months after giving birth, Their babies will also be followed for 6 months for respiratory and general health outcomes.

The SISTAQUIT trial is coordinated by research staff from the University of Newcastle, and the research team includes both Indigenous and non-Indigenous investigators and research staff. The study is supported by a grant jointly funded by the Global Alliance for Chronic Disease (GACD) and the National Health and Medical Research Council (NHMRC), and supported by fellowships awarded to GGould from the NHMRC and Cancer Institute NSW.

Trial website

www.newcastle.edu.au/SISTAQUIT

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Gillian Gould

Address

Level 4, Hunter Medical Research Institute
School of Medicine and Public Health
The University of Newcastle
PO Box 833
Newcastle NSW 2300

Country

Australia

Phone

+61 (0)403615563

Fax

61 (0)2 4033 5692

[email protected]

Contact person for public queries

Name

A/Prof Gillian Gould

Address

Level 4, Hunter Medical Research Institute
School of Medicine and Public Health
The University of Newcastle
PO Box 833
Newcastle NSW 2300

Country

Australia

Phone

+61 (0)403615563

Fax

61 (0)2 4033 5692

[email protected]

Contact person for scientific queries

Name

A/Prof Gillian Gould

Address

Level 4, Hunter Medical Research Institute
School of Medicine and Public Health
The University of Newcastle
PO Box 833
Newcastle NSW 2300

Country

Australia

Phone

+61 (0)403615563

Fax

61 (0)2 4033 5692

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

SISTAQUIT acknowledges the principles of and the right to Data Sovereignty, for Aboriginal and Torres Strait Islander peoples---
(From the Maiam nayri Wingara (www.maiamnayriwingara.org) Briefing paper, 2018):
"Indigenous Data Sovereignty is the right of Indigenous peoples to determine the means of collection, access, analysis, interpretation, management, dissemination and reuse of data pertaining to the Indigenous peoples from whom it has been derived, or to whom it relates. Indigenous data sovereignty centres on Indigenous collective rights to data about our peoples, territories, lifeways and natural resources (Kukutai & Taylor 2016; Snipp 2016)."
Given the very sensitive nature of the data being collected, the trial protocol states that all data collected will be published only in a non-identifying (aggregate) form, and that sites and/or health providers will only be identified in presentations and/or publications with explicit written consent by the site and/or health provider.

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

Source	Title	Year of Publication	DOI
Embase	SISTAQUIT: training health care providers to help pregnant Aboriginal and Torres Strait Islander women quit smoking. A cluster randomised controlled trial.	2022	https://dx.doi.org/10.5694/mja2.51604
Embase	Respiratory, birth and health economic measures for use with Indigenous Australian infants in a research trial: a modified Delphi with an Indigenous panel.	2020	https://dx.doi.org/10.1186/s12887-020-02255-x
Embase	Feasibility and acceptability of Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy multicomponent implementation intervention and study design for Australian Indigenous pregnant women: A pilot cluster randomised step-wedge trial.	2019	https://dx.doi.org/10.1016/j.addbeh.2018.10.036

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically