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Trial registered on ANZCTR


Registration number
ACTRN12621001675819
Ethics application status
Approved
Date submitted
8/10/2021
Date registered
7/12/2021
Date last updated
7/12/2021
Date data sharing statement initially provided
7/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Te Ara Waiora-Can the implementation of Human Papillomavirus (HPV) primary self-testing prevent cervical cancer in NZ?: Te Tai Tokerau
Scientific title
Te Ara Waiora-Can the implementation of HPV primary self-testing prevent cervical cancer in NZ?: Te Tai Tokerau
Secondary ID [1] 304187 0
None
Universal Trial Number (UTN)
U1111-1268-9503
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical cancer 323333 0
Condition category
Condition code
Cancer 320898 320898 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Te Ara Waiora-Implementing HPV primary testing to prevent cervical cancer in NZ- Te Tai Tokerau : A non-inferiority trial
The primary aim of this project is to test whether the universal offer of HPV self- test to all women is non-inferior to the cervical screening coverage in the current cytology cervical screening program. The intervention is therefore the offer of an HPV self-test. Clinics will be randomly selected to be implementation clinics ( i.e offer of HPV self-test) or comparison clinics ( ie offer of routine standard are - cervical smear for cytology) and screening uptake over 2 years recruitment will be compared.

Posters and flyers with self-test HPV information specifically designed for this study will be displayed in implementation clinics. There is written and verbal information specifically designed for this study, supplied to the women to explain the HPV tests and to explain how to take the swab. Women will be able to take the swab in the clinic . In some circumstances the woman may be visited at home by a health worker and will be able to take the swab at home. The time needed to take the swab if it is self collected is around 1 minute.
Women will be contacted if they are due their cervical smear in the usual way (phone, letter, text) , overdue women ( over due a smear is defined as 4 or more years since last smear) will be contacted in the usual way to explain the HPV tests and women who are due or overdue will be approached opportunistically if they attend the clinic for another reason.

Clinicians (nurses, doctors) and kaiawhina ( community health workers) in the primary care practices will deliver the intervention with prior training. These clinicians and community health workers are the womens' usual primary care givers.
The offer of the HPV self-test swab will be delivered face to face and provided individually.
The offer of HPV tests will be made once to women over the two years of recruitment if they accept the offer. If they don't accept the offer, several attempts may be made over the two years of recruitment, usually every 3 months up to 6 attempts or more.
The offer of the HPV self-test swab will be made in the clinic or in the participant's home if visited by the community health worker or in a community centre.
It is anticipated that most women will take the swab themselves but there may be women who choose to have it taken by their clinician in the clinic.
Intervention adherence will be measured as this is the primary outcome - the screening coverage compared with comparison clinics.
Intervention code [1] 321895 0
Early detection / Screening
Comparator / control treatment
Clinics will be randomly selected to be comparison clinics ( ie offer of routine standard care - cervical smear for cytology) and screening uptake over 2 years recruitment will be compared.
Control group
Active

Outcomes
Primary outcome [1] 329161 0
To compare the uptake of screening utilising the universal offer of HPV self-testing approach, to the uptake of screening utilising current standard of care: cervical cytology alone determined by collecting and analysing pathology results and auditing of patient management systems
Timepoint [1] 329161 0
at the conclusion of the 2 year recruitment period 2021-2023
Secondary outcome [1] 401688 0
Proportion of women having an HPV self-test - by collection and analysis of pathology results
Timepoint [1] 401688 0
At the conclusion of the 2 year recruitment period
Secondary outcome [2] 401689 0
Proportion of women having either an HPV self-test, clinician HPV test or cervical cytology (uptake of screening) as composite secondary outcome - determined by collection of pathology results, HPV results and cytology results in implementation clinics.
Timepoint [2] 401689 0
At the conclusion of the 2 year recruitment period
Secondary outcome [3] 401690 0
Proportion of women having an HPV test with a positive result for HPV 16, 18 - composite secondary outcome - determined by collection and analysis of pathology results,
Timepoint [3] 401690 0
At the conclusion of the 2 year recruitment period
Secondary outcome [4] 401691 0
Proportion of women having an HPV test with a positive result for HPV ‘other’ who then have a cervical cytology test (as proposed by national screening program) -determined by collection of pathology results, HPV results and cytology results in implementation clinics.
Timepoint [4] 401691 0
At the conclusion of the 2 year recruitment and 1 year post-randomisation follow up
Secondary outcome [5] 401692 0
Proportion of women having an HPV test with a positive result for HPV ‘other’ and a negative/mild dysplasia cytology result who return for an HPV test after 1 year (as proposed by national screening program) - determined by collection of pathology results, HPV results and cytology results in implementation clinics.
Timepoint [5] 401692 0
At the conclusion of the 2 year recruitment and 1 year post-randomisation follow up
Secondary outcome [6] 401693 0
Proportion of women with HPV 16, 18 as a composite group attending colposcopy as per triage - determined by collection of pathology results, biopsy and cytology results and from attendance data collected by colposcopy clinics .
Timepoint [6] 401693 0
At the conclusion of the 2 year recruitment and 1 year post-randomisation follow up
Secondary outcome [7] 401694 0
Prevalence of high-grade lesions (CIN2, CIN3, Carcinoma) among women attending colposcopy -determined by collection of pathology results, biopsy and cytology results and from attendance and treatment data collected by colposcopy clinics .
Timepoint [7] 401694 0
At the conclusion of the 2 year recruitment and 1 year post-randomisation follow up
Secondary outcome [8] 401695 0
Barriers and facilitators to the triage system for women with a HPV positive test - this will be determined by one on one qualitative interviews with participants who give consent to be interviewed by trained qualitative interviewers
Timepoint [8] 401695 0
At the conclusion of the 2 year recruitment period and 1 year post-randomisation follow-up
Secondary outcome [9] 401696 0
Barriers and facilitators to delivering HPV self-testing for primary care providers- this will be determined by one on one qualitative interviews or group interviews with providers who give consent to be interviewed by trained qualitative interviewers
Timepoint [9] 401696 0
At the conclusion of the 2 year recruitment period and 1 year post-randomisation follow-up
Secondary outcome [10] 402344 0
Proportion of women having an HPV test with a positive result for HPV 'other' - determined by collection and analysis of pathology results,
Timepoint [10] 402344 0
At the conclusion of the 2 year recruitment period

Eligibility
Key inclusion criteria
Maori and non-Maori women aged 25-69 years living in Te Tai Tokerau/Northland region due or over due a cervical smear
Minimum age
25 Years
Maximum age
69 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who have had treatment for pre-cancer or cervical cancer and are under active follow up by the National Cervical Screening Program for test of cure.


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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 NSCP coverage report from December 2019 for the Northland DHB shows that approximately 72.5% of women (33,403/46,090) aged 25-69 were screened over a period of 3 years. This corresponds to a two-year screening coverage of 48.3%. A total of eight practices and 6,400 women (four practices offering HPV-self-testing universally over a two-year period to approximately 3,200 women, and four practices providing routine clinical care data for approximately 3,200 women about cervical cytology uptake) will give 80% power at a one-sided significance level of 2.5% to detect a non-inferiority margin of 10% between the two groups (i.e. the screening rates at participating practices will be no worse than 10% less than the screening rate obtained from the comparative data). This margin of error was chosen as we believe it is the smallest value that is clinically relevant. For this sample size we assumed a two-year screening rate of 48.3% in the comparative data and 49.3% in the participating practices, and an average practice size of 800 participants and intra-cluster correlation coefficient of 0.01.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
6400
Accrual to date
Final
Recruitment outside Australia
Country [1] 24180 0
New Zealand
State/province [1] 24180 0
Northland/ Te Tai Tokerau

Funding & Sponsors
Funding source category [1] 308563 0
Government body
Name [1] 308563 0
Health Research Council of New Zealand
Country [1] 308563 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
Victoria University of Wellington
Faculty of Health
Room 122, Easterfield Building,
Kelburn campus
Kelburn
Wellington

PO Box 600
Wellington 6140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309415 0
None
Name [1] 309415 0
Address [1] 309415 0
Country [1] 309415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308505 0
Southern Health and Disabilities Ethics Committee of New Zealand
Ethics committee address [1] 308505 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 308505 0
New Zealand
Date submitted for ethics approval [1] 308505 0
31/08/2021
Approval date [1] 308505 0
21/09/2021
Ethics approval number [1] 308505 0
21/STH/188

Summary
Brief summary
The hypothesis of the trial is that the approach of the universal offer of HPV self-testing will screen at least as many women as the offer of cervical cytology in the current screening program. The objective of this study is to screen 3200 eligible wahine (women) in the implementation arm by offer of self-taken vaginal HPV test and compare to 3200 women in the comparison arm of the study who have a standard cervical smear. These results will inform an efficient, accessible, wahine-centred primary HPV screening programme to reduce cervical cancer incidence and death in Aotearoa New Zealand.
Trial website
Trial related presentations / publications
Public notes
The proposed screening approach called universal offer of HPV self-testing will be to firstly offer the woman an HPV self-test as the primary test. Those who wish to, can have a cervical smear or a clinician administered swab. All three (HPV self-test, Cervical liquid based cytology (LBC) and clinician swab) will count as a screen for coverage in this approach. The study will inform the National Cervical Screening Programme (NCSP) on how best to implement a high quality, equitable, efficient and sustainable primary HPV screening program utilising the universal offer of HPV self-testing approach. Effective screening solutions involving low clinical contact such as HPV self-testing have additional national and international significance in the context of COVID-19.
This trial seeks to provide evidence that a universal offer of HPV self-testing reaches as many women as the present, more intrusive, cervical cytology screening. The study will also test implementation resources such as media, information leaflets, methods of accessibility, and acceptability of the screening approach to women and healthcare providers (using qualitative interview methods).
We will adapt a database to perform the equivalent function as the National Cervical Screening Register for women who have an HPV test. The canSCREEN database is a fully developed, secure cancer screening registry platform developed and operated in Australia which will be modified to meet the needs of Te Tai Tokerau. Senior primary care clinicians and the practice manager at the implementation practices and senior researchers will have access to the canSCREEN database.
De-identified data will be accessed at six month intervals from four comparison practices who will continue with business as usual (cervical cytology). The New Zealand Cervical screening program still relies upon the “in-person” cervical cytology screen for the majority of wahine so those offered cervical cytology screen are still receiving recognized Aotearoa/New Zealand mandated and accepted treatment.
This study will also answer important questions about the pathway for wahine who need further investigation after a positive HPV test.
Te Tatai Hauora o Hine Centre for Women’s Health Research and Mahitahi Hauora, Northland PHE have partnered to undertake this trial implementing Human Papillomavirus (HPV) self-testing in Te Tai Tokerau.

Contacts
Principal investigator
Name 110942 0
Prof Bev Lawton
Address 110942 0
Centre for Women’s Health Research - Te Tatai Hauora O Hine
Faculty of Health -| Te Wahanga Tatai Hauora
Victoria University of Wellington - Te Whare Wananga o te Upoko o te Ika a Maui
PO Box 600, Wellington, 6140, New Zealand
Country 110942 0
New Zealand
Phone 110942 0
+64 21463762
Fax 110942 0
Email 110942 0
[email protected]
Contact person for public queries
Name 110943 0
Bev Lawton
Address 110943 0
Centre for Women’s Health Research - Te Tatai Hauora O Hine
Faculty of Health - Te Wahanga Tatai Hauora
Victoria University of Wellington - Te Whare Wananga o te Upoko o te Ika a Maui
PO Box 600, Wellington, 6140, New Zealand
Country 110943 0
New Zealand
Phone 110943 0
+64 21463762
Fax 110943 0
Email 110943 0
[email protected]
Contact person for scientific queries
Name 110944 0
Bev Lawton
Address 110944 0
Centre for Women’s Health Research - Te Tatai Hauora O Hine
Faculty of Health - Te Wahanga Tatai Hauora
Victoria University of Wellington - Te Whare Wananga o te Upoko o te Ika a Maui
PO Box 600, Wellington, 6140, New Zealand
Country 110944 0
New Zealand
Phone 110944 0
+64 21463762
Fax 110944 0
Email 110944 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data is identifiable so will not be shared


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
SourceTitleYear of PublicationDOI
EmbaseTe Ara Waiora-Implementing human papillomavirus (HPV) primary testing to prevent cervical cancer in Aotearoa New Zealand: A protocol for a non-inferiority trial.2023https://dx.doi.org/10.1371/journal.pone.0280643
N.B. These documents automatically identified may not have been verified by the study sponsor.