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Trial registered on ANZCTR


Registration number
ACTRN12617001255370
Ethics application status
Approved
Date submitted
7/08/2017
Date registered
29/08/2017
Date last updated
7/07/2021
Date data sharing statement initially provided
24/02/2020
Date results information initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
He Tapu Te Whare Tanagata - Does offer of Human Papilloma Virus self -testing to under-screened Maori women increase cervical screening coverage?
Scientific title
He Tapu Te Whare Tanagata - Does offer of Human Papilloma Virus self -testing to under-screened Maori women increase cervical screening coverage?
Secondary ID [1] 292507 0
nil known
Universal Trial Number (UTN)
U1111-1201-1846
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer and pre-cancer 304144 0
Condition category
Condition code
Cancer 303473 303473 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study uses a parallel group comparison design, where usual standard care (control group) or the intervention (HPV self-testing program) will be allocated by primary health care clinic. Inclusion criteria: Maori women who have not had a cervical smear screen in the last 4 years.
Brief title
Offer of self -testing HPV swab to under-screened Maori women

1) Educational Intervention for clinicians and community workers
Materials - Educational material (written/presentation/teaching sessions) given to doctors, nurses, community workers by experts in HPV from research team
Who will deliver intervention - Research team (Professor oncological gynaecology, professor Obstetrics and Gynaecology, sexual health physician/ senior research fellow, family physician/ researcher with expertise in women’s health) will provide educational material and sessions for nurse, doctors and community workers
Mode of delivery - Educational sessions to clinicians will be offered to groups of clinicians from intervention primary care practices in small tutorial setting
Number of times intervention offered - Education sessions will be offered twice to groups of clinicians over 3 months - 2 x 1 hour sessions
Location- Education sessions will be offered in primary care setting/clinic/local community hall

2) Intervention for participants – under-screened Maori women offered self –taken vaginal swab for HPV

Materials - Instructions and diagrams for women being offered HPV self-testing will be co-designed by research team plus input from primary health clinicians, community workers and the women themselves (focus groups) ( draft HPV information and consent is attached to ANZCTR registration form)

Procedures -Women will receive verbal, written and /or pictorial instructions from a doctor, nurse or kaiawhina (community health worker) about how to perform the HPV self-test, a self-collected vaginal sample. Women will self-collect a vaginal sample using a swab. The instructions will detail how to insert the swab into the vagina and place it into a collection container that has been labelled by the healthcare worker with the name, date of birth and unique NHI (National Health Index) number. Specimens are transported at room temperature to local Laboratories, who have agreed to handle the transportation of the samples, with their daily shipments, to national central Laboratories. HPV genotyping will be carried out using Real-time High Risk HPV assay validated for the use of dry swabs. This distinguishes HPV-16 and HPV-18 from other high-risk types and from negative samples.

Who will deliver intervention – the (participants) woman’s usual primary care clinician (family doctor or nurse) or community health worker will deliver the information to participants

Mode of delivery - HPV swab testing will be offered by doctor, nurse or community worker, face-to-face individually

HPV self-testing will be offered between 1 - 5 times over one year to under-screened Maori women

Location- HPV self- testing will be offered in patients home, community venues such as local meeting houses (Maraes) if facilities allow, primary care clinic

Results – results of self- testing for HPV will be given by the woman’s usual primary care clinician ( doctor or nurse.) This can be done by phone or text if the result is negative or if results positive for high risk HPV an appointment will be made for the woman to obtain result and explanation face to face. Results will be available 7-14 days after test has been taken.
Results will also be entered into the National Screening Unit data base (as per usual cervical smear results). This process has been discussed with the screening unit CEO and clinician in charge of cervical screening database.
Any positive result will be followed up and referred for colposcopy by the woman’s usual primary care clinician.

Our study site is Northland where Maori women have almost twice the incidence of cervical cancer compared to non-Maori but almost four times the mortality. In Northland, cervical screening for Maori is approximately 66%. Women fulfilling inclusion criteria will be identified by primary care and matched with the National Screening Unit (NSU) on NHI to confirm screening history. All primary care clinics in the geographical area will be approached and recruited and randomised to intervention or control (usual care). We will recruit until target met.

Intervention code [1] 298692 0
Early detection / Screening
Intervention code [2] 298693 0
Prevention
Comparator / control treatment
The study uses a parallel group comparison design, where the control group is primary health care clinic offering usual standard care in the offer of cervical screening to Maori women who are under-screened ( cervical smear > 4 years ago). Once the study is completed and if successful, the four clinics used initially for control (usual standard care) comparisons will be offered access to the HPV self-testing program. 'Usual care' is offer of appointment for cervical smear by letter or phone call to women who have not had a cervical smear for 4 or more years.
Control group
Active

Outcomes
Primary outcome [1] 302847 0
Primary outcome: Rate of HPV self-testing in intervention practices compared to rate of cervical smear uptake in control practices.
Outcome assessed by data linkage to primary care clinic records, laboratory results data and data from National Screening Unit NSU.
Timepoint [1] 302847 0
The primary outcome will be assessed once 400 underscreened Maori women are recruited into study- it is anticpated that this will take up to 18 months and as recruitment starts Feb 2018 so would anticpate to be ended by August 2019
Secondary outcome [1] 337224 0
Secondary outcomes: For those HPV tested:
proportion of women with abnormal screen (positive for oncogenic HPV),
Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services).
Timepoint [1] 337224 0
this will be assessed once 400 underscreened Maori women are recruited and results of HPV tests are known - anticpated to be by Sept 2019
Secondary outcome [2] 337225 0
proportion of women with HPV attending colposcopy,
Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services).
Timepoint [2] 337225 0
this will be assessed once 400 underscreened women are recruited and results of HPV tests are known, referrals to colposcopy made and attendance at colposcopy known- anticpated by Jan 2020
Secondary outcome [3] 337226 0
proportion of women with abnormal histology on colposcopy,
Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services).
Timepoint [3] 337226 0
this will be assessed once 400 underscreened women are recruited and results of HPV tests are known, referrals to colposcopy made, attendance at colposcopy known and results from colposcopy and biopsies reported - anticpated by April 2020
Secondary outcome [4] 337228 0
Composite proportion of women with CIN2, CIN3,
These higer grade diagnoses are often measured compostiely in the literature.
Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services).
Timepoint [4] 337228 0
this will be assessed once 400 underscreened women are recruited and results of HPV tests are known, referrals to colposcopy made, attendance at colposcopy known and results from colposcopy and biopsies reported - anticpated by April 2020
Secondary outcome [5] 337229 0
proportion of women with carcinoma-in situ
Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services).
Timepoint [5] 337229 0
this will be assessed once 400 underscreened women are recruited and results of HPV tests are known, referrals to colposcopy made, attendance at colposcopy known and results from colposcopy and biopsies reported - anticpated by April 2020
Secondary outcome [6] 337827 0
proportion of women with cervical cancer
Data linkage to primary care clinic records and national screening unit data which collects results from colposcopy ( specialist gynaecology hospital services).
Timepoint [6] 337827 0
this will be assessed once 400 underscreened women are recruited and results of HPV tests are known, referrals to colposcopy made, attendance at colposcopy known and results from colposcopy and biopsies reported - anticpated by April 2020
Secondary outcome [7] 337828 0
proportion of HPV negative women.
Data linkage to primary care clinic records and national screening unit data
Timepoint [7] 337828 0
this will be assessed once 400 underscreened Maori women are recruited and results of HPV tests are known - anticpated to be by Sept 2019

Eligibility
Key inclusion criteria
women aged 25-69
Minimum age
25 Years
Maximum age
69 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
women who do not give consent, women who have learning disabilities such that they cannot give informed consent

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)
primary care clinics will be randomised to intervention and control. All women who attend an intervention clinic receive the intervention, All women who attend the control clinic will receive the control (usual care).
Allocation will be blocked (block size 4) using a random number generator, and based at a central administration site (University of Otago, Wellington). Since the clinic will be (randomly) allocated before individual patient eligibility is determined, it is not possible to blind the participant or the health care team to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator ( randomisation.com) will determine the treatment intervention allocation of the clinics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomisation is by clinic ( cluster randomised trial)
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Four clinics will be randomly allocated to the intervention and four clinics to usual care. On average, there will be 100 unscreened Maori women per clinic to give 400 per treatment arm. At January 2020 the proportion screened in each arm will be compared( primary outcome) Four hundred/group will provide 85% power to detect a difference between 30-45% based on an estimated ICC of 0.05-0.1. Multivariate logistic regression with a random effect of clinic will compare screening rates while adjusting for co-variates.

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 outside Australia
Country [1] 9081 0
New Zealand
State/province [1] 9081 0
Northland

Funding & Sponsors
Funding source category [1] 297079 0
Government body
Name [1] 297079 0
Health Research Council of New Zealand
Address [1] 297079 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street (GPS: 50 Grafton Road), Grafton, Auckland 1010
Postal Address: PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 297079 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
Faculty of Health
Victoria University of Wellington
42 Kelburn Parade
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 296082 0
None
Name [1] 296082 0
Address [1] 296082 0
Country [1] 296082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298257 0
Health and Diasability Ethics Committee
Ethics committee address [1] 298257 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] 298257 0
New Zealand
Date submitted for ethics approval [1] 298257 0
31/08/2017
Approval date [1] 298257 0
19/02/2018
Ethics approval number [1] 298257 0

Summary
Brief summary
Even though cervical cancer is preventable, our current screening programme is failing Maori women. There are unacceptable disparities being experienced by Maori women, from access to screening to mortality. Maori women are twice as likely to die from cervical cancer than non-Maori women. Our project - He Tapu Te Whare Tangata - aims to increase cervical screening coverage through HPV self-testing, delivered through community-based health practices. We will use an innovative technology that screens women for infection with the types of Human Papilloma Virus (HPV) that cause cervical cancer. This project will enable what works for Maori women to inform any national roll-out of HPV screening. The project is Maori led and Maori centered. It will build Maori research and workforce capability, and improve the detection of pre-cancerous lesions in Maori women. This will ultimately reduce the unnecessary inequity in mortality from a preventable cancer that disproportionately affects Maori women. Eight primary care practices (and their clinicians and community workers) will be allocated to either to usual standard care (cervical screening with a speculum) or the intervention (self HPV testing program). All women (not just Maori) women who have not screened in the last 4 years will be identified through primary care and will constitute the clinic cohort to reach for screening either by standard usual care or by the intervention program. There will be no charge for the HPV test or follow up of abnormal results. Intervention: clinics will offer women in this group self testing including information and education.
Usual Standard Care
Clinics will offer women in this group a cervical smear using usual standard care. Any changes over time in this usual standard care for each practice will be documented. Data from the National Screening Unit will identify which women were screened ( by whichever method) within the study period.
We hypothesise that introducing an HPV self-testing program (He Tapu Te Whare Tangata) will result in higher cervical screening rates than the usual standard care for Maori who have not had a cervical screen in the last 4 years.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1990 1990 0 0
/AnzctrAttachments/373360-HPV self-test info book draft.docx (Participant information/consent)
Attachments [2] 1991 1991 0 0
/AnzctrAttachments/373360-HPV self test participation information.doc (Participant information/consent)

Contacts
Principal investigator
Name 76498 0
Prof Beverley Lawton
Address 76498 0
Centre for Womens Health Research
Faculty of Health
Victoria University of Wellington
42 Kelburn Parade
Kelburn
Wellington 6140
Country 76498 0
New Zealand
Phone 76498 0
+6421463762
Fax 76498 0
Email 76498 0
bev.lawton@vuw.ac.nz
Contact person for public queries
Name 76499 0
Dr E Jane MacDonald
Address 76499 0
Centre for Womens Health Research
Faculty of Health
Victoria University of Wellington
42 Kelburn Parade
Kelburn
Wellington 6140
Country 76499 0
New Zealand
Phone 76499 0
+64 21 845381
Fax 76499 0
Email 76499 0
e.jane.macdonald@vuw.ac.nz
Contact person for scientific queries
Name 76500 0
Dr E Jane MacDonald
Address 76500 0
Centre for Womens Health Research
Faculty of Health
Victoria University of Wellington
42 Kelburn Parade
Kelburn
Wellington 6140
Country 76500 0
New Zealand
Phone 76500 0
+6421845381
Fax 76500 0
Email 76500 0
e.jane.macdonald@vuw.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no individual's data will be available
the data will be aggregated to protect privacy and comply with ethics approval
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 12464 0
22 December 2020
Aust N Z J Obstet Gynaecol 2020; 1–7
DOI: 10.1111/ajo.13285
EJ MacDonald , S Geller, N Sibanda, K Stevenson, L Denmead, A Adcock , F Cram,
M Hibma, P Sykes, B Lawton
Reaching under-screened/never-screened indigenous peoples with human papilloma virus self-testing: A community-based cluster randomised controlled trial
Attachments [1] 12464 0
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary
n/a