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Trial registered on ANZCTR


Registration number
ACTRN12621000553875
Ethics application status
Approved
Date submitted
8/10/2020
Date registered
12/05/2021
Date last updated
12/05/2021
Date data sharing statement initially provided
12/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cervical screening pathway - A model for empowering rural solutions
Scientific title
A model for empowering rural solutions - a randomised controlled community trial using Point of Care HPV testing
Secondary ID [1] 302495 0
HRC 20-550
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical cancer 319353 0
Condition category
Condition code
Cancer 317310 317310 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a cluster crossover intervention trial, with communities (study sites) as clusters.
Pathway 1 ( Intervention) is an HPV self-test with onsite Point of Care (POC) results within one hour paired with kanohi ki te kanohi (face to face) information, support and immediate appointments for a secondary service colposcopy for those who are HPV positive.
Pathway 2 (Control) is HPV self-test with swab sent to laboratory, and the usual result giving, information and support, and usual referral pathways to colposcopy for those who are HPV highr risk positive. Results are usually received within 7 working days from the lab, referral to colposcopy entails the primary care clnican writing a letter to the gynaecology department and and once triaged by the gyanecologist an appointment is sent to the patient (woman). The Ministry of Health guidelins recommend 20 working days from receiving referral to appointment for high grade cervcial changes and 40 working days for low grade cervcial changes.
We hypothesise that Pathway 1 will improve timely diagnosis and treatment access for women with high risk HPV compared to Pathway 2.

Information written , pitcorial and verbal will be provided for recruited women by trained clinicians and community health workers on how to take the swab,. Information will also be provided on the process of colposcopy and support will be given to help attendance at colposcopy appointments for women with positive high risk HPV results ( such as a support person to accompany the womanand petrol vouchers or transport help).
The clinicians ( primary care doctors and nurses) and community health workers will be provided with training on HPV by a team of HPV experts before recruitment starts; its role in cervical cancer and the science on HPV testing to detect pre-cancerous cervical changes compared to cytology from a cervical smear sample
A training will be held for each intervention site ( pathway 1) on the Point of Care machine by certified trainers- both quality audit and processing of swabs. The trainees will be GPs, nurses and community health workers who have a knowledge and connection with their community and the primary care clinics.
- training will be provide face to face in small groups
- trainng will be provided before recruitment starts and the trainers /experts will remain on site for the first few days of recruitment to ensure no issues with the POC testing and results. Repeat training updates will be provided at appropriate intervals - 6 monthly updates
The HPV self test can be taken by the woman herself or by a clinician at the woman's request. The sample can be taken in the clinic, at home or in a community centre or suitable venue that has a private toilet facility.

For all trials:
The HPV swab is to be offered to all women aged between 25-69 who are registered with the primary care site who are due a cervical smear but priority will be given to women who are currently underscreened ( no smear for 4 years or more) or who have never had a cervical smear.
The pathway to colposcopy in both arms ( pathways) will be assessed using the NZ Ministry of Health guidelines for time to colposcopy for a high grade cytology result.

Intervention code [1] 318789 0
Early detection / Screening
Comparator / control treatment
Pathway 1 ( Intervention) is HPV self-test with onsite Point Of Care results within one hour paired with kanohi ki te kanohi (face to face) information, support and immediate appointments for a secondary colposcopy service for those who are HPV high risk positive.
Pathway 2 (Control) is HPV self-test with swab sent to laboratory, and the usual result giving, information and support, and usual referral pathways for colposcoy for those who are HPV high risk positive.
Eligibility criteria are all women aged 25-69 years eligible for a cervical screen in these two rural areas who agree to an HPV test but priority will be under-screened or never-screened Maori women. Women who opt for a cervical smear will be excluded from this study.


Control group
Active

Outcomes
Primary outcome [1] 325367 0
Primary Outcome- Intervention vs Control
Proportion of women with an HPV positive test having a colposcopy
This will be determined by direct data feedback from the colposcopy departments who are an integral part of the study and copies of the results of biopsies and cytology taken at colposcopy will be sent ( as on consent forms for participants) to the senior research investators .
Timepoint [1] 325367 0
within 20 working days (MOH Indicator) of referral
Secondary outcome [1] 387683 0
Secondary Outcomes: Intervention vs Control
1. Proportion of women with an HPV positive test having a colposcopy
This will be determined by direct data feedback from the colposcopy departments who are an integral part of the study and copies of the results of biopsies and cytology taken at colposcopy will be sent ( as on consent forms for participants) to the senior research investators .
Timepoint [1] 387683 0
within 40 days of referral (MOH indicator )
Secondary outcome [2] 387684 0
2. Time from test to patient notification of results (positive or negative)
as determined from medical records data
Timepoint [2] 387684 0
for control pathway any time after test taken- expected within one month
Secondary outcome [3] 387685 0
3. Time from test and time from receiving results to treatment for women with positive results/high grade histology
as determined from medical records data and colposcopy data
Timepoint [3] 387685 0
within 6 months
Secondary outcome [4] 387686 0
For both groups: (Intervention and Control)
4. Numbers of HPV positive, HPV negative results and invalid results

copies of results ( as consented by participants) will be sent to research team
Timepoint [4] 387686 0
within one year recruitment period
Secondary outcome [5] 387687 0
5. Numbers of high grade lesions (CIN2 CIN3, Carcinoma)
copies of results ( as consented by participants) will be sent to research team and data wil be received from colposcopy team
Timepoint [5] 387687 0
wihtin 2 year recruitment period
Secondary outcome [6] 387688 0
6. Proportion of under-screened / never screened women receiving test and follow up
as determined from patient management systems in primary care where partcipant is registered and matched with copies fo results sent to research team
Timepoint [6] 387688 0
within 2 year recruitment period

Eligibility
Key inclusion criteria
All women aged 25-69 years eligible for a cervical screen in these two rural areas who agree to an HPV test. This age group is in line with NCSP changing the national screening criteria to the 25-69 year age group in November 2019. Women who are due for a smear or who are under-screened (under-screened defined as never screened or 4 years or more since last screen) are invited to participate but in line with the iwi and community focus, priority will be under-screened or never-screened Maori women.
Minimum age
25 Years
Maximum age
69 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
any woman outside that age group
any woman who chooses a cervical smear instead of an HPV swab
any woman who has had her cervix removed ( hysterectomy with removal of cervix)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
There are two primary care sites - one will be randomsied to intervention for the first year and the otehr site will be control. There will be cross over to the other site for the second year. of recruitment. The clinics are randomised not the women.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
In discussion with the community and iwi and on advice from HRC biostatistician the clinics will identify the list of under-screened and never screened women and half will be randomised to the intervention for Year one and half will be randomised to the intervention for Year two recruitment.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size Calculation
The primary hypothesis is that the Intervention will increase the proportion of women who attend and receive colposcopy within 20 working days compared to the Control. The target communities are predominantly Maori women in a rural setting. Based on the latest percentage reported for Maori women throughout New Zealand, we assume that 55% of women in the control arm will be reviewed at colposcopy within 20 working days following referral for a positive HPV test. We aim to detect a 50% increase (RR=1.5) from 55% to 83% in the primary outcome for the Intervention arm with 80% power. A sample size of 320 tests in each arm in a two-cluster, two-period, cluster randomised crossover trial will give 80% power to detect a 50% increase in the Intervention arm. It is estimated that a sample size of 1280 participants are required to achieve this.

Analysis
A hierarchical logistic regression model will be used to analyse the data to test the primary hypothesis that the Intervention will increase the proportion of women who attend and receive colposcopy within 20 working days of referral by 50% relative to the Control. Secondary analyses will compare time to notification and time to colposcopy between the Intervention and Control groups. Survival analysis will be used to account for loss-to-follow up. Other analyses will compare proportions that receive screening during the study period.

Recruitment
Recruitment status
Recruiting
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] 23050 0
New Zealand
State/province [1] 23050 0
Tairawhiti and Hawkes Bay

Funding & Sponsors
Funding source category [1] 306921 0
Government body
Name [1] 306921 0
Health Research Council of New Zealand
Address [1] 306921 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street (GPS: 50 Grafton Road), Grafton, Auckland 1010
Postal address:PO Box 5541, Victoria Street West, Auckland 1142
Country [1] 306921 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
Kelburn Parade
Wellington

PO Box 600
Wellington 6140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 307482 0
None
Name [1] 307482 0
Address [1] 307482 0
Country [1] 307482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307071 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 307071 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] 307071 0
New Zealand
Date submitted for ethics approval [1] 307071 0
13/11/2020
Approval date [1] 307071 0
02/12/2020
Ethics approval number [1] 307071 0
20/NTB/311

Summary
Brief summary
This iwi/community/researcher partnership, utilising the cervical cancer screening pathway as an example, will test an innovative model using new technology, to enable the community to control their health care delivery pathways.
The study purpose is to compare two pathways from HPV self-testing , if result shows high risk HPV to colposcopy (- an examination which determines if there are pre-cancer changes in the cells of the cervix)- to see if timely and appropriate diagnosis and treatment can be improved.
Early diagnoiss and treatment of abnormal cells on the cervix can prevent cervical cancer which affects Maori women more than Pakeha women.
We hypothesise that HPV self-testing with onsite POC results ( results available on site in one hour), kanohi ki-te-kanohi (face-to-face) information, and immediate appointments made for a secondary service for HPV positive results, will improve timely diagnosis and treatment for women, compared to HPV self-testing with usual result and referral pathways.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105926 0
Prof Bev Lawton
Address 105926 0
Centre for Women's Health Research
42 Kelburn Parade
Victoria University of Wellington
Kelburn
Wellington
6140
Country 105926 0
New Zealand
Phone 105926 0
+6421463762
Fax 105926 0
Email 105926 0
bev.lawton@vuw.ac.nz
Contact person for public queries
Name 105927 0
Prof Bev Lawton
Address 105927 0
Centre for Women's Health Research
42 Kelburn Parade
Victoria University of Wellington
Kelburn
Wellington
6140
Country 105927 0
New Zealand
Phone 105927 0
+6421463762
Fax 105927 0
Email 105927 0
bev.lawton@vuw.ac.nz
Contact person for scientific queries
Name 105928 0
Prof Bev Lawton
Address 105928 0
Centre for Women's Health Research
42 Kelburn Parade
Victoria University of Wellington
Kelburn
Wellington
6140
Country 105928 0
New Zealand
Phone 105928 0
+6421463762
Fax 105928 0
Email 105928 0
bev.lawton@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
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 9390 0
Study protocol
Citation [1] 9390 0
Link [1] 9390 0
Email [1] 9390 0
e.jane.macdonald@vuw.ac.nz
Other [1] 9390 0
Attachment [1] 9390 0
Type [2] 9392 0
Ethical approval
Citation [2] 9392 0
Link [2] 9392 0
Email [2] 9392 0
e.jane.macdonald@vuw.ac.nz
Other [2] 9392 0
Attachment [2] 9392 0
Type [3] 9393 0
Informed consent form
Citation [3] 9393 0
Link [3] 9393 0
Email [3] 9393 0
e.jane.macdonald@vuw.ac.nz
Other [3] 9393 0
Attachment [3] 9393 0
Type [4] 9394 0
Statistical analysis plan
Citation [4] 9394 0
Link [4] 9394 0
Email [4] 9394 0
e.jane.macdonald@vuw.ac.nz
Other [4] 9394 0
Attachment [4] 9394 0
Summary results
No Results