Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000699763
Ethics application status
Approved
Date submitted
22/04/2022
Date registered
16/05/2022
Date last updated
21/05/2024
Date data sharing statement initially provided
16/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to investigate the impact of the introduction of HPV testing in the NZ general practice setting
Scientific title
The feasibility and impact of HPV-based cervical screening incorporating the choice of a vaginal self-test in the NZ primary care setting
Secondary ID [1] 306804 0
Nil.
Universal Trial Number (UTN)
U1111-1276-2570
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer (screening) 325894 0
Condition category
Condition code
Cancer 323201 323201 0 0
Cervical (cervix)
Public Health 323574 323574 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over a six month* screening period patients who are due or overdue for their smear test will be invited to take part in the study. They will undertake a high risk human papillomavirus (hrHPV) screening test for cervical cancer.**

Participants will be able to select one of the following ways to take the hrHPV test:
1 Vaginal hrHPV self sample at home
2 Vaginal hrHPV self sample at their General Practice (GP) clinic (with or without medical staff assistance)
3 Cervical hrHPV sample taken by a doctor or nurse (with or without concurrent cytology).

Vaginal hrHPV self tests will be taken utilising a dry floq swab inserted in the vagina and transported in a sterile sealed container. Cervical hrHPV tests will be taken under direct visualisation by an accredited smear-taker using a cervibroom or equivalent and placed in liquid-based cytology medium. Self testing will take around 5 minutes to complete. A clinician taken test will take up to 10 minutes.

The hrHPV test will be performed utilising an accredited lab and an hrHPV assay validated for cervical hrHPV screening.

Test results will be returned to the participant's GP. The GP will provide appropriate follow up and inform participants of their results.

* The screening period may be extended for an additional 3 months to allow time for patients who have been contacted to decide whether they wish to take part.
** Only one hrHPV test will be required during the screening period, unless the sample is deemed insufficient (e.g. incorrectly labelled), in which case the participant will be asked to repeat it.
Intervention code [1] 323277 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330943 0
The number (and percentage) of participants that undertook a:
- Vaginal test at home
- Vaginal test at their GP clinic without staff assistance
- Vaginal test at their GP clinic with staff assistance
- Cervical test without concurrent cytology
- Cervical test with concurrent cytology.

Data obtained from participating GP clinics.
Timepoint [1] 330943 0
By the end of screening period.
Primary outcome [2] 330955 0
The number (and percentage) of participants who had the following hrHVP result:
- HPV 16
- HPV 18
- Other hrHPV (listed by genotype where available)
- hrHPV not detected.

Data obtained from participating GP clinics and laboratories.
Timepoint [2] 330955 0
By six months after the end of the screening period.
Primary outcome [3] 330957 0
The mean, median and range for the time between an hrHPV test report being issued and GP referral for colposcopy.

Data to be presented separately by whether participants had a cervical or vaginal hrHPV test, and whether the referral was made with or without cytology results.

Data to also be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics and laboratories.
Timepoint [3] 330957 0
By six months after the end of the screening period.
Secondary outcome [1] 408244 0
The number (and percentage) of participants with: 1,2,3 or >3 attempts to be contacted prior to their hrHPV test.

Data obtained from participating GP clinics.
Timepoint [1] 408244 0
By the end of screening period.
Secondary outcome [2] 408436 0
The mean, median and range for time from the first study appointment to an hrHPV test being conducted, for each participant.

Data obtained from participating GP clinics.
Timepoint [2] 408436 0
By the end of screening period.
Secondary outcome [3] 408437 0
The mean, median and range for time from first the contact attempt to an hrHPV test being conducted, for each participant.

Data obtained from participating GP clinics.
Timepoint [3] 408437 0
By the end of screening period.
Secondary outcome [4] 408438 0
The number (and percentage) of participants who were successfully contacted to take part in the study by:
- Letter
- Text
- Opportunistic invitation at their GP clinic
- A face to face appointment with a staff member at their GP clinic
- A phonecall with a staff member from their GP clinic
- Other form of contact.

Data obtained from participating GP clinics.
Timepoint [4] 408438 0
By the end of screening period.
Secondary outcome [5] 408439 0
The mean, median and range for the time from an hrHPV test being undertaken to being received by the laboratory for analysis, for each participant.

Data to be presented separately by whether participants had an hrHPV test at home or at their GP clinic.

Data obtained from participating GP clinics and laboratories.
Timepoint [5] 408439 0
By six months after the end of the screening period.
Secondary outcome [6] 408440 0
The mean, median and range of charges (NZD) for each type of hrHPV test listed under Primary Outcome 1 above.

This will be reported by whether the tests were subsidised or not.

Data obtained from participating GP clinics.
Timepoint [6] 408440 0
By the end of screening period
Secondary outcome [7] 408441 0
The mean, median and range for the time from an hrHPV test to the results report being issued.

Data obtained from participating GP clinics and laboratories.
Timepoint [7] 408441 0
By six months after the end of the screening period.
Secondary outcome [8] 408779 0
In participants who underwent hrHPV testing and had an unsatisfactory result, the reason for that result:
- Incorrect labelling
- Sample unsatisfactory
- Other.

Data obtained from participating GP clinics and laboratories.
Timepoint [8] 408779 0
By six months after the end of the screening period.
Secondary outcome [9] 408780 0
In participants who underwent hrHPV testing and had an unsatisfactory result, the number (and percentage) that:
- Did have a repeat hrHPV test
- Did not have a repeat hrHPV test.

Data obtained from participating GP clinics and laboratories.
Timepoint [9] 408780 0
By six months after the end of the screening period.
Secondary outcome [10] 408781 0
In participants who underwent hrHPV testing and had a repeat test, the mean, median and range for the time from the first hrHPV test to the repeat hrHPV test.

Data obtained from participating GP clinics and laboratories.
Timepoint [10] 408781 0
By six months after the end of the screening period.
Secondary outcome [11] 408782 0
The mean, median and range for the time from an hrHPV test result report being issued and the participant being informed of the result.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics and laboratories.
Timepoint [11] 408782 0
By six months after the end of the screening period.
Secondary outcome [12] 408783 0
The number (and percentage) of participants informed of their hrHPV result by:
- Face to face appointment with a staff member at their GP clinic
- Phonecall with a staff member from their GP clinic
- Text
- Other form of contact.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics.
Timepoint [12] 408783 0
By six months after the end of the screening period.
Secondary outcome [13] 408784 0
The reason cytology was performed in participants that had cytology results issued from the sample taken during a cervical hrHPV test:
- Requested by GP due to previous high grade lesion (test of cure)
- Requested by GP due to previous abnormal cytology
- Requested by GP due to symptoms
- Requested by GP for other reason
- Performed by lab due to detection of hrHPV (not GP requested)
- Performed by lab due to identification of need to test for cure (not GP requested),
- Other reason.

Data obtained from participating GP clinics and laboratories.
Timepoint [13] 408784 0
By six months after the end of the screening period.
Secondary outcome [14] 408785 0
The reason cytology was performed in participants that had cytology test* performed after an hrHPV test and before colposcopy:
- Positive for hrHPV result
- Other reason.

*Please note for this and subsequent outcomes the term “cytology test” refers to a cytology sample taken at a GP clinic after an hrHPV test and before colposcopy.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics.
Timepoint [14] 408785 0
By six months after the end of the screening period.
Secondary outcome [15] 408786 0
The number (and percentage) of participants with 0, 1, 2 or 3 invitations for a cytology appointment, in participants who are recommended to have cytology.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics.
Timepoint [15] 408786 0
By six months after the end of the screening period.
Secondary outcome [16] 408787 0
The reason for no cytology report (prior to colposcopy) in participants positive for hrHPV and had a vaginal hrHPV test:
- Cytology not considered feasible by the GP
- Participant declined
- Participant unable to be contacted
- Other.

Data to be presented separately for participants positive for HPV16 and/or 18 and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics.
Timepoint [16] 408787 0
By six months after the end of the screening period.
Secondary outcome [17] 408788 0
In participants that had a cytology test prior to colposcopy, the mean, median and range for the time between an hrHPV test result report being issued and a cytology sample being undertaken.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics and laboratories.
Timepoint [17] 408788 0
By six months after the end of the screening period.
Secondary outcome [18] 408789 0
In participants that had a cytology test prior to colposcopy, the mean, median and range for the time from a cytology sample being undertaken to the results report being issued.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics and laboratories.
Timepoint [18] 408789 0
By six months after the end of the screening period.
Secondary outcome [19] 408790 0
In participants that had a cytology test prior to colposcopy, the number (and percentage) with a result of:

- Negative for dysplasia or malignancy
- ASC-US (atypical squamous cells of undetermined significance - excluding ASC-US possible high grade)
- LSIL (low grade squamous intraepithelial lesion)
- ASC-H (atypical cells of undetermined significance, possible high grade)
- HSIL (high grade squamous intraepithelial lesion)
- Cancer (invasive squamous carcinoma of the cervix)
- Adenocarcinoma
- Cancer other
- AGC/AIS (atypical glandular cells / adenocarcinoma-in-situ)
- Unsatisfactory sample.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics and laboratories.
Timepoint [19] 408790 0
By six months after the end of the screening period.
Secondary outcome [20] 408791 0
In participants that had a cytology test prior to colposcopy, the mean, median and range for the time from their cytology sample being undertaken to being informed of the result.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics.
Timepoint [20] 408791 0
By six months after the end of the screening period.
Secondary outcome [21] 408805 0
In participants that had a cytology test prior to colposcopy, the number (and percentage) informed of their cytology results by:
- Face to face appointment with a staff member at their GP clinic
- Phonecall with a staff member from their GP clinic
- Text
- Other form of contact.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics.
Timepoint [21] 408805 0
By six months after the end of the screening period.
Secondary outcome [22] 408808 0
In participants that had a cytology test prior to their colposcopy referral, the mean, median and range for the time between the cytology result report being issued and referral for colposcopy.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics and laboratories.
Timepoint [22] 408808 0
By six months after the end of the screening period.
Secondary outcome [23] 408809 0
The number (and percentage) of participants that had a referral for colposcopy by classification of urgency.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics.
Timepoint [23] 408809 0
By six months after the end of the screening period.
Secondary outcome [24] 408810 0
In participants referred for colposcopy, the number (and percentage) that received 1, 2, 3 or >3 invitations for an appointment.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from colposcopy clinics.
Timepoint [24] 408810 0
By six months after the end of the screening period.
Secondary outcome [25] 408811 0
In participants that had a colposcopy, the mean, median and range for time from GP referral to their colposcopy appointment.

Data to be presented separately for each classification of urgency.

Data to also be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics and colposcopy clinics.
Timepoint [25] 408811 0
By six months after the end of the screening period.
Secondary outcome [26] 408812 0
In participants that had a cytology test during colposcopy, the number (and percentage) with a result of:
- Negative for dysplasia or malignancy
- ASC-US (atypical squamous cells of undetermined significance - excluding ASC-US possible high grade)
- LSIL (low grade squamous intraepithelial lesion)
- ASC-H (atypical cells of undetermined significance, possible high grade)
- HSIL (high grade squamous intraepithelial lesion)
- Cancer (invasive squamous carcinoma of the cervix)
- Adenocarcinoma
- Cancer other
- AGC/AIS (atypical glandular cells / adenocarcinoma-in-situ)
- Unsatisfactory sample.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics, laboratories and/or colposcopy clinics.
Timepoint [26] 408812 0
By six months after the end of the screening period.
Secondary outcome [27] 408813 0
In participants that had colposcopy, the number (and percentage) that had a visualised result of:
- Unsatisfactory
- No abnormality detected
- CIN1
- CIN2
- CIN3
- Adenocarcinoma
- Squamous cell carcinoma
- Other.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics or colposcopy clinics.
Timepoint [27] 408813 0
By six months after the end of the screening period.
Secondary outcome [28] 408814 0
In participants that had colposcopy, the number (and percentage) that had the transformation zone visualised.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics or colposcopy clinics.
Timepoint [28] 408814 0
By six months after the end of the screening period.
Secondary outcome [29] 408817 0
In participants that had colposcopy, the number (and percentage) that had a biopsy.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.


Data obtained from participating GP clinics or colposcopy clinics.
Timepoint [29] 408817 0
By six months after the end of the screening period.
Secondary outcome [30] 408818 0
In participants that had colposcopy with a biopsy, the number (and percentage) that had a result of:
- Unsatisfactory
- No abnormality detected
- CIN1
- CIN2
- CIN3
- Adenocarcinoma
- Squamous cell carcinoma
- Other.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics, laboratories or colposcopy clinics.
Timepoint [30] 408818 0
By six months after the end of the screening period.
Secondary outcome [31] 408821 0
In participants that had colposcopy, the number (and percentage) that had each treatment recommendation.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics or colposcopy clinics.
Timepoint [31] 408821 0
By six months after the end of the screening period.
Secondary outcome [32] 408822 0
In participants that had colposcopy, the number (and percentage) that had each treatment.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics or colposcopy clinics.
Timepoint [32] 408822 0
By six months after the end of the screening period.
Secondary outcome [33] 408823 0
The mean, median and range for times from colposcopy to initiation of each of the treatments in outcome 32 above.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics or colposcopy clinics.
Timepoint [33] 408823 0
By six months after the end of the screening period.
Secondary outcome [34] 408824 0
Incidence of CIN2+ in participants by cytology result.

Data to be presented separately for participants negative for hrHPV, participants positive for HPV16 and/or 18, and participants positive for hrHPV other than 16 or 18.

Data obtained from participating GP clinics, laboratories and colposcopy clinics.
Timepoint [34] 408824 0
By six months after the end of the screening period.
Secondary outcome [35] 408825 0
Where numbers permit, all outcomes will be presented by:
- Screening history (previously undergone cervical treatment/had an abnormal smear, or not)
- Age band (<25, 25 to 34 years, 35 to 54 years, 55 to 69 years, >69 years)
- Self reported ethnicity (NZ European/Other, Maori, Pacific Island or Asian)
- Socioeconomic deprivation index (Quintiles 1 through to 5)
- Region (Christchurch, Wellington or Whanganui and surrounding areas).
Data obtained from participating GP clinics, laboratories and colposcopy clinics.
Timepoint [35] 408825 0
By six months after the end of the screening period.
Secondary outcome [36] 408826 0
Mean, median and range for the per participant cost (NZD) to the participant's GP clinic for each of the following:
- hrHPV self test at home or clinic without support
- hrHPV self test at clinic with support
- hrHPV cervical test by a nurse
- hrHPV cervical test by a doctor
- Cytology test as part of hrHPV cervical test
- Cytology test performed separately to the hrHPV test
- Colposcopy referral.

Data obtained from participating GP clinics.
Timepoint [36] 408826 0
By six months after the end of the screening period.
Secondary outcome [37] 408827 0
The number of patients at participating clinics who are due or overdue for cervical cancer screening during the six month screening period that did not take part in the study (deidentified data). Of these patients, the number (and percentage) that did have cervical cytology during the screening period and did not have cervical cytology during the screening period.

Data obtained from participating GP clinics.
Timepoint [37] 408827 0
By the end of the screening period.

Eligibility
Key inclusion criteria
People enrolled in the practice who are eligible for cervical screening as part of the National Cervical Screening Programme (NCSP)* and are recalled for cervical screening or opportunistically attend the provider and are due for a cervical screen within the study enrolment period.

Notes
Patients who are recalled for screening but report symptoms at the time of their screening test will be eligible for the study, however a strong recommendation for a clinical assessment will be made.

Patients who are invited to participate in this study can do so if they agree to participate within 3 months of the completion of the recruitment period (i.e., before 1 April 2023).

*For full details of inclusion for NCSP screening, please refer to the 2020 Ministry of Health Clinical Practice Guidelines for Cervical Screening in New Zealand at www.nsu.govt.nz.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who are unable or unwilling to provide informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2022
Actual
19/08/2022
Date of last participant enrolment
Anticipated
Actual
30/05/2023
Date of last data collection
Anticipated
31/08/2023
Actual
19/10/2023
Sample size
Target
3000
Accrual to date
Final
3311
Recruitment outside Australia
Country [1] 24696 0
New Zealand
State/province [1] 24696 0

Funding & Sponsors
Funding source category [1] 311141 0
Government body
Name [1] 311141 0
National Screening Unit, Ministry of Health
Country [1] 311141 0
New Zealand
Primary sponsor type
University
Name
Otago University
Address
2 Riccarton Avenue
Christchurch Central
Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 312488 0
None
Name [1] 312488 0
Address [1] 312488 0
Country [1] 312488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310666 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 310666 0
Ethics committee country [1] 310666 0
New Zealand
Date submitted for ethics approval [1] 310666 0
28/04/2022
Approval date [1] 310666 0
01/07/2022
Ethics approval number [1] 310666 0

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

Contacts
Principal investigator
Name 118454 0
A/Prof Peter Sykes
Address 118454 0
University of Otago
2 Riccarton Avenue
Christchurch 8011
Country 118454 0
New Zealand
Phone 118454 0
+64274429832
Fax 118454 0
Email 118454 0
peter.sykes@otago.ac.nz
Contact person for public queries
Name 118455 0
Peter Sykes
Address 118455 0
University of Otago
2 Riccarton Avenue
Christchurch 8011
Country 118455 0
New Zealand
Phone 118455 0
+64 3 364 0530
Fax 118455 0
Email 118455 0
peter.sykes@otago.ac.nz
Contact person for scientific queries
Name 118456 0
Peter Sykes
Address 118456 0
University of Otago
2 Riccarton Avenue
Christchurch 8011
Country 118456 0
New Zealand
Phone 118456 0
+64 3 364 0530
Fax 118456 0
Email 118456 0
peter.sykes@otago.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?




Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.