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Trial registered on ANZCTR
Registration number
ACTRN12622001148763
Ethics application status
Approved
Date submitted
15/08/2022
Date registered
22/08/2022
Date last updated
22/08/2022
Date data sharing statement initially provided
22/08/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Experiences of wahine undergoing colposcopy at an urban marae based kaupapa Maori primary health clinic for the management of abnormal cervical smears.
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Scientific title
Experiences of women undergoing colposcopy at an urban marae based health clinic
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Secondary ID [1]
307741
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cervical dysplasia
327317
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cervical cancer screening
327378
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Condition category
Condition code
Cancer
324448
324448
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0
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Cervical (cervix)
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Public Health
324501
324501
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Women requiring colposcopy will be offered the option of having this performed at the marae primary health clinic. The colposcopy will be performed by one gynaecologist (JO) who is a certified colposcopist. She will be adhering to national cervical screening and Cervical Quality Improvement Programme (cQUIP) guidelines. It is anticipated that this colposcopy will be equivalent to a colposcopy performed at the hospital (which is routine care). These colposcopy outcomes will be audited against national guidelines, as is standard for colposcopy. Colposcopy results and outcomes will be recorded in the hospital system, as is routine for colposcopy.
Following their colposcopy, women will be asked to participate in an interview seeking to explore their experiences of the colposcopy. It is this information that the research is primarily seeking. It is anticipated this will take about one hour. THe interviews will be conducted by one researcher (MC) at a time and venue convenient to the women - this may be at the marae health clinic, in their homes, over zoom. There will only be one interview and it will take place within one month of the colposcopy. The interview will be recorded and transcribed.
Women have the option of having their colposcopy at the marae and declining to paticipate in the interview.
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Intervention code [1]
324213
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Early detection / Screening
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Comparator / control treatment
no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Experiences of colposcopy provided at the urban marae based kaupapa Maori primary health clinic - evaluated and explored through semi-structured qualitative interviews with end-users.
The interview will take approximately one hour It will be audio recorded. It will be one on one. Semi structured questions will be used..
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Assessment method [1]
332260
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Timepoint [1]
332260
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Interview following baseline colposcopy
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Secondary outcome [1]
412749
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The number of women who accepted appointment at marae health clinic when offered (as alternative to the hospital based clinic).
A log of women who were offered an appointment at the marae health clinic will be kept. Information will be collected as to the number who accepted the offer versus who elected to be seen at the hospital clinic.
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Assessment method [1]
412749
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Timepoint [1]
412749
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one year post commencement of recruitment.
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Secondary outcome [2]
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Attendance rates (and DNA - do not attend rates) for colposcopy at the urban based marae health kaupapa Maori primary health clinic will be recorded.
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Assessment method [2]
412750
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Timepoint [2]
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one year post commencement of recruitment.
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Secondary outcome [3]
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Reasons for declining an appointment at the marae based colposcopy clinic.
People who have declined to attend the marae health clinic colposcopy clinic and have instead elected for colposcopy at Wellington hospital (as is routine) will be offered an interview to share their views as to their reasons for choosing to be seen at the hospital colposcopy clinic.
It is anticipated that the interview will take up to one hour. THe interviews will be conducted by one researcher (MC) at a time and venue convenient to the women - this may be at the hospital, in their homes, or over zoom. There will only be one interview and it will take place within one month of the hospital colposcopy appointment. The interview will be recorded and transcribed.
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Assessment method [3]
413068
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Timepoint [3]
413068
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One year after commencement of recruitment
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Eligibility
Key inclusion criteria
Wahine who are willing to undertake colposcopy an an urban based marae kaupapa Maori primary health clinic..
Women referred for colposcopy at Wellington Hospital / Te Whatu ora.
Women who were offered colposcopy at an urban based marae kaupapa Maori primary health clinic but declined and elected to be seen at Wellington Hosptial / Te Whatu ora.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
none
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
This is a small feasibility/acceptability project to explore the implementation of a colposcopy service at an urban based marae kaupapa Maori primary health clinic.
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Due to the small sample size there will be insufficient power to detect statistically significant differences. As such we have purposefully designed the outcomes as qualitative to prioritise people’s experiences and views toward acceptability. The interviews will be recorded and analysed through reflective thematic analysis (semi-inductive).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
12/09/2022
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Actual
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Date of last participant enrolment
Anticipated
7/08/2023
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Actual
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Date of last data collection
Anticipated
7/08/2023
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
24941
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New Zealand
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State/province [1]
24941
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Wellington
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Funding & Sponsors
Funding source category [1]
312010
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Government body
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Name [1]
312010
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Health Research Council
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Address [1]
312010
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Level 3/110 Stanley Street, Grafton, Auckland 1010
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Country [1]
312010
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New Zealand
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Funding source category [2]
312011
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Charities/Societies/Foundations
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Name [2]
312011
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Australian Society for Colposcopy and Cervical pathology
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Address [2]
312011
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ASCCP Secretariat
PO Box 717
Indooroopilly
QLD 4068
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Country [2]
312011
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Australia
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Primary sponsor type
Hospital
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Name
Wellington Hospital / Te Whatu Ora
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Address
2DHB Research Office Manager | Centre of Clinical Excellence 2DHB
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
313575
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Address [1]
313575
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Country [1]
313575
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
311430
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Northern A Health and Disability Ethics Committee
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Ethics committee address [1]
311430
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Ministry of Health
133 Molesworth Street
POBox 5013
Wellington 6011
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Ethics committee country [1]
311430
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New Zealand
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Date submitted for ethics approval [1]
311430
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Approval date [1]
311430
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01/08/2022
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Ethics approval number [1]
311430
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2022 FULL 12365
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Summary
Brief summary
This is a small feasibility project to explore whether a colposcopy service provided at an urban marae kaupapa Maori primary health clinic facilitates access. We have purposefully designed the outcomes as qualitative to prioritise people’s experiences and views toward acceptability. Colposcopy is performed when women have abnormal cervical screening tests (smears or HPV tests). Currently colposcopy is performed at Wellington Hospital. This trial will offer women requiring colposcopy the option of having it performed at an urban marae based kaupapa Maori primary health clinic. All wahine who were eligible for colposcopy at the marae and their whanau will be invited to share their views, experiences, and through prompt questions as necessary, to ascertain how provision of a marae-based service facilitated access. People who have declined to attend the marae health centre colposcopy clinic will be offered the opportunity to share their views as to their reasons for choosing to be seen at the Wellington hospital colposcopy clinic.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
121070
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Dr Judy Ormandy
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Address
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University of Otago Wellington
23A Mein Street
Newtown
Wellington 6242
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Country
121070
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New Zealand
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Phone
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+64 4 918 6858
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
121071
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Dr Judy Ormandy
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Address
121071
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University of Otago Wellington
23A Mein Street
Newtown
Wellington 6242
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Country
121071
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New Zealand
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Phone
121071
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+64 4 918 6858
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Fax
121071
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Email
121071
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[email protected]
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Contact person for scientific queries
Name
121072
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Dr Judy Ormandy
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Address
121072
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University of Otago Wellington
23A Mein Street
Newtown
Wellington 6242
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Country
121072
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New Zealand
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Phone
121072
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+64 4 918 6858
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Fax
121072
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Email
121072
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Individual participant data will not be shared due to small sample size, to minimise risk of identifying participants.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4844
Study results article
Yes
https://doi.org/doi: 10.1111/ajo.13803
Ormandy J, Phillips S, Campbell M, Haenga-Melvin B...
[
More Details
]
Aust NZ J Obst Gynaeco - 2024 - Ormandy - I was able to make a better decision about my health W hine experiences of.pdf
Documents added automatically
No additional documents have been identified.
Download to PDF