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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
22/07/2024
Date data sharing statement initially provided
22/08/2022
Date results provided
22/07/2024
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.
Scientific title
Experiences of women undergoing colposcopy at an urban marae based health clinic
Secondary ID [1] 307741 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical dysplasia 327317 0
cervical cancer screening 327378 0
Condition category
Condition code
Cancer 324448 324448 0 0
Cervical (cervix)
Public Health 324501 324501 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 324213 0
Early detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332260 0
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..
Timepoint [1] 332260 0
Interview following baseline colposcopy
Secondary outcome [1] 412749 0
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.
Timepoint [1] 412749 0
one year post commencement of recruitment.
Secondary outcome [2] 412750 0
Attendance rates (and DNA - do not attend rates) for colposcopy at the urban based marae health kaupapa Maori primary health clinic will be recorded.
Timepoint [2] 412750 0
one year post commencement of recruitment.
Secondary outcome [3] 413068 0
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.

Timepoint [3] 413068 0
One year after commencement of recruitment

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose of the study
Diagnosis
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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.
Phase
Not Applicable
Type of endpoint/s
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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/09/2022
Actual
29/09/2022
Date of last participant enrolment
Anticipated
7/08/2023
Actual
9/02/2023
Date of last data collection
Anticipated
7/08/2023
Actual
9/02/2023
Sample size
Target
30
Accrual to date
Final
31
Recruitment outside Australia
Country [1] 24941 0
New Zealand
State/province [1] 24941 0
Wellington

Funding & Sponsors
Funding source category [1] 312010 0
Government body
Name [1] 312010 0
Health Research Council
Country [1] 312010 0
New Zealand
Funding source category [2] 312011 0
Charities/Societies/Foundations
Name [2] 312011 0
Australian Society for Colposcopy and Cervical pathology
Country [2] 312011 0
Australia
Primary sponsor type
Hospital
Name
Wellington Hospital / Te Whatu Ora
Address
2DHB Research Office Manager | Centre of Clinical Excellence 2DHB
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 313575 0
None
Name [1] 313575 0
Address [1] 313575 0
Country [1] 313575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311430 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 311430 0
Ethics committee country [1] 311430 0
New Zealand
Date submitted for ethics approval [1] 311430 0
Approval date [1] 311430 0
01/08/2022
Ethics approval number [1] 311430 0
2022 FULL 12365

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

Contacts
Principal investigator
Name 121070 0
Dr Judy Ormandy
Address 121070 0
University of Otago Wellington
23A Mein Street
Newtown
Wellington 6242
Country 121070 0
New Zealand
Phone 121070 0
+64 4 918 6858
Fax 121070 0
Email 121070 0
[email protected]
Contact person for public queries
Name 121071 0
Judy Ormandy
Address 121071 0
University of Otago Wellington
23A Mein Street
Newtown
Wellington 6242
Country 121071 0
New Zealand
Phone 121071 0
+64 4 918 6858
Fax 121071 0
Email 121071 0
[email protected]
Contact person for scientific queries
Name 121072 0
Judy Ormandy
Address 121072 0
University of Otago Wellington
23A Mein Street
Newtown
Wellington 6242
Country 121072 0
New Zealand
Phone 121072 0
+64 4 918 6858
Fax 121072 0
Email 121072 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 will not be shared due to small sample size, to minimise risk of identifying participants.


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
No additional documents have been identified.