Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000768594
Ethics application status
Approved
Date submitted
3/06/2024
Date registered
24/06/2024
Date last updated
24/06/2024
Date data sharing statement initially provided
24/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Experiences of wahine undergoing colposcopy and community co-located clinics
Scientific title
Evaluating the feasibility and experiences of women accessing co-located colposcopy services in community clinics
Secondary ID [1] 312273 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow on study from ACTRN12622001148763

Health condition
Health condition(s) or problem(s) studied:
cervical cancer 333993 0
Condition category
Condition code
Public Health 330662 330662 0 0
Health service research
Cancer 330854 330854 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed primary research activity entails assessing the feasibility of providing colposcopy services at three locations: , Hora Te Pai, Ora Toa Takapuwahia & Ora Toa Canon’s Creek. It will build on the success of a clinic set up at Maraeroa Marae Health Clinic.
The colposcopy clinics will be delivered by Wellington Hospital gynaecologists at community health centres. Women will be eligible for the intervention if they have been referred hospital colposcopy services by the primary care provider following abnormal cervical screening. The intervention will be offered for 3 years. Attendance rates wll be monitored. Feasibility will be further assessed by noting any cases who are unable to have their colposcopy completed in the community.

Wahine experiences will be assessed via a post-appointment korero interview at a time an location suitable for wahine, following the appointment. This will be audio-recorded and follow semi-structured questions. It is anticipated that this will take approximately 30 minutes. There will be purposeful sampling of participants aiming for equal numbers from each of the community clinics. There will be approximately 80 participants selected for interviews, aiming for equal numbers from each of the community clinics.
Intervention code [1] 328734 0
Early detection / Screening
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338414 0
Wahine experiences of accessing co-located colposcopy services.
Timepoint [1] 338414 0
Following the colposcopy
Secondary outcome [1] 435815 0
Service evaluation through descriptive data analysis of attendance at co-located and hospital colposcopy services
Timepoint [1] 435815 0
At the conclusion of the study

Eligibility
Key inclusion criteria
Wahine referred to Te Whatu Ora Capital & Coast colposcopy services by their primary care provider
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
decline to participate

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The interviews will be recorded and analysed through reflective thematic analysis (semi-inductive).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
26/12/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 26360 0
New Zealand
State/province [1] 26360 0
Wellington

Funding & Sponsors
Funding source category [1] 316660 0
Government body
Name [1] 316660 0
Health Research Council
Country [1] 316660 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 318845 0
Government body
Name [1] 318845 0
Te Whato Ora Capital & Coast
Address [1] 318845 0
Country [1] 318845 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315440 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 315440 0
https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/
Ethics committee country [1] 315440 0
New Zealand
Date submitted for ethics approval [1] 315440 0
Approval date [1] 315440 0
13/05/2024
Ethics approval number [1] 315440 0
2024 AM 12365

Summary
Brief summary
Working in partnership with Te Whatu Ora Capital & Coast, kaupapa Maori healthcare providers and community service Mana Wahine, we aim to better meet the needs of wahine Maori for the management (and treatment) of positive cervical screening results through colposcopy clincs co-located at three kaupapa Maori primary healthcare services in the Wellington region.
With input from wahine, we will develop and evaluate colposocpy resources
It is hypothesized that community co-located colposcopy clinics will be preferred by wahine over traditional hospital based clinics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134702 0
Dr Judy Ormandy
Address 134702 0
University of Otago Wellington 23A Mein Street Newtown Wellington 6242
Country 134702 0
New Zealand
Phone 134702 0
+64 210429917
Fax 134702 0
Email 134702 0
[email protected]
Contact person for public queries
Name 134703 0
Judy Ormandy
Address 134703 0
University of Otago Wellington 23A Mein Street Newtown Wellington 6242
Country 134703 0
New Zealand
Phone 134703 0
+64 210429917
Fax 134703 0
Email 134703 0
[email protected]
Contact person for scientific queries
Name 134704 0
Judy Ormandy
Address 134704 0
University of Otago Wellington 23A Mein Street Newtown Wellington 6242
Country 134704 0
New Zealand
Phone 134704 0
+64 210429917
Fax 134704 0
Email 134704 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


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.