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Trial registered on ANZCTR


Registration number
ACTRN12616001401448
Ethics application status
Approved
Date submitted
3/10/2016
Date registered
10/10/2016
Date last updated
3/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a human papilloma virus (HPV) self-sampling for cervical screening in Maori women in West Auckland
Scientific title
Feasibility of Waitemata and Auckland District Health Board (DHB ) Human Papilloma Virus (HPV) self-sampling for cervical screening in Maori Women in West Auckland
Secondary ID [1] 290259 0
Nil known
Universal Trial Number (UTN)
U1111-1188-3226
Trial acronym
HPV-SS
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Cervical screening 300477 0
Human papilloma virus 300478 0
Self-sampling 300479 0
Condition category
Condition code
Public Health 300335 300335 0 0
Health service research
Infection 300344 300344 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using a novel HPV detection method (low vaginal self-sampling with cotton swab and HPV molecular testing with the Roche Cobas 4800 platform), as a primary screening test for cervical screening. Invitation through the primary care clinic (monthly matched lists between primary care enrolled patient and cervical screening register is routine practice, these lists will be used for recruitment). Invitation to attend the clinic, discuss the study and consent. Women able to complete the self-sampling at the clinic (in the bathroom) during this visit or take it home and return the kit to the clinic. Women are asked their preference for receipt of results. All results are provided to women, even it is usual practice for the clinic not to return negative results. Negative results will be phoned or text per patient preference. Positive results women will be phoned and asked to attend a clinic to discuss with the GP, practice nurse or research nurse. The completed kits are stable for 6 months for analysis and will be processed if received before this date.

Feasibility study of the impact of this intervention on cervical screening programme participation. The study is therefore assessing: a novel device, a potential process-of-care change, impact on behavioural change and preventive care.
Intervention code [1] 296052 0
Early detection / Screening
Comparator / control treatment
No control group - feasibility and acceptability study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299799 0
Participation rate (uptake) of HPV self-sampling. Sample population are eligible women identified on primary care data-matched lists as never-screened or underscreened (5 years since last recorded screen) and Maori. The proportion of these women able to be contacted, who perform the self test and for whom a laboratory test result is received.
Timepoint [1] 299799 0
12 months post offer of self-test kit from datamatched list.
Primary outcome [2] 299800 0
Prevalence of high risk HPV genotypes from self test low vaginal swab, as detected by the Roche Cobas 4800 platform (negative, positive HPV16, HPV18, or 'other' high risk HPV type).
Timepoint [2] 299800 0
12 months post offer of self-test kit from datamatched list.
Primary outcome [3] 299801 0
Follow up rate of HPV positive women for cytology with primary care provider or colposcopy at hospital clinic as assessed by National Cervical Screening Programme Register (records all cytology and histology events), general practice electronic records, and colposcopy clinical electronic records.
Timepoint [3] 299801 0
6 months post HPV positive test recorded in the National Cervical Screening Programme Register.
Secondary outcome [1] 328168 0
Provider knowledge questionnaire - composite outcome based on validated questionnaire tool developed in the UK Sue Sherman (Keele University) with primary care providers (Ref below) localised with permission. This questionnaire has ethical approval from Massey University Institutional Committee, and is already in use with providers in the Auckland and Wellington regions). This questionnaire will be completed with different health disciplines within primary care as part of the provider education training package.
Reference: Patel H, Austin-Smith K, Sherman SM, Tincello D, Moss EL. Knowledge, attitudes and awareness of the human papillomavirus amongst primary care practice nurses: an evaluation of current training in England. Journal of Public Health. 2016.

Knowledge questionnaire for women - composite outcome based on a qualitative tool developed in the UK by Sue Sherman (Keele University) HPV public knowledge questionnaire (Ref below) has been localised with permission for this purpose. This questionnaire will be optional for women, and will be completed prior to the HPV self-sample test in order to more accurately reflect baseline level of HPV knowledge before detailed discussion related to self-sampling consent.
Reference: Sherman SM, Nailer E, Minshall C, Coombes R, Cooper J, Redman CWE. Awareness and knowledge of HPV and cervical cancer in female students: A survey (with a cautionary note). Journal of Obstetrics and Gynaecology. 2016;36(1):76-80
Timepoint [1] 328168 0
12 months post offer of self-test kit from datamatched list.
Secondary outcome [2] 328169 0
Resource requirements for follow-up >90%.
Assessed by the research nurse and Independent Service Provider of support to services (support to cytology and to colposcopy). Variables are support for specific activities (none, childcare, transport, financial, visit attendance, further information/education) for those women who are referred for support.
Timepoint [2] 328169 0
6 months post HPV positive test recorded in the National Cervical Screening Programme Register.

Eligibility
Key inclusion criteria
Age 30-69
Never-screened or under-screened (5 years from previous test)
Maori ethnicity
Resident Waitemata DHB or Auckland DHB
Enrolled in a West Auckland general practice
Minimum age
30 Years
Maximum age
69 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous High Grade history with incomplete clinical follow up
Symptomatic
Pregnant

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Feasibility and acceptability study
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics and thematic analysis

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] 8292 0
New Zealand
State/province [1] 8292 0
Auckland

Funding & Sponsors
Funding source category [1] 294627 0
Government body
Name [1] 294627 0
Waitemata District Health Board
Address [1] 294627 0
15 Shea Tce, Takapuna 0740
Private Bag 93-503
Auckland
Country [1] 294627 0
New Zealand
Funding source category [2] 294628 0
Charities/Societies/Foundations
Name [2] 294628 0
Awhina Charitable Trust
Address [2] 294628 0
North Shore Hospital
Private Bag 93-503
Takapuna 0740
Auckland
Country [2] 294628 0
New Zealand
Primary sponsor type
Individual
Name
Dr Karen Bartholomew
Address
Waitemata District Health Board
15 Shea Tce, Takapuna 0740
Private Bag 93-503
Auckland
Country
New Zealand
Secondary sponsor category [1] 293492 0
None
Name [1] 293492 0
None
Address [1] 293492 0
Country [1] 293492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296068 0
HDEC Central Committee
Ethics committee address [1] 296068 0
Ethics Committees
Protection Regulation and Assurance
Ministry of Health
PO Box 5013
Wellington 6140
Ethics committee country [1] 296068 0
New Zealand
Date submitted for ethics approval [1] 296068 0
13/10/2016
Approval date [1] 296068 0
25/11/2016
Ethics approval number [1] 296068 0
16STH176

Summary
Brief summary
While overall cervical cancer rates have reduced, Maori women are still twice as likely as non-Maori women to be diagnosed or die from cervical cancer. Auckland and Waitemata DHBs have low Maori cervical screening coverage rates (56.4% and 59.2%, respectively), which remain longstanding despite local and national initiatives to reduce screening barriers. Improving access to cervical screening for Maori women remains a priority for the Ministry of Health and in the Auckland and Waitemata DHBs Maori Health Plans (indicator 5). Innovative ways to address access barriers are required.

In the context of announced changes by the Ministry of Health from the traditional ‘pap smear’ (cytology) to human papilloma virus (HPV) testing to screen women for cervical cancer, there is a window of opportunity to consider the novel technology of self-sampling to improve screening coverage in a New Zealand context relevant for our population. Self-sampling means that women can perform a low vaginal swab themselves (cervical sampling is not required) rather than requiring a speculum examination from a health professional. The sample could be taken at home or in a health care setting, or potentially another appropriate community setting. HPV detection using vaginal self-sampling is as accurate as clinician-sampling, provided that high performing assays are used to test the samples for the presence of HPV.

The objective of this small initial study is to examine the feasibility and acceptability of self-sampling in Maori women as the key audience for this novel technology, and to determine pathway requirements to follow up HPV-positive women. The investigators are committed to Maori health gain and working in partnership with Maori providers, primary care and hospital services. This work purposefully commences with Maori women, to ensure that this novel technology is appropriate and optimised to address inequalities before assessing the technology with other groups of women in our population.
Trial website
Trial related presentations / publications
Public notes
Attachments [2] 1146 1146 0 0
Attachments [3] 1147 1147 0 0
Attachments [4] 1148 1148 0 0
Attachments [6] 1150 1150 0 0
Attachments [7] 1151 1151 0 0
Attachments [8] 2095 2095 0 0
Attachments [9] 2096 2096 0 0

Contacts
Principal investigator
Name 69422 0
Dr Karen Bartholomew
Address 69422 0
Waitemata District Health Board
Level 1, 15 Shea Tce, Takapuna 0740
Private Bag 93-503
Auckland
Country 69422 0
New Zealand
Phone 69422 0
+64 09 486 8920 ext 5434
Fax 69422 0
Nil
Email 69422 0
Karen.Bartholomew@waitematadhb.govt.nz
Contact person for public queries
Name 69423 0
Dr Karen Bartholomew
Address 69423 0
Waitemata District Health Board
Level 1, 15 Shea Tce, Takapuna 0740
Private Bag 93-503
Auckland
Country 69423 0
New Zealand
Phone 69423 0
+64 09 486 8920 ext 5434
Fax 69423 0
Nil
Email 69423 0
Karen.Bartholomew@waitematadhb.govt.nz
Contact person for scientific queries
Name 69424 0
Dr Karen Bartholomew
Address 69424 0
Waitemata District Health Board
Level 1, 15 Shea Tce, Takapuna 0740
Private Bag 93-503
Auckland
Country 69424 0
New Zealand
Phone 69424 0
+64 09 486 8920 ext 5434
Fax 69424 0
Nil
Email 69424 0
Karen.Bartholomew@waitematadhb.govt.nz

No information has been provided regarding IPD availability
Summary results
No Results