ANZCTR - Registration

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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

19/02/2021

Date data sharing statement initially provided

19/02/2021

Date results information initially provided

19/02/2021

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]

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

Human papilloma virus

Self-sampling

Condition category

Condition code

Public Health

Health service research

Infection

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]

Early detection / Screening

Comparator / control treatment

No control group - feasibility and acceptability study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

12 months post offer of self-test kit from datamatched list.

Primary outcome [2]

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]

12 months post offer of self-test kit from datamatched list.

Primary outcome [3]

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]

6 months post HPV positive test recorded in the National Cervical Screening Programme Register.

Secondary outcome [1]

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]

12 months post offer of self-test kit from datamatched list.

Secondary outcome [2]

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]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

7/11/2016

Actual

14/12/2016

Date of last participant enrolment

Anticipated

6/11/2017

Actual

1/08/2018

Date of last data collection

Anticipated

31/07/2018

Actual

31/01/2019

Sample size

Target

200

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Waitemata District Health Board

Address [1]

15 Shea Tce, Takapuna 0740
Private Bag 93-503
Auckland

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Awhina Charitable Trust

Address [2]

North Shore Hospital
Private Bag 93-503
Takapuna 0740
Auckland

Country [2]

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]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HDEC Central Committee

Ethics committee address [1]

Ethics Committees
Protection Regulation and Assurance
Ministry of Health
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

13/10/2016

Approval date [1]

25/11/2016

Ethics approval number [1]

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