Feasibility of a human papilloma virus (HPV) self-sampling for cervical screening in Maori women in West Auckland

• Register: ANZCTR
• Last refreshed on: 1 March 2021
• Main ID: ACTRN12616001401448
• Date of registration: 10/10/2016
• Prospective Registration: Yes
• Primary sponsor: Dr Karen Bartholomew
• 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
• Date of first enrolment: 14/12/2016
• Target sample size: 200
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001401448.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Dr Karen Bartholomew

• Name: Dr Karen Bartholomew

Key inclusion & exclusion criteria

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
Exclusion criteria: Previous High Grade history with incomplete clinical follow up
Symptomatic
Pregnant

Age minimum: 30 Years
Age maximum: 69 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Cervical screening;Human papilloma virus;Self-sampling;
Cervical screening
Human papilloma virus
Self-sampling

Infection - Sexually transmitted infections

Public Health - Health service research

Intervention(s)

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.

Primary Outcome(s)

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

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

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

Secondary Outcome(s)

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

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

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Waitemata District Health Board

Awhina Charitable Trust

Ethics review

Status: Approved
Approval date: 25/11/2016
Contact:

HDEC Central Committee

Results

• Results available: Yes
• Date Posted: 19/02/2021
• Date Completed: 31/01/2019