None listed
Conditions
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.
Interventions
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 a
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.
Sponsors
Dr Karen Bartholomew
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 69 Years
Healthy volunteers
Yes
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
Outcome results
None listed