The feasibility and impact of HPV-based cervical screening incorporating the choice of a vaginal selftest in the NZ primary care setting
LETS
TEST FOR HPV (AND PREVENT CERVICAL CANCER)
Associate Professor Peter Sykes, Dr Carrie Innes, Dr John McMenamin, Associate Professor Lynn McBain, Dr Ben Hudson, Dr Melanie Gibson Professor Beverley Lawton, Dr Jonathan Williman, Rebecca Bell, Dr Janine Nip
The problem
HPV testing more protective for cancer than conventional cytology Risk of cancer at 5 yrs following neg HPV less than 3 yrs from cytology BMJ 2014;348: Ronco G, Efficacy of HPV-based screening for prevention of invasive cervical cancer: Lancet. 2014 Feb 8;383(9916).
HPV
testing can be undertaken on a clinician taken cervical sample or a self taken vaginal swab
What is the hitch? ∎ HPV PCR detects HPV not precancer ∎ HPV is common and normally transient ∎ Approx 1 in 10 will have hrHPV but 1 in 100 have precancerous abnormalities ∎ Risk of cancer varies with different High risk HPV ∎ Colposcopic assessment of all women with HPV not appropriate or feasible ∎ Need to triage (cytology/repeat test/HPV type) ∎ Cytology can only be performed on a cervical sample ∎ Diagnostic pathway a cause for screening failure
What we don’t know ∎ While a number of screening programs utilise HPV testing there is little experience of the option of self-testing for all women. ∎ What will be the impact of introducing HPV screening that incorporates the option of the self test for all women in the NZ health system? ∎ Will the option of HPV self-testing be associated with improved uptake in underscreened women? ∎ What are the logistics of delivering HPV testing within NZ primary care? ∎ What proportion of women will choose the self-test? ∎ What proportion of women will have a positive HPV test? ∎ For women with a positive HPV test, what resources are required to ensure all women receive appropriate ongoing care? ∎ How do we accommodate exceptions including women who require a cervical “test of cure”? ∎ What proportion of women screened will be referred to colposcopy?
Study Protocol Recruit 3000 women due or overdue for screen over 6 months Practice selection (methodical sample) - 17 general practice clinics 3 regions of NZ Women approached by letter text and/or in person Informed consent 3 choices of HPV screening (self-test at home, self-test/clinicianassisted in practice, or cervical LBC HPV test) Study participation is free but women may still need to pay for their screen Referral pathway agreed with NCSP Data collection regarding process of recruitment triage and referral
Screening pathway
Let’s Test for HPV REDCap Database A Powerful Research Database
REDCap Form Who to complete Important notes Eligibility Recall team/Practice Consent Recall team/Practice Verbal or written New Participant Recall team/Practice Upload NSU Spreadsheet & Recall Resource Usage Recall team/Practice NSU excel spreadsheet of people due or overdue for screening. Add Recall Resource Usage (e.g., number and type of contacts) for all people who are contacted for screening. At the end of study, deidentified data for patients who cannot be contacted or who are contacted but decline to participate in the study sent to the Research Team. NSU Spreadsheet Research Team The Research Team will upload data from the NSU spreadsheet for consented participants. Recall Resource Usage Research Team The Research Team will upload data from the Recall Resource Usage excel for consented participants. HPV test episode Recall team/Practice HPV test result from Lab report Research Team Research Team will obtain a copy of this data from the lab and enter into REDCap directly HPV test result communication Recall team/Practice Cytology recall if requested Recall team/Practice Cytology result Research Team Research Team will obtain a copy of this data from the lab and enter into REDCap directly Cytology test result communication Recall team/Practice Colposcopy referral if required Recall team/Practice Colposcopy visit Research Team Research Team will obtain a copy of this data from the Colp clinic and enter into REDCap directly Histology result Research Team Research Team will obtain a copy of this data from the Colp clinic and enter into REDCap directly Incident and Notes Log Recall team/Practice or as appropriate To document any patient-specific incidents, protocol deviations, adverse events, or notes etc that are not considered Serious Adverse Events. Serious Adverse Event Recall team/Practice or as appropriate To document any patient specific Serious Adverse Events.
Ethical considerations
https://neac.health.govt.nz https://ethics.health.govt.nz/https://ichgcp.net/ National Ethical Standards for Health and Disability Research https://www.otago.ac.nz
Ethical considerations
• Recognition of patient vulnerability • Informed consent • Cost to participants
Let’s Test for HPV • Early experience of implementation • Debra Smith • Whanganui Project Lead
HPV testing in Whanganui Our people Centralised recall Invitation strategies Equity Research in Primary Care
governance oversight
Advisory Group
Our people Local
Practice
Screening Coordinator Relationships
Centralised recall Screening coordinator invites eligible patients Trial of invitation strategies – letter, text, phone Request a kit or visit their practice
Recruitme nt
Telehealth consultation Contact their practice Opportunistic
Equity
invitations Opportunistic recruitment Language
Priority
Video engagement
Research in Primary Care
Real-life
learning; relevant and practical Continuous improvement Value for people –learning and development
Discoveries and Challenges Response to invitations Research in Primary Care • Data collection • Detail • Discovering the issues Navigating change, introducing something new • Communication • Support
Opportunitie s Local HPV knowledge and skill Value of Research in Practice Primary Care has a voice with evidence National implementation HPV self-test cervical screening
Summary
People and relationships Communication Research in practice Discovery
The patient experience
Tacey Linton RN Gonville Health Whanganui
• Women's concerns/confusion around is cervical HPV an STI? • Some questions are: • - is there treatment I need to take if my swab detects HPV? • - Has my partner given me an STI? • - How did he get HPV?
• -Some women think by having the HPV vaccines they will never get cervical cancer. • -Concerns: is this stopping women from coming in for smears? • -Not all women have all 3 HPV vaccines. Why?
• Women who take self testing kits home are needing follow up phone calls from nurse due to no results have come through for over one month since having kit.
• Results of HPV detection causing some concerns for some
• Some women upset because they have had normal smears in past and now they have an abnormal result eg HPV pos
• Associate Professor Lynn McBain • Head of Department | Department of Primary Health Care & General Practice • Te Tari Hauora Tūmatanui me te Mātauranga Rata Whānau • Deputy Dean | University of Otago Wellington Campus • Te Whare Wānanga o Otagō ki Pōneke • University of Otago, Wellington
2022 Summer Students ∎ Aiming to have 3 health professional students doing summer research projects ∎ Understanding staff perspectives ∎ Supported by GP academic departments Wellington and Christchurch ∎ Starting in November 2022complete by mid February 2023
• To describe the experience of primary care staff of screening using hrHPV testing.
Primary care experience in the “Let’s test for HPV” study
• To identify any aspects of the screening process (invitation, sampling, results, and subsequent diagnostic pathways following an hrHPV positive result) that present challenges for primary care staff or could be streamlined.
• To identify any steps in the pathway that are perceived to be difficult for patients or pose barriers for equitable participation in screening by Māori, Pasifika and rural participants.
• To share study findings with primary care and other stakeholders in a timely way.
