1. Introducing the National Cervical Screening Program: providing your patients the right advice November Dr Hilary Bower Medical Coordinator Family Planning NSW

2. Aims of this session To understand the National Cervical Screening Program: implementation on December 1st How to explain the National Cervical Screening Program to patients? How to access supporting resources?

3. Epidemiology of cervical cancer
Cervical cancer is the 15th most commonly diagnosed cancer in Australian women, accounting for 1.5% of cancers in Australian women
Since 1991, 50% decrease in mortality due to cervical cancer, largely due to our NCSP: a public health success story!
80% of women with cervical cancer had not had a Pap smear in the previous 5 years
Australian Institute of Health and Welfare. Cervical Screening in Australia
Canberra: AIHW 2016. Cancer Series no.97 Cat. no. CAN 95.
Australian Institute of Health and Welfare. Cancer in Australia
2017. Cancer series no.101. Cat. no. CAN 100. Canberra: AIHW
Of all deaths from cervical cancer across the world, nearly 9 out of 10 occur in less developed regions - shows the benefit of an organised screening program. High incidence of cervical cancer: Africa, Melanesia, Central America, Caribbean, South America

4. Time for a change….. Timely for Australia to take a lead with an
evidence-based program based on:
new understanding of HPV & cancer
new testing technologies
a successful National HPV vaccination program
First ten years

5. HPV: the ‘common cold’ of the genitals!
Up to 80% of people infected in their lifetime; usually resolves within years
 > 99% cervical cancer linked to oncogenic HPV subtypes
14 oncogenic HPV types (16 & 18 more likely to persist detected in 70%–80% cases cervical cancer)
Penetrative intercourse not strictly necessary; HPV can be transferred to the cervix from an infection at the introitus
Transmission via genital skin-to-skin contact, vaginal sex, oral sex & anal sex
Introduction of the Gardasil-9 in 2018!

6. The link between HPV infection and cervical cancer
2% of persistent oncogenic infections associated with cancer; takes about 10 years to develop
CIN 3: up to a 1/3 will progress to invasive cancer within 10–20 years
Progression from HPV infection to invasive cervical cancer is not necessarily a linear process. In fact, not only can HPV infections be cleared within a relatively short time, but if cervical abnormalities develop, they can also regress over time. This makes cervical cancer preventable in many cases. Identifying women with oncogenic HPV infection allows closer monitoring of risk before abnormal cellular changes occur.
Note that only about 60% of infected women develop circulating antibodies. This means that laboratory tests for the presence of antibodies is not useful for individual management but can be used in epidemiologic studies, with appropriate correction. Namely, it is unclear whether anti-HPV antibody developed following natural HPV infection protects against reinfection, and whether loss of HPV detection reflects virilogic clearance or establishment of viral latency.
Individuals with persistent oncogenic HPV infection are at an increased risk of developing high grade squamous intraepithelial lesion/s (HSIL) However, some women with these high-grade changes can show regression to low-grade squamous intraepithelial lesion/s (LSIL) over time. LSIL show higher rates of spontaneous regression compared to HSIL
It has been estimated that 30–50% of untreated CIN2 and approximately 30% of CIN3 regress spontaneously

7. National Cervical Screening Program from 1st December ensuring all women (vaccinated and unvaccinated) have access to a program that is acceptable, effective and efficient and based on current evidence Aim for up to 36 % fewer cervical cancers
H ome & Environment
E ducation & Employment
Activities
D rugs
Aim for up to 39% fewer cx ca ( esp in unvaccinated)
S exuality
S uicide/Depression

8. Understanding the new National Cervical Screening Program
All women who have ever been sexually active will be invited for Cervical Screening Test at 25 years
Women will be managed using a risk-based approach that is dependent on the cervical screening test results
Cervical screening may cease between 70 and 74 if regular screening tests with –ve results and a –ve exit result
Routine screening carried out every 5 years for women with no symptoms or history suggestive of cervical cancer
Invitations and reminders will be sent by the National Register to screen-eligible women
Penetrative intercourse not strictly necessary; HPV can be transferred to the cervix from an infection at the introitus
Transmission via genital skin-to-skin contact, vaginal sex, oral sex & anal sex

9. What is the Cervical Screening Test?
The Cervical Screening Test has 2 components: 1. HPV DNA test with partial genotyping (to allow independent detection and reporting of HPV 16 and 18; other oncogenic HPV types are reported as a pooled result) 2. Reflex liquid based cytology (LBC) if the HPV test is +ve for any oncogenic HPV type (performed automatically on the same sample); results of LBC used to inform colposcopy

10. Your essential guide….
“National Cervical Screening Program: Guidelines for the Management of Screen Detected Abnormalities, Screening in Specific Populations and Investigation of Abnormal Vaginal Bleeding.”

11. Why is primary HPV testing replacing the Pap test?
A significant false-negative rate for Pap vs HPV tests (30% vs 2-3%) required more frequent screening to minimise failure to detect disease
Women who test HPV -ve are at very low risk of HSIL and cancer for at least 5 years
Compared with cytology, HPV testing provides 60–70% greater protection against invasive cervical cancers; significantly reduced incidence of adenocarcinomas
Opportunity for self collection in under-screened populations
Renshaw AA et al. Cancer Cytopathology 2001;93: Dr Guglielmo Ronco et al. Lancet 2014;383:524-32
Penetrative intercourse not strictly necessary; HPV can be transferred to the cervix from an infection at the introitus
Transmission via genital skin-to-skin contact, vaginal sex, oral sex & anal sex

12. Why use partial genotyping?
Partial genotyping allows for separate detection of HPV 16 and 18; other oncogenic HPV types will be reported as a pooled result
HPV 16 and 18 are associated with cervical abnormalities that are less likely to regress and more likely to progress to high-grade cervical abnormalities, compared with other oncogenic HPV genotypes
Improves risk stratification/assessment in the screening program
Castle PE et al. Obstet Gynecol 2009;113:18-25; Kjaer SK, et al. J Natl Cancer Inst 2010;102: ; Schiffman M, et al. Cancer Epidemiol Biomarkers Prev 2011;20:
Penetrative intercourse not strictly necessary; HPV can be transferred to the cervix from an infection at the introitus
Transmission via genital skin-to-skin contact, vaginal sex, oral sex & anal sex

13. Explaining changes to the screening age: routine screening not recommended < 25
Cervical cancer very rare in young women
Screening < 25 years has not reduced invasive cancer rates or deaths in this age group or in year olds
HPV vaccination already showing a reduction in screen-detected abnormalities in women <25 years of age
Cervical abnormalities common < 25 years and usually resolve; over-diagnosis and over-treatment not desirable
History of childhood sexual abuse or early sexual debut (< 14 years, prior to HPV vaccination): consider a HPV test between 20—24 years
Symptomatic women of ANY age should be assessed with a co-test
Peirson L et al Syst Rev 2013;2:35; Kyrgiou M,et al Lancet 2006;367:489-98; Sasieni et al BMJ 2009; Schlect NF J Natl Cancer Inst 2003;95:
Penetrative intercourse not strictly necessary; HPV can be transferred to the cervix from an infection at the introitus
Transmission via genital skin-to-skin contact, vaginal sex, oral sex & anal sex

14. A co-test is different to a Cervical Screening Test!
A co-test is when a sample is tested for HPV DNA and cytology at the same time
Not part of routine screening & must be specifically requested on the pathology request form:
at follow up of certain abnormalities eg glandular abnormalities after normal colposcopy
as part of Test of Cure (after treated CIN2/3)
for some women post hysterectomy
for DES-exposed women
for women treated for adenocarcinoma in situ (AIS)
as part of Ix of abnormal vaginal bleeding or an abnormal looking cervix

15. What will change in clinical practice?
Discuss changes to the screening program for asymptomatic women
Transition clients to the new program
Collect the Cervical Screening Test using a liquid based medium (slides no longer used)
Order a CST on the pathology request form (or a co-test if indicated) Discuss results and risk assessment
Use the new management guidelines
Inform clients about the National Cancer Screening Register

16. The cervical screening pathway for asymptomatic women under National Cervical Screening Program (NCSP) from December 1st 2017

18. What should you expect from a lab report
What should you expect from a lab report? results are stratified by risk
An overall cervical screening risk assessment:
Low risk – oncogenic HPV negative
Intermediate risk - e.g. HPV detected (not 16/18 and LBC negative or LSIL )
Higher risk - e.g. HPV detected (16/18)
A statement of test(s) performed and results:
HPV test result including LBC result (if performed)
A recommendation for follow up:
taking account of result, screening history and clinical notes

19. Sara is +ve for HPV 16: what do you do?
Sara’s result is higher risk
referral to colposcopy regardless of LBC result
If LBC is unsatisfactory, repeat LBC at time of colposcopy
If LBC result predicts invasive disease referral within 2/52
If LBC result PHSIL/HSIL referral within 8/52

20. Sara is +ve for HPV (non 16/18): what do you do?
Reflex LBC
Unsatisfactory
PHSIL/HSIL or any glandular
Invasive disease
Normal or LSIL/PLSIL
Rpt LBC 6-12/52
Rpt HPV 12/12
Colposcopywithin 8/52
Colposcopy within 2/52
+ve HPV(any type)-colposcopy
-ve HPV
Retest 5 years

21. Sara has a glandular abnormality?
All glandular abnormalities refer to an expert gynaecologist for colposcopy
including “Atypical endocervical/glandular cells of undetermined significance”
Follow up of completely excised AIS:
annual co testing indefinitely
any abnormal result refer for a colposcopy

22. Unsatisfactory results: the Cervical Screening Test cannot be evaluated
‘unsatisfactory HPV’ or ‘unsatisfactory LBC’ test report
unsatisfactory HPV: test cannot be performed due to inhibition (e.g. too much blood) or insufficient human DNA in sample
unsatisfactory LBC: insufficient cells or technical problems such as excess blood or lubricant
advise a repeat sample 6-12 weeks later after rectifying the reason (refer straight for colposcopy if unsatisfactory LBC and +ve HPV 16 or 18)

23. Maximising sample quality
Ensure adequate transfer of cellular material from the implements to the liquid medium
Use warm water rather than commercial lubricants to avoid cell agglutination and cellular loss (if used: avoid carbomer and carbopol polymer lubricants; use sparingly and avoid speculum tip)
Defer routine screening during menstruation but don’t delay diagnostic co-testing for abnormal vaginal bleeding
Avoid intravaginal medication for 48hrs prior to testing

24. Self-collection of a vaginal HPV test

25. Self-collection of a vaginal HPV sample
Alternative for eligible under or never-screened women who have declined invitations to participate in conventional screening
Eligibility:
30 years + and never had cervical screening
30 years + and overdue by 2 years  or longer
Facilitated by a health professional within a healthcare clinic
Dry flocked swab self-inserted into vagina

26. Self-collection of a vaginal HPV sample
Lower sensitivity and specificity than a clinician-collected HPV sample (pooled sensitivity and specificity ratios of 0.88 ( ) and 0.96 ( ) respectively for CIN 2 or worse
Cannot perform reflex LBC; if HPV 16 or 18 detected refer directly for colposcopy; other oncogenic HPV requires examination and clinician sample for LBC)
Arbyn M et al. Lancet Oncol 2014; 15:

27. Transition into the National Cervical Screening Program
Women aged 25 to 74 will be invited for a Cervical Screening Test two years after their last Pap test (new migrants & refugees)
Women already screened under 25 will be a sent a letter advising rescreening at age 25; an invitation letter (and reminders) will be sent from the NCSR at age 24 and 9m
Women overdue by 2 years of more and >30 years old will be invited to screen and self collection an option.
Women under surveillance for an abnormal Pap test: follow guidelines
Provide cytology screening if due until Dec 1st!

28. Screening for specific populations:
Pregnancy & Postpartum
Post-menopause
Early sexual activity
Immune-compromise (screen every 3 years)
Post-hysterectomy
DES-exposure in utero
Transgender men with a cervix (consider a short course of vaginal oestrogen)
Women with abnormal vaginal bleeding or an abnormal appearing cervix

29. Screening for specific populations
Pregnancy – perform if due (use a broom-type sampler brush NOT a cytobrush or combi-brush)
Self-collection not recommended
Postpartum - screen > 6 weeks after delivery; if breastfeeding or no menses, consider prior short course vaginal oestrogen
Post-menopausal – no recommendation for routine vaginal oestrogen; consider if vaginal dryness/superficial dyspareunia or if reflex LBC unsatisfactory due to atrophy, insufficient cells or inflammation or prior to colposcopy

30. Screening in specific populations: immunocompromised
Immune-deficiency - HIV +ve or solid organ transplant recipients screen 3 yearly if normal screening history
Consider 3 yearly screening in other immune-deficient women:
congenital primary immune deficiency
immunosuppressant therapy
bone marrow transplant recipients
screening young women(20-24 years) if immune deficient for more than 5 years.
+ve HPV (any type) referral for colposcopy (with experienced gynaecologist) regardless of LBC result. . ))

31. Screening in specific populations: Diethylstilboestrol (DES) exposure
Women exposed to DES in utero: should be offered an annual co-test (HPV + LBC) and expert colposcopy and examination of the cervix and vagina indefinitely.
Not for self collection
No evidence of increased risk for ‘DES granddaughters’- routine screening recommended ( 5 yearly HPV testing)
1Pharmaceuticals WHO 2012
Probably 2000 years old
No longer registered for human use DES exposure in utero early 50s – their mothers are 70-80s
aginal adenosis is a known precursor of CCa that affects between 34–88% of deS-exposed women and less than 4% of unexposed women
What about Fiona’s daughter Sarah …. Nor of the sons!
Routine screening (but if women have concerns testing similar to that recommended for their mothers could be considered on an individual basis)
Frequent follow-up of this cohort of women will enable the timely observation and early treatment of any deSassociated changes

32. Investigation of women with abnormal vaginal bleeding
Probably 2000 years old
No longer registered for human use DES exposure in utero early 50s – their mothers are 70-80s
aginal adenosis is a known precursor of CCa that affects between 34–88% of deS-exposed women and less than 4% of unexposed women
What about Fiona’s daughter Sarah …. Nor of the sons!
Routine screening (but if women have concerns testing similar to that recommended for their mothers could be considered on an individual basis)
Frequent follow-up of this cohort of women will enable the timely observation and early treatment of any deSassociated changes

33. Abnormal vaginal bleeding (post-coital, intermenstrual, postmenopausal)
Malignancy uncommon but must be excluded; consider pregnancy, STIs, polyps, coagulopathies, ovulatory disorders, endometrial disorders, vaginal atrophy, hormonal contraception
Women of ANY age with signs or symptoms suggestive of cervical cancer should have a co-test
Co-test: a HPV DNA test AND liquid based cytology on the same sample
Co-test has high negative predictive value for HSIL/CIN3
Do not delay co-test due to the presence of blood: co-testing improves reduced sensitivity of individual tests
Management of co-test results……..

34. Investigation of women with abnormal vaginal bleeding

35. Management after treatment: Test of Cure
Gynaecological review at 4-6months post treatment CIN2/3
Subsequent surveillance is called a ‘Test of Cure’; usually performed in primary care:
co-test (HPV and LBC) at 12 m and annually thereafter until all components negative on 2 consecutive occasions
 At anytime during Test of Cure:
+HPV 16/18 or
LBC PHSIL/HSIL colposcopy
any glandular lesion

37. Some groups are more likely to be under or never-screened
Aboriginal and Torres Strait Islander
Culturally & Linguistically Diverse ( CALD)
History of sexual trauma and/or domestic violence
Living in a rural or remote areas,
Identify as lesbian, bisexual, or same sex attracted
Transgender men (with a cervix)
Older women
Women with disabilities (intellectual or physical)
Women from lower socioeconomic status
Women who have received the HPV vaccine

38. How to improve screening uptake?
Cultural awareness-including language barriers
Provide educational leaflets and posters
Stress importance of cervical screening as a preventative measure - prevents cancer
Asking if prefer to see a female colleague
Consider self-collection for eligible women

39. Understanding the National Cancer Screening Register
Single record for cervical & bowel cancer screening; will be linked to HPV vaccine registry
Records screening & colposcopy data; provides screening Hx to labs to inform recommendations
Health Care Provider portal
Consumer portal: limited information e.g. check due date for test or change address.
Sends letters of invitation and reminders; women can opt for reminders by mail, or SMS; can nominate a personal representative
Women can ‘opt off’ by contacting the NCSR (initially by phone with or without support from clinician); previously via pathology request form and lab
Health Care Providers portal - enabling health care professionals to retrieve information about participation, screening history & to check if reminders sent
Delay in electronic portal implementation in December ,initial access by phone contact

40. The cervical screening consultation: what’s new and what’s the same
Discussion about screening; history taking; informed consent
Addressing screening barriers and opportunistically screening
Experience IS THE SAME FOR THE PATIENT with speculum examination
Sample of cells from squamo-columnar junction; no slides!
Opportunity for self-collection for eligible under-screened women
Completion of pathology request form for Cervical Screening Test (history, symptoms, examination)
Lab performs HPV test +/- reflex LBC
For specific indications order a co-test on the form

41. The cervical screening consultation: what’s new and what’s the same
Timely receipt of abnormal results; clear documentation of consultation and any follow-up
Discussion of results; risk assessment for cervical abnormality:
Low risk: invited to screen in 5 years
Intermediate risk: invited to screen in 12 m to check HPV clearance
Higher risk: referred for colposcopy
Using the new management guidelines
Informing women about the National Cancer Screening Register

42. Resources for women and health professionals

43. Resources for health professionals
Clinical guidelines wiki.cancer.org.au/australia/Guidelines: Cervical_cancer/Screening
Clinical guidelines - Short Form Summary
Clinical guidelines - Long Form Summary

44. Resources Background information on the Renewal www.msac.gov.au
NPS MedicineWise Learning modules on the changes to the National Cervical Screening Programhttps://learn.nps.org.au/mod/page/view.php?id=7804
National HPV Vaccination Program Register
HPV vaccination

45. FPNSW resources Talkline: phone 1300 658 886
Reproductive and Sexual Health: an Australian Clinical
Practice Handbook 3rd edition
Fact Sheets: Cervical Screening and HPV vaccination
Everything you need to know about the changes to NSCP

46. Key messages
Encourage eligible women (vaccinated and unvaccinated) to attend for cervical screening; opportunistically screen
New National Cervical Screening Program starts 1st December; evidence-based tests and protocols
‘More accurate and less harm’
The Cervical Screening Test replaces the Pap test on 1st December no more slides!
Encourage primary prevention with HPV vaccination
Know where to go for information (including for specific populations)

47. Thank you and any questions?
First ten years