1. Introducing HPV triage and test of cure into the NHS Cervical Screening Programme
SEC Cancer Screening QA Reference Centre & Maggie Cooper, Maggie Cooper Training

2. What is changing?
In 2012, the NHS Cervical Screening Programme will introduce HPV Testing as part of routine cervical screening
HPV Triage is the term used for HPV testing to help labs determine whether women should be referred to colposcopy
HPV Test of Cure is the term used for HPV testing to help determine if women may be moved from a frequent testing regime following treatment to routine recall for screening

3. Why is HPV testing being introduced?
Women with borderline changes or mild dyskaryosis will be tested to establish which show high risk HPV. They can then be referred immediately to colposcopy. Women who do not have high risk HPV can be reassured and returned rapidly to routine recall.
Allows colposcopy resources to be allocated more effectively.
The follow up of treated women in the NHS Cervical Screening Programme (NHSCSP) has involved annual screening for up to 10 years before their return to routine recall. By employing the HPV test of cure approximately 80% of treated women will avoid having to undergo annual cytology tests.

4. As a cytology sample taker, what do I need to know?
The test procedure
Which samples will be HPV tested
How to interpret combined cytology & HPV test results
How to answer women’s questions about HPV testing
Implications for confidentiality & consent

5. The cytology test procedure
The cytology test procedure will not change – the sample is taken using the Cervex Brush (5 clockwise rotations) and is rinsed into the LBC pot as usual
HPV testing is carried out in the laboratory on the residue of liquid in the pot after cytology screening, if required – there is no additional test for the woman
14 day turnaround will still apply
Infection control procedures need to be thorough so that the sample is not contaminated

6. Infection Control Paper couch roll & disposable blanket
Clean couch in between patients
Handwashing before and after the procedure
Sterilisation of equipment or single use items
Avoidance of cross infection by keeping dirty and clean equipment separate
Use dry paper towel to adjust light
Use a tissue to hold LBC vial when preparing the sample
Disposal of waste correctly

7. Who is eligible? All women aged 25-64
HPV triage and test of cure will apply
whether women attend their GP practice,
GUM or Contraception and Sexual
Health/Family Planning Clinic for screening

8. Which samples will be HPV tested?
Not all samples need to be HPV tested –
For triage, only samples that are borderline or mild dyskaryosis
For test of cure, only follow up samples that are negative, borderline or mild dyskaryosis
HPV testing is being introduced in two stages:
Year one
􀂃 HPV testing for triage will be conducted only on the first occurrence of a borderline or mild sample in eligible women routinely invited for screening
􀂃 test of cure will be restricted to newly treated women with normal, borderline or mild cytology six months after treatment.
Year two
􀂃 testing for triage will be extended to all borderline and mild samples
􀂃 test of cure will be extended to all women treated for CIN who have normal, borderline or mild cytology six months after treatment.

9. What about inadequates?
Inadequate cytology tests will be repeated as current protocol (repeat after 3 months)
Under triage, if cytology is borderline and HPV test is unavailable, another cytology test will be required after 6 months
Under triage, if cytology shows mild dyskaryosis and HPV test is unavailable, the woman will be referred to colposcopy
Under test of cure, an unavailable HPV test will follow the same protocol as a test which shows high risk HPV

10. Cytology & HPV test results
Cytology reports from the lab may include HPV test results as a supplementary infection code.
Women will continue to receive their cytology and HPV test results in a letter from PCT Call & Recall.
The procedure associated with each type of recommended action (routine recall, repeat test, or refer to colposcopy) will continue to be as set out in the current practice guidelines.

11. Understanding HPV infection - How to answer women’s questions about HPV testing
Cervical cancer is a rare disease in the UK
There are over 100 subtypes of HPV. Most do not cause significant disease.
Low-risk HPV subtypes may cause (non-oncogenic) low-grade abnormalities such a genital warts. HPV triage/test of cure is not concerned with these low-risk subtypes.

12. Human Papilloma Virus (HPV)
Persistent high-risk HPV can cause CIN and cervical cancer; types 16 and 18 are found in 70% of cancer cases.
HPV testing aims to detect persistent infection with oncogenic (high-risk) subtypes (particularly 16 & 18)
Transient HPV infection is common, especially in women under 35 years.
Infection persists in 20-30% of women, putting them at increased risk of developing cervical cancer.
Women or their partners may have had HPV for many years without knowing it.
There is no reliable treatment to clear the virus.

13. Approx. likelihood of regression
Disease progression
Time
Months
Years
CIN II
CIN III
Invasive
cervical cancer
HPV infection;
koilocytosis
Normal
epithelium
CIN I
Borderline Mild Moderate Severe Dyskaryosis
CIN I 57% CIN II 43% CIN III 32%
Approx. likelihood of regression
Burd EM. Clin Microbiol Rev 2003; 16: 1–17.
Ostor AG. Int J Gynecol Pathol 1993; 12(2):
Solomon D et al. JAMA 2002; 287: 2114–9.

14. HPV transmission HPV transmission is via intimate contact
Studies have shown that infection in virgins is rare, though any type of nonpenetrative sexual contact is associated with increased risk
Condoms offer only a degree of protection, because of the HPV field effect over the whole of the genitalia
Up to 80% of the population have had HPV at some point in their lives
In most women HPV will not cause long term harm and will be cleared by their immune system

15. Co factors Age at first intercourse
Use of oral contraception for >5 years
Smoking reduces the number of Langerhans cells in the cervix. Markers of immune function.
High parity (4 or more FT pregnancies)
Previous exposure to other STIs such as chlamydia trachomatis & HSV2* causes damage to the epithelium allowing HPV to enter
Multiple partners/concurrent partners/serial monogamy with no gap does not allow the virus to clear
HIV+ve women
*NHSCSP Publication 22 October The Aetiology of Cervical Cancer

16. What is HPV triage?
Only 15 to 20% of women with borderline nuclear changes or mild dyskaryosis have a significant abnormality that needs treatment.
High-risk HPV testing in this group is effective in identifying which women may need treatment.
All cervical samples showing borderline nuclear changes or mild dyskaryosis are tested for high-risk HPV.
Women whose samples show high-risk HPV are referred immediately to colposcopy.
Women whose samples have no high-risk HPV can be safely returned to routine recall.

17. What is HPV test of cure?
Women who have a normal, borderline or mild cervical screening result six months after treatment for CIN and who also test negative for high-risk HPV have a very low risk of residual disease.
Samples taken six months post treatment that are cytology negative are HPV tested.
Women whose samples show no high-risk HPV will proceed to three year routine recall – avoiding the need for up to 10 years of annual cervical screening.
Women who have an abnormal cervical screening result or whose samples show high-risk HPV six months after treatment will be referred back to colposcopy.

18. Terminology
Women are frequently confused by the term ‘wart virus’. It is incorrect and should be avoided
Using the term ‘HPV positive’ can arouse concern and may be confused with ‘HIV positive’
Result letters will indicate that ‘high-risk HPV’ has been detected

19. HPV testing
Will be introduced into the NHS Cervical Screening Programme in 2012
Funding has been made available and is held by NHSCSP
Only labs analysing 35,000 + samples can test for HPV
Local Cancer Screening QA office and PCT will decide which lab will do the testing

20. How do I protect myself against HPV?
HPV infection cannot be treated, only CIN
Attend cervical screening regularly
Vaccination is now available to protect against 16, 18 subtypes up to the age of 25
HPV vaccination will help to prevent HPV infection/CIN in the future.

21. Psychological impact of HPV infection
Surprise and anxiety
Guilt and shame are closely linked to concerns about transmission and disclosure to future sexual partners
Providing clear and accurate information to women can considerably reduce the anxiety they experience and the possible stigma associated with HPV
Women should be assured that having sex just once exposes them to many subtypes of HPV and this exposure should be viewed as normal
RCN:2006

22. Confidentiality & Consent
As it is a sexually transmitted infection, maintaining patient confidentiality is particularly crucial when discussing a positive HPV test result.
All staff must comply and be signed up to the national screening programme confidentiality and information security policies at:
The usual procedure for obtaining informed consent for cervical screening will also cover high-risk HPV testing (as HPV testing will be performed automatically if indicated by the test result). No separate consent is required.

23. NHS pilots Sentinel Sites Implementation Project (2008) of HPV triage
Proved HPV triage is acceptable to women because it reduces the need for early repeat tests and speeds up referral to colposcopy where indicated.
Showed that 46% of women with (first) borderline nuclear changes and 83% of women with (first) mild dyskaryosis contained high risk HPV.
Women whose samples show no high-risk HPV are very unlikely to develop cervical cancer.
Colposcopy referrals rose significantly before falling back somewhat.
There was full evaluation of effectiveness and the process

24. The process of rolling out HPV triage and test of cure
HPV triage and test of cure are being rolled out across the NHS Cervical Screening Programme
Timescales vary, but all SEC should be implemented by spring/summer 2012
Implementation will follow national protocols.

26. Call Recall
Local call and recall computer software has been adapted to incorporate HPV results.
Invitation and result letters are being revised to include information on HPV and test results, where HPV testing is performed.
Each woman will receive an HPV factsheet with her invitation for screening.

27. HPV vaccination
Over 80% of girls in England aged have been vaccinated against HPV ( )
Effect of vaccine not seen until at least with full effect by 2024
Vaccine does not protect against all types of HPV
Effectiveness if full course not given unclear
Vital to keep accurate records of all those who have been vaccinated

28. Information for Primary Care
All practices and clinics will be sent copies of HPV Triage and Test of Cure Information for Primary Care near the time of HPV testing implementation in each area.
Further copies will be available from:
Department of Health publication orderline quoting HPVFOLDER
Telephone:
Textphone:

29. Cascade Training
All sample takers who have not attended the formal training session need cascade training
This may be done by the person who attends the session using the resources made available
In addition there is an online training option
The HPV training will be a module of the existing
elearning package used for updating

30. References and bibliography
Annual HPV vaccine Uptake in England
British Journal of Cancer 2010 Mar 2:102(5):933-9
Multi-site study of HPV type specific prevalence in women with cervical cancer, intraepithelial neoplasia and normal cytology,in England. Br J Cancer 2010;209-16
Cancer Research 2008 mortality & incidence data accessed
Human papillomavirus(HPV)and cervical cancer - the facts RCN:2006
Multi-site study of HPV type specific prevalence in women with cervical cancer, intraepithelial neoplasia and normal cytology in England. Br J Cancer 2010;209-16
Wallboomers JM, Jacobs MV, Manos MM et al ( 1999) Human Papillomavirus is a necessary cause of invasive cervical cancer worldwide Journal of Pathology. 189,1,12-19
Xavier Bosch. F. The Aetiology of Cervical Cancer NHSCSP Publication 22 October 2005

31. Questions?