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

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Presentation on theme: "Introducing HPV triage and test of cure into the NHS Cervical Screening Programme SEC Cancer Screening QA Reference Centre & Maggie Cooper, Maggie Cooper."— Presentation transcript:

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 womens 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 womens 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 Disease progression Invasive cervical cancer Time Years Months Normal epithelium HPV infection; koilocytosis CIN I CIN II CIN III 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): 186-192. Solomon D et al. JAMA 2002; 287: 2114–9. Borderline Mild Moderate Severe Dyskaryosis

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 2005 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: http://www.cancerscreening.nhs.uk/patient-info.html 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.

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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 12-13 have been vaccinated against HPV (2008-09) Effect of vaccine not seen until at least 2016-18 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: 0300 123 1002 Textphone: 0300 123 1003 www.orderline.dh.gov.uk

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 2008-9 www.dh.gov.ukwww.dh.gov.uk 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 9.2010 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 www.cancerscreening.nhs.uk Xavier Bosch. F. The Aetiology of Cervical Cancer NHSCSP Publication 22 October 2005

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