1. HPV Immunisation update 1.Update on the programme 2.Overview of Surveillance strategy 3.Details of proposed surveillance linked to the cervical screening programme

2. HPV immunisation 3 dose immunisation given at school to girls in secondary S2 (aged 12-13) Catch-up immunisation for girls up to the age of 17 (including school leavers) Protects against 2 HR types of HPV that cause ~70% of cervical cancer

3. DATA MANAGEMENT GROUP Lead: Dr David Cromie CORE IMPLEMENTATION GROUP HPS Project Team / Sub-Group Leads / Scottish Government / Education Authorities / SGPC NATIONAL STEERING GROUP Scottish Government (CMO, Policy, Pharmacy, Education, Primary, Comms) / Health Protection Scotland / NHS Boards (immunisation coordinators – N,E,W / Health Scotland / SGPC / Pharmacy / Virology / NSS ISD / Education Authorities / CHPs / School Health Services….. PROGRAMME CO-ORDINATION 14 x NHS HEALTH BOARDS (local implementation groups) UK LIAISON SERVICE DELIVERY GROUP (incl PHARMACY & PROCUREMENT) Lead: Dr Lesley Wilkie PUBLIC & PROFESSIONAL COMMUNICATIONS & EDUCATION Lead: Ms Julia Mackay EPIDEMIOLOGY & SURVEILLANCE GROUP Lead: Dr Martin Donaghy Human Papillomavirus (HPV) Immunisation Programme Governance

5. DATA MANAGEMENT GROUP Lead: Dr David Cromie CORE IMPLEMENTATION GROUP HPS Project Team / Sub-Group Leads / Scottish Government / Education Authorities / SGPC NATIONAL STEERING GROUP Scottish Government (CMO, Policy, Pharmacy, Education, Primary, Comms) / Health Protection Scotland / NHS Boards (immunisation coordinators – N,E,W / Health Scotland / SGPC / Pharmacy / Virology / NSS ISD / Education Authorities / CHPs / School Health Services….. PROGRAMME CO-ORDINATION 14 x NHS HEALTH BOARDS (local implementation groups) UK LIAISON SERVICE DELIVERY GROUP (incl PHARMACY & PROCUREMENT) Lead: Dr Lesley Wilkie PUBLIC & PROFESSIONAL COMMUNICATIONS & EDUCATION Lead: Ms Julia Mackay EPIDEMIOLOGY & SURVEILLANCE GROUP Lead: Dr Martin Donaghy Human Papillomavirus (HPV) Immunisation Programme Governance

6. Aims for public health surveillance of the HPV programme in Scotland Evaluate the effect of the immunisation programme on HPV and HPV-related disease Inform decision making on the future optimum mix of immunisation, screening and HPV testing to reduce cervical cancer in Scotland. Monitor vaccine failure and adverse events that may be linked to immunisation

7. Core elements 1. Vaccine uptake 2. Adverse events that may be associated with immunisation 3. Knowledge attitudes and awareness in the vaccination era 4. The impact of the immunisation programme on HPV infection in the population 5. The impact of the immunisation programme on Cervical Cancer & Precursors (CIN+)

8. Vaccine uptake Working closely with ISD Routinely monitor and publish immunisation uptake rates as for other childhood immunisations

9. Safety MHRA yellow card Post-licensing long term studies Analysis of UK disease incidence statistics Register of vaccination in pregnancy

10. Attitudinal Research Scotland (December 2007) Method: qualitative interview study to explore the views of a sample of parents, young people (108) and school teachers undertaken in 7 schools in a range of local authority areas Key findings: Low knowledge levels Immunisation programme welcomed Drug safety Some misconceptions Information – clear and honest and in a variety of formats

11. Scotland Catchup immunisation begins this year (girls in S5-S6 & school leavers aged 16-17)) Screening begins at age 20 First immunised cohort invited for screening in 2010

12. Timeline

13. The impact of the immunisation programme on HPV infection in the population Baseline information (UK published and Scottish national prevalence study) Ongoing surveillance of HPV infection and circulating genotypes

14. HPV types and cervical cancer HPV Type Percentage of cervical cancer cases caused by HPV type Cumulative total 1658.1% 1815.7%73.8% 314.0%77.8% 452.9%80.7% 334.4%85.1% 581.2%86.3% 520.6%86.9% 351.6%88.5% 561.0%89.5% 390.2%89.7% 510.2%89.9% 680.3%90.2% 590.1%90.3% Other1.4%91.7% No type identified8.3%100%

15. Population under surveillance Females 20 – 24 years of age – who are immunised and attend cervical screening decline immunisation but attend cervical screening are immunised but do not attend cervical screening are neither immunised nor attend cervical screening

16. The Cervical Screening population HPV prevalence and subtypes in a sample from the screened population ongoing Monitor abnormal smears, and cervical abnormalities and type specific prevalence for cancer precursors (CIN 2&3) periodic

18. Preserving confidentiality – 1b) LBCs Source Lab CHI = Study ID ISD CHI = Unique Anon ID = Study ID SNHPVRL Study ID SCCRS ID HPS Unique Anon ID = Study ID SCCRS ID

19. Cervical screening – uptake by age group Scotland 2001/2 to 2006/7 Source ISD: Uptake for Cervical Screening by Age Group: Scotland 1, 1st April 2001 - 31st March 2007 Percentage uptake of females who had a record of a previous smear taken within last 3.5 years

20. Surveillance in the non-screened population Options: Direct survey approach Testing of residual specimens

21. Postal Testing Kits – non-attenders “Teaser” mailing – pre-information + opt-out Postal Testing Kit arrives Reminder mailing Issues Low response rate expected Acceptability Ethical issues –giving results –preserving confidentiality –Not an alternative to screening Practical issues – organising the survey

22. HPS NHS Health Boards General Practice (GPRN)

23. Collaboration Specialist Virology Laboratory Statistical Expertise Cervical cancer screening Service ISD HPA Coordination - HPS

24. Proposed ethical approval Data Linkage (SCCRS & CHSP-S) –HPS Clinical Governance –Privacy Advisory Committee Cervical Screening: HPV Testing + Data issues –HPS Clinical Governance Defaulters: Data & HPV Testing –Research Ethics

25. Fundamentals Surveillance Year – calendar year from Jan 2009 Overall population –20-24 yr olds –Females Not vaccinated and do or do not present for CS Vaccinated and do or do not present for CS Timeline – 12 years 55% of cohort presenting for smears 2006/7 Minimise use of Personally Identifiable Information (PII)