Cervical cancer screening as part

1. Cervical cancer screening as part of State health program:– Tamil Nadu Health Systems Project Experience Dr. Jerard M Selvam Deputy Director, State NCD cell Tamil Nadu Health Systems Project

2. Target Disease … Cervical Cancer – Indian Scenario • New cervical cancer cases diagnosed annually • India : 1,32,082 • World : 4,93,243 • Deaths due to cervical cancer annually • India : 74,118 • World : 2,73,505 India - 27% India - 27% Rest of World - 73% Rest of World - 73% India accounts for ~27% of new Cervical Cancer cases in world India accounts for 27% of deaths due to Cervical Cancer in world 1. X. Castellsagué, S. de Sanjose, T. Aguado, K. S. Louie, L. Bruni, J.Muñoz, M. Diaz, K. Irwin, M. Gacic, O. Beauvais, G. Albero, E. Ferrer, S. Byrne, F. X. Bosch. HPV and Cervical Cancer in the World. 2007 Report. WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Available at: www.who.int/hpvcentre

3. Why Cervical Cancer is an important cancer needing intervention? • High Incidence in India • Ranked I among the cancers affecting women in Tamil Nadu and Breast cancer is ranked No.II in Tamil Nadu • Awareness on the disease is poor and 85% of women in Tamil Nadu seek care only at the advanced stage of the disease • PAP smear considered as the only tool for screening • There was no any screening program addressing the community • Hesitation and fear to seek care among the women in the community • The need for a robust model to pilot and learn from it was the need of the hour

4. Limitations Of Cytology Over Visual Methods As A Screening Procedure… • Requires complex infrastructure ( trained OG Specialists, Cytologists & Cytotechs). • PAP smear test and HPV smear not cost effective especially in the low resource settings. • Moderate to low sensitivity though the specificity is high. • High rate of false-negative test results. • Results are not immediately available. • Requires multiple visits. • Likely to be inadequate among postmenopausal women.

5. Provide Govt. with an evaluated experience to make an effective model to combat the NCD – Cervical Cancer on a large scale. Cost of services Field effectiveness Operational issues Challenges faced To incorporate the same in the existing Govt. Health System Objectives of Pilot experience

6. Pilot DistrictsBasically agricultural districts

7. Pilot Period 3 years; Feb 2007 – Jan 2010 Target population Women between 30 - 60 yrs of age both symptomatic and asymptomatic taking into account the fact that malignant transformation is higher between 25 – 55 yrs.

8. Protocols Developed by expert committee, wetted by TATA memorial Institute of Cancer, wetted and approved further by WHO

9. Cancer Screening Programmes

10. Screening Tool for the Pilot project of TNHSPVisual Inspection with Acetic Acid & Lugol’s Iodine (VIA/VILI) under magnification • Simple, easy-to-learn approach • Minimal infrastructure required • High sensitivity - low proportion of false negatives. • Test results available immediately. • Decreased loss to follow up as the results read and interpreted then and there • Any trained health worker can do it and it does not require that only a Doctor or a Specialist should do the test

11. In Spite Of Certain Limitations.... • Moderate specificity may result in over-referral and over-treatment in a single-visit approach. • Less accurate when used in post-menopausal women. • There is a need for developing standard training methods and quality assurance measures. • Rater dependent. • In spite of these limitations, VIA combined with VILI is an effective public health tool for screening cervical cancer if a well planned program is in place

12. PERSONNEL INVOLVED ...

13. Stages of Intervention

14. TRAINING ... • VIA / VILI MOs & SNs ( 2days ) Within the district • Colposcopy and Cryotherapy OG Specialists ( 5 days ) Chennai (KGH) • Processing specimens & preparing slides Lab Technicians ( 15 days ) Govt. Rajaji MCH, Madurai

15. Equipments & Reagents Supplied Equipments Reagents • 1 VIA / VILI kit - screening centres • 1 Colposcopy, 2 Endo Cervical Curettes, 2 Endo Cervical Speculums, 2 Cryotherapy instruments - Colposcopy Centres • 1 Computer supplied to the DPMU office For Screening Lugols Iodine Acetic Acid Sodium Hypochlorite solution For Pathology Isopropyl Alcohol Cover slips XyleneMicroslides DPX Glycerol Paraffin Wax Acetic Acid Eosin & Haematoxylin Alum Hydrochloric Acid

16. Village Link Volunteers’- Community Activities…

17. POSTERS & STICKERS

18. Hospital flex boards…

19. Compiled Report For The Pilot

20. Lessons Learnt From Pilot … • Difficulties in creating awareness in remote areas • Acceptability of screening by women due to fear & inaccessibility • Non adherence to the protocol • Dilution of the services of the human resources supplied for project • Reluctance of all the Medical Personnel at all levels – participating & maintaining accuracy of reporting • Errors in reporting • False/Incomplete addresses • Incomplete reports • False reporting.

21. Variations in positivity ... Ideal – 12 – 25% (ref: IARC ); Out of 100 women screened 12-25 to be positive Theni – consistently < 5%; average – 2% Thanjavur – highly variant; on the higher side – 30%; on the lower side -5%; average – 8%

22. Evaluation Of The Pilot Cost Evaluation Concurrent Evaluation • Public Health Foundation of India • Rs.102 per person screened • Potential to upscale with well planned follow up strategies • National Institute of Epidemiology with ICMR • Inputs well taken and implemented simultaneously by the Project team

23. Scale up… Based on the success of the pilot and the lessons learnt, the Non Communicable Diseases intervention program has been scaled up to the entire state of Tamil Nadu, targeting 4 NCDs, namely, • Cancer Cervix • Cancer Breast • Hypertension • Diabetes Mellitus

24. Lessons learnt in pilot and addressed in scale up

25. Lessons learnt in pilot and addressed in scale up

26. Target population ALL men and women at and above the age of 30 years in ALL the districts of Tamil Nadu

27. PHASING OF DISTRICTS - PHASE I and PHASE II DISTRICTS

28. Modes of Intervention Four approaches • Clinical intervention • Community intervention • Work place intervention • School based intervention

29. Package of services for the four interventions

30. Breast / Cervical Cancer Screening and treatment programme - an overview Target Women screened for Breast cancer (CBE) / Cervical Cancer (VIA/VILI) PHC, GH, GMCH, ESIC dispensaries & hospitals, 100 municipal dispensaries & hospitals Secondary evaluation using Mammography / FNAC , Biopsy, Nipple secretion cytology / Colposcopy GH, GMCH, ESIC hospitals, 10 municipal hospitals Microscopic confirmation through Histopathological examination GMCH Staging and treatment GMCH

31. Key activities • Government orders obtained • Protocols for screening and treatment vetted by technical experts and approved by WB • Appointment of an exclusive female NCD staff nurses for the health facilities ( 1 per PHC, 2 per all other centres ; ESIC spared) • Appointment of Regional Medical Officers • Procurement of forms, registers, patient cards

32. key preparatory activities... • Procurement of equipments • Procurement of reagents and drugs – (based on an initial calculation for the quarter of implementation) • Developing HMIS screens – NCD online entry and reporting screens • Evolving training plan and rolling out training activities • NCD cell worked on preparation of modules both in English and Tamil • Field testing of modules

33. Key preparatory activities.... • Printing of modules, forms, cards, registers, protocols completed and deployed • Steps initiated for implementing IEC / BCC packages • Sensitization of key officials • TOT on the NCD intervention program and skill based training on VIA / VILI and Colposcopy completed followed by district level trainings • Districts which have completed the training have started to implement the program

34. Training Plan

35. Training on Colposcopy /Cryotherapy Techniques & VIA / VILI Method of Screening State Level TOT 5 days state level Training of Trainers (TOT) for Gynecologists identified from districts (Level I trainers) District Level training of Gynecologists 5 days training for all Gynecologists in the district by master trainers (Level II trainers) • Training of district level staff by level II trainers • Female Medical Officers * & Staff Nurses from GH, Medical College Hospital & PHCs • ANMs from PHCs from the district.

36. Reagents, Equipments & Drugs flow mechanism • Reagents, Consumables and Equipments are supplied through TNMSC directly to the health facilities • Patient Welfare Funds (PWF) should be effectively used for managing acute shortage of reagents and minor repair of equipments

37. List of modules under NCD intervention programme 1.Manual for programme managers (English & Tamil) 2.Clinical manual for medical and paramedical staff (English) 3.Manual on Colposcopy & Cryotherapy for medical professionals (English) 4.Manual on VIA/VILI & CBE procedures for medical and paramedical staff (English) 5.Module for lab technicians and pharmacists (Tamil) 6.Module for Field health staffs(Tamil) 7.Module for ANM(Tamil) 8.Module for CPs/CRPs for community based intervention(Tami)

38. TRAINING MODULES

39. TRAINING MODULES

40. SERVICES FOR CERVICAL CANCER

41. PATIENT ID CARD

46. NCD Online screens with CDSS NCD online screens developed and deployed on the existing HMS platform Clinical decision support system (CDSS) integrated with the screens for the assistance of physicians and NCD staff nurses

47. SNAP SHOTS OF NCD ONLINE SCREENS

48. NCD registration screen 1 2 3 Suspected Cancer screen 5 4 6

49. Mammography screen Colposcopy screen Histopathology Examination screen FNAC/Biopsy screen

50. Cancer Staging & Treatment screens