1. Cervical Cancer Screening and Treatment at Malamulo Hospital in Rural Malawi: A two-year comprehensive review Crischelle Shank, MD; Jacqueline Uy, MD; Christina Miller, MD; Karen Studer, MD, MPH; Marc Debay, MD, PhD 9.11.2014

2. 2 Activity Disclaimer ACTIVITY DISCLAIMER It is the policy of the AAFP that all individuals in a position to control content disclose any relationships with commercial interests upon nomination/invitation of participation. Disclosure documents are reviewed for potential conflicts of interest (COI), and if identified, conflicts are resolved prior to confirmation of participation. Only those participants who had no conflict of interest or who agreed to an identified resolution process prior to their participation were involved in this CME activity. Dr. Crischelle Shank, Dr. Jacqueline Uy, Dr. Christina Miller, Dr. Karen Studer, Dr. Marc Debay have indicated they have no relevant financial relationships to disclose.

3. Outline Why cervical cancer prevention? –Burden of disease Setting up a program –Countrywide services –Malamulo’s program –Data to date –Residency input Challenges/future directions 3

4. Worldwide: Cervical Cancer ASR, age-standardized incidence rates; Rates per 100,000 women per year. Data sources: Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on 15/01/2014.

7. Cervical Cancer Deaths 7

8. Cervical Cancer Mortality Rates Note: * Rates per 100,000 women per year. Source: IARC, Globocan 2008. Age-specific data from GLOBOCAN 2008 were obtained from IARC, personal communication. Country/ Region 0-1415-4445-5455-6465+Crude Rate ASRCum. Risk World03.518.725.930.78.27.80.87 Africa0.14.440.465.680.510.817.62.10 Malawi016.196154.898.521.738.34.32

9. Cervical Cancer in Malawi

11. HPV-16 & HPV-18 Prevalence

14. Cervical Cancer Services in Malawi Reproductive Health Unit (MOH) –40+ sites in Malawi with VIA (Visual Inspection with Acetic acid) trained personnel –Only ½ functional due to poor supply of cryo tips and CO2 Queen Elizabeth Central Hospital –VIA, cryotherapy and radical hysterectomies for stage 1-2 invasive cervical cancer Malamulo Seventh Day Adventist Hospital 14

15. Malamulo SDA Hospital 208 beds Rural southern Malawi, small urban practice Acute care and community health Highest HIV prevalence (18- 22%) 15

16. Malamulo Timeline & Partners 12/2011 TB policy change opens new space 2/2012 PAPS International contact 3/2012 Loma Linda University offers to train cytotechnologists 5/2012 Malawi’s Reproductive Health Unit meeting 9/2012 on-site training and mass screening of 1200+ patients, local pathology support 16

17. 17 12/2011 TB policy change opens new space

18. Malamulo Timeline & Partners 12/2011 TB policy change opens new space 2/2012 PAPS International contact 3/2012 Loma Linda University offers to train cytotechnologists 5/2012 Malawi’s Reproductive Health Unit meeting 9/2012 on-site training and mass screening of 1200+ patients, local pathology support 18

19. Malamulo Timeline & Partners 12/2011 TB policy change opens new space 2/2012 PAPS International contact 3/2012 Loma Linda University offers to train cytotechnologists 5/2012 Malawi’s Reproductive Health Unit meeting 9/2012 on-site training and mass screening of 1200+ patients, local pathology support 19

20. 20

21. Malamulo Timeline & Partners 12/2011 TB policy change opens new space 2/2012 PAPS International contact 3/2012 Loma Linda University offers to train cytotechnologists 5/2012 Malawi’s Reproductive Health Unit meeting 9/2012 on-site training and mass screening of 1200+ patients, local pathology support 21

22. Malamulo Timeline & Partners 12/2011 TB policy change opens new space 2/2012 PAPS International contact 3/2012 Loma Linda University offers to train cytotechnologists 5/2012 Malawi’s Reproductive Health Unit meeting 9/2012 on-site training and mass screening of 1200+ patients, local pathology support 22

23. PAPS International Team 23

24. Training 2 week training course –1 week theory –1 week observed screening 9 nurses 3 clinical officers 3 physicians (colposcopy, LLETZ) 2 lab techs trained in Loma Linda, CA 24

25. Clinic Cycle 25 Initial Patient Visit: Pap Smear & Breast Exam Abnormal exam findings reviewed by CO/MD same day 2 week Pap results If normal, return in 1 year if HIV+, 2 years if HIV- If abnormal, colposcopy, biopsy, LLETZ in the afternoon. Results sent to Blantyre for confirmation with pathologist. 3-4 week pathology results: If hysterectomy required schedule with surgeon within 2 weeks * Follow-up intervals are specific to our program

26. Cytology Readings On site US-trained MSDAH staff cytologist –Quality control: 10% of normal + all abnormal slides sent to pathologist in Blantyre –Quarterly review of misreads 26

27. Data Collection Paper forms (English) Electronic data entry and analysis started May 2013 –Resident led effort –Routine descriptive statistics –Patterns of utilization –Pathologic profile 27

28. 28 Data 2012-2014 Total No. of Visits 2664 Total No. of Pap Smears 2454 Normal2246 (92%) Abnormal208 (8%) Unknown210

29. Pap Smears per month (n=2454) 29

30. Pap Smears excluding Opening (n=1089) 30

31. Demographics 31 Patient Demographics Age Range 14-90 Average Age 38.8 HIV +26% HIV -64% HIV unknown 10%

32. Age Distribution with HIV Serostatus 32

33. Abnormal Pap Normal Pap HIV + 105 (17%)520 (83%) HIV - 87 (6%)1492 (94%) RR = 3, p<0.00001 (n = 2,204) Abnormal Findings & HIV Serostatus

34. Abnormal Findings 34 HIV + (n=107) HIV - (n=87)

35. Types of Interventions Colposcopies174 Biopsies19 LLETZ99 Hysterectomies42 Palliative Care9 Interventions (2012-2014) Abnormal Paps: n = 210

36. Comprehensive Reproductive Health Program Development Cervical cancer screening Treatment –Cryotherapy, LLETZ, Hysterectomy Clinical breast cancer screening HIV testing STI treatment Male circumcision Family planning 36

37. Sustainability Free care to HIV+ Donation funding for pathology Financially sustainable if >20% private pay (Paps for village women <$1) Local cytotechnicians trained via LLU Community buy-in Appropriate partners (training, supplies) 37

38. Challenges/Future Directions Locally Maintaining quality control Explore HPV variation (funding) Malawi policy Addition of Guardasil vaccination? Cytotechnologist registration Expanding/ Replicating the Program Publication 38

39. Zikomo! 39

40. 40

41. Client Demographics Age Range 14-90 Average Age 38.8 HIV +26% HIV -64% HIV unknown 10% 41