HPV Infection and Cervical Cancer in Uganda: Challenges and Opportunities Jane Cashin, B.Pharm MPH...

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HPV Infection and Cervical Cancer in Uganda: Challenges and Opportunities

Jane Cashin, B.Pharm MPH Capstone Project

December 6, 2011Capstone Supervisor: Paul Gaist, Ph.D., MPH.

Presentation Outline

• Introduction/Background

• Burden of Cervical Cancer in Uganda

• Causes of HPV Infection and Cervical Cancer

• Prevention and Treatment Strategies

• Implementation of a HPV Vaccination Program

• Lessons Learned

• Barriers to a National HPV Immunization Program

• Update

• Conclusion Page 2

Introduction

Cervical cancer:

• 2nd most common cancer among women worldwide1

• Over 274,000 deaths annually1

• Over 529,000 new cases annually1

• 99% of cases caused by Human Papillomavirus

infection (HPV) 2

• Almost 90% of cases and deaths occur in low-income

countries 1,3

• Typically affects women over 30 years old in the

middle of their productive adult life 2

Background

Catholic Medical Mission Board (CMMB)4

• U.S. based non-governmental organization focused exclusively on international healthcare

Gardasil Access Program Proposal (GAP)5

• CMMB applied to GAP for donation to vaccinate 36,000 girls with HPV vaccine across 20 sites in Kampala and Gulu districts

Map of Uganda

Burden of Cervical Cancer in Uganda

• Population: 33 million7

• 49% of population under age 157

• Age-adjusted incidence of

approx. 48 cases per 100,000

women 1

• 3,577 new cases annually1

• 2,464 deaths annually1

• Among highest incidence and

mortality worldwide1

• Leading cause of cancer deaths

in Uganda1 Source. U.S Department of State (2010) 6

The Natural History of HPV Infection and Cervical Cancer

Causes of HPV infection and Cervical Cancer

Source: World Health Organization, 20062Page 6

Causes of HPV Infection and Cervical Cancer

HPV genotypes

• HR-HPV 16 and 18 - cause 70% of cervical cancer cases8

• Vaccines - Gardasil and Cervarix cover HR-HPV 16 and 189,10

• Gardasil covers LR-HPV 6 and 11- cause 90% of genital warts9

Risk Factors

• Early sexual debut11

• Early marriage11

• Number of lifetime partners12

• Presence of sexually transmitted diseases13

• Frequent births13

• Family history13Page 7

Prevention and Treatment StrategiesPrimary Prevention• Vaccination

Secondary Prevention• Pap smear14

• HPV DNA testing - careHPV test designed for low-income countries14

• VIA (visual inspection with acetic acid)14

Treatment• Cryotherapy, LEEP, cone biopsy, and laser treatment15

• Chemotherapy and radiation therapy15

• Limited options in Uganda due to late diagnosis16Page 8

“Screen and Treat” Approach

• Screening and treatment in a single visit16

New Paradigm• Screening once or twice a lifetime combined with

adolescent vaccination17

Current Efforts in Uganda• Limited screening and treatment16

• National screening and HPV immunization proposed16

Prevention and Treatment Strategies

Prevention and Treatment StrategiesThe Strategic Plan for Cervical Cancer Prevention and Control in Uganda 2010-2014 4

Goals to be Achieved by 2015• 80% of eligible girls aged 10-14 years to be vaccinated in 10

new districts by 2013; entire country by 2015• 80% of eligible women aged 25-49 years will be screened and

treated for precancerous cervical lesions• 80% of eligible women with precancerous cervical lesions will

be provided diagnostic services• 90% of Ugandans will be reached with information, education,

and communication material about cervical cancer• 65% of eligible women with cervical cancer will be provided

radiation therapy and chemotherapy Page 10

Implementation of a HPV Vaccination Program

Unique Characteristics of HPV Vaccination18

• Optimal age range – adolescent girls not typically involved in planned health initiatives• Gender issues• Sexually transmitted infection• Long delay of benefits – at least 10-20 years

HPV Vaccines: Evidence for Impact Project (from PATH)18

In Uganda provided strong evidence base to formulate:• Vaccine delivery strategy• Communication strategy• Advocacy strategy

Implementation of a HPV Vaccination ProgramFormative Research in Public Health Planning18

• Ecological Conceptual Framework levels of influence – intrapersonal, interpersonal, community, institutional, and policy

Socio-cultural factors of HPV and Cervical Cancer 18,19

• Vaccine decision making• Understanding and awareness of cervical cancer• Prior experience with vaccine• Specific HPV vaccine concerns• Information needed to foster acceptance

Lessons Learned

Schools can be Successful Venues for HPV vaccination20

Ibanda: school-based, grade-based vaccination program• All grade 5 girls eligible (in or out of school)• Over 85% vaccine coverage

Nakasongola: age-based criteria and integrated with Child Day Plus Program (CDP) in schools

• 10 year old girls (in or out of school)• Doses 1 and 3 with CDP and dose 2 given through outreach• Above 50% vaccine coverage• Challenge with age-based criteria

Lessons Learned Adding HPV Vaccine to an existing program reduces costs20

Child Day Plus Program• Operates twice a year (dose 2 given through outreach)• 90% saving in personnel cost over school-based stand alone

program

Communication and Education Strategy20

• Teachers critical to HPV vaccination in schools

Operational Issues20

• Cold chain and health infrastructure were fairly adequate

Adequate preparation and well-coordinated efforts are critical20

• Opportunity to assess and strengthen healthcare and education systems prior to vaccination

Monitoring, Evaluation and Dissemination of Results20

Barriers to a National HPV Immunization Program

Programmatic Feasibility20

• High coverage with school-based or CDP integrated

programs

• Comprehensive understanding of information needs, targeted

messaging and effective communication strategies

Health Policy and Health Systems

• Strategic Plan scale-up cost $US 103.8 million16

• Health system is overstretched and poorly funded 20

Source: HPV Vaccine Demonstration Project 2010 20,21

Note: Figures do not include the cost of the vaccine

School-based

Child Days Plus

3.15 1.659.45 4.95

1.29 0.77

0.89 0.67

28% 40%72% 60%

Uganda

Total cost for three doses(US$)Total cost per dose (US$)

Modified Cost (excludes salaries, allowances, start-up costs and depreciation) (US$)

Modified Cost per dose (excludes salaries, allowances, start-up costs) (US$)

Implementation costs

Modified Cost

Cost breakdownStart-up costs

Cost Estimates for the Introduction of HPV vaccine, PATH Project 2008-2009

Barriers to a National HPV Immunization ProgramFinancing HPV Vaccine

Barriers to a National HPV Immunization Program

Financing HPV Vaccine

• Merck offered HPV vaccine to GAVI Alliance at US$ 5 per dose21

• November 2011 – GAVI Board meets to decide whether to open a funding window21

• Possible co-payment of US$0.20-0.40 per dose• All HPV vaccinations in PATH demonstration project were

free20

What will be the actual cost of HPV vaccine in Uganda?

Update GAP Application

• Denied by Merck due to roll-out of national HPV immunization in Uganda• Merck to donate 360,000 first doses of HPV vaccine• Uganda MOH to buy doses 2 and 3 of HPV vaccine

Role of CMMB

• Role in national immunization initiative?

GAVI Alliance

• Funding window Page 18

Conclusion

• Cervical Cancer is a severe burden in Uganda• HPV vaccination program in schools is feasible with high level

of vaccine coverage • Cost of implementing and sustaining a program remain

unanswered • Progress has been made in developing efficient low-cost

screening approaches in low-income countries• Ugandan Government has a strong commitment to cervical

cancer prevention and screening• Accessibility and affordability of HPV vaccination and

screening remain barriers

References1. Ferlay, J., Shin, H., Bray, F., Forman, D., Mathers, C., Parkin, (2010).GLOBOCAN 2008 v1.2, Cancer Incidence and

Mortality Worldwide: IARC CancerBase No. 10 [Internet].Lyon, France: International Agency for Research on Cancer; 2010. Accessed on October 1, 2011 from http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=800

2. World Health Organization. United Nations Population Fund. (2006). Preparing for the introduction of HPV vaccines: policy and programme guidance for countries. Accessed on October 10, 2011from http://whqlibdoc.who.int/hq/2006/WHO_RHR_06.11_eng.pdf

3. Katahoire, R. A., Jitta, J., Kivumbi, G., Murokora, D., Arube, W. J., Siu, G., . . . LaMontagne, D. S. (2008). An assessment of the readiness for introduction of the HPV vaccine in Uganda. African Journal of Reproductive Health, 12(3), 159-172.

4. Catholic Medical Mission Board (CMMB) (2010). Accessed October 1, 2011 from http://www.cmmb.org/ 5. Gardasil Access Program.(2011). Welcome to Gardasil Access Program. Accessed on October 24, 2011 from

http://www.gardasilaccessprogram.org/6. U.S. Department of State. (2010). Background note: Uganda. Accessed on October 1, 2011 from

http://www.state.gov/r/pa/ei/bgn/2963.htm7. World health Organization.(2009). Global Health Observatory Data Repository. Accessed on October 1, 2011 from

http://apps.who.int/ghodata/?vid=20300&theme=country#8. Murray,P.,Rosenthal,K.,Pfaller,M.(2009). Medical Microbiology( 6th edition).Philadelphia, PA. Mosby Elsevier.9. Merck & Co.Inc.(2011). Gardasil Package Insert. Accessed on October 20, 2011 from

http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf10. GlaxoSmithKline.(2011). Cervarix Package Insert. Accessed on October 20, 2011 from

http://us.gsk.com/products/assets/us_cervarix.pdf 11. Asiimwe, S., Whalen, C. C., Tisch, D. J., Tumwesigye, E., & Sethi, A. K. (2008). Prevalence and predictors of high-risk

human papillomavirus infection in a population-based sample of women in rural Uganda. International Journal of STD & AIDS, 19(9), 605-610. doi:10.1258/ijsa.2008.008025

12. Banura, C., Franceschi, S., Doorn, L. J., Arslan, A., Wabwire-Mangen, F., Mbidde, E. K., . . . Weiderpass, E. (2008). Infection with human papillomavirus and HIV among young women in Kampala, Uganda. The Journal of Infectious Diseases, 197(4), 555-562. doi:10.1086/526792

13. Blossom, D. B., Beigi, R. H., Farrell, J. J., Mackay, W., Qadadri, B., Brown, D. R., . . . Salata, R. A. (2007). Human papillomavirus genotypes associated with cervical cytologic abnormalities and HIV infection in Ugandan women. Journal of Medical Virology, 79(6), 758-765. doi:10.1002/jmv.20817 Page 20

References14.Bosch, F. X. (2011). Human papillomavirus: Science and technologies for the elimination of cervical cancer. Expert

Opinion on Pharmacotherapy, 12(14), 2189-2204. doi:10.1517/14656566.2011.596527

15. World Health Organization.(2006). Comprehensive cervical cancer control: A guide to essential practice. Geneva: WHO.

16. Ministry of Health, Uganda. (2010). Strategic Plan for Cervical Cancer Prevention and Control in Uganda. 2010-2014. Accessed on October 1, 2011from www.rho.org/files/PATH_Uganda_cxca_strat_plan_2010-2014.pdf

17. Goldie, S. J., Gaffikin, L., Goldhaber-Fiebert, J. D., Gordillo-Tobar, A., Levin, C., Mahe, C., Alliance for Cervical Cancer Prevention Cost Working Group. (2005). Cost-effectiveness of cervical-cancer screening in five developing countries. The New England Journal of Medicine, 353(20), 2158-2168. doi:10.1056/NEJMsa044278

18. Bingham,A.,Janmohamed,A.,Bartolini,R.,Creed-Kanashiro,H.,Katahoire,A.,Khana…Tsu,V. (2009). An approach to formative research in HPV vaccine introduction planning in low resource settings. The Open Vaccine Journal, (2),1-16.

19. PATH. (2009). Shaping a Strategy to Introduce HPV Vaccines in Uganda: Formative Research Results from the HPV Vaccines: Evidence for Impact Project. PATH and Child Health and Development Centre (CHDC). Seattle. Accessed on October 1, 2011 from http://www.rho.org/files/PATH_FRTS_Uganda.pdf

20. PATH. (2010). HPV Vaccine Demonstration Project in Uganda: Results, Lessons Learnt, and Recommendations. PATH, Uganda National Expanded Programme on Immunization (UNEPI), and the Child Health and Development Centre (CHDC).Seattle. Accessed on October 1, 2011 from http://www.rho.org/files/PATH_Uganda_HPV_demo_OR_summary_2010.pdf

21. Mugisha,E. (2010). HPV Vaccine Demonstration Project: New Evidence and Strategies for Prevention of Cervical Cancer. (PowerPoint slides). Accessed on October 15, 2011 from http://www.unfpa.org/public/site/global/lang/en/pid/6859

22. GAVI press release. 2011, June 6. GAVI welcomes lower prices for life-saving vaccines. Accessed on October 30, 2011from http://www.gavialliance.org/library/news/press-releases/2011/gavi-welcomes-lower-prices-for-life-saving-vaccines/

HPV Infection and Cervical Cancer in Uganda: Challenges and Opportunities Jane Cashin, B.Pharm MPH...

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