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
Page 3
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
Page 4
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
Page 5
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
Page 9
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
Page 11
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
Page 12
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
Page 13
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
Page 14
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 $US 103.8 million16
• Health system is overstretched and poorly funded 20
Page 15
Source: HPV Vaccine Demonstration Project 2010 20,21
Note: Figures do not include the cost of the vaccine
School-based
Child Days Plus
3.15 1.659.45 4.95
1.29 0.77
0.89 0.67
28% 40%72% 60%
Uganda
Total cost for three doses(US$)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$)
Implementation costs
Modified Cost
Cost breakdownStart-up costs
Cost Estimates for the Introduction of HPV vaccine, PATH Project 2008-2009
Barriers to a National HPV Immunization ProgramFinancing HPV Vaccine
Page 16
Barriers to a National HPV Immunization Program
Financing HPV Vaccine
• Merck offered HPV vaccine to GAVI Alliance at US$ 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?
Page 17
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
Page 19
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/
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