HPV Surveillance in Family Planning Settings Baseline Data and Future Plans

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HPV Surveillance in Family Planning
SettingsBaseline Data and Future Plans

• Deblina Datta MD
• Division of STD Prevention, CDC
• September 19, 2006
• National Title X Grantee Meeting
• Phoenix, AZ

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HPV Epidemiology

• Most common sexually transmitted infection
• 20 million prevalent infections
• 5.5 million incident infections per year
• Most infections are self-limited and cleared by
  the body in 1-2 years, native immunity

Weinstock et al. Perspectives on Sexual and
Reproductive Health 2004
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HPV Types

• Over 40 types involved in genital infection
• High risk (HR), oncogenic types (16, 18, 31,
  33, 35, 39, 45, 51, 52, 56, 58.)
• association with cervical neoplasia, anogenital
  cancers
• Types 16, 18 70 of cervical cancer
• Low risk, nononcogenic types (6, 11, 42, 43,
  44)
• association with genital warts, low grade
  cervical neoplasia
• LR-HPV Types 6, 11 90 of genital warts

Munoz, NEJM 2003348518-27
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Natural History of HPV Infection
Within 1 Year
1-5 Years
Up to Decades
InitialHPV Infection
Persistent Infection
CIN 2/3
Cervical Cancer
CIN 1
Cleared HPV Infection
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Estimated Annual Abnormal Pap Tests, U.S.
CA 15,000
HSIL 300,000
LSIL 1,000,000
ASC-US 2,000,000
Modified from Hildesheim, A., National Cancer
Institute
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6
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90
Modified from Chesson et al. Perspectives on
Sexual and Reproductive Health 2004, 36(1) 11-19)
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Surveillance for HR-HPV

• Prior to establishment of our project, no
  national surveillance system for HR-HPV infection
  in US
• No routine testing
• Not a reportable infection
• Case reporting not feasible
• Potential benefits of HR-HPV sentinel
  surveillance among women
• Measure national HPV burden
• Inform cancer prevention activities
• Valuable adjunct to cancer surveillance
• Inform vaccination programs

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HPV Sentinel Surveillance Project (HSS)

• First national surveillance system to measure
  HR-HPV prevalence in US women
• Broad in scope
• Large numbers of women enrolled
• Standardized methods (enrollment, data
  collection, lab testing)
• Multi-year surveillance
• Jan 2003-Dec 2005
• Measure prevalence of HR-HPV in women from
• Geographically diverse locations throughout US
• Different populations (e.g. attending different
  clinic types)
• Different ages
• Different races/ethnicities

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HSS Sites6 cities, 10 family planning clinics
Seattle, WA
Boston, MA
Baltimore, MD
Denver, CO
Los Angeles, CA
New Orleans, LA
STD Clinics (8) Primary Care Clinics (8) Family
Planning Clinics (10)
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Participating HSS FP Sites

• ProHealth, Tapestry (MA)
• Maternity Center East, East Baltimore Medical
  Center (MD)
• Orleans Parish Family Planning (LA)
• PHSKC Family Planning (2 sites, WA)
• Eastside Neighborhood Health Center Adolescent
  Clinic, Hyde Park Health Clinic (CO)
• Koryo Clinic (CA)

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Enrollment Criteria

• Eligible women
• Age 14-65 yrs
• Due for routine screening cervical cytology
• Exclusion criteria
• History of hysterectomy
• History of treatment on cervix last 12 months
• Currently menstruating
• Pregnant

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Surveillance Protocol

• Clinical and epidemiologic data
• Questionnaire data (e.g. demographics, risk
  factors)
• Medical records data (e.g. cytology results)
• Cervical specimen
• Laboratory data
• Hybrid Capture 2 HR-HPV probe (Digene,
  Gaithersburg, MD)
• 13 HR types16, 18, 31, 33, 35, 39, 45, 51, 52,
  56, 58, 59, 68
• Local labs
• Cervical cytology
• Local labs
• conventional and liquid-based cytology
• Bethesda 2001 guidelines
• PCR and typing

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Age Distribution of HSS Participants
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Race/Ethnicity of HSS Particpants
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Enrollment by City into HSS
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HR-HPV Prevalence by Age Group
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HR-HPV Prevalence by Race/Ethnic Group
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HR-HPV Prevalence by City
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16
52
53
39
51
59
18
66
31
45
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HR-HPV Prevalence by Cytology
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Future of HPV Surveillance

• Which endpoints
• Genital warts
• Pap abnormalities
• Histological abnormalities
• HPV infection
• HPV type
• Which populations
• Cervical cancer screening population
• Abnormal pap/histology
• How frequently to measure
• Periodic
• continuous

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IPP Core Data Elements

• Sex
• Age
• Date of birth
• Race/ethnicity
• Limited geographic data (patient residence)
• Visit date
• Specimen type (cervical, urine, etc)
• Health care provider ID
• Health care provider type
• CT test type and result
• GC test type and result

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Proposed Data Elements

• HPV vaccine received?
• Pap test result
• HPV test result
• Collection of remnant biological specimen
• Cervical biopsy data (associated colpo clinics)
• Genital wart detection

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HPV Sentinel Surveillance (HSS)Acknowledgements

• HSS Patients
• Clinic Staff in All Sites/Cities
• Baltimore, MD
• PIs Khalil Ghanem, Jonathan Zenilman
• Toni Flemming, Hope Johnson, Jeff Yuenger
• Boston, MA
• PI Sylvie Ratelle
• Laura Smock, Shelia Nelson
• Denver, CO
• PI Judy Shlay
• Julie Subiador, Mark Foster
• Los Angeles, CA
• PI Peter Kerndt
• Tracie McClain, Ross Cranston
• Susan Walker, Sarah German

• New Orleans, LA
• PI Michael Hagensee
• Janine Hatala, Cheryl Cheeks
• Seattle, WA
• PIs Bethany Weaver and Laura Koutsky
• Tara McPartland, Maria Elena Bendana, Akhila
  Balasubramanian
• CDC (Atlanta, GA)
• Division of STD Prevention, NCHSTP-Deblina Datta,
  Cristen Suhr, Hillard Weinstock, Rob Nelson,
  Akbar Zaidi, John Douglas, Alicia Edwards
• Division of Viral and Rickettsial Diseases,
  NCID-Elizabeth Unger, RuthAnn Tucker, David Swan,
  Ashley Goodroe, Juanita Onyekwuluje

Slides-Dunne,Lawson,Newman
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Thank you