1. Monitoring HPV vaccine impact in Connecticut
Linda Niccolai, PhD
Yale School of Public Health
2008 National STD Prevention Conference
Chicago, IL

2. Overview
Multi-site, CDC-funded project to monitor HPV vaccine impact through laboratory-based surveillance of cervical cancer precursors
Adding cervical cancer precursors to list of reportable diseases

3. It Takes a Village CT Emerging Infections Program (EIP)
James Meek MPH, Ruthanne Marcus MPH, Pamela Julian MPH, Robert Heimer PhD
CT Department of Public Health
James Hadler MD MPH, Lynn Sosa MD, Matt Cartter MD MPH, Maria Andrews MPH
Yale School of Public Health
Linda Niccolai PhD, Daina Barauskas MPH(c)
Other local partners
For example: Hospital and commercial pathology laboratories
National partners
For example: CDC, other EIP sites

4. Purpose of EIP project Goal Specific Aims
To develop and implement laboratory-based reporting of cervical intraepithelial neoplasia grades 2 and 3 (CIN 2/3) and adenocarcinoma in situ (AIS)
Specific Aims
Monitor trends in CIN 2/3 & AIS diagnoses
Monitor trends in HPV type-specific CIN 2/3 & AIS
Estimate vaccination patterns and screening histories among cases

5. Overview of EIP project
Currently funded for 2 years at 4 EIP sites
CT, NY, TN, CA
Defined catchment areas
Typically county level
Laboratory-based surveillance for CIN 2/3 & AIS
All cases reported using 1-page case report form
Enhanced surveillance for more detailed information on a representative subset including clinical history (vaccine, screening) and specimen collection (typing)

6. Protocol Labs send case report form to Yale EIP
Resident of New Haven Co.
Resident outside New Haven Co.
Verify diagnosis is reportable
Verify diagnosis is reportable
Enter into state surveillance database
Enter into state surveillance database
Enhanced surveillance on subset age 18-39
Ask labs to send biopsy specimens
Collect additional clinical information

7. Conducting a provider survey
Purpose
To identify all pathology labs that process cervical biopsy specimens for New Haven Co. residents
Methods
Telephone survey of providers likely to conduct cervical biopsies including OB/GYN, IM, FP, others
Results
We identified 11 pathology laboratories
8 hospital-based, 3 commercial
Largest labs include Yale, Quest

8. Approach to working with pathology labs
Initial contact
Explain purpose of project
Follow-up
Meet to discuss implementation
Key points of partnership
Flexibility and ease
Importance of and benefit to labs
Public health significance

9. Background on disease reporting in CT
All states have lists of reportable diseases that are considered to have “public health importance”
Needs to be flexible to conduct surveillance for new conditions when they arise (e.g. Lyme disease, HIV), yet process of approval by legislature cumbersome, political and time consuming
In 1985, Connecticut General Statutes Section 19a-2a that mandates disease reporting was amended to include, “Annually issue a list of reportable diseases and reportable laboratory findings and amend such list as he (Commissioner of Public Health) deems necessary”.
Law made CT unique at the time in flexibility to conduct surveillance and when to begin

10. Process
State Epidemiologist selects and convenes an Advisory Committee to make recommendations to the Commissioner of Public Health
Advisory Committee composed representatives from groups that must do the work of reporting (e.g. lab directors, hospital epidemiologists) and other stake holders (public health officials)
Meet annually to discuss, vote, and make recommendations (majority) to Commissioner
Commissioner makes a final decision and approves list before Jan 1 each year
Lists disseminated

11. Making CIN 2/3 & AIS reportable
Rationale
Evaluate vaccination efforts
Gain more information to guide vaccination programs and strategies
Issues raised by committee
Overlap with tumor registry
Specimen collection – feasibility and liability
Patient confidentiality
Outcome
Recommended to and accepted by Commissioner

13. Contact us! Linda Niccolai Yale School of Public Health (203) 785-7834

14. What to report?
To direct case-specific PH intervention (e.g. treatment, exposure)
To plan or evaluate PH programs to prevent disease when public health intervention is available
To gain more information that may be necessary before prevention can be implemented
Points 2 & 3 are particularly salient for vaccines
E.g. varicella, pneumococcal disease