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

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

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

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

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)

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

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

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

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

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

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

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

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