New Mexico (NM) is the only state with the capacity to fully monitor cervical cancer screening and human
papillomavirus (HPV) prevention using a state-wide woman-based electronic informatics system under
mandated reporting. We are uniquely positioned to address gaps in understanding HPV vaccine impact and
effectiveness within a mulit-cultural US population suffering many disparities. Our project will accomplish
three integrated specific aims required to provide definitive baseline characterizations of the opportunistic
cervical cancer screening program in NM. In Aim 1, we will establish the individual HPV genotype distribution
of 37 HPV genotypes needed to appropriately monitor expected or unexpected population-based impact of
HPV vaccines. Although we have performed a state-wide sampling of over 60,000 cervical samples
targeting all women with abnormal Pap tests and a random sample of women with normal Pap tests, our
existing resources were limited to HPV genoytping of 40,000 samples. In this Aim we will achieve the
targeted sample size by performing the additional 20,000 HPV genotype assays.We will describe the agespecific
population-based genotype distribution and determine the genotype-specific risk for CIN2+
outcomes across the 2 year grant period. In Aim 2, we will convene a pathology panel to determine
consensus diagnoses for ~8,000 cervical biopsies including >CIN/AIS. The consensus diagnoses will be
compared to community-based diagnoses determined for the same specimens through use of the NM HPV
Pap Registry (NMHPVPR) data warehouse. We will create a gold standard slide set that will enable
standardization of future population-based assessments, a prerequisite for determining the real-world impact
and effectiveness of HPV vaccination. In Aim 3 we will develop a shared image resource of the cervical
biopsy tissues and validate the use of image-based versus glass-based diagnoses. Because the impact of
HPV vaccines is expected to increase over time, longitudinal periodic assessments will be expected to span
several decades. Image-based diagnostic standards will be critical to future population evaluations.
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