Community Awareness, Resources and Education (CARE) Project - Project 3 will determine if Appalachian women have unique risk factors for an abnormal Pap smear that might contribute to the increased risk of cervical abnormalities, specifically cancer, in their communities.
The aim of CARE: Project 3 is to determine the social, behavioral, and biological variables that might contribute to increased risks of an abnormal Pap smear in Appalachian women in Ohio. To accomplish these aims, a case-control study was proposed. Women age 18 and older with an intact cervix, not pregnant, and no current or past history of invasive cervical cancer are recruited at the time of their scheduled Pap smear from clinics/physician practices in Appalachian region of Ohio. Women receiving Pap tests at participating medical clinics/physician practices are recruited for a case control epidemiologic study assessing HPV prevalence and its impact on cervical intraepithelial neoplasia (CIN). Cervical mucus will be collected for Human Papillomavirus (HPV) assays and stored for potential other assays related to HPV. Serum will be drawn for HPV serology and stored for future analysis. Controls are defined as women with a normal Pap smear. Cases are defined as women with abnormal Pap smear (from atypical squamous cells of uncertain significance (ASCUS) to cancer.
Study Type
OBSERVATIONAL
Enrollment
2,394
University of Michigan
Ann Arbor, Michigan, United States
The Ohio State University
Columbus, Ohio, United States
Social/environmental variables of access to screening were analyzed to see if they contribute to increased risk of developing abnormalities among Appalachian women.
On the day of study enrollment, survey data and specimens were obtained from the participants.
Time frame: Participant completed all activites on the 1 day of the clinic visit.
Behavioral variables of age of onset of sexual intercourse, number of partners, male partner factors, multiparity, oral contraceptive use, and smoking were analyzed to see if they contribute to the increased risk of developing abnormalities.
On the day of study enrollment, survey data and specimens were obtained from the participants.
Time frame: Participant completed all activites on the 1 day of the clinic visit.
Biological variables of HPV status, HPV type, HPV variants, HPV viral load, and serology to HPV were analyzed to see if they contribute to the increased risk of developing cervical abnormalities among Appalachian women.
On the day of study enrollment, survey data and specimens were obtained from the participants.
Time frame: Participant completed all activites on the 1 day of the clinic visit.
Combinations of social, behavioral, and biological determinants were analyzed to see which contribute to the increased risk of developing cervical abnormalities among Appalachian women.
On the day of study enrollment, survey data and specimens were obtained from the participants.
Time frame: Participant completed all activites on the 1 day of the clinic visit.
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