Community Awareness, Resources and Education (CARE I): Project 3

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community Awareness, Resources and Education (CARE I): Project 3

Conditions
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Cervical Abnormality

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18 years or older Able to give informed consent Intact cervix No prior history of invasive cervical cancer English speaking Willing to have biological specimens stored for future studies Resident of Appalachian Ohio Exclusion Criteria: Pregnant Medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance. Smokers (will be contacted by study team to see if they are eligible/willing to participate in CARE: Project 2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Pap smear<br>Women with normal pap test. | |
| Abnormal Pap smear<br>Women with abnormal pap test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participant completed all activites on the 1 day of the clinic visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Participant completed all activites on the 1 day of the clinic visit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appalachian, abnormal pap test