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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Abnormality

Detailed Description

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 (Actual): 2394

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Ohio
    • Columbus, Ohio, United States, 43201
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Woman 18 years or older that are nonpregnant with intact cervix and no cervical cancer who present for a Pap smear. Must be residents of an Appalacian Ohio county.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Normal Pap smear; Women with normal pap test.
Abnormal Pap smear; Women with abnormal pap test.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors that impede follow-up and treatment of abnormal or suspicious Pap smear findings were identified.	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.
New molecular markers related to cervical cancer were explored.	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.

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: University of Michigan
• Investigators: Principal Investigator: Electra D. Paskett, PhD, The Ohio State University Center for Population Health and Health Disparities

Publications and helpful links

General Publications

• Patel DA, Rozek LS, Colacino JA, Van Zomeren-Dohm A, Ruffin MT, Unger ER, Dolinoy DC, Swan DC, Onyekwuluje J, DeGraffinreid CR, Paskett ED. Patterns of cellular and HPV 16 methylation as biomarkers for cervical neoplasia. J Virol Methods. 2012 Sep;184(1-2):84-92. doi: 10.1016/j.jviromet.2012.05.022. Epub 2012 Jun 1.
• Ruffin MT 4th, Hade EM, Gorsline MR, DeGraffinreid CR, Katz ML, Kobrin SC, Paskett ED. Human papillomavirus vaccine knowledge and hypothetical acceptance among women in Appalachia Ohio. Vaccine. 2012 Aug 3;30(36):5349-57. doi: 10.1016/j.vaccine.2012.06.034. Epub 2012 Jun 27.
• Reiter PL, Katz ML, Ruffin MT, Hade EM, DeGraffenreid CR, Patel DA, Paskett ED, Unger ER. HPV prevalence among women from Appalachia: results from the CARE project. PLoS One. 2013 Aug 30;8(8):e74276. doi: 10.1371/journal.pone.0074276. eCollection 2013. Erratum In: PLoS One. 2013;8(10). doi:10.1371/annotation/7a4cfd0a-cf77-430e-89a0-b2576268e2eb.

Helpful Links

• Jamesline

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 11, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Appalachian; abnormal pap test
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: OSU-0490