Clinical trial NCT02113514: Community Awareness, Resources and Education (CARE I): Project 3
Official title: Community Awareness, Resources and Education (CARE I): Project 3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Abnormality
Keywords: Appalachian
abnormal pap test
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2014-04-14
Enrollment: 2394
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Social/environmental variables of access to screening were analyzed to see if they contribute to increased risk of developing abnormalities among Appalachian women.
timeFrame: Participant completed all activites on the 1 day of the clinic visit.
Secondary outcomes:
measure: 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.
timeFrame: Participant completed all activites on the 1 day of the clinic visit.
measure: 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.
timeFrame: Participant completed all activites on the 1 day of the clinic visit.
measure: Combinations of social, behavioral, and biological determinants were analyzed to see which contribute to the increased risk of developing cervical abnormalities among Appalachian women.
timeFrame: Participant completed all activites on the 1 day of the clinic visit.
Other outcomes:
measure: Factors that impede follow-up and treatment of abnormal or suspicious Pap smear findings were identified.
timeFrame: Participant completed all activites on the 1 day of the clinic visit.
measure: New molecular markers related to cervical cancer were explored.
timeFrame: Participant completed all activites on the 1 day of the clinic visit.
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: The Ohio State University Center for Population Health and Health Disparities
name: Electra D. Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.