Carolina Women's

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*What is the purpose of the study?*
We are conducting a research study that examines the immune response to viral infection, specifically human papilloma virus (HPV). Certain types of HPV cause warts on the hands or feet, while others can cause visible genital warts or cervical abnormalities that can lead to cervical cancer. In 90% of women, the immune system eliminates the virus before they are aware they have an infection. The purpose of this study is to analyze a portion of the Pap test to determine which immune system signals are needed to detect and eliminate HPV and examine lifestyle factors that influence the immune response.

*Am I qualified?*
We are seeking freshmen women to participate in this voluntary study.

*How much time will the study take?*
You will be asked to come in for 2 visits a year lasting about one-hour each. The visits will be approximately 6 months apart. The study will continue for the duration of your enrollment at the University.

*What do I have to do?*
The first step would be to call the Women’s Care Clinic and make an appointment with the Nurse Practitioner (NP). The NP will ask you to fill out an extensive confidential survey at the beginning of each visit. The survey will not be reviewed by the NP. The survey includes questions about sexual behavior, drug and alcohol use, your grades and SAT scores. It will take about 20 minutes to complete. The next step is a physical examine including monitoring of blood pressure, weight and routine pelvic examination. The first visit will also include a one time blood draw to be used for research purposes. During the pelvic exam, the NP will collect a sample of cells from your cervix and send them to the lab to look for cervical abnormalities; this Pap test is a routine part of your Women’s Health exam. A second collection of cells will be taken, as well as a sample of cervical mucus for research purposes. You will receive your Pap results from Women’s Care Clinic. If you receive an abnormal pap result, you will receive the standard treatment and follow-up care; and you will be able to continue your participation in the study.

*What are the risks?*
The Pap tests pose minimal risk to your health. You may experience vaginal spotting that generally resolves spontaneously without treatment. The one time blood draw can cause localized bruising.

*What are my benefits of participation in this study?*
Since you will be asked to return for a Pap test twice a year, your health will be closely followed. The $35 cost of each Pap test will be covered by the study. The knowledge gained from this study will eventually aid in the development of new treatment protocols for women with cervical abnormalities.

*What is the cost?*
There will be no costs to you for your participation in this study.

*How will my information be protected?*
The survey will be barcoded to ensure confidentially and kept in a locked file. This information may be published, but all data will be reported together and no identification of individuals will be included.




			Page Last Updated:
			03/06/2008