The human papillomaviruses (HPV) are a group of more than 100 types of viruses, most of which cause warts or papillomas that are not cancer causing. The types of HPV that cause common warts on the hands and feet are different from the types that cause growths in the mouth and genital areas. A woman's cervix becomes infected with HPV when the virus is transmitted via sexual intercourse with an infected partner, making HPV infection one of the most common sexually transmitted diseases (STDs). More than 30 types of HPV can be passed from one person to another through sexual contact.

HPV is now recognized as the major cause of cervical cancer. Low-risk HPV types rarely develop into cancer. These include HPV-6 and HPV-11, the main types found in genital warts. HPV viruses that can lead to the development of cancer are referred to as high-risk, and include HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, and 69.

Most HPV infections, including infection with high-risk types, go away on their own and do not cause abnormal growths. Only a small number of women with HPV will develop cervical cancer. Studies suggest that the chance of a woman developing cervical cancer depends on a variety of factors acting together with high-risk HPVs.

The Female HPV study, funded by the National Cancer Institute, involves studying HPV among women in Hawai'i. The study will identify factors that affect an HPV infection and may increase the risk of developing cervical cancer, such as the kinds of foods that are eaten, sexual activity, immune characteristics, and other factors.

You may qualify for this study if you are female, at least 18 years of age, not currently pregnant and at least 6 months post-partum, have not had a hysterectomy, not immune-compromised (e.g., transplant recipient, HIV-positive, or within 6 months cancer chemotherapy), no history of blood-clotting disorders, and plan to reside on Oahu two or more years. Women do not have to be infected with HPV to participate in the study.

Before you decide whether to participate, a researcher will explain the study to you, its purpose, how it may help you and what you have to do. Once you understand the study and agree to take part, you will be asked to sign a consent form. You may be asked to come for up to 16 visits over a period of 5 years. At each visit you will have a Pap smear and samples (swabs and brushes) taken of your mouth, cervix and anal-rectal region to look for infection with the Human Papillomavirus, herpes simplex virus, and other sexually transmitted infections, and the presence of cytokines which are small proteins that help fight off infection. A fasting blood sample will be taken to measure nutrients and you will be asked questions about yourself and your lifestyle. If you are unable to fast 10-12 hours before your scheduled appointment, you will be asked to return to the clinic the following morning for a fasting blood sample. The estimated time for each visit is about 1.5 hours.

A PAP test or smear is done to check for abnormal cells in the cervix that may lead to cervical cancer. A physician or nurse practitioner uses a small spatula and brush to collect a sample of cells from the cervix and upper vagina. These cells are then placed on a slide and tested for abnormalities.

You will receive no cost Pap tests, no cost HPV testing, a no cost diet analysis, no cost parking, and $40 compensation for time and travel. The study will not provide or pay for any treatment.

The Female HPV Study is being conducted on Oahu by the Cancer Research Center of Hawai'i and at the University of Hawaii Health Services Center.

You can enroll in this study by calling our HPV study line at 564-5999, Monday-Friday, 9:00 am - 5:00 pm.

If you have further questions about the study or a research-related injury, please contact Dr. Marc Goodman, Cancer Research Center of Hawaii, 1236 Lauhala Street, Honolulu, HI, 96813, telephone (808) 586-2985. If you cannot get satisfactory answers to your questions or if you have comments or complaints about your treatment in this study, you may contact the Committee on Human Studies, University of Hawaii, 2540 Maile Way, Honolulu, HI 96822, telephone (808) 539-3955.