The Human Papillomavirus (HPV) Transmission Pilot Study

The Human Papillomavirus (HPV) Transmission Pilot Study

This transmission pilot study is a prospective study to determine feasibility of enrolling female partners into an international transmission study. Companion study to MCC-13930.

We planned to enroll 150 female sexual partners, 75 per year for 2 years, of male study participants in the HPV Infection in Men (HIM) Study. The enrollment period is from June 2006 through May 2008 and participants will be followed through May 2010. At all study visits participants will undergo interviews, a physical exam and laboratory analysis for HPV for a total of 5 clinical visits scheduled every 6 months over 2 years of follow-up. In addition, at each study visit, participants will provide blood for HPV antibody analyses. At enrollment, visit 3 and visit 5 a Pap smear test will be done. At the enrollment visit, study participants will complete a questionnaire designed to assess social and behavioral risk factors for the acquisition of HPV. At each subsequent study visit, participants will be asked to provide updated information to assess changes in risk behaviors such as condom use, relations with new partners, and tobacco use.

Inclusion Criteria:

• Female partners of HIM Study participants
• report no abnormal Pap smear during the past 6 months;
• have not had a hysterectomy
• have never been diagnosed with genital warts;
• are not pregnant;
• residents of southern Florida;
• are not and have not been enrolled in an HPV vaccine trial;
• willing to comply with scheduled visits every 6 months for 2 years.

Exclusion Criteria:

• Do not meet the Inclusion Criteria.