The Human Papillomavirus (HPV) Transmission Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00823511
First received: January 13, 2009
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition
Human Papillomavirus Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Human Papillomavirus (HPV) Transmission Pilot Study

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Proportion of men in the HIM study willing to invite their female partner to participate in partner study, proportion of female partners who: a) contact clinic for enrollment in study b) are eligible to participate in the study c) enroll in study. [ Time Frame: 2 year accrual period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of female partners who report being monogamous with the HIM partner, proportion of women that are both HPV sero negative and HPV DNA negative at enrollment, proportion of women who comply with study protocol over 2 years of follow up. [ Time Frame: 2 years per participant ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: October 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Female Partners
Female partners of HIM Study participants

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Female partners of HIM Study participants - Companion study to MCC-13930. Residents of Southern Florida.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823511

Locations
United States, Florida
Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Anna Giuliano H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00823511     History of Changes
Other Study ID Numbers: MCC-14881, USF IRB 104923
Study First Received: January 13, 2009
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
HPV
Human Papillomavirus Infection
Cervix Uteri
Cancer Control
Risk Assessment, Detection & Intervention
Sexually Transmitted
Neoplasia
Carcinogenesis
Cervix

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014