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The Human Papillomavirus (HPV) Transmission Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823511
First Posted: January 15, 2009
Last Update Posted: January 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
  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 ]

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 ]

Enrollment: 137
Study Start Date: October 2006
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: January 13, 2009
First Posted: January 15, 2009
Last Update Posted: January 28, 2015
Last Verified: January 2015

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:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections