The Human Papillomavirus (HPV) Transmission Pilot Study

January 27, 2015 updated by: H. Lee Moffitt Cancer Center and Research Institute
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center & Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Female Partners
Female partners of HIM Study participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 year accrual period

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years per participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Anna Giuliano, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (Estimate)

January 15, 2009

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-14881
  • USF IRB 104923

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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