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

January 13, 2009
March 18, 2014
October 2006
January 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00823511 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Human Papillomavirus Infection
Not Provided
Female Partners
Female partners of HIM Study participants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
137
December 2014
January 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823511
MCC-14881, USF IRB 104923
No
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Not Provided
Principal Investigator: Anna Giuliano H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP