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The Human Papillomavirus (HPV) Transmission Pilot Study


N/A
18 Years
N/A
Open (Enrolling)
Female
Human Papillomavirus Infection

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Trial Information

The Human Papillomavirus (HPV) Transmission Pilot Study


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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.

Outcome Time Frame:

2 year accrual period

Safety Issue:

No

Principal Investigator

Anna Giuliano

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-14881

NCT ID:

NCT00823511

Start Date:

October 2006

Completion Date:

December 2013

Related Keywords:

  • Human Papillomavirus Infection
  • HPV
  • Human Papillomavirus Infection
  • Cervix Uteri
  • Cancer Control
  • Risk Assessment, Detection & Intervention
  • Sexually Transmitted
  • Neoplasia
  • Carcinogenesis
  • Cervix
  • Warts
  • Papillomavirus Infections

Name

Location
Moffitt Cancer Center & Research Institute Tampa, Florida  33612-9497