The Human Papillomavirus (HPV) Transmission Pilot Study

Human Papillomavirus Infection Clinical Trial

Official title:

The Human Papillomavirus (HPV) Transmission Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823511
• Other study ID #: MCC-14881
• Secondary ID: USF IRB 104923
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: January 27, 2015
• Start date: October 2006
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Locations

Country	Name	City	State
United States	Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 year accrual period	No
Secondary	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.		2 years per participant	No

External Links

•   Moffitt Cancer Center Clinical Trials website