Prevalence, Persistence, and Risk Factors for Oral Human Papillomavirus (HPV) Infections in College Women (HOP-IN)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01289873
First received: February 2, 2011
Last updated: September 9, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine how common oral HPV infections are in college women. The investigators also will find out what risk factors are associated with having oral HPV infections. The investigators hypothesize that approximately 3% of women will have oral HPV, and that HPV will be associated with oral sexual behaviors and with smoking behaviors. Finally, for those women with oral HPV- the investigators will determine whether the infections are persistent (still present) at 3-, 6-, and 12-months after the initial diagnosis.


Condition
Human Papillomavirus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence, Persistence, and Risk Factors for Oral HPV Infections in College Women

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Prevalence of oral HPV [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
    any oral HPV at enrollment


Secondary Outcome Measures:
  • Persistence of oral HPV over 1 year of follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Determine whether HPV remains present at 3-months, 6-months, and 12-months after enrollment


Enrollment: 1036
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

female college students

Criteria

Inclusion Criteria:

  • Age >=18 years
  • Female
  • Currently enrolled as a college student

Exclusion Criteria:

  • Unable to provide an oral rinse sample
  • Unable to complete survey
  • Unable to provide contact information
  • Already completed study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289873

Locations
United States, Florida
Student Health Care Center
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Robert L Cook, MD, MPH University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01289873     History of Changes
Other Study ID Numbers: Merck IISP 37942
Study First Received: February 2, 2011
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014