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

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ClinicalTrials.gov Identifier: NCT01289873
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : September 10, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Human Papillomavirus

Study Design

Study Type : Observational
Actual Enrollment : 1036 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence, Persistence, and Risk Factors for Oral HPV Infections in College Women
Study Start Date : May 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Prevalence of oral HPV [ Time Frame: at enrollment ]
    any oral HPV at enrollment


Secondary Outcome Measures :
  1. Persistence of oral HPV over 1 year of follow-up [ Time Frame: 1 year ]
    Determine whether HPV remains present at 3-months, 6-months, and 12-months after enrollment


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01289873     History of Changes
Other Study ID Numbers: Merck IISP 37942
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: August 2013