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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01289873
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : September 10, 2013
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Florida

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 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
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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

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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

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.

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 identifier (NCT number): NCT01289873

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

Responsible Party: University of Florida 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