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

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

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 ]
    any oral HPV at enrollment

Secondary Outcome Measures:
  • 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

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)

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.
  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 identifier: 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
  More Information

Responsible Party: University of Florida Identifier: NCT01289873     History of Changes
Other Study ID Numbers: Merck IISP 37942
Study First Received: February 2, 2011
Last Updated: September 9, 2013 processed this record on August 18, 2017