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

Prevalence, Persistence, and Risk Factors for Oral HPV Infections in College Women

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.

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus

• Study Type: Observational
• Enrollment (Actual): 1036

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Student Health Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

female college students

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of oral HPV	any oral HPV at enrollment	at enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistence of oral HPV over 1 year of follow-up	Determine whether HPV remains present at 3-months, 6-months, and 12-months after enrollment	1 year

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Robert L Cook, MD, MPH, University of Florida

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): September 10, 2013
• Last Update Submitted That Met QC Criteria: September 9, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: Merck IISP 37942