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

Human Papillomavirus Clinical Trial

— HOP-IN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289873
• Other study ID #: Merck IISP 37942
• Status: Completed
• Phase: N/A
• First received: February 2, 2011
• Last updated: September 9, 2013
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1036
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus

Locations

Country	Name	City	State
United States	Student Health Care Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of oral HPV	any oral HPV at enrollment	at enrollment	No
Secondary	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	No