NCT01289873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,036

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 10, 2013

Status Verified

August 1, 2013

Enrollment Period

1.3 years

First QC Date

February 2, 2011

Last Update Submit

September 9, 2013

Conditions

Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

  • Prevalence of oral HPV

    any oral HPV at enrollment

    at enrollment

Secondary Outcomes (1)

  • Persistence of oral HPV over 1 year of follow-up

    1 year

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female college students

You may qualify if:

  • Age \>=18 years
  • Female
  • Currently enrolled as a college student

You may not qualify if:

  • Unable to provide an oral rinse sample
  • Unable to complete survey
  • Unable to provide contact information
  • Already completed study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Student Health Care Center

Gainesville, Florida, 32610, United States

Location

Study Officials

  • Robert L Cook, MD, MPH

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2011

First Posted

February 4, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 10, 2013

Record last verified: 2013-08

Locations

US(1)