A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study

Not Applicable

• Conditions: Genital Human Papilloma Virus Infection
• Interventions: Drug: Gardasil

• Registration Number: NCT01133509
• Lead Sponsor: Eastern Virginia Medical School

Brief Summary

In this pilot study, we intend to demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV testing via ThinPrep®Pap testTM and surveillance. We intend to provide improved access to healthcare and monitoring through administration of vaccine to eligible patients and 1 year follow up for patients involved in this study.

Females meeting inclusion/exclusion criteria participating in the study (n=100) that have not had a cytology test in 2 or more years will be offered the Thin Prep® cytology test. This study will allow surveillance of disease through cytology and HPV DNA testing via collection of data using Thin Prep® cytology with reflex HPV DNA testing according to established guidelines as described below.

Provide improved access to healthcare and monitoring through administration of vaccine for eligible females as established by guidelines. Patients will receive first vaccine in the ED and will have arranged follow up for administration of the 2 month and 6 month series of the HPV vaccination. Through data collection, we intend to determine if there is a need for vaccination and determine if patients are likely to follow up..

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-04
• Study Start: 2009-09
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-05-31
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-23
• Primary Completion: 2012-09
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 3 years of beginning sexual activity or by age 21 years whichever occur first.
• resident of the City of Norfolk, Virginia
• uninsured

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Exclusion Criteria

• Pregnant women
• Women with Hysterectomy with cervical excision
• Women who received full HPV vaccine series
• Known history of cervical cancer
• Male sex
• Loop electrocautery excision procedure(LEEP)
• Cold-Knife conization

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gardisil	Gardasil	gardisil

Primary Outcome Measures

Name	Time	Method
To demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and /or cytology)are presenting to the ED,by analysis of a constructed survey,cytology/HPV testing via ThinPrep Pap test and surveillance	two years

Trial Locations

Locations (1)

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States