A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study
Genital Human Papilloma Virus Infection
Conditions: official terms
Papillomavirus Infections - Uterine Cervical Neoplasms - Virus Diseases
Study Type
Study Phase
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Gardasil
Type: Drug
Overall Status
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..
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 26 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- 3 years of beginning sexual activity or by age 21 years whichever occur first.

- resident of the City of Norfolk, Virginia

- uninsured

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
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Status: Recruiting
Start Date
September 2009
Completion Date
October 2012
Eastern Virginia Medical School
Eastern Virginia Medical School
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page