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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01133509
Recruitment Status : Unknown
Verified August 2012 by Alicia Devine, MD, Eastern Virginia Medical School.
Recruitment status was:  Recruiting
First Posted : May 31, 2010
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):

Study Description
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..

Condition or disease Intervention/treatment
Genital Human Papilloma Virus Infection Drug: Gardasil

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Model for the Implementation of the Cervical Cancer Screening and HPV Vaccination in the Emergency Department: a Pilot Study.
Study Start Date : September 2009
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : October 2012
Arms and Interventions

Arm Intervention/treatment
Drug: Gardasil
0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months
Other Name: Human Papillomarvirus, HPV vaccine, Gardisil, Silgard

Outcome Measures

Primary Outcome Measures :
  1. 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 [ Time Frame: two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133509

Contact: Alicia Devine, MD 757-388-3397 aliciadevine@mac.com
Contact: LaBarbara Edlow, RN 757-388-5224 ldedlow@sentara.com

United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Principal Investigator: Alicia S Devine, MD, JD         
Sponsors and Collaborators
Eastern Virginia Medical School
Merck Sharp & Dohme Corp.
Principal Investigator: Alicia Devine, MD Eastern Virginia Medical School
More Information

Additional Information:
Responsible Party: Alicia Devine, MD, Principal Investigator, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01133509     History of Changes
Other Study ID Numbers: 33249
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Virus Diseases
Papillomavirus Infections
Disease Attributes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Tumor Virus Infections