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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Eastern Virginia Medical School.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Alicia Devine, MD, Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01133509
First received: November 4, 2008
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Genital Human Papilloma Virus Infection
 Drug: Gardasil

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
gardisil
gardisil
 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

  Eligibility
Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133509

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

Locations
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.
Investigators
Principal Investigator: Alicia Devine, MD Eastern Virginia Medical School
  More Information

Additional Information:
Center of Disease Control  This link exits the ClinicalTrials.gov site
American Cancer Society  This link exits the ClinicalTrials.gov site
United States Preventative Service Task Force  This link exits the ClinicalTrials.gov site

Publications:
M Plummer, M Schiffman, PE Castle,M Maucort-Boulch and CM Wheeler, A 2-year prospective study of HPV persistence among women with ASCUS or LSIL cytology, J Infect Dis 195 (2007) 1582-1598.

Responsible Party: Alicia Devine, MD, Principal Investigator, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01133509     History of Changes
Other Study ID Numbers: 33249
Study First Received: November 4, 2008
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015