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.

Resource links provided by NLM:

MedlinePlus related topics: Cervical Cancer

U.S. FDA Resources

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 (Adult)
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

American College of Obstetrics and Gynecology This link exits the ClinicalTrials.gov site

United States Preventative Service Task Force This link exits the ClinicalTrials.gov site

Publications:

Bosch X, Harper D. Prevention strategies of cervical cancer in the HPV vaccine era. Gynecol Oncol. 2006 Oct;103(1):21-4. Epub 2006 Aug 17. Review.

Lonky NM. Risk factors related to the development and mortality from invasive cervical cancer clinical utility and impact on prevention. Obstet Gynecol Clin North Am. 2002 Dec;29(4):817-42, viii. Review.

Society of Gynecologic Oncologists Education Resource Panel Writing group, Collins Y, Einstein MH, Gostout BS, Herzog TJ, Massad LS, Rader JS, Wright J. Cervical cancer prevention in the era of prophylactic vaccines: a preview for gynecologic oncologists. Gynecol Oncol. 2006 Sep;102(3):552-62. Review.

Kinney W, Sung HY, Kearney KA, Miller M, Sawaya G, Hiatt RA. Missed opportunities for cervical cancer screening of HMO members developing invasive cervical cancer (ICC). Gynecol Oncol. 1998 Dec;71(3):428-30.

Plummer M, Schiffman M, Castle PE, Maucort-Boulch D, Wheeler CM; ALTS Group. A 2-year prospective study of human papillomavirus persistence among women with a cytological diagnosis of atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion. J Infect Dis. 2007 Jun 1;195(11):1582-9. Epub 2007 Apr 16.


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:


Emergencies Uterine Cervical Neoplasms Virus Diseases Papilloma Papillomavirus Infections Disease Attributes Pathologic Processes Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms	Neoplasms by Site Neoplasms 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

ClinicalTrials.gov processed this record on September 23, 2016

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