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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Phase
Genital Human Papilloma Virus Infection	Drug: Gardasil	Not Applicable

Study Design

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 26 Years (Adult)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Center of Disease Control 

American Cancer Society 

American College of Obstetrics and Gynecology 

United States Preventative Service Task Force 

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
First Posted:	May 31, 2010
Last Update Posted:	August 23, 2012
Last Verified:	August 2012

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