A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study
NCT ID: NCT01133509
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2009-09-30
2012-10-31
Brief Summary
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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..
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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gardisil
gardisil
Gardasil
0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months
Interventions
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Gardasil
0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* resident of the City of Norfolk, Virginia
* uninsured
Exclusion Criteria
* 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
18 Years
26 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eastern Virginia Medical School
OTHER
Responsible Party
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Alicia Devine, MD
Principal Investigator
Principal Investigators
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Alicia Devine, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School
Locations
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Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Countries
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Central Contacts
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References
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Bosch X, Harper D. Prevention strategies of cervical cancer in the HPV vaccine era. Gynecol Oncol. 2006 Oct;103(1):21-4. doi: 10.1016/j.ygyno.2006.07.019. Epub 2006 Aug 17. No abstract available.
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. doi: 10.1016/s0889-8545(02)00021-9.
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. doi: 10.1016/j.ygyno.2006.07.022.
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. doi: 10.1006/gyno.1998.5135.
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. doi: 10.1086/516784. Epub 2007 Apr 16.
Related Links
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American Cancer Society
American College of Obstetrics and Gynecology
Other Identifiers
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33249
Identifier Type: -
Identifier Source: org_study_id