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

Primary Purpose

Genital Human Papilloma Virus Infection

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gardasil
Sponsored by
Eastern Virginia Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Human Papilloma Virus Infection

Eligibility Criteria

18 Years - 26 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sentara Norfolk General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

gardisil

Arm Description

gardisil

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
November 4, 2008
Last Updated
August 21, 2012
Sponsor
Eastern Virginia Medical School
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01133509
Brief Title
A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study
Official Title
A Model for the Implementation of the Cervical Cancer Screening and HPV Vaccination in the Emergency Department: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Virginia Medical School
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. 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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Human Papilloma Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gardisil
Arm Type
Other
Arm Description
gardisil
Intervention Type
Drug
Intervention Name(s)
Gardasil
Other Intervention Name(s)
Human Papillomarvirus, HPV vaccine, Gardisil, Silgard
Intervention Description
0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Devine, MD
Phone
757-388-3397
Email
aliciadevine@mac.com
First Name & Middle Initial & Last Name or Official Title & Degree
LaBarbara Edlow, RN
Phone
757-388-5224
Email
ldedlow@sentara.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Devine, MD
Organizational Affiliation
Eastern Virginia Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia S Devine, MD, JD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16919714
Citation
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.
Results Reference
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PubMed Identifier
12509097
Citation
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.
Results Reference
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PubMed Identifier
16979432
Citation
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.
Results Reference
background
PubMed Identifier
9887244
Citation
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.
Results Reference
background
PubMed Identifier
17471427
Citation
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.
Results Reference
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Links:
URL
http://www.cdc.gov/std/hpv/default.htm
Description
Center of Disease Control
URL
http://www.acog.org/
Description
American College of Obstetrics and Gynecology
URL
http://www.ahrq.gov/clinic/uspstfix.htm
Description
United States Preventative Service Task Force

Learn more about this trial

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

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