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

Overview

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..

Full Title of Study: “A Model for the Implementation of the Cervical Cancer Screening and HPV Vaccination in the Emergency Department: a Pilot Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: Gardasil
    • 0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months

Arms, Groups and Cohorts

  • Other: gardisil
    • gardisil

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 26 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eastern Virginia Medical School
  • Collaborator
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alicia Devine, MD, Principal Investigator – Eastern Virginia Medical School
  • Overall Official(s)
    • Alicia Devine, MD, Principal Investigator, Eastern Virginia Medical School
  • Overall Contact(s)
    • Alicia Devine, MD, 757-388-3397, aliciadevine@mac.com

References

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.

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