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

NCT01133509 | Unknown DMC

• 1 other identifier: 33249
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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..

Conditions

Genital Human Papilloma Virus Infection

Outcome Measures

Primary Outcomes (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

  two years

Study Arms (1)

gardisil

OTHER

gardisil

Drug: Gardasil

Interventions

Gardasil DRUG

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

Also known as: Human Papillomarvirus, HPV vaccine, Gardisil, Silgard

gardisil

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of beginning sexual activity or by age 21 years whichever occur first.
• resident of the City of Norfolk, Virginia
• uninsured

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 16919714 BACKGROUND

• 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.

  PMID: 12509097 BACKGROUND

• 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.

  PMID: 16979432 BACKGROUND

• 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.

  PMID: 9887244 BACKGROUND

• 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.

  PMID: 17471427 BACKGROUND

Related Links

• American Cancer Society
• American College of Obstetrics and Gynecology
• United States Preventative Service Task Force

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Viral Vaccines

Study Officials

• Alicia Devine, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Devine, MD

CONTACT

757-388-3397; aliciadevine@mac.com

LaBarbara Edlow, RN

CONTACT

757-388-5224; ldedlow@sentara.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: May 31, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

US (1)