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A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study
Recruitment status was: Recruiting
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Purpose
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 | Intervention |
|---|---|
| Genital Human Papilloma Virus Infection | Drug: Gardasil |
| Study Type: | Interventional |
| Study Design: | 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. |
- 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 26 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01133509
| Contact: Alicia Devine, MD | 757-388-3397 | aliciadevine@mac.com | |
| Contact: LaBarbara Edlow, RN | 757-388-5224 | ldedlow@sentara.com |
| United States, Virginia | |
| Sentara Norfolk General Hospital | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Principal Investigator: Alicia S Devine, MD, JD | |
| Principal Investigator: | Alicia Devine, MD | Eastern Virginia Medical School |
More Information
Additional Information:
Publications:
| Responsible Party: | Alicia Devine, MD, Principal Investigator, Eastern Virginia Medical School |
| ClinicalTrials.gov Identifier: | NCT01133509 History of Changes |
| Other Study ID Numbers: |
33249 |
| Study First Received: | November 4, 2008 |
| Last Updated: | August 21, 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 |
ClinicalTrials.gov processed this record on August 23, 2017