To hear about similar clinical trials, please enter your email below
Trial Title:
A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study
NCT ID:
NCT01133509
Condition:
Genital Human Papilloma Virus Infection
Conditions: Official terms:
Papillomavirus Infections
Papilloma
Vaccines
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gardasil
Description:
0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months
Arm group label:
gardisil
Other name:
Human Papillomarvirus, HPV vaccine, Gardisil, Silgard
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..
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
26 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sentara Norfolk General Hospital
Address:
City:
Norfolk
Zip:
23507
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alicia S Devine, MD, JD
Email:
Principal Investigator
Start date:
September 2009
Completion date:
October 2012
Lead sponsor:
Agency:
Eastern Virginia Medical School
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Eastern Virginia Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01133509
http://www.acog.org/
