A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study
|ClinicalTrials.gov Identifier: NCT01133509|
Recruitment Status : Unknown
Verified August 2012 by Alicia Devine, MD, Eastern Virginia Medical School.
Recruitment status was: Recruiting
First Posted : May 31, 2010
Last Update Posted : August 23, 2012
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 or disease||Intervention/treatment||Phase|
|Genital Human Papilloma Virus Infection||Drug: Gardasil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Model for the Implementation of the Cervical Cancer Screening and HPV Vaccination in the Emergency Department: a Pilot Study.|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||October 2012|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133509
|Contact: Alicia Devine, MDfirstname.lastname@example.org|
|Contact: LaBarbara Edlow, RNemail@example.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|