Genital Human Papilloma Virus Infection
Conditions
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..
Interventions
DRUGGardasil
0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months
Sponsors
Merck Sharp & Dohme LLC
Eastern Virginia Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 26 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactAlicia Devine, MD
Backup ContactLaBarbara Edlow, RN
Outcome results
None listed