Genital Human Papilloma Virus Infection Clinical Trial
Official title:
A Model for the Implementation of the Cervical Cancer Screening and HPV Vaccination in the Emergency Department: a Pilot Study.
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..
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01654822 -
AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
|
Phase 2 |