A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study

Eastern Virginia Medical School (EVMS)

Status: Unknown

Conditions: Genital Human Papilloma Virus Infection

Treatments: Drug: Gardasil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01133509

33249

Details and patient eligibility

About

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..

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

gardisil

Other group

Description:

gardisil

Treatment:

Drug: Gardasil