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..
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | October 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 26 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Eastern Virginia Medical School | Merck Sharp & Dohme Corp. |
United States,
Bosch X, Harper D. Prevention strategies of cervical cancer in the HPV vaccine era. Gynecol Oncol. 2006 Oct;103(1):21-4. Epub 2006 Aug 17. Review. — View Citation
Kinney W, Sung HY, Kearney KA, Miller M, Sawaya G, Hiatt RA. Missed opportunities for cervical cancer screening of HMO members developing invasive cervical cancer (ICC). Gynecol Oncol. 1998 Dec;71(3):428-30. — View Citation
Lonky NM. Risk factors related to the development and mortality from invasive cervical cancer clinical utility and impact on prevention. Obstet Gynecol Clin North Am. 2002 Dec;29(4):817-42, viii. Review. — View Citation
Plummer M, Schiffman M, Castle PE, Maucort-Boulch D, Wheeler CM; ALTS Group. A 2-year prospective study of human papillomavirus persistence among women with a cytological diagnosis of atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion. J Infect Dis. 2007 Jun 1;195(11):1582-9. Epub 2007 Apr 16. — View Citation
Society of Gynecologic Oncologists Education Resource Panel Writing group, Collins Y, Einstein MH, Gostout BS, Herzog TJ, Massad LS, Rader JS, Wright J. Cervical cancer prevention in the era of prophylactic vaccines: a preview for gynecologic oncologists. Gynecol Oncol. 2006 Sep;102(3):552-62. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01654822 -
AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections
|
Phase 2 |