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临床试验/NCT01133509
NCT01133509Unknown不适用

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

Eastern Virginia Medical School1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
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

研究概览

简要总结

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..

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 3 years of beginning sexual activity or by age 21 years whichever occur first.
  • resident of the City of Norfolk, Virginia
  • uninsured

排除标准

  • Pregnant women
  • Women with Hysterectomy with cervical excision
  • Women who received full HPV vaccine series
  • Known history of cervical cancer
  • Loop electrocautery excision procedure(LEEP)
  • Cold-Knife conization

研究组 & 干预措施

gardisil

Other

gardisil

干预措施: Gardasil (Drug)

结局指标

主要结局

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

时间窗: two years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alicia Devine, MD

Principal Investigator

Eastern Virginia Medical School

研究点 (1)

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