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临床试验/NCT03088995
NCT03088995已完成不适用

Pre-operative Screening for HIV and Viral Hepatitis B and C: Pilot Study in Stomatology

Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
Measure of viral hepatitis B infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment

研究概览

简要总结

The purpose of the OPDEP pilot study is to assess the feasibility of implementing a pre-operative HIV / HCV / HBV screening proposal for all persons over 18 years of age and refer for surgical intervention under general anesthesia in the Department of Stomatology of the Pitié-salpêtrière hospital.

Patients undergoing treatment in Stomatology have particular areas at risk for the infections we are looking for: young patients, precarious situation, drug use, migrants ...

The aim is to evaluate the conditions for a generalization of screening in the framework of the preoperative assessment.

详细描述

The HIV epidemic is still active in France, with 7 000 to 8 000 new infections per year.There are an estimated 150,000 people living with HIV in France. Data from the hidden epidemic show that:

  • approximately 30,000 patients are unaware of their HIV status
  • that the Ile de France area accounts for 44% of new infections. For over 20 years, the patient-initiated HIV counseling and testing system has helped thousands of people to know about their HIV status, but coverage for counseling and testing low. In 2007, WHO and UNAIDS published guidance on provider-initiated HIV counseling and testing in health facilities to improve acceptance and access to prevention, treatment And care.

It is in this context that, in France, the National Plan for the Fight against AIDS and Sexually Transmitted Infections (STI) 2010-2014 recommended strengthening the screening strategies, making it its Public Health dimension, Reintegrating into an overall preventive approach. The expected benefits of routine screening would thus be individual as well as collective: routine screening could be a means of controlling infection by modifying risk behaviors, it could be a preventive tool by allowing earlier diagnosis Of the disease, it could be associated with an evolution of the management and the prognosis of the infection by allowing the initiation of an antiretroviral treatment in the acute phase of the infection. In 2011, the Ministry of Health systematized the screening proposal to the entire population, considering this strategy as cost-effective with a direct individual benefit and a Public Health benefit by reducing the number of transmission. In this Plan, health authorities recommend that hospital doctors and city general practitioners prescribe HIV testing much more widely than they do, while targeting persons belonging to an identified risk group and those Low "apparent" risk.

Screening remains a critical problem in the management with 20-30% of patients diagnosed at a late stage (CD4 <200 / mm3).

According to the Institute of Health Watch, about 100 000 hepatitis C viral patients are undiagnosed in France with differences in prevalence according to sex and age.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and women
  • > 18 years
  • address for surgical intervention under general anesthesia in the Department of Stomatology of Pitié-Salpêtrière.
  • have given their oral consent during the consultation of anesthesia.

排除标准

  • refusal of screening
  • any patient already known to be HIV-positive / HBV / HCV.

结局指标

主要结局

Measure of viral hepatitis B infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment

时间窗: 12 months

Measure of viral hepatitis B infection assessed by serology using ARCHITECT AgHBs qualitative II kit

Measure of HIV infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment

时间窗: 12 months

Measure of HIV infection assessed by serology using ARCHITECT Ag/Ac VIH Combo kit

Measure of viral hepatitis C infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment

时间窗: 12 months

Measure of viral hepatitis C infection assessed by serology using ARCHITECT Anti-HCV kit

次要结局

未报告次要终点

研究者

发起方
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
申办方类型
Other
责任方
Sponsor

研究点 (1)

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