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临床试验/NCT02959684
NCT02959684Unknown不适用

Strategic Screening for Infectious Diseases (Tuberculosis, HIV, HBV, HCV) Amongst Migrants in France

University Paris 7 - Denis Diderot18 个研究点 分布在 1 个国家目标入组 70,000 人开始时间: 2017年4月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70,000
试验地点
18
主要终点
Comparison of the number of HIV, HBV or HCV positive patients identified in both arms of the screening strategy.

研究概览

简要总结

To evaluate the efficacy of a new screening for infectious diseases: tuberculosis, HIV, HBV and HCV, based on risk factors questionnaires (TB screen for tuberculosis and TROD screen for HIV and hepatitis) amongst a population of legal migrants during their mandatory medical check-up. This study aims for a global improvement of screening and care for migrants.

详细描述

In France, the prevalence of infectious diseases such as tuberculosis, HIV/HBV/HCV is high amongst migrants originating from certain countries, hence the official guidelines recommending targeted testing. The rapid testing devices (TROD) give immediate results and reduce missed opportunities. However their use is not yet widespread and migrant populations remain insufficiently tested. Regarding the UNAIDS 90-90-90 goal, France is failing the screening part of the treatment cascade, while 90% of patients are treated and have undetectable viral load. Risk scores based on the best known risk factors for these infections (HIV/HBV/HCV) have previously been developed. They have helped build a pilot of a new unique questionnaire: TROD screen. An electronic survey, called TB screen, was designed to screen for tuberculosis amongst asylum seekers in Switzerland and validated. This survey enables to detect signs of active tuberculosis and may replace the use of pulmonary radiography, thus reducing exposure to X-rays.

It is a prospective multi-centric observational study validating screening tests for HIV/HBV/HCV in two phases:

  • Phase 1: a risk score will be validated, including a qualitative study analyzing its acceptability
  • Phase 2: its performance will be compared with that of a screening targeted based on the country of origin The phase 1 and phase 2 will include respectively 10.000 and 5000 participants.

For tuberculosis, the efficacy of the improved version of TB screen will be compared with a systematic radiography.

Participation to this study will be voluntary and independent from the delivery of a residence permit. Participants will be informed of it and will systematically receive information about prevention of those infectious diseases.

研究设计

研究类型
Observational
观察模型
Other
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

  • Migrants undergoing the routine medical visit
  • Giving informed consent (oral consent)

排除标准

  • Asylum seekers
  • Persons not understanding the questionnaire
  • Persons aware of their HIV, HBV or HCV positive status

结局指标

主要结局

Comparison of the number of HIV, HBV or HCV positive patients identified in both arms of the screening strategy.

时间窗: 2 years

Number of tuberculosis patients identified through the modified TB screen questionnaire

时间窗: 2 years

次要结局

  • Cost-effectiveness of the TROD screen questionnaire compared with a non-targeted screening, calculated in terms of cost per QALY (quality-adjusted life years) gained through this program(2 years)
  • Predictive value of the questionnaire TB screen.(2 years)
  • Predictive value of the questionnaire TROD screen.(2 years)
  • Number of HIV/HBV/HCV patients linked to care after being identified through TROD screen.(2 years)

研究者

发起方
University Paris 7 - Denis Diderot
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Martin Duracinsky

Dr

University Paris 7 - Denis Diderot

研究点 (18)

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