Strategic Screening for Infectious Diseases (Tuberculosis, HIV, HBV, HCV) Amongst Migrants in France
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
- 是
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
Dr Martin Duracinsky
Dr
University Paris 7 - Denis Diderot
