Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests As a Tool for Screening and Access to Care Among At-Risk Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 327
- 试验地点
- 2
- 主要终点
- Accessibility of Testing Results
研究概览
简要总结
This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM).
Infection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly.
The overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •At least 18 years of age
- •Seeking care at the CASO MDM health care center
- •Accept to be followed at Saint-Antoine Hospital in the event of a positive test.
排除标准
- •Currently under physician's care for viral hepatitis (HBV/HCV-specific) or HIV
- •Already has been tested (must give any of the following as evidence):
- •results from HBV and HCV and HIV tests dating at least 3 months back
- •results from HCV and HIV tests dating at least 3 months back and HBV serology indicating that the participant is immunized against HBV.
结局指标
主要结局
Accessibility of Testing Results
时间窗: Evaluated once, up to 4 months after testing
The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.
次要结局
- Access to Care(Evaluated once, up to 4 months after testing)