HCV RNA Fingerstick Assay as Useful Point of Care of Diagnostic Tool for Drug Users in Brussels
Completed
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT04610762
- Lead Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Brief Summary
The main objective of this study is to assess the interest (linkage to care) of the Cepheid GeneXpert HCV VL Fingerstick test in Brussels among drug users or former users in contact with the Réseau Hépatite C Bruxelles organization through different partners of this network.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
- (ex) drug users
- a risk of Hepatitis C infection
- French speaking
- Either patient with a positive serology for HCV who have never performed HCV RNA by Polymerase chain reaction (PCR) by a peripheral venous sampling (due to difficult venous access, financial problem, medical insurance problem or other reasons) either patient with a suspicion of reinfection for whom the HCV RNA PCR by peripheral venous sampling is not reimbursed by health insurance
Exclusion Criteria
- Age <18 years
- Cepheid GeneXpert HCV VL Fingerstick will not use to assess the Sustained Virological Response (SVR) at 12 weeks after the end of an antiviral treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of interest and impact of this new method by the number of participants tested in outreach approaches 1 year after the start of recruitment
- Secondary Outcome Measures
Name Time Method Acceptability by the participants of the use of the Cepheid GeneXpert HCV VL Fingerstick on day of enrollment The participants will answer to a qualitative questionnaire about the Cepheid device and will give their preference between the Cepheid GeneXpert HCV VL test to routine venous tests
Number of participants with a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick who will be taken in charge by hepatologist one year after enrollment Number of participants with a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick who will initiate a anti-viral treatment one year after enrollment Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and the initiation of antiviral treatment up one year after enrollment Number of participants with a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick who have a Sustained Virological Response (SVR) at 12 weeks after the end of treatment one year after enrollment Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and a recovery defined by a Sustained Virological Response (SVR) up one year after enrollment
Trial Locations
- Locations (1)
CHU Saint-Pierre
🇧🇪Bruxelles, Belgium
CHU Saint-Pierre🇧🇪Bruxelles, Belgium