HCV RNA Fingerstick Assay as Useful Point of Care of Diagnostic Tool for Drug Users in Brussels

Study Overview
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Brief Summary
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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.

Official Title
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Using the Cepheid GeneXpert HCV VL Fingerstick Test as a Diagnostic Tool for Chronic Hepatitis C Among Drug Users in Brussels

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Diagnostic Test: GeneXpert HCV VL Fingerstick test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| (Ex) Drug users recognized at-risk population of infection with Hepatitis C virus<br> | Diagnostic Test: GeneXpert HCV VL Fingerstick test<br>* The participants will have a molecular test (GeneXpert HCV VL Fingerstick, Cepheid) that quantifies hepatitis C virus (HCV) RNA levels directly from a fingerstick blood sample.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability by the participants of the use of the Cepheid GeneXpert HCV VL Fingerstick | 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 | on day of enrollment | 
| 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 | 
| 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 the initiation of antiviral treatment |  | up 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug user, Point-of-care of molecular diagnostics, hepatitis C RNA, Fingerstick, GeneXpert HCV Viral Load, linkage to care