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

Centre Hospitalier Universitaire Saint Pierre103 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

103

Conditions

Hepatitis C, Chronic

Interventions

GeneXpert HCV VL Fingerstick testDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Saint-Pierre

Brussels, Belgium

Outcomes

Primary Outcomes

Evaluation of interest and impact of this new method by the number of participants tested in outreach approaches

Time frame: 1 year after the start of recruitment

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: one year after enrollment

Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and the initiation of antiviral treatment

Time frame: 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)

Time frame: up one year after enrollment

Data from ClinicalTrials.gov

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