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

Centre Hospitalier Universitaire Saint Pierre

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Diagnostic Test: GeneXpert HCV VL Fingerstick test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04610762

CE/20-10-01

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

103 participants in 1 patient group

(Ex) Drug users recognized at-risk population of infection with Hepatitis C virus

Treatment:

Diagnostic Test: GeneXpert HCV VL Fingerstick test