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

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Diagnostic Test: GeneXpert HCV VL Fingerstick test

• 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

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-10-30
• Study Start: 2020-11-17
• Primary Completion: 2021-11-17
• Study Completion: 2022-11-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

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

Arm && Interventions

Group	Intervention	Description
(Ex) Drug users recognized at-risk population of infection with Hepatitis C virus	GeneXpert HCV VL Fingerstick test	-

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