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

Sponsor
Centre Hospitalier Universitaire Saint Pierre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04610762
Collaborator
Cepheid (Industry), Réseau Hépatite C Bruxelles (Other), Gilead Sciences (Industry), AbbVie (Industry)
300
Enrollment
1
Location
24.4
Anticipated Duration (Months)
12.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: GeneXpert HCV VL Fingerstick test

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Using the Cepheid GeneXpert HCV VL Fingerstick Test as a Diagnostic Tool for Chronic Hepatitis C Among Drug Users in Brussels
Actual Study Start Date :
Nov 17, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Diagnostic Test: GeneXpert HCV VL Fingerstick 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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of interest and impact of this new method by the number of participants tested in outreach approaches [2 years after the start of recruitment]

Secondary Outcome Measures

  1. 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

  2. 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]

  3. 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]

  4. 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]

  5. Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and the initiation of antiviral treatment [up one year after enrollment]

  6. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Saint-Pierre Bruxelles Belgium 1000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Saint Pierre
  • Cepheid
  • Réseau Hépatite C Bruxelles
  • Gilead Sciences
  • AbbVie

Investigators

  • Principal Investigator: Jean-Pierre Mulkay, MD, Centre Hospitalier Universitaire Saint Pierre
  • Principal Investigator: Lise Meunier, MD, ASBL Réseau Hépatite C Bruxelles

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT04610762
Other Study ID Numbers:
  • CE/20-10-01
First Posted:
Oct 30, 2020
Last Update Posted:
Feb 9, 2022
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire Saint Pierre
Drug user, Point-of-care of molecular diagnostics, hepatitis C RNA, Fingerstick, GeneXpert HCV Viral Load, linkage to care
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis

Study Results

No Results Posted as of Feb 9, 2022