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Completed

NCT Number: NCT04610762

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chemically-Induced Disorders Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Drug Misuse Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Pierre

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GeneXpert HCV VL Fingerstick test

Diagnostic 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.

Primary outcomes

  1. 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

  1. Acceptability by the participants of the use of the Cepheid GeneXpert HCV VL Fingerstick

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: one year after enrollment

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Collaborators

  • AbbVie
  • Cepheid
  • Gilead Sciences
  • Réseau Hépatite C Bruxelles

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 30, 2020
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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