Clinical trial NCT04610762: HCV RNA Fingerstick Assay as Useful Point of Care of Diagnostic Tool for Drug Users in Brussels
Official title: Using the Cepheid GeneXpert HCV VL Fingerstick Test as a Diagnostic Tool for Chronic Hepatitis C Among Drug Users in Brussels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Keywords: Drug user, Point-of-care of molecular diagnostics, hepatitis C RNA, Fingerstick, GeneXpert HCV Viral Load, linkage to care
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: Cepheid
name: Réseau Hépatite C Bruxelles
name: Gilead Sciences
name: AbbVie
First posted: 2020-10-30
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All marginalized (ex) drug users with a positive serology (for HCV) without a confirmed diagnosis of chronic hepatitis C, who are in contact with the Réseau Hépatite C Bruxelles organization and other front-line partners in Brussels

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of interest and impact of this new method by the number of participants tested in outreach approaches
timeFrame: 1 year after the start of recruitment
Secondary outcomes:
measure: Acceptability by the participants of the use of the Cepheid GeneXpert HCV VL Fingerstick
timeFrame: on day of enrollment
measure: Number of participants with a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick who will be taken in charge by hepatologist
timeFrame: one year after enrollment
measure: Number of participants with a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick who will initiate a anti-viral treatment
timeFrame: one year after enrollment
measure: 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
timeFrame: one year after enrollment
measure: Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and the initiation of antiviral treatment
timeFrame: up one year after enrollment
measure: Time between a positive HCV RNA test with Cepheid GeneXpert HCV VL Fingerstick and a recovery defined by a Sustained Virological Response (SVR)
timeFrame: up one year after enrollment
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Jean-Pierre Mulkay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ASBL Réseau Hépatite C Bruxelles
name: Lise Meunier, MD
role: PRINCIPAL_INVESTIGATOR
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