The study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France.
Active DUs will be recruited using a Respondent-Driven Sampling (RDS) method. Hosted in the temporary community care facility (the research site), located outside the existing care facilities in the city, participants will benefit from HCV/HIV/HBV screening, on-site measurement of HCV-RNA and liver fibrosis, early treatment, treatment follow-up and risk and harm reduction tools related to their risk practices. Peers will be present in this unique structure and will accompany participants throughout their treatment. Participants will be referred during treatment to existing care facilities but followed up in the research up to 44 to 48 weeks after initiation of treatment to assess the rate of re-infection. The number of active DUs in the population will be estimated by using a capture/recapture method nested in the RDS survey Secondary objectives of the research are: * To estimate the seroprevalence of hepatitis C in active DUs in Montpellier; * To estimate the size of the active DUs population in the city of Montpellier using a capture/recapture method; * To estimate HCV care cascade steps in active DUs in Montpellier; * To identify the factors associated with HCV treatment failure; * To determine the proportion of treated and cured HCV patients who re-infect within months after end of treatment; * To estimate the seroprevalence of hepatitis B and HIV infection in active DUs in Montpellier.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
554
All patients will have HCV screening using rapid tests. HIV and HBV testing will also be conducted and patients will be appropriately referred to appropriate health services.
HCV-RNA assay (GeneXpert, Cepheid) will be performed for all participants with positive HCV serology to determine if patients have chronic hepatitis C (defined by HCV-RNA\>10 UI/mL). In addition a measure of the liver stiffness will be performed.
Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.
CHU Montpellier
Montpellier, France
Proportion of treated and cured DU participants.
Proportion of treated and cured DU participants among those with a detectable HCV-RNA at pre-inclusion.
Time frame: SVR12 (12 weeks after end of HCV treatment)
Proportion of participants with a HCV positive serology
Proportion of participants with a HCV positive serology among all participants
Time frame: Screening RDS
Estimated number of drug users in the city of Montpellier
Estimated number of drug users in the city of Montpellier by capture/recapture survey
Time frame: Screening RDS
Proportion of participants with detectable HCV-RNA
Proportion of patients with HCV RNA \> 10 IU/mL among those with positive HCV serology
Time frame: Screening RDS
Proportion of participants initiating anti-viral treatment
Proportion of patients with chronic hepatitis who initiate the treatment among patients with HCV-RNA \>10 UI/mL
Time frame: Day 0
Rate of reinfection
Proportion of cured participants re-infected within months after end of treatment defined by positive HCV-RNA of different genotype at SVR12 or by positive HCV-RNA at W44/48
Time frame: Week 48
Hepatitis B infection rate
Proportion of participants with HBs antigene and positive B-DNA at baseline
Time frame: Screening RDS
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HIV infection rate and ART coverage
Proportion of participants with positive HIV serology at baseline and proportion of participants with anti-viral treatment among HIV positive participants at baseline
Time frame: Screening RDS