Drug Use, HCV Infection
Conditions
Keywords
Hepatitis C, RDS survey, Communauty-based intervention, Viral hepatitis C
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTHCV screening
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.
DIAGNOSTIC_TESTDiagnosis of hepatitis C
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.
DRUGHCV treatment
Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Effectiveness-implementation hybrid study type 2. This study design will simultaneously allow assessing the effectiveness of the model, using the percentage of HCV cure as criteria, and the feasibility by measuring potential obstacles during implementation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age\> 18 years * Be an active drug user defined by: 1. Report current and regular (Last uptake no more than 3 days ago and at least 10 times a month) use of illicit psychoactive substances other than cannabis (heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or misused medications (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine) AND 2. Positive urine test for a psychoactive substance other than cannabis (Heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or a misused medication (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine).
Exclusion criteria
* Inability to understand the study * Be under guardianship, curatorship or future protection mandate * Lack of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of treated and cured DU participants. | SVR12 (12 weeks after end of HCV treatment) | Proportion of treated and cured DU participants among those with a detectable HCV-RNA at pre-inclusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated number of drug users in the city of Montpellier | Screening RDS | Estimated number of drug users in the city of Montpellier by capture/recapture survey |
| Proportion of participants with detectable HCV-RNA | Screening RDS | Proportion of patients with HCV RNA \> 10 IU/mL among those with positive HCV serology |
| Proportion of participants initiating anti-viral treatment | Day 0 | Proportion of patients with chronic hepatitis who initiate the treatment among patients with HCV-RNA \>10 UI/mL |
| Proportion of participants with a HCV positive serology | Screening RDS | Proportion of participants with a HCV positive serology among all participants |
| Hepatitis B infection rate | Screening RDS | Proportion of participants with HBs antigene and positive B-DNA at baseline |
| HIV infection rate and ART coverage | Screening RDS | Proportion of participants with positive HIV serology at baseline and proportion of participants with anti-viral treatment among HIV positive participants at baseline |
| Rate of reinfection | Week 48 | 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 |
Countries
France
Outcome results
None listed