A Community-based Intervention Among Active Drug Users in Montpellier

Study Overview
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Brief Summary
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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
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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.

Official Title
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Towards Ending HCV Infection Among Active Drug Users: a Community-based Intervention in Montpellier.

Conditions
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Drug Use, HCV Infection

Intervention / Treatment
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* Diagnostic Test: HCV screening
* Diagnostic Test: Diagnosis of hepatitis C
* Drug: HCV treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 years Be an active drug user defined by: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All patients<br>All participants recruited during the RDS survey. | Diagnostic Test: HCV screening<br>* 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.<br>|
| Other: HCV infected patients<br>HCV-RNA assay (GeneXpert, Cepheid) will be performed to determine if patients have chronic hepatitis C (defined by HCV-RNA>10 UI/mL) | Diagnostic Test: Diagnosis of hepatitis C<br>* 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.<br>|
| Other: Patients with hepatitis C<br>Patients diagnosed with chronic hepatitis C will be prescribed with DAA treatment on research site. After one month they will be referred to conventional health structure for treatment follow-up. | Drug: HCV treatment<br>* Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of treated and cured DU participants. | Proportion of treated and cured DU participants among those with a detectable HCV-RNA at pre-inclusion. | SVR12 (12 weeks after end of HCV treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with a HCV positive serology | Proportion of participants with a HCV positive serology among all participants | 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 | Screening RDS | 
| Proportion of participants with detectable HCV-RNA | Proportion of patients with HCV RNA > 10 IU/mL among those with positive HCV serology | 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 | 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 | Week 48 | 
| Hepatitis B infection rate | Proportion of participants with HBs antigene and positive B-DNA at baseline | Screening RDS | 
| 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 | Screening RDS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, RDS survey, Communauty-based intervention, Viral hepatitis C