NCT04008927

A Community-based Intervention Among Active Drug Users in Montpellier

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug Use
• HCV Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HCV 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_TEST	Diagnosis 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.
DRUG	HCV treatment	Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.

Timeline

• Start date: 2020-09-18
• Primary completion: 2021-09-10
• Completion: 2021-09-10
• First posted: 2019-07-05
• Last updated: 2022-07-22

Locations

1 site across 1 country: France