Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04008927
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2019-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Community-based Intervention Among Active Drug Users in Montpellier
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
Official Title:
Towards Ending HCV Infection Among Active Drug Users: a Community-based Intervention in Montpellier.
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICONE
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: