A Community-based Intervention Among Active Drug Users in Montpellier (ICONE)

July 21, 2022 updated by: ANRS, Emerging Infectious Diseases

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

554

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34394
        • CHU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All patients
All participants recruited during the RDS survey.
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.
Other: HCV infected patients
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
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.
Other: Patients with hepatitis C
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
Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of treated and cured DU participants.
Time Frame: 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.
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
Time Frame: Screening RDS
Proportion of participants with a HCV positive serology among all participants
Screening RDS
Estimated number of drug users in the city of Montpellier
Time Frame: Screening RDS
Estimated number of drug users in the city of Montpellier by capture/recapture survey
Screening RDS
Proportion of participants with detectable HCV-RNA
Time Frame: Screening RDS
Proportion of patients with HCV RNA > 10 IU/mL among those with positive HCV serology
Screening RDS
Proportion of participants initiating anti-viral treatment
Time Frame: Day 0
Proportion of patients with chronic hepatitis who initiate the treatment among patients with HCV-RNA >10 UI/mL
Day 0
Rate of reinfection
Time Frame: 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
Week 48
Hepatitis B infection rate
Time Frame: Screening RDS
Proportion of participants with HBs antigene and positive B-DNA at baseline
Screening RDS
HIV infection rate and ART coverage
Time Frame: 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
Screening RDS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: HELENE DONNADIEU-RIGOLE, MD, PhD, CHU Montpellier, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Actual)

September 10, 2021

Study Completion (Actual)

September 10, 2021

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 21, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 95050 ICONE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drug Use

Clinical Trials on HCV screening

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe