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Completed

NCT Number: NCT04008927

A Community-based Intervention Among Active Drug Users 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.

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Key information

Conditions

Drug Use Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections HCV Infection Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Montpellier

Montpellier, 34394, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCV screening

Diagnostic Test

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.

Diagnosis of hepatitis C

Diagnostic Test

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.

HCV treatment

Drug

Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of participants with a HCV positive serology

    Time frame: Screening RDS

    Proportion of participants with a HCV positive serology among all participants

  2. 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

  3. 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

  4. 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

  5. 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

  6. Hepatitis B infection rate

    Time frame: Screening RDS

    Proportion of participants with HBs antigene and positive B-DNA at baseline

  7. 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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

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

Acronym: ICONE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 5, 2019
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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