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

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: HCV Infection; Drug Use

Treatments: Drug: HCV treatment; Diagnostic Test: Diagnosis of hepatitis C; Diagnostic Test: HCV screening

Study type: Interventional

Funder types: Other

Identifiers

NCT04008927

ANRS 95050 ICONE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 554 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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554 participants in 3 patient groups

All patients

Other group

Description:

All participants recruited during the RDS survey.

Treatment:

Diagnostic Test: HCV screening

HCV infected patients

Other group

Description:

HCV-RNA assay (GeneXpert, Cepheid) will be performed to determine if patients have chronic hepatitis C (defined by HCV-RNA\>10 UI/mL)

Treatment:

Diagnostic Test: Diagnosis of hepatitis C

Patients with hepatitis C

Other group

Description:

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.

Treatment:

Drug: HCV treatment