A Community-based Intervention Among Active Drug Users in Montpellier

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-18

Study Completion Date

2021-09-10

Brief Summary

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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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Detailed Description

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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

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Drug Use HCV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Effectiveness-implementation hybrid study type 2. This study design will simultaneously allow assessing the effectiveness of the model, using the percentage of HCV cure as criteria, and the feasibility by measuring potential obstacles during implementation.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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All patients

All participants recruited during the RDS survey.

Group Type OTHER

HCV screening

Intervention Type 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.

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)

Group Type OTHER

Diagnosis of hepatitis C

Intervention Type 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.

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.

Group Type OTHER

HCV treatment

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

HCV treatment

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

Intervention Type DRUG

Eligibility Criteria

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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).