A Community-based Intervention Among Active Drug Users in Montpellier

Not Applicable

Completed

• Conditions: Drug Use; HCV Infection
• Interventions: Drug: HCV treatment; Diagnostic Test: Diagnosis of hepatitis C; Diagnostic Test: HCV screening

• Registration Number: NCT04008927
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Study Start: 2020-09-18
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with hepatitis C	HCV treatment	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.
HCV infected patients	Diagnosis of hepatitis C	HCV-RNA assay (GeneXpert, Cepheid) will be performed to determine if patients have chronic hepatitis C (defined by HCV-RNA\>10 UI/mL)
All patients	HCV screening	All participants recruited during the RDS survey.

Primary Outcome Measures

Name	Time	Method
Proportion of treated and cured DU participants.	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 Outcome Measures

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

Trial Locations

Locations (1)

CHU Montpellier; 🇫🇷 Montpellier, France