Community Intervention to Eliminate HCV Among People Who Use Drugs.

NCT05794646 | Active Not Recruiting DMC

• 1 other identifier: ANRS 0336s ICONE 2
• Study Type: interventional
• Target: 3,400
• Locations: 2 countries
• Sites: 4

Brief Summary

The goal of this interventional study is twofold with the evaluation of the feasibility and potential usefulness of an implementation strategy, and the efficiency of a community-based model of mass screening and immediate treatment of hepatitis C among People Who Use Drugs (PWUD) in three major cities in mainland France (Paris, Lyon and Marseille) and in one overseas city (Fort-de-France). The investigators will also describe the psychological and infectious comorbidities of drug users, determine the stages of the HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), HIV (Human Immunodeficiency Virus) care cascade, and analyze the factors associated with HCV treatment failure. A qualitative study will investigate the acceptability of the RDS model. Participants will be screened in an out of bound research center and receive appropriate treatment for infectious, addictological and psychiatric troubles. They will receive coupons to give to their peers for them to participate in the study. Researchers will also compare the acceptability of referral to psychiatric care directly at the research site (intervention group) with that of referral directly to a city facility (control group).

Conditions

HCV; Substance Use Disorders

Keywords

Hepatitis C Virus; mental health; RDS; peers; Test and Treat; People who use drugs

Outcome Measures

Primary Outcomes (2)

• Percentage of HCV cured PWUD participants (SVR12) among those with a positive HCV viral load at baseline

  Number of HCV cured PWUD participants, defined as SVR12, i.e. undetectable HCV RNA viral load in a veinous sample measured by quantitative PCR (polymerase chain reaction) 12 weeks after the end of the antiviral treatment; divided by the number of participants with a positive HCV viral load in a veinous sample at baseline.

  12 weeks after the end of the 2 to 3 months HCV treatment

• Acceptability and relevance of the RDS and implementation strategy : a qualitative study

  The investigators will use a socio-anthropological method to target the PWUD participating in the RDS as well as the workers in the places where the RDS will have started. In each study city, 15 semi-structured interviews will be conducted with PWUD who participated in the RDS. Participants who are not followed up in outreach structures will be over-represented to delve deeper into the pathways of these individuals. Two focus groups in each city will be carried-out (one before the implementation of the RDS and one at the end of the study), in order to collect their feelings on the use and relevance of the toolkit for the implementation of the RDS. The interviews and focus groups will be conducted using an interview grid that will be constructed to meet the objectives of the study. This grid will guide the investigators around different main themes: people's backgrounds, role of the facilitators, perception of RDS (understanding, acceptability, strengths and weaknesses).

  From before the RDS implementation until the end of the study, up to 2 years

Secondary Outcomes (22)

• Number of PWUD in the arrondissements of Paris (neighborhoods involved in seed distribution), and the cities of Lyon, Marseille and Fort-de-France

  At the end of the RDS

• Proportion of participants with positive HCV RNA among all participants

  At baseline

• Assessment of HCV cascade of care at inclusion : participants with a positive HCV RDT

  At baseline

• Assessment of HCV cascade of care at inclusion : participants with known HCV status

  At baseline

• Assessment of HCV cascade of care at inclusion : participants who were treated for HCV

  At baseline

Study Arms (1)

Intervention

OTHER

Community-based intervention with screening and treatment initiation for HCV elimination among PWUD

Other: Hybrid effectiveness-implementation study type 2

Interventions

Hybrid effectiveness-implementation study type 2 OTHER

Diagnosis of hepatitis C; Assessment of hepatic fibrosis; Treatment of hepatitis C; Assessment of psychological disorders and treatment or referral.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• Person who uses drugs, defined as:
• Reported psychoactive substance use and
• Positive urine test for at least one of the following: heroin, amphetamines, cocaine, MDMA (methylenedioxymethamphetamine), ecstasy, or misused opioid medications (methadone, buprenorphine or opiates used for a reason other than its original prescription (effects seeking) or used in a way that does not comply with its marketing authorisation (injected, snorted, taken multiple times beyond the prescribed dosage)) ;
• Informed and signed consent

You may not qualify if:

• Inability to understand the study;
• Being under guardianship, curatorship or mandate of future protection;

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (4)

Lyon

Lyon, Auvergne-Rhône-Alpes, 69000, France

Location

Marseille

Marseille, PACA, 13000, France

Location

Paris

Paris, Île-de-France Region, 75000, France

Location

Martinique

Fort-de-France, Martinique, 97200, Martinique

Location

MeSH Terms

Conditions

Substance-Related Disorders; Hepatitis C; Psychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Personal Satisfaction; Behavior

Study Officials

• Hélène Donnadieu, PhD

  PCCEI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This type 2 hybrid 'effectiveness-implementation' study makes it possible to simultaneously evaluate the efficiency of the model on clinical criteria of HCV cure, and its feasibility by measuring the potential obstacles and the relevance of its implementation.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 3, 2023
• Study Start: October 2, 2023
• Primary Completion: May 16, 2025
• Study Completion: September 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication and for 15 years.
• Access Criteria: Open to anyone at https://recherche.data.gouv.fr/

Locations

MA (1); FR (3)