Community intervention to eliminate hepatitis C among drug users
Community Intervention to Eliminate HCV Among People Who Use Drugs. Implementation Study in the Cities of Paris, Marseille, Lyon and Fort-de-France, France.
This study is testing a community program to see if mass screening and immediate treatment for hepatitis C can help people who use drugs in major cities in France.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ANRS, Emerging Infectious Diseases Government |
| Locations | 4 sites (Lyon, Auvergne-Rhône-Alpes and 3 other locations) |
| Trial ID | NCT05794646 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the feasibility and effectiveness of a community-based model for mass screening and immediate treatment of hepatitis C among people who use drugs (PWUD) in major cities in France. Participants will be screened for HCV and other infectious and psychiatric conditions, with treatment provided on-site. The study also seeks to understand the psychological and infectious comorbidities of drug users and analyze factors associated with treatment failure. Additionally, a qualitative component will assess the acceptability of the recruitment model used in the study.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 18 years old who actively use drugs and have a positive urine test for specific substances.
Not a fit: Patients who are unable to understand the study or are under legal guardianship will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the prevalence of hepatitis C among high-risk populations, improving overall public health outcomes.
How similar studies have performed: Previous studies have shown success with community-based interventions for HCV treatment among similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 Exclusion criteria: * Inability to understand the study; * Being under guardianship, curatorship or mandate of future protection; * Person participating in another research study with an exclusion period still in progress at the time of pre-inclusion.
Where this trial is running
Lyon, Auvergne-Rhône-Alpes and 3 other locations
- Lyon — Lyon, Auvergne-Rhône-Alpes, France (Recruiting)
- Paris — Paris, Ile De France, France (Completed)
- Marseille — Marseille, Paca, France (Recruiting)
- Martinique — Fort-de-France, Martinique (Not_yet_recruiting)
Study contacts
- Principal investigator: Hélène Donnadieu, PhD — Pccei
- Study coordinator: Hélène Donnadieu, PhD
- Email: h-donnadieu@chu-montpellier.fr
- Phone: +33467337811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.