Substance Use Disorders Clinical Trial
— ICONE2Official title:
Community Intervention to Eliminate HCV Among People Who Use Drugs. Implementation Study in the Cities of Paris, Marseille, Lyon and Fort-de-France, France.
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).
Status | Recruiting |
Enrollment | 3400 |
Est. completion date | June 15, 2025 |
Est. primary completion date | May 16, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Lyon | Lyon | Auvergne-Rhône-Alpes |
France | Marseille | Marseille | Paca |
France | Paris | Paris | Ile De France |
Martinique | Martinique | Fort-de-France |
Lead Sponsor | Collaborator |
---|---|
ANRS, Emerging Infectious Diseases |
France, Martinique,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Number of PWUD in the arrondissements of Paris (neighborhoods involved in seed distribution), and the cities of Lyon, Marseille and Fort-de-France | Estimated 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 | |
Secondary | Proportion of participants with positive HCV RNA among all participants | Number of participants with a positive HCV RNA divided by the number of participants | At baseline | |
Secondary | Assessment of HCV cascade of care at inclusion : participants with a positive HCV RDT | Number of participants with a positive HCV RDT | At baseline | |
Secondary | Assessment of HCV cascade of care at inclusion : participants with known HCV status | Number of participants with known HCV status (declarative) among participants with a positive HCV RDT | At baseline | |
Secondary | Assessment of HCV cascade of care at inclusion : participants who were treated for HCV | Number of participants who were treated for HCV (self-reported) among participants with known HCV status | At baseline | |
Secondary | Assessment of HCV cascade of care at inclusion : participants with known chronic hepatitis C status and undetectable HCV RNA | Number of participants with known chronic hepatitis C status and undetectable HCV RNA among participants who were treated for HCV | At baseline | |
Secondary | HCV treatment failure defined as detectable viral load 12 weeks after HCV treatment completion | HCV treatment failure defined as detectable HCV RNA viral load measured in a veinous sample by quantitative PCR 12 weeks after the end of the antiviral treatment | 12 weeks after the end of the 2 to 3 months HCV treatment | |
Secondary | Cost of the intervention per screened participant | All costs of the intervention divided by the number of participants screened | Through study completion, an expected time frame of 2 years | |
Secondary | Cost of the intervention per participant cured of hepatitis C | All costs of the intervention divided by the number of participants cured of hepatitis C | Through study completion, an expected time frame of 2 years | |
Secondary | Proportion of participants with a positive HIV RDT among participants | Number of participants with a positive HIV RDT divided by the number of participants | At baseline | |
Secondary | HIV care cascade assessment at inclusion : participants with known HIV status | Number of participants with known HIV status | At baseline | |
Secondary | HIV care cascade assessment at inclusion : HIV-positive participants on antiretroviral therapy | Number of HIV-positive participants on antiretroviral therapy among participants with known HIV status | At baseline | |
Secondary | HIV care cascade assessment at inclusion : participants on effective antiretroviral therapy | Number of participants on effective antiretroviral therapy (HIV RNA < 50 copies/ml) among HIV-positive participants on antiretroviral therapy | At baseline | |
Secondary | Proportion of participants with detectable HBsAg | Number of participants with detectable HBsAg divided by the number of participants | At baseline | |
Secondary | Proportion of participants in Fort-de-France with a positive PCR for gonorrhea | Number of participants in Fort-de-France with a positive PCR for gonorrhea divided by the number of participants in Fort-de-France | At baseline | |
Secondary | Proportion of participants in Fort-de-France with a positive PCR for chlamydia | Number of participants in Fort-de-France with a positive PCR for chlamydia divided by the number of participants in Fort-de-France | At baseline | |
Secondary | Proportion of participants in Fort-de-France with a positive test for syphilis | Number of participants in Fort-de-France with a positive test for syphilis divided by the number of participants in Fort-de-France | At baseline | |
Secondary | Prevalence of psychological pathologies | Prevalence of psychological pathologies diagnosed by the MINI questionnaire (nurse trained beforehand notably on the psychosis module) with the use of 3 modules: Major depressive episode, psychotic disorders and suicidal risk following the positive QST questionnaire | At baseline | |
Secondary | Success of infectious diseases referral | Proportion of participants referred to an infectious diseases structure who went to their consultation | At 6 months | |
Secondary | Success of addictological referral | Proportion of participants referred to an addictological structure who went to their consultation | At 6 months | |
Secondary | Success of psychiatric referral at 3 months | Proportion of participants referred to a psychiatric structure in the city who went to their consultation | At 3 months | |
Secondary | Success of psychiatric referral at 6 months | Proportion of participants referred to a psychiatric structure in the city who went to their consultation | At 6 months |
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