Community Intervention to Eliminate HCV Among People Who Use Drugs. Implementation Study in the Cities of Paris, Marseille, Lyon and Fort-de-France, France.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 3,400
- Locations
- 7
- Primary Endpoint
- Acceptability and relevance of the RDS and implementation strategy : a qualitative study
Study Overview
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).
Detailed Description
Current state of knowledge:
In France, the prevalence of chronic hepatitis C in the general population was 0.3% in 2015. However, this prevalence is much higher in certain population subgroups. Thus PWUD are a population at risk of HCV infection (risky behaviors, sharing injection equipment).
In order to achieve the goal of eliminating hepatitis C by 2025 in France, three types of actions must be taken: developing off-premises screening strategies, improving access to treatment, and improving prevention. These actions correspond to micro-elimination practices.
Although there are many possible sites of care for PWUD, many PWUD do not attend the prevention and care system.
Despite the advent of new direct antiviral agents (DAAs) that cure infection in more than 95% of cases and the indication to treat all PWUDs, access to HCV treatment in this at-risk group remains low. Better control of HCV infection in high-risk groups such as PWUD would, beyond the individual benefit, greatly reduce the dynamics of the epidemic.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Acceptability and relevance of the RDS and implementation strategy : a qualitative study
Time Frame: From before the RDS implementation until the end of the study, up to 2 years
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).
Percentage of HCV cured PWUD participants (SVR12) among those with a positive HCV viral load at baseline
Time Frame: 12 weeks after the end of the 2 to 3 months HCV treatment
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.
Secondary Outcomes
- 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)
- HCV treatment failure defined as detectable viral load 12 weeks after HCV treatment completion(12 weeks after the end of the 2 to 3 months HCV treatment)
- 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)
- Proportion of participants with detectable HBsAg(At baseline)
- Proportion of participants in Fort-de-France with a positive test for syphilis(At baseline)
- Assessment of HCV cascade of care at inclusion : participants who were treated for HCV(At baseline)
- Assessment of HCV cascade of care at inclusion : participants with known chronic hepatitis C status and undetectable HCV RNA(At baseline)
- Cost of the intervention per screened participant(Through study completion, an expected time frame of 2 years)
- Cost of the intervention per participant cured of hepatitis C(Through study completion, an expected time frame of 2 years)
- HIV care cascade assessment at inclusion : HIV-positive participants on antiretroviral therapy(At baseline)
- Proportion of participants with a positive HIV RDT among participants(At baseline)
- HIV care cascade assessment at inclusion : participants with known HIV status(At baseline)
- HIV care cascade assessment at inclusion : participants on effective antiretroviral therapy(At baseline)
- Proportion of participants in Fort-de-France with a positive PCR for gonorrhea(At baseline)
- Proportion of participants in Fort-de-France with a positive PCR for chlamydia(At baseline)
- Success of psychiatric referral at 6 months(At 6 months)
- Prevalence of psychological pathologies(At baseline)
- Success of infectious diseases referral(At 6 months)
- Success of addictological referral(At 6 months)
- Success of psychiatric referral at 3 months(At 3 months)