Towards Ending HCV Infection Among Active Drug Users: a Community-based Intervention in Montpellier.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- Proportion of treated and cured DU participants.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age> 18 years
- •Be an active drug user defined by:
- •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
- •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).
排除标准
- •Inability to understand the study
- •Be under guardianship, curatorship or future protection mandate
- •Lack of informed consent
研究组 & 干预措施
All patients
All participants recruited during the RDS survey.
干预措施: HCV screening (Diagnostic Test)
HCV infected patients
HCV-RNA assay (GeneXpert, Cepheid) will be performed to determine if patients have chronic hepatitis C (defined by HCV-RNA>10 UI/mL)
干预措施: Diagnosis of hepatitis C (Diagnostic Test)
Patients with hepatitis C
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.
干预措施: HCV treatment (Drug)
结局指标
主要结局
Proportion of treated and cured DU participants.
时间窗: 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.
次要结局
- Proportion of participants with detectable HCV-RNA(Screening RDS)
- Rate of reinfection(Week 48)
- HIV infection rate and ART coverage(Screening RDS)
- Estimated number of drug users in the city of Montpellier(Screening RDS)
- Proportion of participants initiating anti-viral treatment(Day 0)
- Proportion of participants with a HCV positive serology(Screening RDS)
- Hepatitis B infection rate(Screening RDS)