Evaluating the Hepatitis C Chain of Addiction Care Pathway for People Who Inject(ed) Drugs in Addiction Care
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- HCV prevalence (both anti-HCV and HCV RNA).
研究概览
简要总结
The investigators want to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. Secondary objective: to measure the impact of hepatitis C clearance on MET (+metabolite) and BUP (+metabolite) trough levels in patients on Opioid substitution Therapy (OST). This is an exploratory, observational study.
详细描述
People who (have) inject(ed) drugs (PWID) are at high risk for hepatitis C infection. Establishing adequate linkage to care in this population can be a challenge. Many of these patients receive opioid substitution, hepatitis C treatment possibly influences pharmacokinetics of those substitutes. This protocol describes a study on hepatitis C in people who (have) inject(ed) drugs (PWID), consisting of two substudies. 1) An exploratory, observational study in which we evaluate the decentralised hepatitis C care pathway in addiction care centres. 2) An observational pharmacokinetic study in hepatitis C patients on opioid substitution therapy (OST) embedded within the first study.
Rationale: 1) Many PWIDs are lost during the process of testing and linkage to care and do therefore not receive adequate hepatitis C treatment. Decentralising care in addiction care centres deems hospital visits unnecessary, an approach that has become increasingly popular in this population over the last few years. This practice however has not yet been evaluated in the Netherlands. 2) In the Netherlands the PWID population is often treated for opioid addiction by opioid substitution therapy (OST) with methadone (MET) or buprenorphine (BUP). There is evidence that liver inflammation has a negative effect on pharmacokinetics of drugs. Consequently, we hypothesize that HCV treatment results in reduced liver inflammation and a decrease in MET and/or BUP levels, which is clinically relevant in the PWID/OST population.
Objective
- to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. 2. to measure the impact of hepatitis C clearance on MET (+metabolites) and BUP (+metabolites) levels and craving in patients on OST.
Study design: This is an exploratory, observational study with a pharmacokinetic observational study embedded within the same population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Able and willing to give informed consent
- •Currently inject or previously injected drugs at least once, including nasal snorting of drugs using aids such as basepipes or straws.
- •Visit the participating addiction care centre at least once during the study period
排除标准
- 未提供
结局指标
主要结局
HCV prevalence (both anti-HCV and HCV RNA).
时间窗: At screening (week 0)
Participants are invited to undergo viral hepatitis screening (standard care)
Treatment acceptance rate.
时间窗: After evaluation (~week 3)
Participants with chronic HCV infection are invited to be treated (standard care)
Sustained virologic response
时间窗: 12 weeks after treatment (~week 30)
Participants who were treated and were 'cured' (standard care)
次要结局
- Change in dosage of MET and BUP during follow-up(through study completion, an average of 1 year)
- Patient reported drug use(through study completion, an average of 1 year)
- Re-infection rate.(through study completion, an average of 1 year)
- Acceptance rate of on-site testing.(through study completion, an average of 1 year)
- Mean decrease in MET and BUP trough levels(through study completion, an average of 1 year)