Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2020-03-01
2023-12-01
Brief Summary
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Detailed Description
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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: 1) 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants
Consecutive people who use drugs and visit the addiction care centre
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Gilead Sciences
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Von den Hoff DW, Berden FAC, Drenth JPH, Schellekens AFA; HepNed, NISPA. Implementation of a decentralized hepatitis C care pathway for people who use drugs in Dutch addiction care. Study protocol for the Hepatitis C: chain of addiction care (CAC) project. Addict Sci Clin Pract. 2022 Nov 30;17(1):67. doi: 10.1186/s13722-022-00350-1.
Other Identifiers
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2019-5939
Identifier Type: -
Identifier Source: org_study_id
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