Clinical trial NCT05401136: Evaluating the Chain of Addiction Care (CAC)
Official title: Evaluating the Hepatitis C Chain of Addiction Care Pathway for People Who Inject(ed) Drugs in Addiction Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C, Chronic
Substance Use Disorders
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: AbbVie
name: Gilead Sciences
First posted: 2022-06-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PWID of 18 years or older who visit the participating addiction care centre

Brief summary: 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.

Detailed description: 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: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* none

Primary outcomes:
measure: HCV prevalence (both anti-HCV and HCV RNA).
timeFrame: At screening (week 0)
measure: Treatment acceptance rate.
timeFrame: After evaluation (~week 3)
measure: Sustained virologic response
timeFrame: 12 weeks after treatment (~week 30)
Secondary outcomes:
measure: Acceptance rate of on-site testing.
timeFrame: through study completion, an average of 1 year
measure: Re-infection rate.
timeFrame: through study completion, an average of 1 year
measure: Mean decrease in MET and BUP trough levels
timeFrame: through study completion, an average of 1 year
measure: Change in dosage of MET and BUP during follow-up
timeFrame: through study completion, an average of 1 year
measure: Patient reported drug use
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: