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Hepatitis c care at opioid clinics boosts treatment access

NCT ID NCT03155906

Disease control Sponsor: Haukeland University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether offering hepatitis C treatment at the same clinic where people receive opioid therapy leads to better outcomes than referring them to a separate infectious disease clinic. About 298 people on opioid therapy with chronic hepatitis C took part. The goal was to see if integrated care increases the number of people cured and improves treatment adherence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Integrated healthcare delivery (HCV treatment at opioid substitution therapy clinics)
What this could lead to
If this approach works, it could make hepatitis C treatment much easier for people on opioid therapy, leading to higher cure rates and fewer new infections.
What could go wrong
This is a completed trial, but the integrated model may not work in all settings or for all patients. Also, reinfection remains a risk if drug use continues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

298 people

The number who actually took part.

Started

May 2017

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Receiving OST from included outpatient clinic * Chronically infected with HCV (HCV RNA positive and also HCV RNA positive or anti-HCV at least 6 months before inclusion) * Eligible for treatment according to national guidelines (criteria specified below) * Obtaining informed consent At the time of study initiation , eligibility for treatment according to national guidelines was defined as follows: * Genotype 1 and 4 independent of degree of fibrosis * Genotype 2 and 3, dependent on significant fibrosis. Significant fibrosis will be assessed with FibroScan indicating elastography of above 7 kPa. Where elastography cannot be obtained, significant fibrosis will be assessed with AST to platelet ratio index (APRI score) of \> 0.7 (http://www.hepatitisc.uw.edu/page/clinical-calculators/apri), i.e. APRI = ASAT levels (in IU/L) / 40 (upper normal levels of ASAT in IU/L) / platelet count (109/L). An APRI score greater than 0.7 had a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis. Exclusion Criteria: * Co-infection with HIV * Severe extrahepatic HCV associated diseases (e.g. cerebral vasculitis, cryoglobulinemia/membranoprolifereative glomerulonephritis (MPGN), renal failure (eGFR \<30), polyarthritis) * Decompensated liver failure assessed with Child-Pugh (CP) score (\>6 points, class B and C) * Currently receiving treatment for HCV

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Conditions

The condition(s) this trial relates to.

chronic hepatitis C virus infection hepatitis C virus infection opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis C, chronic Opioid dependence, on agonist therapy

Contacts and locations

Locations

  • Department of Addiction Medicine, Haukeland University Hospital

    Bergen, Hordaland, 5020, Norway

  • LAR Helse Stavanger HF

    Stavanger, Rogaland, 4010, Norway

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