Opportunstic Hepatitis C Virus Treatment

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-06-30

Brief Summary

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The project will assess the effect of opportunistically treating hepatitis C virus (HCV) infection immediately when HCV-infected people who inject drugs are hospitalized for acute care in psychiatric, interdisciplinary specialized drug treatment or somatic wards. We will compare this approach with the current standard of care (SOC), which is referral to the outpatient clinic at the medical department following discharge.

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Detailed Description

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The overall objective is to show that opportunistic and immediate administration of HCV treatment is more efficient compared to referral-based SOC. The specific objectives are: 1) to compare the intervention and SOC groups with regards to treatment completion, treatment uptake and virologic response ; 2) to assess the rate of reinfection after successful HCV treatment; and 3) to assess the frequency of resistant associated substitutions before and after virologic treatment failure.

We will use a stepped wedge design and include patients in 7 clusters

Following randomization of the cluster to the immediate treatment, physicians at the participating wards will be notified in writing that for the next time period patients diagnosed with HCV infection should be treated immediately. In addition, lectures presenting the opportunistic approach will be given and the Department of Microbiology will add a brief text to the result of HCV RNA testing reminding about the opportunistic approach. In the medical and the psychiatric departments, consultants from the departments of infectious diseases or gastroenterology will prescribe immediate treatment. In the departments that provide addiction treatment, local physicians will prescribe treatment. Treatment will be prescribed in accordance with current Norwegian treatment recommendations. The intensity of care after discharge will be individualized at the discretion of the treating physician.

Conditions

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Hepatitis C Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic clinical trial. Cluster randomised with stepped wedge design

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard of care

Hospitalised patients with hep C are referred to the outpatient clinic at the medical department following discharge.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Referral at discharge

Opportunistic treatment

Hospitalised patients with hep C are opportunistically and immediately treated when hospitalized for acute care in psychiatric, addiction treatment or somatic wards

Group Type EXPERIMENTAL

Opportunstic treatment

Intervention Type OTHER

opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards

Interventions

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Opportunstic treatment

opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards

Intervention Type OTHER

Standard of care

Referral at discharge

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Above 18 years of age
* HCV RNA positive
* Inpatient at participating ward
* Signed informed consent must be obtained and documented according to national and local regulations

Exclusion Criteria

* Pregnancy or breastfeeding.
* In involuntarily health care.
* Ongoing treatment of hepatitis C.
* Current participation in another trial that might affect the current study.
* Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No