Opportunstic Hepatitis C Virus Treatment

NCT04220645 | Completed DMC

• 1 other identifier: 2019/128
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Treatment completion

  Proportion in each arm who have been dispensed the last 28 days package of HCV treatment

  12 weeks

Secondary Outcomes (3)

• Sustained virological response

  24 weeks

• Reinfection

  Two years

• End of treatment response

  12 weeks

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Other: Standard of care

Opportunistic treatment

EXPERIMENTAL

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

Other: Opportunstic treatment

Interventions

Opportunstic treatment OTHER

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

Opportunistic treatment

Standard of care OTHER

Referral at discharge

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

AkershusUH

Lørenskog, Select A State Or Province, 0278, Norway

Location

Related Publications (2)

• Midgard H, Malme KB, Pihl CM, Berg-Pedersen RM, Tanum L, Klundby I, Haug A, Tveter I, Bjornestad R, Olsen IC, Finbraten AK, Dalgard O. Opportunistic Treatment of Hepatitis C Infection Among Hospitalized People Who Inject Drugs (OPPORTUNI-C): A Stepped Wedge Cluster Randomized Trial. Clin Infect Dis. 2024 Mar 20;78(3):582-590. doi: 10.1093/cid/ciad711.

  PMID: 37992203 DERIVED

• Midgard H, Finbraten AK, Malme KB, Berg-Pedersen RM, Tanum L, Olsen IC, Bjornestad R, Dalgard O. Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs. Trials. 2020 Jun 15;21(1):524. doi: 10.1186/s13063-020-04434-8.

  PMID: 32539853 DERIVED

MeSH Terms

Conditions

Hepatitis C; Substance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pragmatic clinical trial. Cluster randomised with stepped wedge design

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: January 7, 2020
• Study Start: October 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)