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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Hospitalised patients with hep C are referred to the outpatient clinic at the medical department following discharge. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opportunstic treatment | Other | opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment completion | Proportion in each arm who have been dispensed the last 28 days package of HCV treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response | HCV RNA undetetctable 12 weeks after end of treatment | 24 weeks |
| Reinfection | A HCV RNA strain not present at baseline is detected during or after treatment |
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Inclusion criteria
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AkershusUH | Lørenskog | Select A State Or Province | 0278 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37992203 | Derived | 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. | |
| 32539853 |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Pragmatic clinical trial. Cluster randomised with stepped wedge design
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| Standard of care | Other | Referral at discharge |
|
| Two years |
| End of treatment response | Proportion in each arm who have undetectable HCV RNA at the end of treatment | 12 weeks |
| 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. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |