AkershusUH
Lørenskog, Select A State Or Province, 0278, Norway
NCT Number: NCT04220645
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lørenskog, Select A State Or Province, 0278, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards
Referral at discharge
Time frame: 12 weeks
Proportion in each arm who have been dispensed the last 28 days package of HCV treatment
Time frame: 24 weeks
HCV RNA undetetctable 12 weeks after end of treatment
Time frame: Two years
A HCV RNA strain not present at baseline is detected during or after treatment
Time frame: 12 weeks
Proportion in each arm who have undetectable HCV RNA at the end of treatment
University Hospital, Akershus
Other
Opportunistic Treatment of Hepatitis C Virus Infection (OPPORTUNI-C): A Pragmatic Clinical Trial of Immediate Versus Outpatient Treatment Initiation Among Hospitalized Patients
Acronym: Opportuni-C
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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