Chronic Hepatitis C Clinical Trial
Official title:
Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients
Primary objective:
- Retention in antiviral treatment (feasibility)
Secondary objectives:
- Mental Health Mental health is monitored by means of the Symptom Checklist 90-R
(SCL-90-R). Its sum score, the Global Severity Index (GSI), serves as indicator. Mental
health will be regarded as stable in case of a change of less than 6 GSI-points,
otherwise mental health will be regarded as improved (GSI - 6 points) or decreased (GSI
+ 6 points).
- Course of Addiction Course of addiction under antiviral treatment will be monitored
according to retention in substitution treatment, compliance with scheduled visits, and
co-consumption of illicit drugs (patients record, urinalysis).
- Sustained viral response (SVR) SVR as measured by polymerase chain reaction 6 months
after per protocol antiviral treatment (ITT-analysis).
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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