Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients
- Conditions
- Hepatitis C
- Registration Number
- NCT02395198
- Lead Sponsor
- Prof. Dr. med. Jens Reimer
- Brief Summary
The aim of the present study is to estimate the national annual prevalence and incidence of current hepatitis C virus (HCV) infections among opioid dependent individuals in opioid substitution treatment (OST) based on a representative sample of approximately 2,500 outpatients in 100 substitution facilities across Germany. Furthermore, the study aims to describe factors influencing HCV therapy initiation and seroconversion during OST.
- Detailed Description
In this non-interventional, observational, longitudinal study, data is collected at two time points. The primary outcome measures HCV prevalence and incidence will be based on documentation from routine patient care at baseline and 12-month follow-up. Secondary outcome measures will be investigated by means of surveys of opioid substituted patients and their clinicians (completed at baseline), as well as data from routine patient care.
The sample size calculation is based on the primary outcome variable of HCV incidence among OST patients. The literature reports an HCV incidence of about 4/100 person-years +/- 2 new infections per 100 person-years in this target group. For a partial sample size of (at least) 32 patients with HCV seroconversion and an observation period of 1 year, 800 HCV antibody-negative patients are needed as an initial group for observation. Assuming an HCV antibody prevalence of 68% among OST patients, 2500 patients are needed in total (32% corresponds to N = 800).
Recruitment of clinicians is conducted via the national Substitution Registry in which all clinicians in Germany, who hold a qualification to prescribe substitution medication, are registered. To ensure that all substituting clinicians in Germany are considered in the present study, the investigators sent study invitations to all 3,356 addresses in the Substitution Registry as of 31.12.2013. Of the clinicians eligible for participation, a representative sample of clinician is drawn according to two criteria: 'German Federal State' (GFS) and 'Number of Patients Per Clinician' (PPC). Using the SPSS Complex Samples Procedure, clinicians are stratified by GFS and PPC, such that each GFS is represented at least once, and such that the same proportions of clinicians per GFS and per PPC category are achieved (to the best of our ability) as in the total sample of clinicians registered in the Substitution Registry.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2467
- minimum age 18
- diagnosed opioid dependence according to the ICD-10
- currently in opioid substitution treatment
- severe mental impairment
- insufficient German reading and writing skills
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method National annual prevalence and incidence of current HCV infections among opioid dependent individuals in substitution treatment 12 months
- Secondary Outcome Measures
Name Time Method Clinician questionnaire: Clinician Reported Outcomes and Data from Routine Patient Care 1 month Substitution treatment, HCV diagnostic and treatment, Consumption of substances, Physical and mental health (Checklist of somatic and psychiatric diseases, CGI), Patient wellbeing (Problem severity, GAF)
Patient questionnaire: Patient Reported Outcomes 1 month Quality of Life, Health-Related Quality of Life (SF-12), Physical health (OTI), Mental health (BSI-18), Autonomy preference (API-Dm), Satisfaction with care (ZAPA), Knowledge, needs and attitudes towards infectious diseases, HCV treatment and treatment experiences
Trial Locations
- Locations (32)
Dr. Eugen Fürmann
🇩🇪Augsburg, Bayern, Germany
Dr. Rudolf Dinkelacker
🇩🇪Crailsheim, Baden Württemberg, Germany
Dr. Uta Menschikowski
🇩🇪Parchim, Mecklenburg-Vorpommern, Germany
Dr. Alexander Cegla
🇩🇪Wenningstedt, Schleswig-Holstein, Germany
Dr. Ernst Soldan
🇩🇪Norderstedt, Schleswig-Holstein, Germany
Dr. Monika Peter-Giglio
🇩🇪Bad Nauheim, Hessen, Germany
Dr. Manfred Hartmann
🇩🇪Herrenberg, Baden-Württenberg, Germany
Dr. Reinhold Burr
🇩🇪Hirrlingen, Baden-Württenberg, Germany
Dr. Andreas Weselek
🇩🇪Ehringshausen, Hessen, Germany
Dr. Georg Kramann
🇩🇪Achim, Niedersachen, Germany
Dr. Maria Viehweger
🇩🇪Chemnitz, Sachsen, Germany
Dr. Manfred Plum
🇩🇪Herne, Nordrhein-Westfalen, Germany
Dr. Gerd Klausen
🇩🇪Berlin, Germany
Dr. Christoph von Ascheraden
🇩🇪St. Blasien, Baden-Württenberg, Germany
Dr. Christine Rose
🇩🇪Goslar, Niedersachsen, Germany
Dr. Helmut Walter
🇩🇪Hamm, Nordrhein-Westfalen, Germany
Dr. Liane Arimond
🇩🇪Trier, Rheinland-Pfalz, Germany
Dr. Georg Wetzig
🇩🇪Frankfurt, Hessen, Germany
Dr. Detmar Jobst
🇩🇪Bonn, Nordrhein- Westfalen, Germany
Dr. Martin Burger und Dr. Wolfgang Lüttecken
🇩🇪Münster, Nordrhein-Westfalen, Germany
Dr. Astrid Weber
🇩🇪Koblenz, Rheinland-Pfalz, Germany
Dr. Wieland Tietje
🇩🇪Bremen, Germany
Dr. Lutz Weinrich
🇩🇪Berlin, Germany
Dr. Barbara Haider
🇩🇪Aichach, Bayern, Germany
Dr. Astrid Beck
🇩🇪Fürstenfeldbruck, Bayern, Germany
Dr. Winfred Dresel
🇩🇪Warngau, Bayern, Germany
Dr. Michel Voss
🇩🇪Köln, Nordrhein-Westfalen, Germany
Dr. Clemens Micus
🇩🇪Berlin, Germany
Dr. Felix Maas
🇩🇪Hamburg, Germany
Dr. Nico le Claire
🇩🇪Hamburg, Germany
Dr. Eckhard Zeigert
🇩🇪Hamburg, Germany
Dr. Wirkner Thiel
🇩🇪Hamburg, Germany