Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients
NCT ID: NCT02395198
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2467 participants
OBSERVATIONAL
2014-08-31
2017-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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HCV negative or in HCV treatment at T1
This group will be followed up at T2
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* diagnosed opioid dependence according to the ICD-10
* currently in opioid substitution treatment
Exclusion Criteria
* insufficient German reading and writing skills
18 Years
ALL
No
Sponsors
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Janssen-Cilag G.m.b.H
INDUSTRY
Prof. Dr. med. Jens Reimer
OTHER
Responsible Party
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Prof. Dr. med. Jens Reimer
Head, Addiction Medicine Unit, University Medical Center Hamburg Eppendorf; Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University
Principal Investigators
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Jens Reimer, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Hamburg-Eppendorf, Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University
Locations
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Dr. Rudolf Dinkelacker
Crailsheim, Baden-Wurttemberg, Germany
Dr. Manfred Hartmann
Herrenberg, Baden-Württenberg, Germany
Dr. Reinhold Burr
Hirrlingen, Baden-Württenberg, Germany
Dr. Christoph von Ascheraden
Saint Blasien, Baden-Württenberg, Germany
Dr. Barbara Haider
Aichach, Bavaria, Germany
Dr. Eugen Fürmann
Augsburg, Bavaria, Germany
Dr. Astrid Beck
Fürstenfeldbruck, Bavaria, Germany
Dr. Winfred Dresel
Warngau, Bavaria, Germany
Dr. Monika Peter-Giglio
Bad Nauheim, Hesse, Germany
Dr. Andreas Weselek
Ehringshausen, Hesse, Germany
Dr. Georg Wetzig
Frankfurt am Main, Hesse, Germany
Dr. Christine Rose
Goslar, Lower Saxony, Germany
Dr. Uta Menschikowski
Parchim, Mecklenburg-Vorpommern, Germany
Dr. Georg Kramann
Achim, Niedersachen, Germany
Dr. Detmar Jobst
Bonn, North Rhine-Westphalia, Germany
Dr. Michel Voss
Cologne, North Rhine-Westphalia, Germany
Dr. Helmut Walter
Hamm, North Rhine-Westphalia, Germany
Dr. Manfred Plum
Herne, North Rhine-Westphalia, Germany
Dr. Martin Burger und Dr. Wolfgang Lüttecken
Münster, North Rhine-Westphalia, Germany
Dr. Astrid Weber
Koblenz, Rhineland-Palatinate, Germany
Dr. Liane Arimond
Trier, Rhineland-Palatinate, Germany
Dr. Maria Viehweger
Chemnitz, Saxony, Germany
Dr. Ernst Soldan
Norderstedt, Schleswig-Holstein, Germany
Dr. Alexander Cegla
Wenningstedt, Schleswig-Holstein, Germany
Dr. Gerd Klausen
Berlin, , Germany
Dr. Clemens Micus
Berlin, , Germany
Dr. Lutz Weinrich
Berlin, , Germany
Dr. Wieland Tietje
Bremen, , Germany
Dr. Nico le Claire
Hamburg, , Germany
Dr. Felix Maas
Hamburg, , Germany
Dr. Wirkner Thiel
Hamburg, , Germany
Dr. Eckhard Zeigert
Hamburg, , Germany
Countries
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References
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Strada L, Schmidt CS, Rosenkranz M, Verthein U, Scherbaum N, Reimer J, Schulte B. Factors associated with health-related quality of life in a large national sample of patients receiving opioid substitution treatment in Germany: A cross-sectional study. Subst Abuse Treat Prev Policy. 2019 Jan 3;14(1):2. doi: 10.1186/s13011-018-0187-9.
Strada L, Schulte B, Schmidt CS, Verthein U, Cremer-Schaeffer P, Kruckeberg S, Reimer J. Epidemiology of hepatitis C virus infection among people receiving opioid substitution therapy (ECHO): study protocol. BMC Infect Dis. 2015 Dec 10;15:563. doi: 10.1186/s12879-015-1307-z.
Other Identifiers
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12748
Identifier Type: -
Identifier Source: org_study_id
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