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Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients (ECHO)

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ClinicalTrials.gov Identifier: NCT02395198
Recruitment Status : Active, not recruiting
First Posted : March 23, 2015
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Janssen-Cilag G.m.b.H
Information provided by (Responsible Party):
Prof. Dr. med. Jens Reimer, Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease
Hepatitis C

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.


Study Type : Observational [Patient Registry]
Actual Enrollment : 2467 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients: Factors Influencing Treatment Initiation and Seroconversion
Study Start Date : August 2014
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort
HCV negative or in HCV treatment at T1
This group will be followed up at T2



Primary Outcome Measures :
  1. National annual prevalence and incidence of current HCV infections among opioid dependent individuals in substitution treatment [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Patient questionnaire: Patient Reported Outcomes [ Time Frame: 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

  2. Clinician questionnaire: Clinician Reported Outcomes and Data from Routine Patient Care [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Opioid dependent outpatients in opioid substitution treatment regardless of treatment setting
Criteria

Inclusion Criteria:

  • minimum age 18
  • diagnosed opioid dependence according to the ICD-10
  • currently in opioid substitution treatment

Exclusion Criteria:

  • severe mental impairment
  • insufficient German reading and writing skills

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395198


Locations
Germany
Dr. Rudolf Dinkelacker
Crailsheim, Baden Württemberg, Germany, 74564
Dr. Manfred Hartmann
Herrenberg, Baden-Württenberg, Germany, 71083
Dr. Reinhold Burr
Hirrlingen, Baden-Württenberg, Germany, 72145
Dr. Christoph von Ascheraden
St. Blasien, Baden-Württenberg, Germany, 79837
Dr. Barbara Haider
Aichach, Bayern, Germany, 86551
Dr. Eugen Fürmann
Augsburg, Bayern, Germany, 86150
Dr. Astrid Beck
Fürstenfeldbruck, Bayern, Germany, 82256
Dr. Winfred Dresel
Warngau, Bayern, Germany, 83627
Dr. Monika Peter-Giglio
Bad Nauheim, Hessen, Germany, 61231
Dr. Andreas Weselek
Ehringshausen, Hessen, Germany, 35630
Dr. Georg Wetzig
Frankfurt, Hessen, Germany, 60316
Dr. Uta Menschikowski
Parchim, Mecklenburg-Vorpommern, Germany, 19370
Dr. Georg Kramann
Achim, Niedersachen, Germany, 28832
Dr. Christine Rose
Goslar, Niedersachsen, Germany, 38640
Dr. Detmar Jobst
Bonn, Nordrhein- Westfalen, Germany, 53229
Dr. Helmut Walter
Hamm, Nordrhein-Westfalen, Germany, 59065
Dr. Manfred Plum
Herne, Nordrhein-Westfalen, Germany, 44652
Dr. Michel Voss
Köln, Nordrhein-Westfalen, Germany, 51065
Dr. Martin Burger und Dr. Wolfgang Lüttecken
Münster, Nordrhein-Westfalen, Germany, 48153
Dr. Astrid Weber
Koblenz, Rheinland-Pfalz, Germany, 56070
Dr. Liane Arimond
Trier, Rheinland-Pfalz, Germany, 54293
Dr. Maria Viehweger
Chemnitz, Sachsen, Germany, 09130
Dr. Ernst Soldan
Norderstedt, Schleswig-Holstein, Germany, 22846
Dr. Alexander Cegla
Wenningstedt, Schleswig-Holstein, Germany, 25980
Dr. Gerd Klausen
Berlin, Germany, 10115
Dr. Clemens Micus
Berlin, Germany, 12043
Dr. Lutz Weinrich
Berlin, Germany, 12555
Dr. Wieland Tietje
Bremen, Germany, 28719
Dr. Nico le Claire
Hamburg, Germany, 20095
Dr. Felix Maas
Hamburg, Germany, 20357
Dr. Wirkner Thiel
Hamburg, Germany, 22043
Dr. Eckhard Zeigert
Hamburg, Germany, 22609
Sponsors and Collaborators
Prof. Dr. med. Jens Reimer
Janssen-Cilag G.m.b.H
Investigators
Principal Investigator: Jens Reimer, Prof. Dr. University Medical Center Hamburg-Eppendorf, Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Jens Reimer, Head, Addiction Medicine Unit, University Medical Center Hamburg Eppendorf; Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02395198     History of Changes
Other Study ID Numbers: 12748
First Posted: March 23, 2015    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prof. Dr. med. Jens Reimer, Universitätsklinikum Hamburg-Eppendorf:
hepatitis c virus
opioid substitution treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents