Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients

Hepatitis C Clinical Trial

— ECHO  

Official title:

Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients: Factors Influencing Treatment Initiation and Seroconversion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02395198
• Other study ID #: 12748
• Status: Active, not recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: May 29, 2017
• Start date: August 2014
• Est. completion date: July 2017

Study information

• Verified date: May 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2467
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Virus Diseases

Locations

Country	Name	City	State
Germany	Dr. Georg Kramann	Achim	Niedersachen
Germany	Dr. Barbara Haider	Aichach	Bayern
Germany	Dr. Eugen Fürmann	Augsburg	Bayern
Germany	Dr. Monika Peter-Giglio	Bad Nauheim	Hessen
Germany	Dr. Clemens Micus	Berlin
Germany	Dr. Gerd Klausen	Berlin
Germany	Dr. Lutz Weinrich	Berlin
Germany	Dr. Detmar Jobst	Bonn	Nordrhein- Westfalen
Germany	Dr. Wieland Tietje	Bremen
Germany	Dr. Maria Viehweger	Chemnitz	Sachsen
Germany	Dr. Rudolf Dinkelacker	Crailsheim	Baden Württemberg
Germany	Dr. Andreas Weselek	Ehringshausen	Hessen
Germany	Dr. Georg Wetzig	Frankfurt	Hessen
Germany	Dr. Astrid Beck	Fürstenfeldbruck	Bayern
Germany	Dr. Christine Rose	Goslar	Niedersachsen
Germany	Dr. Eckhard Zeigert	Hamburg
Germany	Dr. Felix Maas	Hamburg
Germany	Dr. Nico le Claire	Hamburg
Germany	Dr. Wirkner Thiel	Hamburg
Germany	Dr. Helmut Walter	Hamm	Nordrhein-Westfalen
Germany	Dr. Manfred Plum	Herne	Nordrhein-Westfalen
Germany	Dr. Manfred Hartmann	Herrenberg	Baden-Württenberg
Germany	Dr. Reinhold Burr	Hirrlingen	Baden-Württenberg
Germany	Dr. Astrid Weber	Koblenz	Rheinland-Pfalz
Germany	Dr. Michel Voss	Köln	Nordrhein-Westfalen
Germany	Dr. Martin Burger und Dr. Wolfgang Lüttecken	Münster	Nordrhein-Westfalen
Germany	Dr. Ernst Soldan	Norderstedt	Schleswig-Holstein
Germany	Dr. Uta Menschikowski	Parchim	Mecklenburg-Vorpommern
Germany	Dr. Christoph von Ascheraden	St. Blasien	Baden-Württenberg
Germany	Dr. Liane Arimond	Trier	Rheinland-Pfalz
Germany	Dr. Winfred Dresel	Warngau	Bayern
Germany	Dr. Alexander Cegla	Wenningstedt	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. med. Jens Reimer	Janssen-Cilag G.m.b.H

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National annual prevalence and incidence of current HCV infections among opioid dependent individuals in substitution treatment		12 months
Secondary	Patient questionnaire: Patient Reported Outcomes	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	1 month
Secondary	Clinician questionnaire: Clinician Reported Outcomes and Data from Routine Patient Care	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)	1 month