NCT02395198

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,467

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

32 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

March 16, 2015

Last Update Submit

May 29, 2017

Conditions

Keywords

hepatitis c virusopioid substitution treatment

Outcome Measures

Primary Outcomes (1)

  • National annual prevalence and incidence of current HCV infections among opioid dependent individuals in substitution treatment

    12 months

Secondary Outcomes (2)

  • Patient questionnaire: Patient Reported Outcomes

    1 month

  • Clinician questionnaire: Clinician Reported Outcomes and Data from Routine Patient Care

    1 month

Study Arms (1)

HCV negative or in HCV treatment at T1

This group will be followed up at T2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Opioid dependent outpatients in opioid substitution treatment regardless of treatment setting

You may qualify if:

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

You may not qualify if:

  • severe mental impairment
  • insufficient German reading and writing skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Dr. Rudolf Dinkelacker

Crailsheim, Baden-Wurttemberg, 74564, Germany

Location

Dr. Manfred Hartmann

Herrenberg, Baden-Württenberg, 71083, Germany

Location

Dr. Reinhold Burr

Hirrlingen, Baden-Württenberg, 72145, Germany

Location

Dr. Christoph von Ascheraden

Saint Blasien, Baden-Württenberg, 79837, Germany

Location

Dr. Barbara Haider

Aichach, Bavaria, 86551, Germany

Location

Dr. Eugen Fürmann

Augsburg, Bavaria, 86150, Germany

Location

Dr. Astrid Beck

Fürstenfeldbruck, Bavaria, 82256, Germany

Location

Dr. Winfred Dresel

Warngau, Bavaria, 83627, Germany

Location

Dr. Monika Peter-Giglio

Bad Nauheim, Hesse, 61231, Germany

Location

Dr. Andreas Weselek

Ehringshausen, Hesse, 35630, Germany

Location

Dr. Georg Wetzig

Frankfurt am Main, Hesse, 60316, Germany

Location

Dr. Christine Rose

Goslar, Lower Saxony, 38640, Germany

Location

Dr. Uta Menschikowski

Parchim, Mecklenburg-Vorpommern, 19370, Germany

Location

Dr. Georg Kramann

Achim, Niedersachen, 28832, Germany

Location

Dr. Detmar Jobst

Bonn, North Rhine-Westphalia, 53229, Germany

Location

Dr. Michel Voss

Cologne, North Rhine-Westphalia, 51065, Germany

Location

Dr. Helmut Walter

Hamm, North Rhine-Westphalia, 59065, Germany

Location

Dr. Manfred Plum

Herne, North Rhine-Westphalia, 44652, Germany

Location

Dr. Martin Burger und Dr. Wolfgang Lüttecken

Münster, North Rhine-Westphalia, 48153, Germany

Location

Dr. Astrid Weber

Koblenz, Rhineland-Palatinate, 56070, Germany

Location

Dr. Liane Arimond

Trier, Rhineland-Palatinate, 54293, Germany

Location

Dr. Maria Viehweger

Chemnitz, Saxony, 09130, Germany

Location

Dr. Ernst Soldan

Norderstedt, Schleswig-Holstein, 22846, Germany

Location

Dr. Alexander Cegla

Wenningstedt, Schleswig-Holstein, 25980, Germany

Location

Dr. Gerd Klausen

Berlin, 10115, Germany

Location

Dr. Clemens Micus

Berlin, 12043, Germany

Location

Dr. Lutz Weinrich

Berlin, 12555, Germany

Location

Dr. Wieland Tietje

Bremen, 28719, Germany

Location

Dr. Nico le Claire

Hamburg, 20095, Germany

Location

Dr. Felix Maas

Hamburg, 20357, Germany

Location

Dr. Wirkner Thiel

Hamburg, 22043, Germany

Location

Dr. Eckhard Zeigert

Hamburg, 22609, Germany

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Jens Reimer, Prof. Dr.

    University Medical Center Hamburg-Eppendorf, Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Addiction Medicine Unit, University Medical Center Hamburg Eppendorf; Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 23, 2015

Study Start

August 1, 2014

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations