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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 : Unknown
Verified May 2017 by Prof. Dr. med. Jens Reimer, Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was:  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.

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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)



Information from the National Library of Medicine

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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
Show Show 32 study locations
Sponsors and Collaborators
Prof. Dr. med. Jens Reimer
Janssen-Cilag G.m.b.H
Investigators
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Principal Investigator: Jens Reimer, Prof. Dr. University Medical Center Hamburg-Eppendorf, Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    
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:
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Hepatitis A
Hepatitis C
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections