Hepatitis CECHONCT02395198
Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients
An observational study of Hepatitis C, run by Prof. Dr. med. Jens Reimer at 32 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 2,467 participants
- Where
- 32 sitesGermany
- Study dates
- Aug 2014to Jul 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Opioid dependent outpatients in opioid substitution treatment regardless of treatment setting
Who may be able to join
- minimum age 18
- diagnosed opioid dependence according to the ICD-10
- currently in opioid substitution treatment
Who cannot join
- severe mental impairment
- insufficient German reading and writing skills
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Germany32 sites
Dr. Georg Kramann
Achim, Niedersachen, 28832
Dr. Barbara Haider
Aichach, Bavaria, 86551
Dr. Eugen Fürmann
Augsburg, Bavaria, 86150
Dr. Monika Peter-Giglio
Bad Nauheim, Hesse, 61231
Dr. Gerd Klausen
Berlin, 10115
Dr. Clemens Micus
Berlin, 12043
Dr. Lutz Weinrich
Berlin, 12555
Dr. Detmar Jobst
Bonn, North Rhine-Westphalia, 53229
Dr. Wieland Tietje
Bremen, 28719
Dr. Maria Viehweger
Chemnitz, Saxony, 09130
Dr. Michel Voss
Cologne, North Rhine-Westphalia, 51065
Dr. Rudolf Dinkelacker
Crailsheim, Baden-Wurttemberg, 74564
Dr. Andreas Weselek
Ehringshausen, Hesse, 35630
Dr. Georg Wetzig
Frankfurt am Main, Hesse, 60316
Dr. Astrid Beck
Fürstenfeldbruck, Bavaria, 82256
Dr. Christine Rose
Goslar, Lower Saxony, 38640
Dr. Nico le Claire
Hamburg, 20095
Dr. Felix Maas
Hamburg, 20357
Dr. Wirkner Thiel
Hamburg, 22043
Dr. Eckhard Zeigert
Hamburg, 22609
Dr. Helmut Walter
Hamm, North Rhine-Westphalia, 59065
Dr. Manfred Plum
Herne, North Rhine-Westphalia, 44652
Dr. Manfred Hartmann
Herrenberg, Baden-Württenberg, 71083
Dr. Reinhold Burr
Hirrlingen, Baden-Württenberg, 72145
Dr. Astrid Weber
Koblenz, Rhineland-Palatinate, 56070
Dr. Martin Burger und Dr. Wolfgang Lüttecken
Münster, North Rhine-Westphalia, 48153
Dr. Ernst Soldan
Norderstedt, Schleswig-Holstein, 22846
Dr. Uta Menschikowski
Parchim, Mecklenburg-Vorpommern, 19370
Dr. Christoph von Ascheraden
Saint Blasien, Baden-Württenberg, 79837
Dr. Liane Arimond
Trier, Rhineland-Palatinate, 54293
Dr. Winfred Dresel
Warngau, Bavaria, 83627
Dr. Alexander Cegla
Wenningstedt, Schleswig-Holstein, 25980
About this study
Official title: Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients: Factors Influencing Treatment Initiation and Seroconversion
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.
Read the 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.
- Conditions
- Hepatitis C
- Keywords
- hepatitis c virus, opioid substitution treatment
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCV negative or in HCV treatment at T1 | This group will be followed up at T2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
National annual prevalence and incidence of current HCV infections among opioid dependent individuals in substitution treatment
Measured: 12 months
Secondary outcomes (2)
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
Measured: 1 month
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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionApr 2017
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,467 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Jens Reimer
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag G.m.b.H
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Jens Reimer, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Jens Reimer, Prof. Dr., Principal investigator, University Medical Center Hamburg-Eppendorf, Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395198
- Sponsor's protocol ID
- 12748
- Acronym
- ECHO
- Status last verified
- May 2017
- First submitted
- 16 Mar 2015
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30606188Strada 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.
PubMed 26653754
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients: Factors Influencing Treatment Initiation and Seroconversion
- ClinicalTrials.gov ID
- NCT02395198
- Acronym / sponsor ID
- ECHO / 12748
- Conditions
- Hepatitis C
- Keywords
- hepatitis c virus, opioid substitution treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,467 participants (actual)
- Lead sponsor
- Prof. Dr. med. Jens ReimerUniversity, hospital or other
- Collaborators
- Janssen-Cilag G.m.b.H
- Study start
- Aug 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 23 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV negative or in HCV treatment at T1 | – | –This group will be followed up at T2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Opioid dependent outpatients in opioid substitution treatment regardless of treatment setting
Key inclusion criteria (3 listed)
- minimum age 18
- diagnosed opioid dependence according to the ICD-10
- currently in opioid substitution treatment
Key exclusion criteria (2 listed)
- severe mental impairment
- insufficient German reading and writing skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
National annual prevalence and incidence of current HCV infections among opioid dependent individuals in substitution treatment
Time frame: 12 months
2 secondary outcomes
Patient questionnaire: Patient Reported Outcomes
Time frame: 1 month
Clinician questionnaire: Clinician Reported Outcomes and Data from Routine Patient Care
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Derived from this study: PubMed 30606188Strada 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.
- Derived from this study: PubMed 26653754Strada 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Reimer, Prof. Dr. principal investigator
University Medical Center Hamburg-Eppendorf, Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Prof. Dr. med. Jens Reimer at 32 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National annual prevalence and incidence of current HCV infections among opioid dependent individuals in substitution treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395198, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.