Clinical trial NCT02395198: Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients
Official title: Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients: Factors Influencing Treatment Initiation and Seroconversion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Keywords: hepatitis c virus
opioid substitution treatment
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag G.m.b.H
First posted: 2015-03-23
Enrollment: 2467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Opioid dependent outpatients in opioid substitution treatment regardless of treatment setting

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.

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.

Eligibility 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

Primary outcomes:
measure: National annual prevalence and incidence of current HCV infections among opioid dependent individuals in substitution treatment
timeFrame: 12 months
Secondary outcomes:
measure: Patient questionnaire: Patient Reported Outcomes
timeFrame: 1 month
measure: Clinician questionnaire: Clinician Reported Outcomes and Data from Routine Patient Care
timeFrame: 1 month
Other outcomes:
Locations:
city: Crailsheim
country: Germany
facility: Dr. Rudolf Dinkelacker
state: Baden Württemberg
city: Herrenberg
country: Germany
facility: Dr. Manfred Hartmann
state: Baden-Württenberg
city: Hirrlingen
country: Germany
facility: Dr. Reinhold Burr
state: Baden-Württenberg
city: St. Blasien
country: Germany
facility: Dr. Christoph von Ascheraden
state: Baden-Württenberg
city: Aichach
country: Germany
facility: Dr. Barbara Haider
state: Bayern
city: Augsburg
country: Germany
facility: Dr. Eugen Fürmann
state: Bayern
city: Fürstenfeldbruck
country: Germany
facility: Dr. Astrid Beck
state: Bayern
city: Warngau
country: Germany
facility: Dr. Winfred Dresel
state: Bayern
city: Bad Nauheim
country: Germany
facility: Dr. Monika Peter-Giglio
state: Hessen
city: Ehringshausen
country: Germany
facility: Dr. Andreas Weselek
state: Hessen
city: Frankfurt
country: Germany
facility: Dr. Georg Wetzig
state: Hessen
city: Parchim
country: Germany
facility: Dr. Uta Menschikowski
state: Mecklenburg-Vorpommern
city: Achim
country: Germany
facility: Dr. Georg Kramann
state: Niedersachen
city: Goslar
country: Germany
facility: Dr. Christine Rose
state: Niedersachsen
city: Bonn
country: Germany
facility: Dr. Detmar Jobst
state: Nordrhein- Westfalen
city: Hamm
country: Germany
facility: Dr. Helmut Walter
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Dr. Manfred Plum
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Dr. Michel Voss
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Dr. Martin Burger und Dr. Wolfgang Lüttecken
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Dr. Astrid Weber
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: Dr. Liane Arimond
state: Rheinland-Pfalz
city: Chemnitz
country: Germany
facility: Dr. Maria Viehweger
state: Sachsen
city: Norderstedt
country: Germany
facility: Dr. Ernst Soldan
state: Schleswig-Holstein
city: Wenningstedt
country: Germany
facility: Dr. Alexander Cegla
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Dr. Gerd Klausen
city: Berlin
country: Germany
facility: Dr. Clemens Micus
city: Berlin
country: Germany
facility: Dr. Lutz Weinrich
city: Bremen
country: Germany
facility: Dr. Wieland Tietje
city: Hamburg
country: Germany
facility: Dr. Nico le Claire
city: Hamburg
country: Germany
facility: Dr. Felix Maas
city: Hamburg
country: Germany
facility: Dr. Wirkner Thiel
city: Hamburg
country: Germany
facility: Dr. Eckhard Zeigert
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University
name: Jens Reimer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.