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
|Condition or disease|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||2467 participants|
|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|
HCV negative or in HCV treatment at T1
This group will be followed up at T2
- National annual prevalence and incidence of current HCV infections among opioid dependent individuals in substitution treatment [ Time Frame: 12 months ]
- 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
- 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)
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
|Principal Investigator:||Jens Reimer, Prof. Dr.||University Medical Center Hamburg-Eppendorf, Centre for Interdisciplinary Addiction Research (CIAR), Hamburg University|