Strada Lisa, Schulte Bernd, Schmidt Christiane Sybille, Verthein Uwe, Cremer-Schaeffer Peter, Krückeberg Sabine, Reimer Jens
Centre for Interdisciplinary Addiction Research, University Medical Centre Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
Federal Institute for Drugs and Medical Devices (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.
BMC Infect Dis. 2015 Dec 10;15:563. doi: 10.1186/s12879-015-1307-z.
Hepatitis C virus infection is highly prevalent among people who inject drugs. Opioid substitution therapy, the standard treatment for opioid dependence, provides an excellent opportunity for the treatment of hepatitis C virus infection due to the close and regular contact between patients and clinicians. However, there is little research on the impact of opioid substitution therapy on the prevalence of the hepatitis C virus at a national level. This paper describes the protocol for the Epidemiology of Hepatitis C Virus Infection among People Receiving Opioid Substitution Therapy (ECHO) study. The aim of this study is to estimate the national prevalence and incidence of hepatitis C virus infection among people receiving opioid substitution therapy in Germany and to describe factors associated with hepatitis C treatment uptake and seroconversion.
METHODS/DESIGN: An observational, longitudinal, multicentre study is being conducted between 2014 and 2016 in a representative sample of approximately 2500 people receiving opioid substitution therapy from about 100 clinicians providing opioid substitution therapy in Germany. Data will be collected during routine patient care and by means of patient and clinician questionnaires at baseline and 12-month follow-up. Stratified sampling will be performed to obtain a representative sample of clinicians providing opioid substitution therapy. The strata will be constructed based on the distribution of the total sample of clinicians providing opioid substitution therapy in Germany according to German Federal State and the number of patients per clinician.
Opioid substitution therapy may be an important strategy to prevent the spread of hepatitis C virus in opioid dependent populations, but its effectiveness may be diminished by our limited understanding of factors associated with treatment uptake and seroconversion. The present study will provide important information for developing strategies to address hepatitis C virus-related disease burden in people receiving opioid substitution therapy.
ClinicalTrials.gov: NCT02395198.
丙型肝炎病毒感染在注射吸毒者中高度流行。阿片类药物替代疗法作为阿片类药物依赖的标准治疗方法，由于患者与临床医生之间密切且定期的接触，为丙型肝炎病毒感染的治疗提供了绝佳机会。然而，在国家层面上，关于阿片类药物替代疗法对丙型肝炎病毒流行率影响的研究很少。本文描述了接受阿片类药物替代疗法人群中丙型肝炎病毒感染流行病学（ECHO）研究的方案。本研究的目的是估计德国接受阿片类药物替代疗法人群中丙型肝炎病毒感染的全国流行率和发病率，并描述与丙型肝炎治疗接受情况和血清转化相关的因素。
方法/设计：2014年至2016年期间，在德国约100名提供阿片类药物替代疗法的临床医生中，对约2500名接受阿片类药物替代疗法的代表性样本进行了一项观察性、纵向、多中心研究。数据将在常规患者护理期间收集，并通过患者和临床医生问卷在基线和12个月随访时收集。将进行分层抽样，以获得提供阿片类药物替代疗法临床医生的代表性样本。分层将根据德国联邦州提供阿片类药物替代疗法临床医生总样本的分布以及每位临床医生的患者数量来构建。
阿片类药物替代疗法可能是预防丙型肝炎病毒在阿片类药物依赖人群中传播的重要策略，但其有效性可能会因我们对与治疗接受情况和血清转化相关因素的有限了解而降低。本研究将为制定应对接受阿片类药物替代疗法人群中丙型肝炎病毒相关疾病负担的策略提供重要信息。
ClinicalTrials.gov：NCT023９5198。
