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Epidemiology of hepatitis C virus infection among people receiving opioid substitution therapy (ECHO): study protocol.

ABSTRACT: BACKGROUND: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. DISCUSSION: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. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02395198.

SUBMITTER: Strada L

PROVIDER: S-EPMC4676160 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Epidemiology of hepatitis C virus infection among people receiving opioid substitution therapy (ECHO): study protocol.

Strada Lisa L Schulte Bernd B Schmidt Christiane Sybille CS Verthein Uwe U Cremer-Schaeffer Peter P Krückeberg Sabine S Reimer Jens J

BMC infectious diseases 20151210

<h4>Background</h4>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 protoc ...[more]

PMID: 26653754

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Project description:IntroductionHepatitis C virus (HCV) infection affects 0.7% of the general population, and up to 40% of people prescribed opioid substitution therapy (OST) in Scotland. In conventional care, less than 10% of OST users are tested for HCV and less than 25% of these initiate treatment. Community pharmacists see this group frequently to provide OST supervision. This study examines whether a pharmacist-led 'test & treat' pathway increases cure rates for HCV.Methods and analysisThis protocol describes a cluster-randomised trial where 60 community pharmacies provide either conventional or pharmacy-led care. All pharmacies offer dried blood spot testing (DBST) for HCV. Participants have attended the pharmacy for OST for 3 months; are positive for HCV genotype 1 or 3; are not co-infected with HIV and/or hepatitis B; have no decompensated liver disease; are not pregnant. For conventional care, pharmacists refer HCV-positive participants to a local centre for assessment. In the pharmacy-led arm, pharmacists assess participants themselves in the pharmacy. Drug prescribing is by nurse prescribers (conventional arm) or pharmacist prescribers (pharmacy-led arm). Treatment in both arms is delivered as daily modified directly observed therapy in a pharmacy. Primary trial outcome is number of sustained virological responses at 12 weeks after treatment completion. Secondary trial outcomes are number of tests taken; treatment uptake; completion; adherence; re-infection. An economic evaluation will assess potential cost-effectiveness. Qualitative research interviews with clients and health professionals assess acceptability of a pharmacist-led pathway.Ethics and disseminationThis protocol has been ethically approved by the East of Scotland Research Ethics Committee 2 (15/ES/0086) and complies with the Declaration of Helsinki and principles of Good Clinical Practice. Caldicott guardian approval was given on 16 December 2016 to allow NHS Tayside to pass information to the cluster community pharmacies about the HCV test status of patients that they are seeing to provide OST supervision. NHS R&D approvals have been obtained from each health board taking part in the study. Informed consent is obtained before study enrolment and only anonymised data are stored in a secured database, enabling an audit trail. Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration numberNCT02706223; Pre-results.

Project description:Hepatitis C virus (HCV) morbidity appears to be high in Mongolia. Yet, the scale and nature of the infection burden is not well-understood. Our study's objective is to systematically review and synthetize all available epidemiological data on HCV antibody (Ab) prevalence, ribonucleic acid (RNA) prevalence, incidence, risk factors to HCV exposure, and circulating HCV genotypes/subtypes among different at-risk populations. Additionally, we aim to estimate national population-level HCV-Ab prevalence and the number of HCV chronically infected individuals in the population of Mongolia.Our systematic review will be reported based on the items outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2009) statement. All reports with primary data collected from surveillance or observational studies on Mongolian populations will be eligible for inclusion if the study sample size is greater than 25. Included reports need to present studies that use biological assay for HCV-Ab ascertainment. We will consider three primary outcomes of interest: HCV-Ab incidence, HCV-Ab prevalence, and HCV genotypes/subtypes among different at-risk populations. In addition, two secondary outcomes of interests will be also collected: HCV RNA prevalence, and unadjusted and/or adjusted statistically significant risk factors for HCV exposure (p value ≤0.05). In order to identify relevant reports, we will search PubMed, Embase, and Index Medicus for the Southeast Asian region. Additionally, we will search Mongolian scientific and medical journals not indexed in PubMed or Embase and the archives of Mongolian local conferences. Lastly, the literature search will be supplemented by checking references of the included reports and identified reviews. We will use broad search criteria with no language or time restrictions. Meta-analyses will estimate pooled HCV-Ab prevalence (by at-risk population, sex, age group, and period), and pooled RNA prevalence among HCV-Ab positive individuals in the general population. Age-adjustment of estimates will be conducted.The proposed systematic review and meta-analysis will produce a comprehensive synthesis of HCV epidemiology in Mongolia. The study will provide empirical evidence to inform health policy decision-making, resource allocation, and planning and implementation of relevant public health interventions.We have not registered with PROSPERO.

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Epidemiology of hepatitis C virus infection among people receiving opioid substitution therapy (ECHO): study protocol.

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Epidemiology of hepatitis C virus infection among people receiving opioid substitution therapy (ECHO): study protocol.

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