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SPHERE-C – Sero-prevalence surveys of hepatitis C in Europe

This project results from a call for tenders by the ECDC, called "The development of a seroprevalence survey for hepatitis C in EU/EEA countries". The call was published on 12/12/2015 and closed on 29/02/2016.

Tender reference number: OJ/27/11/2015-PROC/2015/034

Main project supervisor at the Robert Koch Institute: Dr. Ruth Zimmermann (FG 34)
Project coordinator: Martyna Gassowski (FG 34)
Advisors: Dr. Viviane Bremer (FG 34), Dr. Ulrich Marcus (FG 34)
Epidemiological support: Stine Nielsen (freelance), Dr. Martin Schlaud (FG 22), Dr. Antje Gößwald (FG 23)
Statistical support: Dr. Matthias an der Heiden (FG 34)
Project manager: Dr. Erika Duffel (ECDC)

Period: June 2016 - June 2019

Funding: The SPHERE-C project is funded by the European Center for Disease Control and Prevention (ECDC).

Background

In order to effectively plan prevention and control efforts, reliable estimates of HCV prevalence are needed. Surveillance data on hepatitis C are available in most EU/EEA countries, however, the quality of the data varies widely and efforts to synchronize case definitions and differentiate between acute and chronic cases have so far not been completely successful. Additionally, due to the largely asymptomatic nature of the infection, diagnosis is often made many years past the acquisition of the virus, when liver disease has already developed and surveillance data thus tend to reflect local testing policies rather than the true incidence and prevalence of the infection. A sero-prevalence survey provides a snapshot of the current epidemiological situation as it identifies all individuals currently infected, regardless of diagnosis-status, and can provide representative estimates of prevalence for the population under investigation.

Reliable estimates of HCV prevalence are important to guide appropriate decisions around testing and treatment on a national level. They help estimate the degree of under ascertainment of infection and can help identify possible gaps in surveillance systems. Reliable prevalence estimates would also be useful to model the burden of disease more precisely and to estimate the effectiveness of primary and secondary prevention over time, if these estimates would be generated repeatedly.

Purpose and general scope

The purpose of this project is to develop detailed technical protocols for undertaking HCV sero-prevalence surveys in the general population. The protocols will provide practical instructions on all relevant areas, ranging from sampling methods, specimen- and data collection and laboratory methods to confidentiality and ethical issues, quality control measures, data management and budgetary considerations. These protocols will serve as practical tools for EU/EEA countries looking to perform a sero-prevalence survey. Based on factors such as available resources and local epidemiological gaps, the protocols will offer different options. In addition to offering the possibility to adapt the survey to a country's needs and resources, the developed protocols are expected to contribute to a standardization of HCV prevalence estimates across EU/EEA countries.

Objectives and aims

Work package 1 (July 2016 - March 2017)

During the first work package, scientific information and evidence essential for conducting representative sero-prevalence surveys of HCV among general populations and key population groups will be collected and synthesized. Based on this information, key objectives for conducting sero-prevalence surveys in EU/EEA countries will be formulated. In a first meeting with a group of epidemiology and virology experts and representatives of EU Member States and key stakeholder agencies, the defined objectives will be critically discussed. Upon the input from the experts, the review of the published literature and available protocols and guidelines, draft protocols will be developed.

Work package 2 (April 2017 – December 2017)

In the second work package three EU/EEA countries will be selected for piloting of the sero-prevalence survey protocols. A second meeting with the expert group will take place, in which the experts will be consulted about the draft protocols and the plans for piloting these protocols. Based on the informed opinions of the experts, the protocols will be further elaborated, and further detailed practical preparation for the pilots conducted.

Work package 3 (January 2018 – June 2019)

During the third work package the protocols will be piloted in three different EU/EEA countries. The findings and experiences of these pilots will be shared in a third meeting with the expert group. The protocols will be revised based on the findings of the pilots and the opinions of the expert panel and will then be presented in a dissemination meeting.

Stand: 09.02.2017

Zusatzinformationen

Gesundheitsmonitoring

In­fek­ti­ons­schutz

Forschung

Kom­mis­sio­nen

Ser­vice

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