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

This project resulted 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: Ida Sperle-Heupel (FG34) (2017-2019), Martyna Gassowski (2016-2017)
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 was funded by the European Centre for Disease Prevention and Control (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 synchronise 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 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 was to develop a detailed technical protocol for undertaking HCV prevalence surveys in the general population. The protocol provides 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. The protocol will serve as a practical tool for EU/EEA countries looking to perform a prevalence survey. Based on factors such as available resources and local epidemiological gaps, the protocol offers different options. In addition to offering the possibility to adapt the survey to a country's needs and resources, the developed protocol is expected to contribute to a standardisation 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 prevalence surveys of HCV among general populations and key population groups was collected and synthesised. Based on this information, key objectives for conducting prevalence surveys in EU/EEA countries was 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 were critically discussed. Upon the input from the experts, the review of the published literature and available protocols and guidelines, a draft protocol was developed.

Work package 2 (April 2017 – December 2017)

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

Work package 3 (January 2018 – June 2019)

During the third work package the protocol was piloted in three different EU/EEA countries: Bulgaria (Stara Zagora), Finland (nationally) and Italy (Catanzaro). The findings and experiences of these pilots were shared in a third meeting with the expert group. The protocol was then revised based on the findings of the pilots and the opinions of the expert panel and finalised.

Stand: 06.02.2020

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