HCV Study Initiation Package, including study protocol

This document is Deliverable 3.1 (“HCV Study Initiation Package, including study protocol”) of the CANCER PREVENTION AT WORK project. It is issued under the responsibility of The National Institute of Public Health, Bucharest, Romania (INSP) with the contribution of a working group comprising principal investigators and team members from the implementation centers in Italy, Romania, Slovakia and principal investigators from partners in Denmark, Germany, Czech Republic and Spain.

The CPW intervention for liver cancer prevention by targeting hepatitis C infection prevention, diagnosis and treatment will be conducted on four different occupational cohorts of minimum 1000 participants (health care workers, retail and finance workers, and metal workers) in the context of routine medical surveillance carried out in occupational health settings

Prevention of hepatitis C at work is normally available only for occupational groups at risk for biological hazards, following specific rules and procedures adopted by each country under the health and safety laws and regulations. However, the routine medical examinations are carried out for many other occupational groups, within the occupational health settings. This can be an opportunity to offer rapid hepatitis C testing to all workers, no matter their risks, complemented by adequate counselling on lifestyle and behavioral changing that can help prevent infectious-related liver cancer. Moreover, in case of positive test results, the recommendation for link with precise diagnosis and treatment will be available immediately together with recommendation for testing of the household members.

The success of such a micro-elimination intervention in occupational health services was little explored. Therefore, the D3.1 consists in a protocol of a multicenter, multinational interventional pilot study aimed at building several types of working cohorts in which to assess the feasibility of hepatitis C prevention through test and cure. The results will be monitored in a follow-up stage.

The protocol, which has been discussed and agreed with all the WP3 partners, will be submitted for local ethical evaluation. Each partner in its own country will undergo necessary procedures for obtaining the approval by local Ethics Committee.

The intended audience of this deliverable consists of members of the CPW consortium and the European Commission.