HPV Study Initiation Package, including study protocol

This document is Deliverable 4.1 (“HPV Study Initiation Package, including study protocol”) of the CANCER PREVENTION AT WORK project. It is issued under the responsibility of The Regional Authority of Public Health, Banská Bystrica, Slovakia (RAPH BB) with the contribution of a working group comprising principal investigators and team members from the implementation centers in Slovakia, Italy, and principal investigators from partners in Denmark, Germany, Czech Republic and Spain.

The CPW intervention for HPV prevention by promoting vaccination against HPV will be conducted on three different occupational cohorts of minimum 1000 participants (health care workers, finance workers, and metal workers including their family members) in the context of routine medical surveillance carried out in occupational health settings.

Occupation health surveillance is mandatory in all European countries: although the mechanisms of its implementation vary between the countries, these programs are in general aimed at diagnosing and preventing work-related diseases. Prevention of occupational cancers has therefore been a component of occupational health surveillance.

In recent years, however, there has been a movement towards including in occupational health surveillance aspects of health promotion which are not occupational in a strict sense. A person as a biopsychosocial unit should be informed about potential health risks and should be protected against them comprehensively.

This approach stems from several considerations:

1. the contact between the worker and the health professional in charge of the surveillance can be seen as a privileged opportunity for health promotion in general;
2. through the worker, the health promotion initiative may reach other groups of the population;
3. because of the periodic nature of the visits entailed by the occupational health surveillance, it is possible to efficiently implement follow-up mechanisms. The conceptual framework of the proposed research is based on the incorporation into on-going occupational surveillance schemes of primary prevention program against HPV infection.

Therefore, the D4.1 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 HPV prevention in the form of anti-HPV vaccination. The results will be monitored in a follow-up stage.

The protocol, which has been discussed and agreed with all the WP4 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.