Funding for this research was provided by:
H2020 Health (733025)
National Health and Medical Research Council (1142363)
Received: 3 February 2020
Accepted: 14 August 2020
First Online: 28 October 2020
Ethics approval and consent to participate
: Implementation sites have presented the study protocol for the implementation effectiveness study to local medical ethical committees and relating regulatory agencies. The committees concluded that this study is to be regarded as implementing evidence-based interventions and no human or animal experiments are involved. Approval letters from the committees are available on request. In Albania, there is no functional national ethical committee yet. As soon as this committee is established, the Albanian partner will submit their protocol for approval. In the meantime, they received approval from their institution to participate in the trial. Ethical approval for the process evaluation was granted by the University of Northumbria, UK (Submission Ref: 11039). Participants are required to provide and sign an informed consent indicating the purpose of the study, the nature, use and management of their data.
: Not applicable.
: Professor Bruno Aouizerate has received honoraria or consulting fees from Janssen-Cilag, Lundbeck, and Lilly. Dr. Samalin has received grants, honoraria, or consulting fees from Janssen-Cilag, Lundbeck, and Otsuka. All other authors declare that they have no competing interests.