[Evelien]

Hi, I know that we as a sponsor did not reach out (pro)actively to community stakeholders but we know that our sites have indeed reached out to community groups at time of recruitment period (was part of their recruitment plan). Some of the sites also have a site set up that provide the opportunity for the subjects to interact and come together at certain time points, not linked to the protocol, but linked to the clinic itself. I have not yet looked into the fact to see if indeed these sites do have a better retention percentage (as retention is becoming our next hurdle as it seems).
The sponsor did reach out to the study staff to take their input into account with regards to INC/EXCL criteria, trial procedures, … and adapted the protocol set up if needed.
I think I can conclude that the formative research was done on “theoretical protocol content level” but not really on the “practical trial implementation” level. For the latest point, we completely relied on site level.