Agreed, Cale. Good point about the necessity of early discussions and consultations on ethical and community issues —ideally, during protocol development!
In this case, some advocates questioned whether the trial was even ‘ethical’ in such a criminalizing environment and with a criminalized, stigmatized group such as IDUs?

What do others think? What else could have been done differently? How would your team strategically manage the situation?.. Think about engagement at all levels!