[Rona]

The lack of clean needles in the prevention package severed or at least significantly strained the relationship between advocates and researchers and created a lack of trust of both the researchers and the research process. It led to the study being viewed as unethical and, because the certainly of the data was called into question, it ultimately undermined the results of the trial and the future support of PrEP. The discussion with stakeholders needs to occur early and often in the trial development process. In this case, there was clearly a heated debate between the researchers and advocates but I’m not clear as to the extent to which there was respectful discussion during which potential options were ever discussed prior to the study initiation. It may be that there would never have been agreement, but again, it’s unclear whether or not drug users who attend the clinics, advocates, ethicists, and health ministry officials were all approached together and whether various options and the impact of the different options were discussed. In this case, while government laws may not have permitted the provision of clean needles, increased engagement from the beginning may have led to the identification of other options, and/or a coming to terms from key stakeholders about the trial design and an acceptance as to the value of the research and/or need for it. Again, I think the inclusion of a broad range of key stakeholders – potential participants to government officials, advocates to ethicists, regulators to providers – could help in identifying and weighing the impact of various options.