If the trial sponsors really wanted to have the trial in Thailand, prior to the trial starting, the research team should have reached out to the ministry of health to discuss and coordinate the prevention services that are not yet approved in country and are considered illegal. Ministry of Health representatives in this case may oppose including PrEP as part of the HIV care prevention package and may not be sustainable in the country after the trial is over. Thailand does not seem like the most opportune country for this trial based on their opposition on the distribution of clean needles.
The trial sponsors should have reached out to the Thai Drug Users’ Network, Thai National Network of People Living with HIV and the Thai AIDS Treatment Action Group prior to the start of the trial and received their input and recommendations for the trial protocol and standard of prevention for trial participants. Engaging them early could have prevented the outcry related to the ethical and operational challenges.
There are also ethical concerns when it comes to the research team not mentioning the concerns raised by stakeholders through the course of the trial in the official results dissemination.
