[Greer]

The conduct of the research team in relation to the community is not one that would support a basic package of HIV prevention, treatment and care services that is tailored to the targeted participants. Engaging community health service providers and advocacy groups at the time of protocol development is critical not only to gain local expertise, assess resources and capacity; but also to establish partnerships in order to provide a continuum care of care for participants. These should take into account local capacity to provide services beyond the trial, and in the immediate term what the impact of providing PrEP could have as an incentive for enrolment. Here, where participants are made of a vulnerable group at risk of criminal prosecution, establishing meaningful partnerships with representative advocacy groups to develop a high quality, appropriate package of care should have been negotiated on an on-going basis. The actions by the research team could exacerbate an environment of distrust and false information, placing the entire study at risk.