It is critical that once participants are enrolled in a study every effort should be employed to ensure they complete their study visits. Going forward it would be helpful to implement GPP during protocol development for these anticipated events with stakeholders by developing a communication and issues management plan.
We had a similar incident where participants who seroconverted during the study blamed the site for infecting them and attempted to sue. We engaged the CAB and reached out to participants to allay the fear that their participation in the study will result in HIV infection. This GPP course has now taught us that issues that are anticipated should be planned for in communication and issues management plan.
