P42.02
Background: Clinical trials are monitored and regulated by independent bodies to ensure participants' safety and ethical conduct. Depending on study progress, these bodies may recommend a trial to continue as is, be modified or stopped. Six such reviews were conducted during the implementation of the VOICE study. We describe the impact of Data & Safety Monitoring Board (DSMB) recommendations on continued study participation in Kampala, Uganda, including retention, researchers' motivation to continue the study, and community perceptions and attitudes about the study.
Methods: Communication plans were used to disseminate DSMB outcomes to 6 tiers of stakeholders including study staff, participants, Institutional Review Board, Community Advisory Board, media, and other key stakeholders, including civil society. A qualitative analysis of DSMB outcome reports and review of participant retention was done. Discussion about different scenarios was done in advance with stakeholders.
Results: Stakeholders across the 6 tiers expressed disappointment with DSMB outcomes in VOICE. “We are ashamed because the doctors treated many infections and we benefited. The tests were expensive and the blood samples showed we did not use the products” (participant). “All our effort has gone to waste” (staff). “HIV drugs disappoint researchers” (media). “We told you that your things will not work, you want to experiment on us” (community member). The number of missed visits increased after dissemination of the Nov 2011 DSMB outcome when a second study arm (tenofovir gel) was stopped; 24% (41/171) as compared to 11% (18/171) in Sept 2011 when the first arm (tenofovir tablet) was stopped (p<0.001).
Conclusions: Communication about negative DSMB outcomes remains a challenge, although communication plans make dissemination more manageable for sites. Data from VOICE suggest that DSMB outcomes may have had a significant impact on visit retention in Kampala.
