The lack of provision of clean needles as part of the prevention package compromised the relationship between the researchers and the advocacy groups. This did not only affect the relationship between researchers and advocacy groups but also the questioned the credibility of using Tenofovir as part of the prevention package. The study was viewed as being unethically and there were many questions relating recruitment activities related to the BTS. The ethical aspect of conducting this study was questioned considering the fact that half of the participants were receiving placebo. The issue here was that such participants were exposed to HIV by not providing them with clean needles. There were also questions relating to post-trial access for participants who took part in this study.
This is were it is important to engage your stakeholders early during your trial design. If this study was discussed with a group of advocates during the early stages of the trial design, the challenges could have been identified early and options made available. The early inclusion of broad range of stakeholders including government officials and Advocacy groups could have ensured proper provision of clean needles to BTS participants
