Ive been thinking about this and I cannot come up with a time at my current position where I felt that stakeholders weren’t engaged before the trial started and there were adverse events as a result.
During protocol development the community educators, representatives and stakeholders are very active. I started my position as community educator right when MTN 017 started recruiting. While I wasn’t part of the pre-implementation, I learned from it and as a site we conduct all of our studies similarly.
As we move into the future of PrEP innovations, the MTN and all of our clinical research looks heavily on community input. After the MTN 017 trial the MTN held a 3 part meeting about how the network should move forward. 1 of the 3 sessions was entirely composed of community voices (myself included). In this session we discussed how men were fine with the product, but did not like the applicator. We felt that we needed better options for microbicides to move forward.
In part a result of those planning sessions, our site will be doing studies to see if there are other delivery options that are viable. MTN 033 will be looking at the possibility of using the gel sans applicator and the DREAM study looks at delivering the medication via enema.
