1. One example of successful stakeholder engagement in protocol development was our consultation with our CAG regarding our targeted populations and outreach for an upcoming vaginal ring PrEP study. Our CAG members, as well as members of our own Community Programs team at Bridge HIV, cited some issues with the current draft of the protocol at the time, which stated that the trial would be open to all those who identified as natal women and still had the requisite anatomy to allow for insertion of the study product. This suggested that transgender men would most likely be candidates for inclusion in the study, depending of course on their surgical history; as such, our Community Programs team was becoming excited with the potential for additional education/outreach to this community, as well as recruitment of transmen for this study. However, the protocol also stipulated that any potential participants who used any form of hormone therapy would not be eligible. Given our own and our CAG members’ knowledge of the local trans male community, we know this combination of criteria would make the vast majority of transmen who were interested in participating ineligible right off the bat, and we were of course concerned, therefore, about promoting the study within a community we might largely have to turn away at the point of screening. The changes that were made as a result of this input included resubmission of the protocol with these issues highlighted; the Microbicides Trials Network is still reviewing this most recent round of feedback, and we and our CAG look forward to hearing back from them soon.
2. If a protocol was sent to our trial site in final form, we would address the GPP recommendation for stakeholder involvement in protocol development by presenting the finalized protocol to our CAG and requesting any feedback they had, since there are often opportunities to submit protocol revisions and updates throughout the trial process. If there were any egregious issues with the protocol as informed by the CAG, we would present this feedback to the larger trials network and attempt to delay trial enrollment at our site until the issues were appropriately resolved, however necessary. If none of this were possible (and I sincerely hope this would never be the case), we would convene another meeting of the CAG to explain the reasons why the suggested revisions to the protocol were unable to be applied or accepted, and we would attempt to find other ways (outside of the technicalities, logistics and bureaucracies of the protocol itself) to address the outstanding protocol issues to the satisfaction of our stakeholders.
