Hello everyone.    My name is Bob Bucklew and I am the Outreach Coordinator for the Case Western Reserve/University Hospitals AIDS Clinical Trials Unit in Cleveland, Ohio.    Our Unit conducts both HIV treatment and prevention trials in northeast Ohio.     Past, current and planned prevention trials have focused on vaginal microbicides, HIV vaccines, PrEP and passive immunization.      Our trials range from Phase I to Phase III, with an accompanying wide variety of people to enroll – from low risk to high risk for contracting HIV.     We  are officially affiliated with three DAIDS-funded networks, the AIDS Clinical Trials Group, the Microbicide Trials Network (MTN), and the HIV Vaccine Trials Network.

I also have the privilege of serving as the Co-Chair of the MTN Community Working Group which has provided me the opportunity to contribute to the world-wide effort of developing safe and effective vaginal and rectal microbicides.    I also am a representative of the MTN on DAIDS’ Community Partners where I serve as the Chair of the Research Priorities Working Group.

I am somewhat familiar with GPP as it has been widely reviewed and discussed within the MTN Community Working Group and Community Partners.   We have found it to be very helpful in enunciating the CWG and CP’s positions on community engagement.    I am much less familiar with the GPP as a guidance tool to be used in my role as Outreach Coordinator at our Unit.    I have found that it always easier to set than to implement policy.   Time constraints, enrollment pressures and the limited ability to get local input into protocols before they are finalized are all issues which can serve as barriers to the full implementation of GPP.

What I hope to get out of this course is a structure that we can implement here in Cleveland to formalize GPP implementation.   While I believe that we are doing quite well in participant engagement, education and informed consent, I believe that we can do a much better job at the larger community stakeholder level.

Thanks to all who have worked on this course.   I can only imagine the level of detail that was required.   Good job.

Bob Bucklew