By Quarraisha Abdool Karim, PhD, Regional Director, Center for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa
When we started to prepare for the CAPRISA 004 tenofovir gel trial, we first had to assess the community and the preparedness of potential participants to be in trials. Would microbicides be acceptable to women and their partners in the communities? Would it be acceptable for community members to participate in a microbicide trial? Would potential participants be able to understand their rights and the basic principles of informed consent? We had to figure out how to establish structures for dialogue between the community and the researchers, and to set up cohorts and see if there were sufficient incident rates of HIV to allow the trial to be completed. That went on for about two years before we enrolled the first participant. All of these steps involved communication, which was important for both information-gathering and building trust. We used many fora to share what the trial was about and the rationale and justification for doing this work.
I’ve never taken an approach of “flying below the radar screen,” but I instead aim for openness and transparency. In the almost 25 years of doing AIDS research, I’ve learned that the public interest in HIV/AIDS research is very different than it is in other types of research. You need to share information as much as possible, with all of the stakeholders. This includes participants, the sponsors of the trial, the site teams and protocol teams, and community advisory boards or research support groups. Other groups we talk to include the Department of Health, regulatory bodies, and our ethics committee. It is important to keep of all these players in the loop, up to date, and engaged in the process early on. This means providing regular updates, as opposed to waiting for when you have a study milestone. Ongoing communication at multiple levels is key.