I think it is likely that additional implementation studies and demonstration projects would play an important role in the scale-up of an effective microbicide or ring. For scale-up to be successful there would need to be information about real world use and a strong foundation of awareness and understanding among those who would need it most. As we have seen with PrEP, issues of stigma and discrimination would need to be addressed through ongoing educational efforts so that they are acceptable and widely adapted for use.
While I’m not involved in working with stakeholders at a specific trial site or even within a network, at the Division of AIDS level we do reach out to stakeholders when a trial is ending to help ensure that messages are consistent, accurate, and timely. We’ve done this with varying degrees of success for different studies. Though we try to be well prepared with our plans in place, there are definitely times we are caught off guard, for example for unexpected trial termination as a result of a DSMB recommendation. In general we have a list of relevant stakeholders for each study that we review and we develop a tiered communication approach and a timeframe within which we communicate results and messages. The same information is shared within a given network and with the sites, so that they in turn can communicate with their stakeholders and through their channels of communication.
With regard to future access of a trial product, I know there access plans are put in place prior to trial initiation and they are developed with key stakeholders (e.g., in country regulatory bodies, ministries of health etc.). One challenge is that issues of access beyond a certain point in time post-trial may be left to the responsibility of the site, working with their institution, Ministries of Health, the specific industry partner and perhaps other donors. As a result, longer term access goes beyond the agreements made when developing/conducting the trial and are not necessarily in our control.
