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Intervention Update: Anticipating the Results of Microbicide Trials

As AVAC Report went to press, the FACTS 001 trial of 1% tenofovir gel was preparing to release its findings. The trial was designed as a confirmatory study of CAPRISA 004, which found evidence of modest protection in the same product, using a “BAT-24” dosing regimen (two doses: one within 12 hours before sex and one within 12 hours after). The results will test the field’s coordination and the world’s patience—whatever they are. If the data show evidence of benefit that warrants licensure and introduction, there will still be a period of time when the finite supply of gel is only available to South African trial participants via post-trial access programs. Other countries will need to trigger national processes that could lead to gel availability via open-label studies or pilot projects.

If the data show no evidence of benefit, there will be people who say that it’s time to abandon user-dependent methods in favor of strategies like the vaginal ring or long-acting injectables, and it will be up to the many stakeholders, from social scientists to young women, to gay men and other men who have sex with men—to argue otherwise. In AVAC Report 2013, we covered this issue in-depth—and we’ve reprinted the core recommendations from that document below.

None of the scenarios are simple. But clear, basic explanations and messages are exactly what’s needed. AVAC is working with many partners to develop resources that will help guide advocates, whatever the result is. Visit avac.org and sign up for our Advocates’ Network email list to be part of this discussion as the data emerge.