About a decade behind vaginal microbicide development, the rectal microbicide field has completed two small Phase I safety trials and is currently conducting a third Phase I trial testing a rectal formulation of tenofovir gel. On the heels of the groundbreaking results from the South African CAPRISA 004 microbicide trial that showed a tenofovir-based gel could provide protection against HIV when applied vaginally, it is critical for the entire field – community members, advocates, scientists and policy makers – to prepare for advanced-stage effectiveness trials of rectal microbicides. In fact, the National Institutes of Health-funded Microbicide Trials Network is currently developing a protocol (MTN 017) for a Phase II rectal microbicide safety trial that would take place at sites in Thailand, South Africa, Peru and the United States, with a launch date sometime in 2012.
Africa needs more of our attention in terms of rectal microbicide advocacy. While IRMA has hundreds of active African members across the continent, until recently rectal microbicides have simply not been part of the larger HIV prevention discussion in Africa. This is partly due to the denial of anal sex among heterosexual men and women and the pervasive homophobia that has denied and criminalized the very existence of gay men and other men who have sex with men (MSM). It had long been incorrectly assumed that the primary (read: only one that matters) means of HIV transmission on the continent was through unprotected vaginal intercourse. The truth is much more complex than that – unprotected anal intercourse DOES play a role in the African epidemic – a significant percentage of heterosexual Africans most certainly engage in anal intercourse, and gay men and other MSM exist in every country, and in most, bear a much higher HIV burden when compared to the general population.
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