The FACTS 001 trial was initiated to confirm the findings of CAPRISA 004, a phase IIB trial conducted in two sites in KwaZulu-Natal, which found that Tenofovir gel—used in a before and after sex regimen—reduced HIV infections by 39%. The FACTS 001 trial had a larger, more diverse group of participants than the CAPRISA 004 trial. MatCH Research Edendale site in Pietermaritzburg was one of 9 South African research sites participating in this important trial. The main findings of the study showed that there was no difference in the rate of new HIV infections occurring in the vaginal Tenofovir gel group compared with the placebo group.
Dissemination of the results has been an important component of the study. Results presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle in February was one component of a comprehensive and concurrent dissemination including to the Department of Health, communities, participants and research staff involved in the trial. A great deal of discussion and debate is taking place since the results were announced. Although disappointing, the results have not deterred researchers in the area who have recommitted themselves to continued efforts in the HIV prevention field.
