CDC Participation in Partners PrEP Study

CDC Participation in Partners PrEP Study

The University of Washington is working with collaborators in Kenya and Uganda to conduct the Partners PrEP Study, which is examining the safety and efficacy of two different PrEP regimens — once-daily tenofovir and once-daily tenofovir plus emtricitabine — among heterosexual couples. CDC co-manages two trial sites in Uganda, in conjunction with The AIDS Support Organization (TASO), the largest indigenous non-governmental organization providing HIV care in Uganda.

This randomized, double-blind, placebo-controlled study operates at nine trial sites in Kenya and Uganda and will include 3,900 serodiscordant couples (couples in which one person is HIV-infected and the other is not). Stable serodiscordant couples are the largest risk group for HIV infection in Africa, and this trial will provide important data on whether PrEP could be used to prevent new HIV infections among this population. HIV-uninfected partners are assigned to one of three groups: tenofovir, tenofovir plus emtracitabine, or placebo. All participants receive ongoing risk reduction counseling and HIV testing, and their safety is monitored by the study’s DSMB and local IRBs. HIV-infected members of the discordant couples receive ongoing HIV care.

The trial is the first to test the safety and efficacy of both tenofovir and tenofovir plus emtricitabine in the same population and will allow investigators to simultaneously evaluate the two drugs as candidates for use as PrEP.