Two of the collaborative teams of investigators will offer PrEP (pre-exposure prophylaxis with antiretroviral drugs) to high-risk uninfected men who have sex with men (MSM) and to transgender women (male to female transgendered persons) located in Los Angeles, San Diego, and Long Beach over the next four years. These investigators also will assess the implementation of TLC+ (testing and linkage to care plus treatment), a strategy to locate, engage, and retain HIV-infected persons in care and start them on life-saving treatment for their HIV infection
A third grantee consortium will not fully implement PrEP or TLC+ at the present time, but will instead plan and pilot PrEP/TLC+ implementation strategies for young MSM of color located in Oakland, Richmond, Berkeley, and other East Bay Area locations.
PrEP involves the provision of antiretroviral drugs and risk reduction counseling to high risk uninfected persons to prevent future HIV infection among those who potentially may be exposed to the virus. Previous international research trials have shown that PrEP has been very effective in preventing new HIV infections among MSM and selected other risk populations, but only when taken as prescribed in addition to ongoing risk reduction counseling. Recent studies have suggested that the mixed results found for some populations may be due to a lack of consistent adherence to the medication, leading to suboptimal or ineffective levels of drug in the body. In addition, other studies have suggested that identification and rapid institution of antiretroviral therapy for people infected with HIV not only improves survival of those treated, but also lowers the level of HIV virus in the community and might ultimately reduce HIV transmission rates.
This will be the largest PrEP/TLC+ demonstration project initiative in the U.S., and will be the first to test PrEP in several communities throughout California. In these demonstration projects in California, PrEP will be delivered as part of a comprehensive prevention package including risk reduction counseling, sexually transmitted infection screening, and other components. Daily Tenofovir/FTC (Truvada®, a tenofovir/emtricitabine two-drug combination pill manufactured and distributed by Gilead Sciences, Inc. of Foster City, CA) based PrEP will be offered to eligible uninfected high-risk men who have sex with men, as well as to transgender women. Gilead Sciences will provide the drug product (brand name Truvada®) to support these studies. The studies will adhere to safety and implementation guidelines issued by the Centers for Disease Control and Prevention.