Project PrEPare, an innovative HIV prevention study designed to explore the safety, acceptability and feasibility of Pre-Exposure Prophylaxis (PrEP) among young men who have sex with men (YMSM) who are at risk for HIV infection. This study will take place at clinical sites across the U.S. with about 300 HIV-uninfected YMSM.
In PrEP, antiretroviral medications that are usually used to treat HIV are taken by uninfected people to reduce their risk of infection. The ground breaking study, iPrEx, found that men and transgender women who have sex with men (MSM) who took a single daily tablet containing the HIV medications emtricitabine and tenofovir (FTC/TDF), known commercially as Truvada®, experienced an average of 44% fewer HIV infections than those who received a placebo (blank pill). Participants whose self-reported adherence to daily PrEP was higher achieved reductions in HIV risk of more than 70%.
Young MSM comprise the largest proportion of new HIV infections in the United States, however they have not been adequately represented in any of the large PrEP efficacy trials conducted around the world to date. Thus, Project PrEPare aims to obtain additional data on the safety and efficacy of FTC/TDF and to evaluate patterns of use, rates of adherence, and patterns of sexual risk behavior among YMSM who are provided with open label FTC/TDF help to determine if PrEP could become a part of a comprehensive HIV prevention package for YMSM in the real world. Project PrEPare is a comprehensive HIV prevention study where all participants will complete one of two proven behavioral HIV-prevention interventions offered at their respective sites, be provided ongoing counseling, regular HIV/STI testing, and medical follow-up along with a daily dose of PrEP. This study is led by Sybil Hosek, PhD, an adolescent psychologist and HIV researcher at Stroger Hospital of Cook County in Chicago.
“Considering that young men who have sex with men continue to be disproportionately affected by the HIV epidemic in the United States, we are excited to gather youth-specific data on PrEP - the newest addition to the ‘toolbox’ of HIV prevention interventions,” said Dr. Hosek. “We must remember, however, that this is only one step in determining whether or not PrEP could become a part of a comprehensive HIV prevention package in the real world.”
Check out a video from iPrEx OLE, an international PrEP trial also run in Chicago at Stroger Hospital/CORE Center.