January 2, 2013
The youth trial of Truvada, a drug which received US Food and Drug Administration approval as an HIV preventative drug, will involve 14 communities from Tampa, Fla. to San Francisco. These new trials are in response to the realization that earlier trials of Truvada's effectiveness and safety did not include enough younger men who have sex with men (MSM), a fact made even more noteworthy since a recent CDC report showed that infections have increased 22 percent among 13-24-year-old MSM and young black males are particularly affected.
University of South Florida (USF) researchers are joining the national study to learn how well the daily pill may protect this high-risk population. This month, USF will begin recruiting 25 participants at its new Ybor Youth Clinic, which serves at-risk youth. Dr. Diane Straub, chief of USF's Division of Adolescent Medicine, will be the principal local investigator for the trial. The study, called Project PrEPare (which stands for Pre-Exposure Prophylaxis), will examine the use of Truvada in a broad HIV-prevention strategy. Participants will also receive free condoms, safe-sex counseling, and monthly HIV testing. Researchers will monitor participants' blood work for evidence of side effects and will administer two bone-density scans throughout the year of the study. Participants will be paid for their time. If any participants become HIV-infected or develop health issues related to Truvada, they may be monitored for an additional year.