Project PrEPare will enroll participants at 14 sites across the country, including USF Health’s Ybor Youth Clinic
Tampa, FL (Dec. 10, 2012) — The University of South Florida is one of 14 clinical sites across the country participating in a follow-up study of the first medication approved to help prevent sexually-acquired HIV infection in people at high risk for the disease.
Project PrEPare is a research study that will target young men who have sex with men (YMSM) – a high-risk group with the largest proportion of new HIV infections in the United States. USF will conduct the only study in the Tampa Bay area to reach this particular population as part of its membership in the national Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN).
The study will gather additional data on the safety, acceptability and feasibility of the FDA-approved drug known as Truvada ® – a once-daily pill containing tenofovir and emtricitabine, two antiretroviral medications usually used to treat HIV. Researchers want to determine if this pre-exposure prophylaxis, or PrEP for short, could become part of a comprehensive HIV prevention package for YMSM in the real world.
Nationwide, Project PrEPare will follow about 200 HIV-negative YMSM, ages 18 to 22. USF Health plans to begin enrolling 25 study participants in January at its Ybor Youth Clinic, a new facility for underserved and at-risk youth.
Along with a daily dose of Truvada, study participants will receive a full range of HIV preventive services – including a proven behavioral HIV prevention intervention, monthly HIV testing, free condoms, counseling, diagnosis and treatment of sexually transmitted infections, and medical follow-up. Each person will be followed for at least 48 weeks, and some could be monitored for more than 2 years.
“While many treatment options are available for HIV-infected youth, we have very little to offer in the way of medications or other biomedical interventions for prevention,” said Dr. Diane Straub, local principal investigator for Project PrEPare and chief of the USF Health Department of Pediatrics Division of Adolescent Medicine.
“It is vitally important to develop practical ways for young people to protect themselves to stem the tide of the HIV epidemic. This study will specifically focus on young adults, and is the first to do so.”
In July, the U.S. Food and Drug Administration approved Truvada for the indication of preventing HIV infections in people having sex with infected individuals.. The approval was based upon several large clinical trials showing that this PrEP significantly reduced the risk of contracting HIV, particularly when individuals adhered to the daily drug regimen. This means that one does not need to be part of the research study in order to receive the drug. He/she may obtain the drug by speaking with their primary care doctor.
USF’s Dr. Diane Straub is the local principal investigator for Project PrEPare, which will investigate whether combination anti-HIV therapy may be feasible as part of a comprehensive prevention package.
Despite Truvada’s established track record for safety and effectiveness among HIV-infected and unaffected adult populations, few enrolled in U.S. clinical studies of PrEP have been younger men, defined as those between ages 18 and 24.
Project PrEPare will target this high-risk group to gain a better understanding of the young men’s unique behavioral and biological considerations. For example, researchers want to know whether younger men will stick closely to taking PrEP and how adherence may affect the medication’s effectiveness. They will evaluate if being in the study leads to any changes in a participant’s sexual risk behavior.
ATN, the national research network overseeing Project PrEPare, is primarily supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, with additional funding from the National Institute on Drug Abuse and the National Institute of Mental Health.
For more information on Project PrEPare, visit http://health.usf.edu/nocms/publicaffairs/now/pdfs/Project PrEPare press materials.pdf.
To learn how to get involved with the Tampa study site, please contact USF Health outreach coordinators Jeremiah Kerr, jkerr1@health.usf.edu or Jadawn Wright, jwright@health.usf.edu, or call (813) 396-9137
Project PrEPare was reviewed and approved by the University of South Florida Institutional Review Board (IRB). The study number is: Pro00010056.
-USF Health-
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a global research university ranked 50th in the nation by the National Science Foundation for both federal and total research expenditures among all U.S. universities.
Media contact:
Anne DeLotto Baier, USF Health Communications
(813) 974-3303 or abaier@health.usf.edu
