HPTN 076: Injectable PrEP

Client-centered models of HIV prevention for women which employ Pre Exposure Prophylaxis (PrEP) examine both drug effectiveness but also drug delivery. It has become critical to understand whether available delivery options are likely to be utilized given individual risk, preference and lifestyle. Most frequently offered as a pill, vaginal film, vaginal ring or gel, injectable PrEP in the form of a shot received every 8 weeks could address below-target adherence found with other techniques, given that protection is provided regardless of a daily oral dose schedule or other use requirements.

In collaboration with the HIV Prevention Trials Network (HPTN), UZCHS-CTU has begun preparations for implementation of the HPTN 076 trial. The study is designed to evaluate the safety and acceptability of the injectable product, TMC278 LA, in healthy, human immunodeficiency virus (HIV)-uninfected women. Approximately 132 HIV-uninfected women, between the ages of 18-45 will be randomized to the trial in the United States and Zimbabwe. The study is headed by Linda-Gail Bekker MD at the University of Cape Town, South Africa, with UZCHS-CTU PI Z. Mike Chirenje MD supporting both protocol development and local implementation. The trial is scheduled for activation in March, 2015 at Spilhaus CRS. For more information, please contact Felix Mhlanga, MBChB, MMed at fmhlanga@uzchs-ctrc.org.


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