Episodic Pre-Exposure Prophylaxis for HIV Prevention Among Gay, Bisexual and Other Men Who Have Sex With Men
James E. Egan
This study is funded by the University of Pittsburgh Center for AIDS Research (CFAR)
This study is designed to implement a clinic-based demonstration project of short-term episodic Pre-Exposure Prophylaxis (Epi-PrEP) for HIV prevention among gay, bisexual, and other men who have sex with men (MSM). PrEP has the potential to dramatically change the landscape of HIV prevention. Questions remain, however, on how best to implement this new technology. At this time it is unrealistic to consider PrEP as a life long intervention for most men. Such a frame (life long use) is inconsistent with predominant patterns of MSM moving in and out of high-risk situations. There are also structural barriers such as medication cost, long-term toxicity, and potential for developing resistance to two classes of antiretroviral drugs.
The overall research design includes providing short-term PrEP through a clinic-based demonstration pilot, use of clinical labs to assess patient appropriateness and adherence outcomes and baseline and post-PrEP follow up surveys. The proposed study is a non-randomized naturalistic study of an observational clinical intervention. Given the overwhelming efficacy evidence of PrEP, a non-drug arm would not produce any findings to further the field. As this technology is new, an appropriate behavioral intervention arm is yet to be designed. This study will help inform a behavioral component which can then be tested in a more rigorous randomized control trial.
Co-Principal Investigators: Ken Ho, James E Egan