HIV Prep Project Overview
HIV prevention science is advancing rapidly, building on treatment success as prevention and once-daily oral pre-exposure prophylaxis (PrEP). However, additional prevention interventions are needed to meet the needs of individuals from diverse populations. Specific challenges in design and analysis include the difficulty of demonstrating statistical superiority or non-inferiority due to the low number of events and identifying appropriate control populations against which to measure efficacy.
Against the background of increasing challenges of conducting clinical trials, The HIV Forum convenes a Pre-Exposure Prophylaxis Project, the PrEP project. The objective of the PrEP Project is to review, discuss, and recommend strategies that would allow for less resource-intensive (cost and time) clinical trial options to approve new PrEP interventions while maintaining regulatory and scientific rigor. The PrEP project has established various working groups that are tasked with taking a deeper dive into specific issues and reporting their findings back to the Steering Committee that oversees and guides the PrEP project.
