HIV Prevention Project Overview

HIV prevention science is advancing rapidly, with an increasing number of products becoming available as pre-exposure prophylaxis (PrEP) and global scale-up of PrEP. Further HIV prevention products, including additional antiretroviral drug-based PrEP options, broadly neutralizing antibodies, and vaccines, are in pre-clinical and clinical development. Additional prevention interventions are needed to meet the preferences and needs of individuals from diverse populations. However, conducting clinical trials for HIV prevention is challenged by 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 the HIV Prevention Project. The objective of the HIV Prevention Project is to review, discuss, and recommend strategies that would allow for ethical and feasible clinical trial options for new HIV prevention interventions. The HIV Prevention Project also considers the implementation of new HIV prevention products, including long-term, real-world, and population-specific safety monitoring. The HIV Prevention 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 HIV Prevention project. Currently active working groups include:

• HIV prevention clinical trial working group
• Long-acting PrEP during pregnancy and lactation working group
• Regulatory pathways for multipurpose prevention technologies working group