Advancing clinical research for next-generation PrEP products requires an adaptation of the traditional clinical trial design. Collaboration of all stakeholders across disciplines to build consensus is essential to meet the current and future PrEP needs. The interactive session will focus on clinical trial design complexities and considerations of alternative approaches, such as the counterfactual approach to estimating HIV incidence in communities where HIV prevention trials are being conducted. Presenters and panelists will discuss the pros and cons of different ways to estimate HIV incidence; the implications for trial design and analysis from the regulatory, acceptability, and practical perspectives; and the impact on future PrEP access for communities participating in the research.

• Presentations
• Session recording