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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.

2 min
Session Opening and Welcome
Veronica MILLER, Forum for Collaborative Research, United States
3 min
Housekeeping and Acknowledgements
Veronica MILLER, Forum for Collaborative Research, United States
5 min
Introductory Remarks
Debra BIRNKRANT, Division of Antivirals, Food and Drug Administration, Center for Drug Evaluation and Research, FDA, United States
10 min
SESSION I: The Future of PrEP l Trial Designs to Meet the Need - Rationale/Approach for a counterfactual based placebo estimate-overview
David GLIDDEN, University of California San Francisco, United States
10 min
How is the "recency assay" being used in HIV programs across regions
Jessica JUSTMAN, Columbia University Medical Center, ICAP, United States
15 min
SESSION II: Testing the new strategy - Two Test Cases: islatravir and lenacapavir phase 3 programs
Michael ROBERTSON, Merck, United States
Moupali DAS, Gilead Sciences, United States
15 min
Live Q&A
Stephanie TROY, DAV, US FDA, United States
Ntando YOLA, Desmond Tutu HIV Foundation, South Africa
Moupali DAS, Gilead Sciences, United States
Michael ROBERTSON, Merck, United States
Tohlang SEHLOHO, Clinical Evaluation & Management, South African Health Products Regulatory Agency, SAHPRA, South Africa
25 min
SESSION III: Challenges and Opportunities in Trial Implementation - Live Q&A
David GLIDDEN, University of California San Francisco, United States
Connie CELUM, United States
Grace KUMWENDA, Pakachere Institute for Health and Development Communication, Malawi
Kathleen MACQUEEN, FHI 360, United States
Jessica JUSTMAN, Columbia University Medical Center, ICAP, United States
Ayesha KHARSANY, Centre for the AIDS Programme of Research in South Africa (CAPRISA), South Africa
Peter MIELE, DAV, US FDA, United States
Thamban I. VALAPPIL, DAV, US FDA, United States
5 min
Closing Thoughts
Veronica MILLER, Forum for Collaborative Research, United States