Advances in HIV post-exposure prophylaxis (PEP): Regulatory challenges and clinical trial designs, International AIDS Conference 2026 Satellite Session, was held in Rio de Janeiro, Brazil on Monday, July 27, 2026
Materials
Session Topic
Introduction - background & framing of session, objectives, outcomes and Wits RHI Perspective
Veronica Miller, Forum for Collaborative Research
Sinead Delany-Moretlwe, Wits RHI
Key findings from the HIV PEP Summit Highlights of the discussion surrounding PEP implementation and trial design
Andrew Mujugira, Infectious Diseases Institute
Funder perspectives
Max Latiallade, Gates Foundation
Community perspectives
Adaobi Olisa, Root to Rise
Moderated Discussion: Moderated audience questions
All Speakers
Ken Mayer, The Fenway Institute
Veronica Miller, Forum for Collaborative Research
Adriano Queiroz da Silva, STI/AIDS Coordination Office, City of São Paulo
Kenneth Ngure, Jomo Kenyatta University (JKUAT) & University of Washington
Boitumelo Semete, South African Health Products Regulatory Authority
Summary/closure
Veronica Miller, Forum for Collaborative Research
Satellite Description: Advances in HIV post-exposure prophylaxis (PEP): Regulatory challenges and clinical trial designs
This symposium highlights deliberations on the future of HIV post exposure prophylaxis (PEP) clinical trial designs, data collection, and regulatory challenges by a working group via the Forum for Collaborative Research at the University of California, Berkeley. This working group brings together diverse stakeholders from different regions to discuss pressing issues relating to the future of HIV PEP. Through a series of presentations and discussions, the symposium aims to highlight and extend the discussion of challenges to and potential solutions for inclusive HIV PEP research that began during the HIV PEP Summit on May 11 and 12 in Johannesburg South Africa. Designing HIV PEP clinical trials requires coordinated efforts and consensus building among researchers, funders, regulatory agencies, community organizations, and policymakers. By emphasizing the importance of collaboration, the symposium deliberates possible pathways on the future of ethical, efficient, and feasible HIV PEP efficacy evaluation, and levels of evidence to inform HIV PEP Guidelines and possible regulatory approval.
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