HIV Post-Exposure Prophylaxis Summit was held on May 11-12, 2026, in Johannesburg, South Africa
Summit Objectives
The workshop aims to accelerate HIV prevention research by building consensus on HIV PEP clinical research that is ethical, efficient, feasible, and acceptable. The summit will consider regulatory perspectives on HIV PEP, the best way to collect efficacy data, alternative clinical trial designs and approaches to collecting data, and discuss single agent PEP regimens in the context of drug resistance and regulatory approval. The working group recognizes the particular importance that African countries and populations have played and will continue to play in HIV research. The workshop will explore the requirements for regulatory approval and guideline development for new regimens through an inclusive approach that incorporates input from academia, community representatives, normative bodies, regulatory authorities, and industry stakeholders. The ultimate objective of the workshop, and working group, is to improve future HIV prevention research and access to new HIV prevention products.
Materials
Session I: Welcome, Summit Overview
Welcome, Housekeeping, Summit Overview
Logan Donaldson, Forum for Collaborative Research
Veronica Miller, Forum for Collaborative Research
Introductory Remarks and Goals
Sinead Delany-Moretlwe, Wits RHI
Helen Rees, Wits RHI
Ken Mayer, Fenway Health
Collaborative Goal Setting/Icebreaker
All Participants
Session II: Sponsors and Funders Updates
Gates Foundation Perspectives
Max Lataillade, Gates Foundation
MSD Perspectives
Paul Schaper, Merck Sharp & Dohme
Gilead Perspectives
Michael Reid, Gilead Sciences
Session III: Preclinical Models, PK/PD, and Existing Knowledge
Pre-clinical Models
Gerardo Garcia-Lerma, US CDC
PK/PD
Charles Flexner, Johns Hopkins University*
Moderated Discussion
All Participants
Session IV: Levels of Evidence; Guidelines and Regulations
US Guidelines
Rupa Patel, Whitman Walker Health*
WHO Guidelines
Michelle Rodolph, World Health Organization
EMA Perspective
Maja Sommerfelt-Grønvold, European Medicines Agency*
SAHPRA Perspective
Boitumelo Semete-Makokotlela, South African Health Products Regulatory Authority
Panel/Open discussion
All Speakers +
Farisai Kuonza, Africa CDC
Adaobi Olisa, Root to Rise
Jeremy Sugarman, Johns Hopkins University
Session V: Clinical Trial Designs and Statistical Considerations
Totality of Evidence
Michael Robertson, BDI Consulting*
Clinical Trial Designs
Andrew Mujugira, Infectious Diseases Institute
Statistical Considerations
Deborah Donnell, Fred Hutchinson Cancer Center
Panel/Open Discussion
All speakers +
Susan Buchbinder, San Francisco Department of Public Health*
James Ayieko, Kenya Medical Research Institute
Michael Reid, Gilead Sciences
Charles Flexner, Johns Hopkins University*
Session VI: Continuation of Day 1 Discussion
Moderated Open Discussion
All Participants
Day 2 Welcome
Welcome and Housekeeping
Logan Donaldson, Forum for Collaborative Research
Veronica Miller, Forum for Collaborative Research
Introductory Remarks, Recap of Day 1, Goals
Sinead Delany-Moretlwe, Wits RHI
Helen Rees, Wits RHI
Ken Mayer, Fenway Health
Setting the Stage for Day 2
All Participants
Session VII: Implementation
Emergency Care Settings
Fikile Mwelase, South African Department of Public Health
Pharmacy Based Settings
Kenneth Ngure, Jomo Kenyatta University (JKUAT) & University of Washington*
Brazil Implementation Settings
Adriano Queiroz da Silva, STI/AIDS Coordination Office, City of São Paulo
PEP Implementation in the US
Jenell Stewert, University of Minnesota School of Public Health and Hennepin Healthcare
Panel and Open Discussion
All Speakers +
Tamara Choola, AFROCAB
Imelda Mahaka, Pangea Zimbabwe AIDS Trust*
Andrew Mujugira, Infectious Diseases Institute
Jerome Singh, University of KwaZulu-Natal
Session VIII: Regulatory Perspectives
Open Discussion
All Regulators and Participants
Session IX: Brainstorming, Consensus Building, and Proposal Writing
Open discussion and Collaborative Writing SessionHIV PEP Trials
All Participants
* Remote Participation