Agenda
AgendaMeeting ReportParticipant List
Summit Objectives
The summit aimed to accelerate HIV prevention research by building consensus on the future of HIV prevention clinical trial designs that are ethical, acceptable, inclusive, feasible, and efficient. The summit considered future clinical trials in the context of evolving epidemiology, standards of HIV prevention, and availability of funding and support for research. It recognized the particular importance that African countries and populations have played and will continue to play in HIV research. There were specific considerations for different HIV prevention products, including antiretroviral drug-based pre-exposure prophylaxis (PrEP), broadly neutralizing antibodies (bnAbs) for HIV prevention, and HIV vaccines.
Session I: Welcome, Summit Overview
Welcome, Housekeeping, Summit
Logan Donaldson, Forum for Collaborative Research
Introductory Remarks and Goals
Veronica Miller, Forum for Collaborative Research
Sinead Delany, Moretlwe, Wits RHI
Collaborative Goal Setting/Icebreaker
All Participants
Session II: State of HIV Prevention Clinical Research
Latest on PrEP + Q&A
Nyaradzo Mgodi, University of Zimbabwe
Latest on bnAbs for HIV Prevention + Q&A
Vincent Muturi-Kioi, IAV
Latest on HIV Vaccines + Q&A
Nigel Garrett, Desmond Tutu Health Foundation
HIV Prevention R&D Landscape + Q&A
Stacey Hannah, AVAC
Session III: Considerations for Future Trial Designs
Funder Perspectives
Max Lataillade, Gates Foundation
Standards of HIV Prevention
Peter Godfrey-Faussett, London School of Hygiene and Tropical Medicine
Community Perspectives
Grace Kumwenda, AVAC
Biostatistical Considerations
Deborah Donnell, Fred Hutchinson Cancer Center
Regulatory Considerations
Kedibone Malatji, South African Health Products Regulatory Authority
Panel/Open Discussion
All Speakers +
Samia Badar, African Vaccine Regulatory
Priscilla Nyambayo, Medicines Control Authority
Chilufya Kasanda, Treatment Advocacy and Literacy Campaign
Session IV: Establishing Efficacy in Clinical Trials
Innovations in HIV Prevention Clinical Trial Designs and The Recency Assay
Flavia Matovu, Makerere University*
Innovative Trial Designs for Infant HIV Prophylaxis
Mark Giganti, Harvard University*
Clinical Trial Design for Contraceptives
Victor Omollo, Kenya Medical Research Institute
Lessons Learned from (non-HIV) Vaccine Trials
Jessica Cowden, International Vaccine Institute
Panel/Open Discussion
All Speakers +
Helen Ndagije, National Drug Authority Uganda
Definate Nhamo, Pangaea Zimbabwe AIDS Trust
Marion Gruber, IAVI*
Leila Mansoor, CAPRISA
Session V: bnAbs for HIV Prevention and HIV Vaccines
What are the Roles of bnAbs and HIV Vaccines?
Nyaradzo Mgodi, University of Zimbabwe
Clinical Trial Design Considerations for bnAbs
Huub Gelderblom, Fred Hutchinson Cancer Research Center*
Panel/Open Discussion
All Speakers +
Ntando Yola, Desmond Tutu Health Foundation
Idah Mulala, Treatment Advocacy and Literacy Campaign
Jessica Cowden, International Vaccine Institute
Vincent Muturi-Kioi, IAVI
Session VI: Clinical Trial Considerations for Specific Populations of Interest
Infants in HIV Prevention Clinical Trials
Maribel Gonzalez Tome, European Medicines Agency*
Including Adolescents in Clinical Trials
Kudzai Hlahla, University of Zimbabwe
Including Pregnant and Lactating People in Clinical Trials
Friday Saidi, University of North Carolina Project Malawi
Ethics Guidance on Including Pregnant Adolescents in Clinical Trials
Suzanne Day, University of North Carolina at Chapel Hill*
Panel/Open Discussion
All Speakers +
Dvora Joseph Davey, University of California Los Angeles / University of Cape Town
Ruth Akulu, HopeStone Insight Uganda
Mark Giganti, Harvard University*
Session VII: Industry and Funder Panel
Industry and Funder Perspectives
Jim Rooney, Gilead Sciences
Rebeca Plank, Merck*
Alex Rinehart, ViiV Healthcare*
Max Lataillade, Gates Foundation
Session VIII: Continued Discussion and Cross-Cutting Issues
Break + Breakout groups + Moderated open discussion
Session IX: Next Steps, Action Items, and Closing Remarks
Closing Remarks and Discussion
Veronica Miller, Forum for Collaborative Research
Helen Rees, Wits RHI
Sinead Delany-Moretlwe, Wits RHI
* Remote Participation