DESIGN APPROACHES FOR CURRENT AND FUTURE HIV PREVENTION EFFICACY TRIALS
VIRTUAL WORKSHOP SERIES
OCTOBER 2020 TO JANUARY 2021
Session 1: Current efficacy trial design approaches – Challenges and lessons learned
VIRTUAL WORKSHOP SERIES
HIV prevention is evolving rapidly with the roll out of new tools such as pre-exposure prophylaxis (PrEP) and treatment as prevention making a significant contribution towards controlling the epidemic.
As a result, the design and conduct of the next generation of prevention trials is impacted and is further affected by the outcomes of ongoing HIV prevention efficacy trials – including oral and injectable antiretrovirals, passively infused monoclonal antibodies, and HIV vaccines.
The first session of the virtual workshop aims to reflect on current trial designs and lessons learned. This session is supported by six bite-size presentations and a panel discussion of the current scientific approaches for establishing efficacy of vaccines in the broader context or Pre-Exposure Prophylaxis (PrEP).
Help us framing the live conversation on 27 October 2020 by watching these bite-size talks and submitting your questions and comments ahead of time using the link under each presentation. You can also email us directly at Enterprise@Iasociety.org and of course get in touch if you need help navigating the event.
To join the live session please pre-register using the button below.
| Presentation | Presenter |
|---|---|
| An introduction to the workshop organization and agenda. | Roger Tatoud, Ph.D. – International AIDS Society – Geneva, Switzerland. |
| Introductory talk – setting the stage | Linda Gail Bekker, MBChB DTMH DCH FCP (SA) PhD – Desmond Tutu HIV Centre – Cape Town, South Africa. |
| PrEP Considerations for the MOSAICO Trial | Susan Buchbinder, MD – Bridge HIV at the San Francisco Department of Health |
| Community-Informed Efforts Towards the MOSAICO Study | Stephaun Wallace, Ph.D., M.S. – Fred Hutchinson Cancer Research Center – University of Washington – Seattle, USA. |
| HPTN 083: Where did we go right? | Raphael Landovitz, M.D. – University of California, San Francisco – San Francisco, USA. |
| Contingency Plans: Modelling effectiveness using placebo counterfactuals | Deborah Donnell, Ph.D. – Fred Hutchinson Cancer Research Center – University of Washington – Seattle, USA. |
| PrEPVacc concepts – Registrational cohort and prequalification period | Eugene Ruzagira, MBChB, MPH, PhD – MRC/UVRI and LSHTM Uganda Research Unit – Entebbe, Uganda. |
| Pre-randomization information can inform counterfactual estimation | David Glidden MD – University of California, San Francisco – San Francisco, USA. |
PrEP Considerations for the MOSAICO trial (S1-03)
Susan Buchbinder, MD
University of California San Francisco
An introduction to the scientific and ethical rational supporting the conduct of the MOSAICO study.
Submit your question here.
Community-Informed Efforts Towards the MOSAICO Study (S1-04)
Stephaun Wallace, Ph.D, M.S.
University of Washington
In this presentation Stephaun Wallace stresses the importance and benefits of community-informed involvement in the design and implementation of the MOSAICO study.
Submit your question here.
HPTN 083: Where did we go right?(S1-05)
Raphael Landovitz, MD
University of California
Raphael Landovitz tells us what went right in the HPTN 083 study of the long acting antiviral Cabotegravir. New data are presented and emphasis is put on adhering to scientifically rigorous principles and persevering despite the retention challenge.
Submit your question here.
Contingency Plans: Modelling effectiveness using counterfactuals (S1-06)
Deborah Donnell, Ph.D.
Fred Hutchinson
Deborah Donnell presents the contingency plans based on a counterfactual approach that were designed should both products tested in HPTN 083 be equally successful and the trial might not have achieved a clear non-inferiorly result.
Submit your question here.
PrEPVacc concepts – Registrational cohort and prequalification period (S1-07)
Eugene Ruzagira, MBChB, MPH, Ph.D.
MRC/UVRI Uganda Research Unit
In this presentation, Eugene Ruzagira outlines the protocol of the Multi Arms Multi Steps (MAMS) PrEPVacc study, the first efficacy trial to test a prophylactic vaccine and PrEP at the same time and that uses a dedicated registration cohort to estimate HIV incidence in the study population.
Submit your question here.
Pre-randomization incidence can approximate a control group
David Glidden, Ph.D.
University of California San Francisco
Following on Eugene Ruzagira presentation of the PrEPVacc efficacy trial, David Glidden discusses the study design and the use of a registration cohort to approximate a control group. Other designs, such as the regency design, are also discussed.
Submit your question here.
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The Global HIV Vaccine Enterprise (the Enterprise) unites stakeholders to share knowledge, foster collaboration, enable solutions and expand support critical to the development of—and future access to—an HIV vaccine.
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