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Licensed Unlicensed Requires Authentication Published by De Gruyter July 18, 2019

Designing the Next Generation of HIV Prevention Efficacy Trials: Synopsis of a 2018 Symposium

Holly Janes, Deborah Donnell and Martha Nason

Abstract

A one-day symposium was held in Seattle, Washington on November 5, 2018, including a broad array of stakeholders in the HIV prevention community. The topic of discussion was the challenge of designing future HIV prevention efficacy trials, given the multiplicity and speed of changes in the field in recent years, the development and rollout of effective prevention tools, and the resultant complexity in designing trials to evaluate new HIV prevention products. The goal was to identify potential statistical trial design approaches worthy of further investigation, as well as gaps in understanding and logical next steps. We overview the themes that emerged from the presentations, panels, and floor discussions, and outline initial next steps in further exploring design options.

Acknowledgements

The organizers thank the Fred Hutch staff who were critical for making the event a success, especially Megan Rabone and Jerry Ockfen; NIAID, the Bill and Melinda Gates Foundation, and the three major NIAID-funded HIV prevention networks (the HVTN, HPTN, and MTN) for funding; the speakers, moderators, and panelists for their collaboration well advance of the event; and to the participants for engaging in the discussion. We also acknowledge Lindsay Carpp for her editorial assistance, and Zoe Moodie, Lynda Emel, and Brett Hanscom who contributed to an earlier version of this synopsis.

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Received: 2019-02-06
Revised: 2019-08-23
Accepted: 2019-06-20
Published Online: 2019-07-18

© 2019 Walter de Gruyter GmbH, Berlin/Boston