AIDSImpact.com:: - Santa Fe, USA 2011

Abstract #373 - Issues raised by biomedical research in prevention
Authors: Presenting Author: Mr Vincent Douris - Sidaction
Additional Authors:
Aim: This session aims at addressing some issues raised by biomedical research in prevention including the use of ARV’s, by either topical or oral way and circumcision. Since the end of the nineties, concerns have been expressed by different actors regarding biomedical trials in prevention. Indeed, the medical legitimacy of investigators and promoters has been progressively challenged and the need for randomized controlled trials to deliver the evidence has been discussed. At the same time, the "evidence-based" discourse has never been so strong than in recent years, and therefore policy-makers ask for indisputable data to be able to adopt new public-health measures. The session will try to tackle this discrepancy. First, the panel will present ethical issues related to several past PrEP trials conducted in African and Asian countries. He will then discuss how AVAC/UNAIDS Guidelines for biomedical HIV prevention trials and UNAIDS/WHO Ethical considerations take into account elements of past controversies in order to address concerns raised about access to care, standard of prevention or other issues. The possible role of communities in the research design and implementation will also be considered. Second, participants will discuss the level of evidence produced by biomedical trials in prevention using methods that public health authorities expect to validate to further develop programs and policies. The questions of efficacy, effectiveness, roll out and scaling up, but also those on of the regimen of evidence, standard of care and prevention will then be considered, in the light of ethical issues discussed earlier.
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