Marseille 2007
| Abstract #224 - The PrEP (HIV Post Exposure Prophylaxis) controversy as the basis of an alternate model for evaluating biomedical prevention. | ||||
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Session: 47.2: Ethics and Law (Parallel) on Wednesday @ 08.30-10.30 in Auditorium/Overflow Chaired by Susan Newcomer, Anjali Nayyar Authors: Presenting Author: Dr Marsha Rosengarten - Goldsmiths, University of London, United Kingdom |
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| Additional Authors: Dr Marsha Rosengarten@gold.ac.uk, Prof Mike Michael, Mr Dean Murphy, Dr Beckie Coleman, | ||||
| Aim: To examine the controversy over PrEP trials in order to identify stakeholder perceptions of trialling and implementing HIV biomedical prevention technologies. | ||||
| Method / Issue: The study analysed stakeholder perceptions of PrEP as identified published literature including refereed journals, websites and reports. Contributors to this literature included trial organizers, advocacy groups, groups claiming to represent those targeted by the trials and funded research consultants. | ||||
| Results / Comments: The rationale for conducting Phase II/III trials of PrEP is based on continuing high rates of HIV infection, factors mitigating against the use of existing non-medical prevention technologies, the effective use of HIV antiretroviral therapy (ART) for prevention of mother-to-child transmission and the apparent effectiveness of a one-month course of ART as a post-exposure prophylaxis (PEP). The rationale for undertaking trials in countries with high HIV incidence is based on the need for statistically significant numbers of trial participants who are at risk of HIV infection and possible long term benefit to themselves and their populations. However, it is also apparent that the arguments for PrEP and for its trialling have contrasted with concerns expressed on behalf of potential trial participants. These concerns include lack of available and ongoing medical infrastructure for dealing with possible short and long term effects of drug toxicity, uneven and uncertain provision of ART drugs plus, in some instances, lack of access to non biomedical prevention technologies (eg free syringes in Thailand) for trial participants. Additionally, concern has been expressed about trial-related behavioural disinhibition on trial communities. Where efficacy is raised in the literature, the concept of partial effectiveness is highlighted as a potential challenge to understandings of infectivity and for sustaining existing prevention, namely condom use. | ||||
| Discussion: The rationale for and concerns about PrEP are specific to the development of an ART based-HIV biomedical prevention technology but also overlap with issues arising from the conduct of trials in middle income countries with high HIV incidence, treatment naive bodies and sometimes without guarantee of full HIV treatment access. Underpinning these concerns is a risk/benefit evaluation of PrEP. This risk/benefit model presumes PrEP is a fixed entity for those involved and distinct from the context in which it is delivered. Yet this is contradicted by the likelihood that it will be only partially effective within and/or across a population of bodies (also anticipated to be the case with any future vaccines). While the framing evident in the PrEP literature is consistent with evaluation of other biomedical interventions, the review elicited the potential for an alternate model of evaluation. This model conceives the research and prevention field as a site where the exchange of knowledge and also biological and pharmaceutical matter is a product of the relations between stakeholders. This provides new insights into the challenges and possibilities of biomedical prevention. | ||||
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