XVIII International AIDS Conference

Abstract

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'Why should communities be interested in clinical trials?' Results from the Brazilian community consultation on the 'Good participatory practice guidelines for biomedical HIV prevention trials' - GPP guidelines, São Paulo, Brazil, 2008

G. Calazans1,2,3, J. Beloqui4,5

1Centro de Referencia e Treinamento DST/Aids de São Paulo, São Paulo, Brazil, 2Faculdade de Ciências Médicas da Santa Casa de São Paulo, São Paulo, Brazil, 3Nepaids - USP, São Paulo, Brazil, 4GIV - Grupo de Incentivo à Vida, São Paulo, Brazil, 5Instituto de Matemática e Estatística - USP, São Paulo, Brazil

Issues: Brazilian community members, who have strategic roles in accompanying HIV and Aids vaccine trials, were gathered in the debate on “Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials” (GPP Guidelines, UNAIDS/AVAC) in order to deepen this debate in the country, improve their advocacy skills towards better participatory practices on HIV prevention trials and provide input to a future revision process.
Description: A two-day consultative meeting was developed engaging 20 Brazilian community members in an exhaustive debate on the entire document of the GPP Guidelines, which they have received prior to the meeting to read it.
Lessons learned: The GPP guidelines were considered very opportune providing a good systematization of participatory practices in clinical trials. Nevertheless, it was recommended that the GPP Guidelines revision process should address a question raised by the group discussion on 'Why should communities be interested in clinical trials?' In this sense, this revision process should incorporate a community perspective and the principle of reciprocity, as a concept that positive and negative responses from the community should be considered proportional and fitting to the benefits and harms they perceive receive from researchers.
Next steps: Brazilian community members recommend for the Brazilian branch of the UNAIDS to formally disseminate the GPP document to the Brazilian Commission on Research Ethics (CONEP) and to local Ethics Committees, to all the committees connected to the Brazilian Program on STD and AIDS, and particularly to the Brazilian Vaccine Committee, aiming to publish it amongst Brazilian AIDS activists and clinical researchers. Considering the general character of the document, this group of Brazilian community members has concluded that different national forums should get to know the GPP guidelines, take it as a debate starter in order to create conditions to the development of a Brazilian document to establish guidelines and regulate participatory practices in clinical trials in Brazil.


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