Volume 12, Number 2, 272-283, DOI: 10.1007/s10461-007-9266-z

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

Kathleen M. Morrow and Monica S. Ruiz

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Abstract

A safe, effective, and acceptable microbicide is needed in order to decisively impact the global AIDS pandemic. As such, microbicide acceptability research is of paramount importance. In order to best utilize limited financial resources and save precious development time, acceptability studies should be fully integrated into preclinical and clinical trial contexts where candidate products are being developed and tested. An integrated approach for examining theoretically valid and relevant variables is needed so that data across studies and products can more effectively advance the field. We propose an approach for measuring factors related to microbicide acceptability in each phase of product development, and dependent on what product-specific knowledge is already established in the field. We discuss the roles that behavioral and social science methodologies should play in all phases of microbicide development, as well as the challenges faced when conducting acceptability research in the context of preclinical and clinical trial settings.

Keywords  Microbicides - Acceptability - Measurement - Clinical trials - Preclinical development

Portions of this work were presented at Microbicides 2006, Cape Town, South Africa, April 2006. Some of the conceptualizations in this manuscript by the first author are derived from work completed under grant number R01 MH064455, R21 MH080591 and CFAR P30 AI42853

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