The development of safe, effective and acceptable microbicides is imperative in the fight against HIV/AIDS.The success of microbicide products will derive from the synergy of their biological functionality and useracceptability. Biological functionality is the integrated result of safe and effective anti-HIV compoundsincorporated into formulations or devices that successfully deliver those compounds to target tissues, fluidsand pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, productrelatedand social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptabilitydepends strongly upon delivery systems with biophysical functions and /or mechanical and materialsproperties that are most conducive to human use. Without both, microbicides' potential to impact the publichealth crisis of HIV/AIDS will be largely limited. Project 3 will integrate and extend our growing knowledgeand methodologies in preclinical microbicide formulation and delivery device sciences, with their counterpartin early human studies of acceptability. It will extend current behavioral strategies for studying gelacceptability in preclinical frameworks, and expand those strategies to intravaginal ring (IVR) applications.Project 3 will first modify existing behavioral tools that measure topical gel acceptability dimensions forpreclinical formulation development; the new tools will incorporate expanded acceptability dimensions toaccount for the use of long-acting gels and IVR devices developed in this U19. We will then extend ourcurrent preclinical in vivo human studies methodology, integrating imaging experiments with behavioralassessment. This will enable joint determination of two critical components of microbicide success: useracceptability and gel functionality. Further, we will use the expanded measures to analyze thecorrespondence between behavioral measures and biophysical measures, creating a statistical frameworkenabling prediction of user ratings of long-acting gel experiences from gel performance measures. Finally,we will examine user ratings of acceptability dimensions associated with these delivery systems, andpropose initial preclinical standards of acceptability for long-acting gels and IVRs.
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