Designing preclinical perceptibility measures to evaluate topical vaginal gel formulations: Relating user sensory perceptions and experiences to formulation properties

Kathleen M. Morrow*, Joseph L. Fava, Rochelle K. Rosen, Sara Vargas, Julia G. Shaw, E. Milu Kojic, Patrick F. Kiser, David R. Friend, David F. Katz, Candelaria Barosso, Michelle Higgins, Jacquelyn Wallace, Lara Thompson, Dana Bregman, Jacob Van Den Berg, Kathleen Jensen, Shira Dunsiger, Anacecilia Panameño, Christopher Colleran, Liz SalomonCharles Covahey, Kenneth H. Mayer, Danielle Dang, Vanessa Frontiero, Lori Panther, Jennifer Peters, Anthony Geonnotti, Marcus Henderson, Bonnie Lai, Meredith Clark, Anthony Tuitupou, Judith Fabian

*Corresponding author for this work

Research output: Contribution to journalArticle

25 Scopus citations

Abstract

The effectiveness of any biomedical prevention technology relies on both biological efficacy and behavioral adherence. Microbicide trials have been hampered by low adherence, limiting the ability to draw meaningful conclusions about product effectiveness. Central to this problem may be an inadequate conceptualization of how product properties themselves impact user experience and adherence. Our goal is to expand the current microbicide development framework to include product "perceptibility," the objective measurement of user sensory perceptions (i.e., sensations) and experiences of formulation performance during use. For vaginal gels, a set of biophysical properties, including rheological properties and measures of spreading and retention, may critically impact user experiences. Project LINK sought to characterize the user experience in this regard, and to validate measures of user sensory perceptions and experiences (USPEs) using four prototype topical vaginal gel formulations designed for pericoital use. Perceptibility scales captured a range of USPEs during the product application process (five scales), ambulation after product insertion (six scales), and during sexual activity (eight scales). Comparative statistical analyses provided empirical support for hypothesized relationships between gel properties, spreading performance, and the user experience. Project LINK provides preliminary evidence for the utility of evaluating USPEs, introducing a paradigm shift in the field of microbicide formulation design. We propose that these user sensory perceptions and experiences initiate cognitive processes in users resulting in product choice and willingness-to-use. By understanding the impact of USPEs on that process, formulation development can optimize both drug delivery and adherence.

Original languageEnglish (US)
Pages (from-to)78-91
Number of pages14
JournalAIDS Research and Human Retroviruses
Volume30
Issue number1
DOIs
StatePublished - Jan 1 2014

ASJC Scopus subject areas

  • Immunology
  • Virology
  • Infectious Diseases

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    Morrow, K. M., Fava, J. L., Rosen, R. K., Vargas, S., Shaw, J. G., Kojic, E. M., Kiser, P. F., Friend, D. R., Katz, D. F., Barosso, C., Higgins, M., Wallace, J., Thompson, L., Bregman, D., Van Den Berg, J., Jensen, K., Dunsiger, S., Panameño, A., Colleran, C., ... Fabian, J. (2014). Designing preclinical perceptibility measures to evaluate topical vaginal gel formulations: Relating user sensory perceptions and experiences to formulation properties. AIDS Research and Human Retroviruses, 30(1), 78-91. https://doi.org/10.1089/aid.2013.0099