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

Abstract

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.

FIG. 1.

Averaged scale items scores for each Perceptibility Scale for Application. 1=do not agree at all; 2=agree a little; 3=agree somewhat; 4=agree a lot; 5=agree completely. Primary constituents for each gel were 3% hydroxyethylcellulose (HEC) (orange); 1.25% carbopol (yellow); 2% HEC and 1.73% carbopol (purple); and 3% HEC and 2.5% carbopol (green). Pairwise comparisons are presented in Table 6. Color images available online at www.liebertpub.com/aid

FIG. 2.

Averaged scale items scores for each Perceptibility Scale for Ambulation. 1=do not agree at all; 2=agree a little; 3=agree somewhat; 4=agree a lot; 5=agree completely. Primary constituents for each gel were 3% hydroxyethylcellulose (HEC) (orange); 1.25% carbopol (yellow); 2% HEC and 1.73% carbopol (purple); and 3% HEC and 2.5% carbopol (green). Pairwise comparisons are presented in Table 6. Color images available online at www.liebertpub.com/aid

FIG. 3.

Averaged scale items scores for each Perceptibility Scale for Sexual Activity. 1=do not agree at all; 2=agree a little; 3=agree somewhat; 4=agree a lot; 5=agree completely. Primary constituents for each gel were 3% hydroxyethylcellulose (HEC) (orange); 1.25% carbopol (yellow); 2% HEC and 1.73% carbopol (purple); and 3% HEC and 2.5% carbopol (green). Pairwise comparisons are presented in Table 6. Color images available online at www.liebertpub.com/aid