This project directly addresses RFA-AI-06-005 request for technologies, strategies or models that contribute to new and more efficient ways of assessing and predicting microbicide acceptability within the preclinical framework of formulation development. Achieving this goal requires integration of behavioral with biophysical determinants of acceptability parameters. This project analyzes correspondence of cognitive and behavioral aspects of user ratings of microbicide characteristics and activity, with biophysical microbicide properties governing vaginal distribution/retention (""""""""deployment"""""""") and hypothesized to correlate with human perceptions of microbicide use. During the R21 project, qualitative interviews, item development strategies and cognitive interviews will enable behavioral investigators to develop a user rating scale for use within the framework of preclinical feasibility studies of candidate microbicides. In parallel, formulation scientists will compute measures of biophysical functioning of 2 current over-the-counter vaginal gels, hypothesized to correlate with the behavioral constructs. Once it is shown that the behavioral tool (i.e., scale) has good psychometric characteristics, relationships between user rating measures and biophysical measures will be evaluated. Correspondence between what users can perceive/evaluate with respect to their experiences using a gel, and what biophysical properties/analysis can predict with respect to these perceptions and user ratings, will be delineated. The project goal is to demonstrate that these two measurement systems can be employed synergistically, toward optimization of 1) microbicide biophysical properties governing effective deployment and biofunctionality, and 2) user ratings of application- and vehicle-associated acceptability. In the R33 these measurement systems will be further evaluated and validated using novel GRAS gel formulations. Finally, a statistical framework that initiates prediction of user ratings of gels will be developed. The microbicide field's ability to co-determine microbicide function and acceptability will dramatically increase its ability to conceive and create optimal formulations in preclinical studies. By linking user ratings with biophysical properties, the resulting behavioral tool (scale) will better inform the preclinical microbicide pipeline, enabling products to be tailored to future users with greater certainty. In sum, this work will contribute methodology leading to rational design of microbicide formulations that co-optimize vaginal distribution and retention with user acceptability.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Exploratory/Developmental Grants Phase II (R33)
Project #
5R33MH080591-05
Application #
7932824
Study Section
Special Emphasis Panel (ZAI1-BLG-A (S1))
Program Officer
Pequegnat, Willo
Project Start
2006-09-28
Project End
2012-12-31
Budget Start
2010-09-01
Budget End
2012-12-31
Support Year
5
Fiscal Year
2010
Total Cost
$429,462
Indirect Cost
Name
Miriam Hospital
Department
Type
DUNS #
063902704
City
Providence
State
RI
Country
United States
Zip Code
02906
Guthrie, Kate Morrow; Dunsiger, Shira; Vargas, Sara E et al. (2016) Perceptibility and the ""Choice Experience"": User Sensory Perceptions and Experiences Inform Vaginal Prevention Product Design. AIDS Res Hum Retroviruses 32:1022-1030
Morrow, Kathleen M; Fava, Joseph L; Rosen, Rochelle K et al. (2014) Designing preclinical perceptibility measures to evaluate topical vaginal gel formulations: relating user sensory perceptions and experiences to formulation properties. AIDS Res Hum Retroviruses 30:78-91
Morrow, Kathleen M; Underhill, Kristen; van den Berg, Jacob J et al. (2014) User-identified gel characteristics: a qualitative exploration of perceived product efficacy of topical vaginal microbicides. Arch Sex Behav 43:1459-67
Tolley, Elizabeth E; Morrow, Kathleen M; Owen, Derek H (2013) Designing a multipurpose technology for acceptability and adherence. Antiviral Res 100 Suppl:S54-9
Mahan, Ellen D; Morrow, Kathleen M; Hayes, John E (2011) Quantitative perceptual differences among over-the-counter vaginal products using a standardized methodology: implications for microbicide development. Contraception 84:184-93
Buckheit Jr, Robert W; Watson, Karen M; Morrow, Kathleen M et al. (2010) Development of topical microbicides to prevent the sexual transmission of HIV. Antiviral Res 85:142-58
Morrow, Kathleen M; Hendrix, Craig (2010) Clinical evaluation of microbicide formulations. Antiviral Res 88 Suppl 1:S40-6