title: Perceptibility and the "Choice Experience": User Sensory Perceptions and Experiences Inform Vaginal Prevention Product Design.
abstract: The development of pericoital (on demand) vaginal HIV prevention technologies remains a global health priority. Clinical trials to date have been challenged by nonadherence, leading to an inability to demonstrate product efficacy. The work here provides new methodology and results to begin to address this limitation. We created validated scales that allow users to characterize sensory perceptions and experiences when using vaginal gel formulations. In this study, we sought to understand the user sensory perceptions and experiences (USPEs) that characterize the preferred product experience for each participant. Two hundred four women evaluated four semisolid vaginal formulations using the USPE scales at four randomly ordered formulation evaluation visits. Women were asked to select their preferred formulation experience for HIV prevention among the four formulations evaluated. The scale scores on the Sex-associated USPE scales (e.g., Initial Penetration and Leakage) for each participant's selected formulation were used in a latent class model analysis. Four classes of preferred formulation experiences were identified. Sociodemographic and sexual history variables did not predict class membership; however, four specific scales were significantly related to class: Initial Penetration, Perceived Wetness, Messiness, and Leakage. The range of preferred user experiences represented by the scale scores creates a potential target range for product development, such that products that elicit scale scores that fall within the preferred range may be more acceptable, or tolerable, to the population under study. It is recommended that similar analyses should be conducted with other semisolid vaginal formulations, and in other cultures, to determine product property and development targets.
authors.affiliation: 1 Centers for Behavioral & Preventive Medicine, The Miriam Hospital , Providence, Rhode Island.|2 Department of Psychiatry & Human Behavior, Warren Alpert Medical School of Brown University , Providence, Rhode Island.|3 Department of Behavioral & Social Sciences, Brown University School of Public Health , Providence, Rhode Island.
authors.forename: Kate Morrow
authors.initials: KM
authors.lastname: Guthrie
authors.affiliation: 1 Centers for Behavioral & Preventive Medicine, The Miriam Hospital , Providence, Rhode Island.|3 Department of Behavioral & Social Sciences, Brown University School of Public Health , Providence, Rhode Island.
authors.forename: Shira
authors.initials: S
authors.lastname: Dunsiger
authors.affiliation: 1 Centers for Behavioral & Preventive Medicine, The Miriam Hospital , Providence, Rhode Island.|2 Department of Psychiatry & Human Behavior, Warren Alpert Medical School of Brown University , Providence, Rhode Island.
authors.forename: Sara E
authors.initials: SE
authors.lastname: Vargas
authors.affiliation: 1 Centers for Behavioral & Preventive Medicine, The Miriam Hospital , Providence, Rhode Island.
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Fava
authors.affiliation: 1 Centers for Behavioral & Preventive Medicine, The Miriam Hospital , Providence, Rhode Island.
authors.forename: Julia G
authors.initials: JG
authors.lastname: Shaw
authors.affiliation: 1 Centers for Behavioral & Preventive Medicine, The Miriam Hospital , Providence, Rhode Island.|3 Department of Behavioral & Social Sciences, Brown University School of Public Health , Providence, Rhode Island.
authors.forename: Rochelle K
authors.initials: RK
authors.lastname: Rosen
authors.affiliation: 4 Department of Bioengineering, University of Utah , Salt Lake City, Utah.
authors.forename: Patrick F
authors.initials: PF
authors.lastname: Kiser
authors.affiliation: 5 Immunology Center, The Miriam Hospital , Providence, Rhode Island.|6 Department of Medicine, Warren Alpert Medical School of Brown University , Providence, Rhode Island.
authors.forename: E Milu
authors.initials: EM
authors.lastname: Kojic
authors.affiliation: 7 CONRAD , Arlington, Virginia.
authors.forename: David R
authors.initials: DR
authors.lastname: Friend
authors.affiliation: 8 Departments of Biomedical Engineering & Obstetrics/Gynecology, Duke University , Durham, North Carolina.
authors.forename: David F
authors.initials: DF
authors.lastname: Katz
mesh_terms: D000293:Adolescent; D000328:Adult; D018890:Chemoprevention / Q000379:methods*; D055808:Drug Discovery / Q000379:methods; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D065129:Pre-Exposure Prophylaxis / Q000379:methods*; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage*; D014838:Volunteers; D055815:Young Adult
chemical_list: D014622:Vaginal Creams, Foams, and Jellies
keywords: HIV/STI; adherence; dosage forms; perceptibility; prevention; product choice