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User input in iterative design for prevention product development: leveraging interdisciplinary methods to optimize effectiveness

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Abstract

The development of HIV-preventive topical vaginal microbicides has been challenged by a lack of sufficient adherence in later stage clinical trials to confidently evaluate effectiveness. This dilemma has highlighted the need to integrate translational research earlier in the drug development process, essentially applying behavioral science to facilitate the advances of basic science with respect to the uptake and use of biomedical prevention technologies. In the last several years, there has been an increasing recognition that the user experience, specifically the sensory experience, as well as the role of meaning-making elicited by those sensations, may play a more substantive role than previously thought. Importantly, the role of the user—their sensory perceptions, their judgements of those experiences, and their willingness to use a product—is critical in product uptake and consistent use post-marketing, ultimately realizing gains in global public health. Specifically, a successful prevention product requires an efficacious drug, an efficient drug delivery system, and an effective user. We present an integrated iterative drug development and user experience evaluation method to illustrate how user-centered formulation design can be iterated from the early stages of preclinical development to leverage the user experience. Integrating the user and their product experiences into the formulation design process may help optimize both the efficiency of drug delivery and the effectiveness of the user.

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Acknowledgements

The authors would like to acknowledge and thank the participants in the iterative user experience studies used as the exemplar in this manuscript. We would also like to thank our colleagues who provide collaborative and thought-provoking insights and guidance as we build a science of user experience and patient input. A. Stege is now affiliated with the Allen Institute for Brain Science, 615 Westlake Ave N, Seattle, WA. K.A. Smith is now at the Hassenfeld Child Health Innovation Institute, Brown University, Providence, RI. E.M. Kojic is now affiliated with Icahn School of Medicine at Mount Sinai, Division of Infectious Diseases, Mount Sinai St. Luke’s and Mount Sinai West, 1111 Amsterdam Ave, New York, NY. Research reported in this publication was supported by the Division of AIDS, The National Institute of Allergy and Infectious Diseases of the National Institutes of Health, under award number R01 AI112002. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Authors and Affiliations

  1. Centers for Behavioral and Preventive Medicine, The Miriam Hospital, 164 Summit Avenue, Providence, RI, 02906, USA

    Kate M. Guthrie, Rochelle K. Rosen, Sara E. Vargas, Melissa Guillen, Melissa L. Getz, Kelley A. Smith & Jaime J. Ramirez

  2. Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Box G-A1, Providence, RI, 02912, USA

    Kate M. Guthrie & Sara E. Vargas

  3. Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02903, USA

    Rochelle K. Rosen

  4. Department of Bioengineering, University of Washington, 3720 15th Avenue NE, Seattle, WA, 98195, USA

    Arielle L. Steger

  5. Division of Infectious Disease, Department of Medicine, Alpert Medical School of Brown University, 593 Eddy Street, Providence, RI, 02903, USA

    Erna M. Kojic

Authors
  1. Kate M. Guthrie
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  2. Rochelle K. Rosen
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  3. Sara E. Vargas
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  4. Melissa Guillen
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  5. Arielle L. Steger
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  6. Melissa L. Getz
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  7. Kelley A. Smith
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  8. Jaime J. Ramirez
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  9. Erna M. Kojic
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Corresponding author

Correspondence to Kate M. Guthrie.

Ethics declarations

The human subject research discussed in this publication complied with all current laws of the USA as codified in 45 CFR 46 and all applicable institutional guidelines. The study was overseen by the applicable human subjects institutional review boards. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). Informed consent was obtained from all participants before being included in the study.

Conflict of interest

The authors declare that they have no conflicts of interest.

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Guthrie, K.M., Rosen, R.K., Vargas, S.E. et al. User input in iterative design for prevention product development: leveraging interdisciplinary methods to optimize effectiveness. Drug Deliv. and Transl. Res. 7, 761–770 (2017). https://doi.org/10.1007/s13346-017-0397-0

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  • DOI: https://doi.org/10.1007/s13346-017-0397-0

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