Literature DB >> 28653286

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

Kate M Guthrie1,2, Rochelle K Rosen3,4, Sara E Vargas3,5, Melissa Guillen3, Arielle L Steger6, Melissa L Getz3, Kelley A Smith3, Jaime J Ramirez3, Erna M Kojic7.   

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.

Entities:  

Keywords:  Adherence; Iterative design; Prevention product development; Sexual health; Translational science; User experience; User input

Mesh:

Substances:

Year:  2017        PMID: 28653286      PMCID: PMC6103777          DOI: 10.1007/s13346-017-0397-0

Source DB:  PubMed          Journal:  Drug Deliv Transl Res        ISSN: 2190-393X            Impact factor:   4.617


  34 in total

1.  Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.

Authors:  Quarraisha Abdool Karim; Salim S Abdool Karim; Janet A Frohlich; Anneke C Grobler; Cheryl Baxter; Leila E Mansoor; Ayesha B M Kharsany; Sengeziwe Sibeko; Koleka P Mlisana; Zaheen Omar; Tanuja N Gengiah; Silvia Maarschalk; Natasha Arulappan; Mukelisiwe Mlotshwa; Lynn Morris; Douglas Taylor
Journal:  Science       Date:  2010-07-19       Impact factor: 47.728

2.  Assessing microbicide acceptability: a comprehensive and integrated approach.

Authors:  Kathleen M Morrow; Monica S Ruiz
Journal:  AIDS Behav       Date:  2007-06-26

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

Authors:  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
Journal:  AIDS Res Hum Retroviruses       Date:  2013-12-09       Impact factor: 2.205

Review 4.  Development of topical microbicides to prevent the sexual transmission of HIV.

Authors:  Robert W Buckheit; Karen M Watson; Kathleen M Morrow; Anthony S Ham
Journal:  Antiviral Res       Date:  2009-10-27       Impact factor: 5.970

Review 5.  In pursuit of functional electrospun materials for clinical applications in humans.

Authors:  Ryan J Stoddard; Arielle L Steger; Anna K Blakney; Kim A Woodrow
Journal:  Ther Deliv       Date:  2016-06-02

6.  Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women.

Authors:  Salim S Abdool Karim; Barbra A Richardson; Gita Ramjee; Irving F Hoffman; Zvavahera M Chirenje; Taha Taha; Muzala Kapina; Lisa Maslankowski; Anne Coletti; Albert Profy; Thomas R Moench; Estelle Piwowar-Manning; Benoît Mâsse; Sharon L Hillier; Lydia Soto-Torres
Journal:  AIDS       Date:  2011-04-24       Impact factor: 4.177

7.  Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites.

Authors:  J van De Wijgert; A Fullem; C Kelly; S Mehendale; S Rugpao; N Kumwenda; Z Chirenje; S Joshi; T Taha; N Padian; R Bollinger; K Nelson
Journal:  J Acquir Immune Defic Syndr       Date:  2001-01-01       Impact factor: 3.731

8.  Perceptibility and the "Choice Experience": User Sensory Perceptions and Experiences Inform Vaginal Prevention Product Design.

Authors:  Kate Morrow Guthrie; Shira Dunsiger; Sara E Vargas; Joseph L Fava; Julia G Shaw; Rochelle K Rosen; Patrick F Kiser; E Milu Kojic; David R Friend; David F Katz
Journal:  AIDS Res Hum Retroviruses       Date:  2016-03-29       Impact factor: 2.205

9.  "Set it and forget it": women's perceptions and opinions of long-acting topical vaginal gels.

Authors:  Jacob J van den Berg; Rochelle K Rosen; Dana E Bregman; Lara A Thompson; Kathleen M Jensen; Patrick F Kiser; David F Katz; Karen Buckheit; Robert W Buckheit; Kathleen M Morrow
Journal:  AIDS Behav       Date:  2014-05

10.  The Promise of Intravaginal Rings for Prevention: User Perceptions of Biomechanical Properties and Implications for Prevention Product Development.

Authors:  Kate Morrow Guthrie; Sara Vargas; Julia G Shaw; Rochelle K Rosen; Jacob J van den Berg; Patrick F Kiser; Karen Buckheit; Dana Bregman; Lara Thompson; Kathleen Jensen; Todd Johnson; Robert W Buckheit
Journal:  PLoS One       Date:  2015-12-22       Impact factor: 3.240

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  6 in total

1.  Designing Dual Compartment HIV Prevention Products: Women's Sensory Perceptions and Experiences of Suppositories for Rectal and Vaginal Use.

Authors:  Kate M Guthrie; Rochelle K Rosen; Melissa Guillen; Jaime J Ramirez; Sara E Vargas; Joseph L Fava; Anthony S Ham; David F Katz; Susan Cu-Uvin; Sheila Tumilty; Kelley A Smith; Karen W Buckheit; Robert W Buckheit
Journal:  AIDS Res Hum Retroviruses       Date:  2021-10-18       Impact factor: 1.723

2.  Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026).

Authors:  José A Bauermeister; Ryan C Tingler; Clara Dominguez; Eileen F Dunne; Craig Hoesley; Ken Ho; Sherri Johnson; Jonathan Lucas; Nicole Macagna; Elizabeth Brown; Holly Gundacker; Melissa Peda; Cindy E Jacobson; Lindsay Kramzer; Devika Singh; Charlene S Dezzutti; Ratiya Pamela Kunjara Na Ayudhya; Mark A Marzinke; Jeanna Piper; Bríd Devlin; Jeremy Nuttall; Ian McGowan; Craig W Hendrix; Ross D Cranston
Journal:  AIDS Behav       Date:  2021-10-17

3.  Young Women's Ratings of Three Placebo Multipurpose Prevention Technologies for HIV and Pregnancy Prevention in a Randomized, Cross-Over Study in Kenya and South Africa.

Authors:  Alexandra M Minnis; Sarah T Roberts; Kawango Agot; Rachel Weinrib; Khatija Ahmed; Kgahlisho Manenzhe; Fredrick Owino; Ariane van der Straten
Journal:  AIDS Behav       Date:  2018-08

Review 4.  Human-Centered Design Lessons for Implementation Science: Improving the Implementation of a Patient-Centered Care Intervention.

Authors:  Laura K Beres; Sandra Simbeza; Charles B Holmes; Chanda Mwamba; Njekwa Mukamba; Anjali Sharma; Virginia Munamunungu; Monica Mwachande; Kombatende Sikombe; Carolyn Bolton Moore; Aaloke Mody; Aybüke Koyuncu; Katerina Christopoulos; Lazarus Jere; Jake Pry; Peter D Ehrenkranz; Ashwin Budden; Elvin Geng; Izukanji Sikazwe
Journal:  J Acquir Immune Defic Syndr       Date:  2019-12       Impact factor: 3.731

5.  User evaluations offer promise for pod-intravaginal ring as a drug delivery platform: A mixed methods study of acceptability and use experiences.

Authors:  Kate M Guthrie; Rochelle K Rosen; Sara E Vargas; Melissa L Getz; Lauren Dawson; Melissa Guillen; Jaime J Ramirez; Marc M Baum; Kathleen L Vincent
Journal:  PLoS One       Date:  2018-05-14       Impact factor: 3.240

6.  Qualitative exploration of intrinsic and extrinsic factors that influence acceptability of semisoft vaginal suppositories.

Authors:  Toral Zaveri; Kimberly A Powell; Kate M Guthrie; Alyssa J Bakke; Gregory R Ziegler; John E Hayes
Journal:  BMC Womens Health       Date:  2018-10-20       Impact factor: 2.809

  6 in total

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