Literature DB >> 34544269

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

Kate M Guthrie1,2,3, Rochelle K Rosen1,3, Melissa Guillen1, Jaime J Ramirez1, Sara E Vargas1,2, Joseph L Fava1, Anthony S Ham4, David F Katz5, Susan Cu-Uvin6,7, Sheila Tumilty7, Kelley A Smith1, Karen W Buckheit4, Robert W Buckheit4.   

Abstract

Dual compartment suppositories are being developed to prevent HIV and other sexually transmitted infections. Such products, for use in the rectum, the vagina, or both, could have a significant public health impact by decreasing global incidence of these diseases. In this study, 16 women each used two rheologically distinct suppositories in their vagina and rectum. User Sensory Perception and Experience (USPE) scales assessed sensory experiences during sexual activity to understand whether, and how, women perceive formulation properties in the vagina and rectum. Qualitative data from individual in-depth interviews captured women's descriptions and comparisons of the experiences. Significant differences and large Cohen's d effect sizes between vaginal and rectal experiences of suppository-A were found for three scales: Application (APP): Product Awareness, SEX: Initial Penetration; and SEX: Effortful. Qualitative data provided user experience details that credibly align with these score differences. Near significant differences and large effect sizes were found for two additional scales: SEX: Perceived Wetness with suppository-A and SEX: Messiness with suppository-B. In addition, other scale scores showed medium-to-large effect sizes that correspond to hypothesized sensations associated with biophysical properties of the suppositories. Statistical significance combined with large effect sizes and qualitative data accurately represent the hypothesized perceptibility of suppository properties and identifies performance characteristics relevant to acceptability and adherence; together these data provide discernment of factors that can guide the development of dual compartment products. The Clinical Trial Registration number: NCT02744261.

Entities:  

Keywords:  dual compartment products; perceptibility; rectal HIV prevention; sensory experiences; suppositories; vaginal HIV prevention

Mesh:

Substances:

Year:  2021        PMID: 34544269      PMCID: PMC9297320          DOI: 10.1089/AID.2021.0038

Source DB:  PubMed          Journal:  AIDS Res Hum Retroviruses        ISSN: 0889-2229            Impact factor:   1.723


  32 in total

Review 1.  The vagina as a route for systemic drug delivery.

Authors:  Alamdar Hussain; Fakhrul Ahsan
Journal:  J Control Release       Date:  2005-01-13       Impact factor: 9.776

2.  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

3.  The Role of Volume in the Perceptibility of Topical Vaginal Formulations: User Sensory Perceptions and Experiences of Heterosexual Couples During Vaginal Sex.

Authors:  Kate M Guthrie; Joseph L Fava; Sara E Vargas; Rochelle K Rosen; Julia G Shaw; Erna M Kojic; Anthony S Ham; Lisa C Rohan; David Katz; Anacecilia Panameño; Christopher Colleran; David F Friend; Karen W Buckheit; Robert W Buckheit
Journal:  AIDS Res Hum Retroviruses       Date:  2020-11-03       Impact factor: 2.205

4.  Vaginal film for prevention of HIV: using visual and tactile evaluations among potential users to inform product design.

Authors:  K M Guthrie; L Rohan; R K Rosen; S E Vargas; J G Shaw; D Katz; E M Kojic; A S Ham; D Friend; K W Buckheit; R W Buckheit
Journal:  Pharm Dev Technol       Date:  2017-06-21       Impact factor: 3.133

5.  "Like Holding an Umbrella Before It Rains": Acceptability of Future Rectal Microbicides Among Men Who Have Sex With Men in India-A Modified Technology Acceptance Model.

Authors:  Venkatesan Chakrapani; Peter A Newman; Murali Shunmugam; Shruta Mengle; Ruban Nelson; Clara Rubincam; Pushpesh Kumar
Journal:  Qual Health Res       Date:  2017-03-20

Review 6.  Rectal drug administration: clinical pharmacokinetic considerations.

Authors:  A G de Boer; F Moolenaar; L G de Leede; D D Breimer
Journal:  Clin Pharmacokinet       Date:  1982 Jul-Aug       Impact factor: 6.447

7.  Behavioral, biological, and demographic risk and protective factors for new HIV infections among youth in Rakai, Uganda.

Authors:  John S Santelli; Zoe R Edelstein; Sanyukta Mathur; Ying Wei; Wenfei Zhang; Mark G Orr; Jenny A Higgins; Fred Nalugoda; Ron H Gray; Maria J Wawer; David M Serwadda
Journal:  J Acquir Immune Defic Syndr       Date:  2013-07-01       Impact factor: 3.731

Review 8.  HIV transmission risk through anal intercourse: systematic review, meta-analysis and implications for HIV prevention.

Authors:  Rebecca F Baggaley; Richard G White; Marie-Claude Boily
Journal:  Int J Epidemiol       Date:  2010-04-20       Impact factor: 7.196

Review 9.  Vulnerability of women in southern Africa to infection with HIV: biological determinants and priority health sector interventions.

Authors:  Matthew F Chersich; Helen V Rees
Journal:  AIDS       Date:  2008-12       Impact factor: 4.177

10.  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

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