The development of safe, effective and acceptable microbicides is imperative in the fight against HIV/AIDS. The success of microbicide products will derive from the synergy of their biological functionality and user acceptability. Biological functionality is the integrated result of safe and effective anti-HIV compounds incorporated into formulations or devices that successfully deliver those compounds to target tissues, fluids and pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, productrelated and social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptability depends strongly upon delivery systems with biophysical functions and /or mechanical and materials properties that are most conducive to human use. Without both, microbicides'potential to impact the public health crisis of HIV/AIDS will be largely limited. Project 3 will integrate and extend our growing knowledge and methodologies in preclinical microbicide formulation and delivery device sciences, with their counterpart in early human studies of acceptability. It will extend current behavioral strategies for studying gel acceptability in preclinical frameworks, and expand those strategies to intravaginal ring (IVR) applications. Project 3 will first modify existing behavioral tools that measure topical gel acceptability dimensions for preclinical formulation development;the new tools will incorporate expanded acceptability dimensions to account for the use of long-acting gels and IVR devices developed in this U19. We will then extend our current preclinical in vivo human studies methodology, integrating imaging experiments with behavioral assessment. This will enable joint determination of two critical components of microbicide success: user acceptability and gel functionality. Further, we will use the expanded measures to analyze the correspondence between behavioral measures and biophysical measures, creating a statistical framework enabling prediction of user ratings of long-acting gel experiences from gel performance measures. Finally, we will examine user ratings of acceptability dimensions associated with these delivery systems, and propose initial preclinical standards of acceptability for long-acting gels and IVRs.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI077289-05
Application #
8380871
Study Section
Special Emphasis Panel (ZAI1-CCH-A)
Project Start
Project End
2014-05-31
Budget Start
2012-06-01
Budget End
2013-05-31
Support Year
5
Fiscal Year
2012
Total Cost
$152,593
Indirect Cost
$11,540
Name
Imquest Biosciences
Department
Type
DUNS #
146051664
City
Frederick
State
MD
Country
United States
Zip Code
21704
Morrow Guthrie, Kate; Vargas, Sara; Shaw, Julia G et al. (2015) The Promise of Intravaginal Rings for Prevention: User Perceptions of Biomechanical Properties and Implications for Prevention Product Development. PLoS One 10:e0145642
Rosen, Rochelle K; van den Berg, Jacob J; Vargas, Sara E et al. (2015) Meaning-making matters in product design: users' sensory perceptions and experience evaluations of long-acting vaginal gels and intravaginal rings. Contraception 92:596-601
Ugaonkar, Shweta R; Clark, Justin T; English, Lexie B et al. (2015) An Intravaginal Ring for the Simultaneous Delivery of an HIV-1 Maturation Inhibitor and Reverse-Transcriptase Inhibitor for Prophylaxis of HIV Transmission. J Pharm Sci 104:3426-39
Katz, David F; Yuan, Andrew; Gao, Yajing (2015) Vaginal drug distribution modeling. Adv Drug Deliv Rev 92:2-13
Gao, Y; Yuan, A; Chuchuen, O et al. (2015) Vaginal deployment and tenofovir delivery by microbicide gels. Drug Deliv Transl Res 5:279-94
van den Berg, Jacob J; Rosen, Rochelle K; Bregman, Dana E et al. (2014) "Set it and forget it": women's perceptions and opinions of long-acting topical vaginal gels. AIDS Behav 18:862-70
Tolley, Elizabeth E; Morrow, Kathleen M; Owen, Derek H (2013) Designing a multipurpose technology for acceptability and adherence. Antiviral Res 100 Suppl:S54-9
Rastogi, Rachna; Teller, Ryan S; Mesquita, Pedro M M et al. (2013) Osmotic pump tablets for delivery of antiretrovirals to the vaginal mucosa. Antiviral Res 100:255-8
Drake, Tyler K; Shah, Tejen; Peters, Jennifer J et al. (2013) Measuring dilution of microbicide gels with optical imaging. PLoS One 8:e82213
Dezzutti, Charlene S; Shetler, Cory; Mahalingam, Alamelu et al. (2012) Safety and efficacy of tenofovir/IQP-0528 combination gels - a dual compartment microbicide for HIV-1 prevention. Antiviral Res 96:221-5

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