The goal of Project 5 is to inform the design of dual compartment microbicide formulations by developing a comprehensive understanding of the user experience, and the impact of that experience on user preferences, product acceptability and, ultimately, product adherence. Project 5 incorporates a series of formative and experimental studies into the overall IPCP dual compartment microbicide development plan. Both men and women will serve as participants. Study 5.1 is a formative mixed methods study, designed to develop RAI (receptive anal intercourse)-specific user sensory perception and experience (USPE) instruments. A set of formulations that represent the range of formulation properties and characteristics believed to be best suited for dual compartment use will be studied. In-depth interviews will be used to generate FRAI-specific items to be incorporated into existing USPE instrumentation. These measures will then be used to evaluate USPE and conventional acceptability constructs with respect to the candidate microbicides being evaluated in Project 4 (USPE studies incorporated into Project 4 referred to as Study 5.2). Finally, Study 5.3 is a randomized trial comparing prototype formulations being developed in this IPCP with respect to USPE and willingness-to-use such formulations. The USPE trial (Study 5.3) will achieve two important goals: 1) psychometrically validate novel and adapted USPE instruments specifically designed for rectal microbicide evaluation, incorporating the current understanding of vaginal USPE into an omnibus conceptualization of dual compartment microbicides, and 2) evaluate users'perceptions and experiences of the physicochemical and rheological properties of rectal microbicide formulations, and how those perceptions and experiences impact conventional acceptability and willingness-to-use variables. By understanding the correspondence between the user experience and preferences, we can better inform formulation design. This knowledge, in combination with the optimization of formulation for delivery of the active pharmaceutical ingredient, will positively impact effectiveness by increasing the likelihood of the microbicide being used as intended, thus contributing to decreases in HIV incidence in those at-risk.

Public Health Relevance

The ability to more fully understand a user perspective allows the design of dual compartment microbicides that are more likely to be incorporated into HIV prevention strategies. Such products would optimize both drug delivery and the user experience, increasing the likelihood of use. The impact of optimized effective dual compartment microbicides on public health would be to decrease global HIV and STI incidence

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
1U19AI101961-01
Application #
8404977
Study Section
Special Emphasis Panel (ZAI1-ESB-A (M2))
Project Start
2012-06-22
Project End
2017-05-31
Budget Start
2012-06-22
Budget End
2013-05-31
Support Year
1
Fiscal Year
2012
Total Cost
$467,037
Indirect Cost
$76,123
Name
Imquest Biosciences
Department
Type
DUNS #
146051664
City
Frederick
State
MD
Country
United States
Zip Code
21704
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Pereira, Lara E; Mesquita, Pedro M M; Ham, Anthony et al. (2015) Pharmacokinetic and Pharmacodynamic Evaluation following Vaginal Application of IQB3002, a Dual-Chamber Microbicide Gel Containing the Nonnucleoside Reverse Transcriptase Inhibitor IQP-0528 in Rhesus Macaques. Antimicrob Agents Chemother 60:1393-400