User-Based Design to Aid in Contraceptive Development by Small Business (R43 Clinical Trial Not Allowed)

The purpose of this Funding Opportunity Announcement (FOA) is to invite SBIR applications to study/identify characteristics that inform acceptability, desirability, and excitement of potential end-users of novel contraceptive products currently in the development pipeline for both men and women. Background In the United States, a large proportion of births are either mistimed or unwanted. The majority of these pregnancies are a result of inconsistent or lack of contraceptive use. There are novel contraceptive products in development that could potentially address unmet needs of women and couples. In order for these products to be successful when they reach the market, a better understanding of the preferred user characteristics (PUCs) of these products is vital. Research Objectives and Scope Applicants must propose behavioral or social science research supporting novel products and/or devices currently undergoing development, including pre-clinical and clinical development, for either male or female contraceptive indications. Such activities would include using established tools in behavioral and social science to gain a better understanding of Preferred User Characteristics (PUCs) of contraceptive products/devices currently in development. These PUCs of the product under development could include but are not limited to: Acceptability of side effect profile or expected side effect profile The manner, frequency, and ease of administration/application The physical/aesthetic properties of the product/device Product efficacy Overall satisfaction with the product/device Or other factors leading to first and/or subsequent use or non-use and/or discontinuation decisions Highly responsive applications would propose PUC research focusing on identifying factors which may influence an individual's choice to use a contraceptive under development, using behavioral and social science tools that measure user perceptions of the drug and/or delivery system, such as ethnographic studies, perceptibility assessments, mental modeling, user journeys, discrete choice, and conjoint analysis. Applicants working in direct collaboration with academic institutions or businesses currently investigating novel contraceptive products and/or devices are highly encouraged but not required. Applications that include the following are not responsive to this FOA: Applications focused on the development of a novel contraceptive itself. Examples of this kind of research would include, but are not limited to: Target validation studies Compound screening and optimization Pharmacokinetic, pharmacodynamic, and toxicokinetic studies Pilot manufacturing studies Safety or side effect profiling studies Animal behavioral studies Applications focused exclusively on currently marketed contraceptive products Use of currently marketed contraceptives would be allowed as a comparison group to your product of interest Applications focused on more than one drug or delivery system Applications focused on products that result in permanent sterilization Applications focused on products where the mechanism of action may act post-fertilization