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

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.

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

“…A 2017 landscape mapping of end-user research in HIV prevention for young women in sub-Saharan Africa identified 53 projects, of which 3 were explicitly HCD. 41 There is often overlap in objectives and methods between HCD, more traditional qualitative methodologies 42,43 ; participatory research 11 ; engineering approaches 44,45 ; and discrete choice experiments as formative research. 46 Although efforts have been made to compare and contrast approaches, 8 distinctions are not concrete.…”

Development of multipurpose technologies products for pregnancy and STI prevention: update on polyphenylene carboxymethylene MPT gel development†

“…Multiple acceptability surveys of preferred vaginal formulations have found support for odorless and colorless gel products and can be an important guide to the development of new vaginal gel products [ 84 ]. Recent studies have provided important information regarding user preferences for the physical and aesthetic properties of gel formulations and can be used to guide MPT formulation composition [ 85 , 86 ].…”

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

“…As development of intravaginal systems for delivery of preventive agents continues, the importance of understanding the user experience as part of the preclinical design process is being acknowledged. [ 26 , 27 ] Our results provide evidence to support continued development of this platform, and offer a considered look at issues that will likely impact the development of vaginal products for long-term use in prevention of HIV, as well as new contraceptive methods and MPTs.…”