Assessing caregiver and child preferences for the development of novel pediatric antiretroviral therapy delivery

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ABSTRACT Current infant antiretroviral therapy (ART) formulations pose barriers to daily adherence due to complex weight-based dosing, conspicuous preparation to reconstitute crushed or dispersible tables, poor palatability, and lack of discreet administration in the context of persistent HIV stigma. These adherence barriers jeopardize infant ART adherence and diminish effectiveness, making patients vulnerable to virologic failure, development of drug resistance, and preventable mortality. Oral dissolvable strips (ODS) are alternative drug formulations with the potential to overcome these challenges and improve pediatric ART adherence and outcomes. In this proposal, we will apply a patient-centered approach to ODS development, in order to design an infant ART product that is more responsive to caregivers’ and patients’ needs and preferences. Aim 1 of the proposed study will use focus group discussions with caregivers of infants living with HIV and interviews with pediatric HIV providers to solicit input on key features of ODS design to maximize acceptability and utility. Integrating findings from Aim 1 regarding patient and provider preferences for ODS characteristics, packaging, and dispensers, Aim 2 will develop 4-6 prototype ODS strips and dispensers. Aim 3 will evaluate user impressions of each prototype and refine designs to deliver a lead candidate for production and eventual field evaluation. By engaging stakeholders in an iterative design process starting from the early phases of design and development, we will maximize the likelihood of developing a product that is acceptable to the caregiver and infant, therefore leading to sustainable adherence.