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

摘要 目前的婴儿抗逆转录病毒疗法(ART)配方对日常坚持构成障碍，原因是 以重量为基础的复杂剂量，明显的制剂，以恢复粉碎或分散 在持续感染艾滋病毒的情况下，餐桌、适口性差以及缺乏谨慎的管理 耻辱。这些坚持障碍危及婴儿抗逆转录病毒治疗的坚持并降低有效性， 使患者容易受到病毒学故障的影响，产生抗药性，并可预防 死亡率。口服可溶药条(Ods)是一种替代药物制剂，具有潜在的 克服这些挑战，提高儿科抗逆转录病毒治疗的依从性和效果。在这 提案中，我们将以患者为中心的方法来开发消耗臭氧层物质，以便 设计一款更能响应照顾者和患者需求的婴儿艺术产品 和喜好。拟议研究的目标1将使用与照顾者的焦点小组讨论 对婴儿艾滋病毒携带者的调查和与儿科艾滋病毒提供者的访谈，以征求对关键问题的意见 消耗臭氧层物质设计的特点，以最大限度地提高可接受性和实用性。整合来自AIM 1的调查结果 关于患者和提供者对消耗臭氧层物质特性、包装和分配器的偏好， AIM 2将开发4-6个消耗臭氧层物质条带和分配器原型。AIM 3将评估用户 对每个原型的印象并改进设计，以提供主要的候选产品和 最终进行实地评估。通过让利益相关者参与迭代设计流程，从 在设计和开发的早期阶段，我们将最大限度地开发 护理者和婴儿可以接受的产品，从而导致可持续发展 坚持不懈。

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.