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

评估护理人员和儿童对开发新型儿科抗逆转录病毒治疗的偏好

• 批准号: 10258934
• 负责人: SARAH Finocchario KESSLER
• 金额: $ 24.02万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258934
• 关键词: Adherence; Age; Area; Caregivers; Characteristics; Child; Childhood; Choking; Clinical; Clinical Trials; Complex; Deglutition; Development; Disclosure; Dose; Drug Compounding; Drug Formulations; Drug resistance; Effectiveness; Ensure; Evaluation; Failure; Feedback; Film; Focus Groups; Formulation; Fostering; Future; HIV; Health; High Prevalence; Infant; Ingestion; Interview; Kenya; Lead; Letters; Oral; Palate; Patients; Perception; Pharmaceutical Preparations; Phase; Preparation; Process; Production; Property; Provider; Regimen; Resources; Risk; Sensory; Structure; Surveys; Tablets; Tactile; Technology; Testing; Tongue; Visual; Weight; Youth; antiretroviral therapy; base; behavioral adherence; care providers; cohort; design; drug development; experience; hazard; impression; improved; infancy; informant; innovation; interest; iterative design; lead candidate; medication compliance; novel; patient oriented; pediatric human immunodeficiency virus; pediatric patients; phase 2 study; preference; prevent; preventable death; prototype; reconstitution; social stigma; therapy adherence; therapy outcome; user centered design; virology

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.

摘要 目前的婴儿抗逆转录病毒疗法（ART）制剂由于以下原因而对日常依从性构成障碍： 基于重量的复杂剂量，显著的制备，以重构粉碎或分散的 在持续存在艾滋病毒的情况下， 耻辱这些依从性障碍危及婴儿ART依从性并降低有效性， 使患者易受病毒学失败、耐药性发展的影响， mortality.口服可溶解条（ODS）是具有潜在的替代药物制剂， 克服这些挑战，改善儿科ART依从性和结果。在这 建议，我们将采用以患者为中心的方法开发ODS，以便 设计一种更能满足看护者和患者需求的婴儿ART产品 和偏好。拟议研究的目标1将使用与护理人员的焦点小组讨论 与儿科艾滋病毒提供者进行访谈， ODS的设计特点，以最大限度地提高可接受性和实用性。整合目标1的结果 关于患者和提供者对ODS特性、包装和分配器的偏好， 目标2将开发4-6个臭氧消耗物质测试条和分配器原型。目标3将评估用户 每个原型的印象，并完善设计，以提供一个领先的候选人生产， 最终的实地评估。通过让涉众参与到迭代设计过程中， 在设计和开发的早期阶段，我们将最大限度地提高开发 产品是可接受的照顾者和婴儿，因此导致可持续的 坚持。