Journal Article

Assessing user preferences for design characteristics of oral dissolvable strips for pediatric HIV medication: a qualitative study

Finocchario-Kessler, Sarah, Maosa, Nicodemus, Thomas, Gregory, Maliski, Edward, Nicolay, Zachary, Sliefert, Michala, Mugendi, George, Wexler, Catherine, Maloba, May, Babu, Shadrack, Mbithi, Yvonne, Acharya, Harshdeep, Were, Frederick

2023

Overview

Background Current infant antiretroviral therapy formulations pose barriers to daily adherence due to complex weight-based dosing, conspicuous preparation, and poor palatability. These adherence barriers jeopardize adherence, making patients vulnerable to virologic failure, development of drug resistance, and preventable mortality. Our team has previously established proof-of-principle for multi-drug oral dissolvable strips as alternative pediatric antiretroviral formulations with the potential to overcome these challenges and improve pediatric ART adherence and outcomes. The objective of this study was to assess caregiver and provider preferences for oral dissolvable strips and its packaging to inform its development. Methods Guided by concepts of user-centered design, we conducted key informant interviews with 30 HIV care providers and focus group discussions targeting caregivers of children < 10 years of age living with HIV at 3 Kenyan hospitals. Key informant interviews and focus group discussions were audio recorded, translated/transcribed verbatim, and hand coded for a-priori and emergent themes. Results A total of 30 providers and 72 caregivers (caring for 83 children, aged 5 months to 18 years) participated in the study. Caregivers and providers expressed a strong desire for an easier way to administer medication, especially among children too young to swallow tablets whole, and expressed enthusiasm around the idea of oral dissolvable strips. Key preferences included a pleasant taste; one strip per dose; small size with rapid dissolution; clear markings and instructions; and no special storage requirements. For packaging, stakeholders preferred individually wrapped strips within a dispenser. The individual packaging should be durable, waterproof, and easy to dispose of in communal spaces. They should also be easy to open, with clear indications where to open. The packaging holding the strips should be durable, re-usable, accommodating of various refill frequencies, and easy to use for children as young as 6. Discussion The concept of oral dissolvable strips was highly acceptable to caregivers of children living with HIV and HIV care providers. 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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Age / Analysis / Anti-Retroviral Agents - therapeutic use / Antiretroviral drugs / Antiretroviral therapy adherence / Antiviral agents / Bioavailability / Care and treatment / Caregivers / Child / Children / Children & youth / Consumer preferences / Disease prevention / Dosage and administration / Drug dosages / Drug resistance / Drug therapy / Focus groups / Health Administration / Health aspects / Health Informatics / Highly active antiretroviral therapy / HIV / HIV (Viruses) / HIV infection in children / HIV Infections - drug therapy / Human immunodeficiency virus / Humans / Infant / Informed consent / Interviews / Kenya / Maternal & child health / Medication Adherence / Medicine / Medicine & Public Health / Mortality / Mothers / Nursing Research / Packaging / Patient compliance / Pediatric antiretroviral therapy / Pediatrics / Pharmaceuticals / Product development / Public Health / Public opinion / Qualitative Research / Standard of care / User-centered design