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Assessing user preferences for design characteristics of oral dissolvable strips for pediatric HIV medication: a
Catherine Wexler1, May Maloba2, Michala Sliefert3
1Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, USA. cwexler@kumc.edu.
Insights
Oral dissolvable strips offer a promising alternative to current infant antiretroviral therapy (ART) formulations. Caregivers and providers strongly prefer these strips for improved adherence and outcomes in children with HIV.
Area of Science:
- Pediatric infectious diseases
- Pharmaceutical formulation development
- Global health
Background:
- Current infant antiretroviral therapy (ART) formulations present significant adherence challenges, including complex dosing and poor palatability, leading to potential virologic failure and drug resistance.
- Oral dissolvable strips have been established as a viable alternative for pediatric ART, aiming to improve adherence and patient outcomes.
Purpose of the Study:
- To assess caregiver and provider preferences for oral dissolvable strips and their packaging to inform product development.
- To gather user-centered design input for optimizing pediatric antiretroviral medication delivery.
Main Methods:
- User-centered design approach utilizing key informant interviews with 30 HIV care providers.
- Focus group discussions with 72 caregivers of children under 10 years living with HIV in Kenya.
- Audio recording, verbatim transcription, and thematic coding of all qualitative data.
Main Results:
- Strong caregiver and provider enthusiasm for oral dissolvable strips, particularly for young children unable to swallow pills.
- Key preferences include pleasant taste, single-dose strips, rapid dissolution, clear instructions, and no special storage.
- Preferred packaging: individually wrapped, durable, waterproof strips within a reusable dispenser, easy for children to open.
Conclusions:
- Oral dissolvable strips are highly acceptable to caregivers and providers for children living with HIV.
- Engaging stakeholders in iterative design maximizes the likelihood of developing an acceptable and sustainable adherence-improving product.
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.
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