'We need this now': Acceptability and usability of a pediatric antiretroviral microarray patch prototype in South Africa and Uganda

Children living with HIV face significant challenges with adherence to daily oral antiretroviral (ARV) treatment due to poor palatability, complicated dosing, and caregiver burden. Long-acting delivery systems designed specifically for children may help overcome these barriers. Microarray patches, also known as microneedle patches, are a needle-free drug delivery technology that could simplify treatment administration and improve adherence. This study explored the acceptability and usability of a pediatric ARV microarray patch prototype among stakeholders in South Africa and Uganda, two countries with a high burden of pediatric HIV. A formative study was conducted in 2024 with 48 participants, including caregivers, community health workers, health care providers, and decision-makers. Data were collected through qualitative methods: interviews, simulated use sessions, and observations. Participants demonstrated high usability of the prototype, with 97% completing all application steps and nearly all reporting the prototype as easy to use and expressing confidence in successful administration. Most participants found the prototypes size, wear time, and temporary skin changes acceptable, and all preferred a weekly patch over daily oral treatment. Applying multiple patches at once to achieve a therapeutic dose was considered feasible. Decision-makers foresaw strong programmatic fit of a pediatric ARV microarray patch if caregivers apply the patch at home following initial facility-based guidance. Overall, the pediatric ARV microarray patch prototype was perceived as highly acceptable and usable across diverse end users, findings that generally align with studies of microarray patches for other use cases (e.g., contraception, HIV pre-exposure prophylaxis, vaccine delivery). The simplicity, comfort, and convenience of a pediatric ARV microarray patch could substantially improve treatment adherence and quality of life for children living with HIV. Further development and clinical evaluation are warranted to advance this promising technology toward real-world use.