In this article, we described a new mobile-Health (mHealth) supported clinical pathway of care for people living with medically stable HIV in terms of platform acceptability, usability and technical feasibility. The EmERGE mHealth platform was codesigned with clinicians and the community, developed using Scrum agile methodology, integrated with hospital information systems and validated in a large prospective cohort study of 2251 participants. The evaluation of this new paradigm of care was conducted using a tailored Health Technology Assessment: the Model for Assessment of Telemedicine Applications. Usability and acceptability were assessed through the System Usability Score and a Patient Reported Experience Measure. The EmERGE platform was successfully deployed across diverse care settings in five European countries and used by 2251 patients and more than 20 clinicians for up to 30 months. Results from the formal evaluation demonstrated that the EmERGE platform is feasible and acceptable, with a high level of usability (median System Usability Score (SUS) 85.0%) and very positive patient-reported experiences (94.2% would recommend to a friend). The EmERGE platform is a secure and General Data Protection Regulation (GDPR)-compliant system with a complete set of functionalities that could be easily adapted to other clinical conditions, clinical sites and health systems thanks to its modular technical architecture.
Keywords: HIV; PREM; SUS; co-design; feasibility; health technology assessment; mHealth; model for assessment of telemedicine applications; patient empowerment; self-management; user acceptance.