Study of a Mobile Health System to Improve Infant Sickle Cell Disease Screening and Care in Uganda

What this Trial Is About

Researchers are evaluating a novel mobile health information management and communication system called SCD SIMCS for newborn screening of sickle cell disease SCD in Uganda. This cluster randomized trial compares the new system to the routine newborn screening strategy at health care centers. The goal is to measure the impact on screening access, coordination of care, and clinical outcomes for infants with SCD. Health facilities are randomized rather than individuals to avoid contamination and better assess system-level effects. The intervention involves the SCD SIMCS app, which uses artificial intelligence to capture, interpret, and transmit point-of-care test results for sickle cell disease to healthcare providers and a centralized data center at the Uganda Ministry of Health. The app includes modules for capturing infant demographic data, interpreting test images, providing educational videos for counseling, and maintaining a digital health passport with longitudinal clinical information. The comparison group receives the routine newborn screening strategy currently used in Ugandan health centers. Participants include infants born or attending child health and maternity services at selected hospitals, with providers at these centers also involved. Baseline assessments of resources and workflows are conducted before implementing the app. Researchers will monitor outcomes including the number and timeliness of referrals for infants with SCD over 12 months, and adjusted mortality rates over 18 months. The study includes follow-up to evaluate these outcomes and the overall effectiveness of the SCD SIMCS system in improving care coordination and clinical results.

Evaluation of an Information Management and Communication System for Population-wide Point-of-Care Infant Sickle Cell Disease Screening