Clinical Trial

Integrating Point of Care Testing (POCT) For Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire

Study acronym: STEP
Not Yet Recruiting Phase 4
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Summary
The goal of this clinical trial is to learn if a multifaceted intervention composed of Gazelle-Multispectral sickle cell disease (SCD) point of care testing (POCT) and early initiation of comprehensive SCD care in children with SCD disease aged 0 - 6 months can improve their clinical outcomes. The main questions it aims to answer are: * Does the intervention lower the number of SCD-related illnesses? * Does the intervention lower the illness incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to a SCD related illness? * Does the intervention lower all-cause death rate (at the end of 1, 2, 3 and 3.5 years of follow-up)? Researchers will compare the multifaceted intervention results with those of historical data (based on erratic SCD testing and treatment) from the region. Participants will undergo a SCD screening test using the Gazelle Multispectral platform and if positive they will undergo confirmatory testing with HemoTypeSC™. Participants with SCD will receive early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea, parental education about the need for regular and, if necessary, urgent medical care.
Trial Details
NCT Number NCT07488520
Lead Sponsor Swiss Tropical & Public Health Institute
Collaborators: Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Novartis Pharma AG, Switzerland
Conditions Sickle Cell Disease (SCD)
Enrollment 120 participants
Start Date 2026-04
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-23