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

Study acronym: STEP
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Lead sponsor: Swiss Tropical & Public Health Institute to Swiss Tropical & Public Health Institute · Study sites: 1 to 2 · Start date changed from estimate of Apr 2026 to Jul 27, 2026 · 3 more Show 6 more changesShow less
    • Lead sponsor: Swiss Tropical & Public Health Institute to Swiss Tropical & Public Health Institute
    • Study sites: 1 to 2
    • Start date changed from estimate of Apr 2026 to Jul 27, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Collaborators: details revised at 1 of 2 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov