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

Starting soon · Phase 4

Conditions studied: Sickle Cell Disease (SCD)

In brief

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.

Key facts

Study ID

NCT07488520

Run by

Swiss Tropical & Public Health Institute

People needed

120

Starts

2026-04-01

Expected to finish

2029-12-01

Last updated by the study team

2026-03-23

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 0 - 6 months old identified at selected health facilities within the study area
• Babies whose age plus the gestation period reaches 37 weeks or more
• Children who did not receive a blood transfusion within the past 90 days
• Children whose parents or guardians have consented to participate in the study by signing a consent form

You may not qualify if…

• Children already diagnosed with SCD
• Children that are participating in another clinical research project
• Children that are critically ill and require emergency treatment

Where it is running

• Yopougon SCD Center of Excellence — Yopougon, Côte d’Ivoire

Full record on ClinicalTrials.gov

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