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Integration af Point of Care Testing (POCT) til nyfødtescreening og tidlig pleje for seglcelleanæmi i Yopougon, Elfenbenskysten (STEP)

30. september 2026 opdateret af: Swiss Tropical & Public Health Institute

Integration af Point of Care Testing (POCT) til nyfødtescreening og tidlig behandling af seglcelleanæmi i Yopougon, Elfenbenskysten

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Sickle cell disease (SCD) is an inherited life-threatening hematological disorder. Globally, every year, an estimated 300,000 children are born with sickle cell anemia (SCD - SS, homozygous form), the most severe form of SCD. About 75% of these births occur in Sub-Saharan Africa (SSA), of whom 50-90% die before their 5th birthday. In high income countries, it has been shown that newborn SCD screening and early comprehensive clinical interventions such as penicillin prophylaxis, safe blood transfusion, hydroxyurea and acute medical care, substantially reduces SCD morbidity and mortality. In low and middle-income countries (LMICs), the implementation of newborn SCD screening and early clinical interventions are largely poor.

The most commonly used newborn SCD screening techniques are isoelectric focusing (IEF), capillary electrophoresis (CE) and cation-exchange high performance liquid chromatography (HPLC). These techniques have a high cost, require skilled staff and a reliable electricity supply, and are therefore not suitable for remote settings in LMICs. In order to overcome these challenges, several point of care tests (POCTs) have been recently developed. The Gazelle Multispectral platform is the first SCD POCT that can be used to identify and quantify hemoglobin variants in newborns and people of any age.

In Côte d'Ivoire, as in many other African countries, the implementation of newborn SCD screening and early clinical interventions are lagging behind, and subsequently SCD morbidity and mortality are high. In this project, the investigators will implement a novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral POCT for newborn SCD screening; and 2) initiation of 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. The investigators will assess the effectiveness and cost of the multifaceted intervention. The effectiveness will be assessed based on the 2.5 - 3.5 years follow-up clinical records of SCD morbidity and mortality (clinical outcomes). The effectiveness data will be compared descriptively with historical data from the region, and used to inform SCD policy in Côte d'Ivoire. Historical data will be obtained from published literature in Cote d'Ivoire or nearby Countries such as Ghana. After three and a half years, the investigators aim to hand over the project to the Ministry of Health of Côte d'Ivoire for integration into its routine health care activities and potential nation-wide scale up.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Côte d’Ivoire
      • Abidjan, Côte d’Ivoire
        • Rekruttering
        • Yopougon Millionnaire extension health center
        • Kontakt:
        • Kontakt:
      • Yopougon, Côte d’Ivoire
        • Ikke rekrutterer endnu
        • Yopougon SCD Center of Excellence
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 sekund til 6 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  1. Children already diagnosed with SCD
  2. Children that are participating in another clinical research project
  3. Children that are critically ill and require emergency treatment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gazelle-Multispectral for newborn sickle cell disease screening; and early clinical interventions

A novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral point of care testing (POCT) for newborn sickle cell disease (SCD) screening; and 2) initiation of early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea and parental education about SCD medical care.
Kombinationsprodukt: Gazelle-Multispectral point of care testing for newborn sickle cell disease screening; and initiation of early comprehensive clinical interventions

A novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral point of care testing (POCT) for newborn sickle cell disease (SCD) screening; and 2) initiation of early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea and parental education about SCD medical care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
Tidsramme: Baseline, 1 year, 2 years, 3 years, and 3.5 years

1a. Number of SCD related morbidity and events i.e. i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations

1b. Morbidity incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to one of the following SCD related morbidity and events: i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations

1c. All-cause mortality rate (at the end of 1, 2, 3 and 3.5 years of follow-up)

Note: The clinical outcomes are a summation of all the different parameters indicated. ''Morbidity'' includes vaso-occlusive crises (VOC); acute chest syndrome, stroke and other underlying causes of illness. ''Events'' include blood transfusions. ''All cause hospitalizations'' are a result of ''morbidities''.
Baseline, 1 year, 2 years, 3 years, and 3.5 years
The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
Tidsramme: Baseline, 1 year, 2 years, 3 years, and 3.5 years

1a. Number of SCD related morbidity and events i.e. i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations

1b. Morbidity incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to one of the following SCD related morbidity and events: i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations

1c. All-cause mortality rate (at the end of 1, 2, 3 and 3.5 years of follow-up)
Baseline, 1 year, 2 years, 3 years, and 3.5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The implementation costs and the cost-effectiveness of a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
Tidsramme: Baseline, 1 year, 2 years, 3 years, and 3.5 years

1a. Total financial and economic costs associated with program roll out

1b. Costs per child screened with POCT

1c. Costs per SCD screen positive child

1d. Annual costs associated with early comprehensive SCD care

1e. Number of morbidity and mortality averted

1f. Cost per morbidity and mortality averted by the multifaceted intervention

Note: Outcomes 1a. to 1d. indicate and represent ''implementation costs''. Outcome 1e. indicates and represents ''effectiveness''. Outcomes 1f. refers to ''cost effectiveness''.
Baseline, 1 year, 2 years, 3 years, and 3.5 years
The budget impact (per year) associated with early comprehensive SCD care for all children who test positive in Côte d'Ivoire
Tidsramme: Baseline, 1 year, 2 years, 3 years, and 3.5 years

1. Annual costs associated with early comprehensive SCD care for all children who test positive
Baseline, 1 year, 2 years, 3 years, and 3.5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Swiss Tropical & Public Health Institute

Samarbejdspartnere

Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Novartis Pharma AG, Switzerland

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. juli 2026

Primær færdiggørelse (Anslået)

1. december 2029

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

24. februar 2026

Først indsendt, der opfyldte QC-kriterier

18. marts 2026

Først opslået (Faktiske)

23. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AO_2025-00105

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (IPD) are available on request to bona fide researchers via the Swiss Center for Scientific Research in Côte d'Ivoire (CSRS), Swiss Tropical and Public Health Institute (Swiss TPH) and Novartis Pharma AG. Data can be granted on a case-by-case basis jointly by the project leaders at the CSRS, Swiss TPH and Novartis. This process is designed to protect participants' confidentiality, which might be compromised if data were publicly available. Requests to access data should be made to Prof. Dr. Benjamin Koudou (CSRS) via guibehi.koudou@csrs.ci or Dr. Acellam Charles Abongomera (Swiss TPH) via charles.abongomera@swisstph.ch or to Novartis according to the criteria and processes described on the Clinical Study Data Request website ClinicalStudyDataRequest.com

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