Integrating point of care testing (POCT) for Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202603830862588

Enrollment

120

Registered

2026-03-25

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Diseases

Interventions

Point of care testing and early comprehensive clinical interventions

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The endpoints for the primary objective - to determine the clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are: 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)	—

Measure

Time frame

The endpoints for the primary objective - to determine the clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are: 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)

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Secondary

Measure	Time frame
The endpoints for secondary objective 1 - to determine 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: 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 The endpoint for secondary objective 2 - to determine the budget impact (per year) associated with early comprehensive SCD care for all children who test positive in Côte d’Ivoire 1. Annual costs associated with early comprehensive SCD care for all children who test positive	—

Measure

Time frame

The endpoints for secondary objective 1 - to determine 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: 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 The endpoint for secondary objective 2 - to determine the budget impact (per year) associated with early comprehensive SCD care for all children who test positive in Côte d’Ivoire 1. Annual costs associated with early comprehensive SCD care for all children who test positive

—

Countries

Cote Divoire

Contacts

Public ContactYapi Aurelien

Coinvestigator

aurelienyapi@hotmail.fr+2250777205263

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026