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

Browse trials for

• Anemia, Sickle Cell 1,134

Keywords

• Sickle cell disease
• Newborn Screening
• Early Care for Sickle Cell Disease
• Point of care testing

Anemia, Sickle Cell

1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.

Lead sponsor

Swiss Tropical & Public Health Institute is the lead sponsor of 58 studies on the registry; 9 are open to participants now.

Study arms

• Experimental
  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.

  Combination Product: Gazelle-Multispectral point of care testing for newborn sickle cell disease screening; and initiation of early comprehensive clinical interventions

Interventions

• Combination productGazelle-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.

Primary outcomes

1. 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) 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''.

   Time frame: Baseline, 1 year, 2 years, 3 years, and 3.5 years

2. 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)

   Time frame: Baseline, 1 year, 2 years, 3 years, and 3.5 years

Secondary outcomes

1. 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 Note: Outcomes 1a. to 1d. indicate and represent ''implementation costs''. Outcome 1e. indicates and represents ''effectiveness''. Outcomes 1f. refers to ''cost effectiveness''.

   Time frame: Baseline, 1 year, 2 years, 3 years, and 3.5 years

2. 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

   Time frame: Baseline, 1 year, 2 years, 3 years, and 3.5 years

Individual participant data

Plan to share: Yes — 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