ヨプーゴン（コートジボワール）における新生児スクリーニングと鎌状赤血球症早期ケアのためのポイント・オブ・ケア・テスト（POCT）の統合 (STEP)
ヨプゴン（コートジボワール）における新生児スクリーニングと鎌状赤血球症の早期ケアのためのポイントオブケアテスティング（POCT）の統合
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Acellam Charles Abongomera, MD, MPH, PhD
- 電話番号：+41612848629
- メール：charles.abongomera@swisstph.ch
研究連絡先のバックアップ
- 名前：Benjamin Koudou, PhD
- 電話番号：+2250777205263
- メール：guibehi.koudou@csrs.ci
研究場所
-
-
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Abidjan、コートジボワール
- 募集
- Yopougon Millionnaire extension health center
-
コンタクト：
- Benjamin Koudou, PhD
- 電話番号：+2250777205263
- メール：guibehi.koudou@csrs.ci
-
コンタクト：
- Aurelien Yapi, MD, MSc.
- 電話番号：+2250777205263 +41612848629
- メール：aurelienyapi@hotmail.fr
-
Yopougon、コートジボワール
- まだ募集していません
- Yopougon SCD Center of Excellence
-
コンタクト：
- Benjamin Koudou, PhD
- 電話番号：+2250777205263
- メール：guibehi.koudou@csrs.ci
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children already diagnosed with SCD
- Children that are participating in another clinical research project
- Children that are critically ill and require emergency treatment
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
時間枠：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:
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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:
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AO_2025-00105
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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