Cameroon HepB Birth Dose Feasibility Pilot
Improving Timeliness of Birth Dose Vaccines in 15 Health Facilities in Cameroon Through Integrating Immunizations Into Maternity and Newborn Care Services: A Feasibility Assessment
調査の概要
詳細な説明
In the Cameroon Expanded Program on Immunization (EPI), the birth dose vaccine for oral polio vaccine (OPV-0) and tuberculosis vaccine (BCG), are recommended with a third birth dose vaccine for hepatitis B (HepB-BD) being considered for introduction.
Although Cameroon introduced the HepB antigen as part of the Pentavalent vaccine into the immunization program in 2005, infants are currently unprotected until the first Penta shot at six weeks. Introduction of HepB-BD is a key priority for the Cameroon government through the National Cancer Strategy document as well as the Hepatitis Prevention and Treatment Guidelines. However, the timeliness of administration of Hepatitis B vaccine within 24 hours of birth is critical to ensure the highest efficacy and prevent transmission of the virus.
While coverage rates for BCG and OPV 0 are relatively high (91% and 78% respectively), these vaccines are often administered weeks or months after birth , not within the 24-hour timeframe recommended for Hepatitis B birth dose. Therefore, there are concerns from the Cameroon National Immunization Technical Advisory Group (NITAG) and other stakeholders on the feasibility of achieving high timely coverage of HepB-BD. The timeliness of administration of the birth dose vaccines within facilities relies on many system components including integrated processes between maternity and immunization units and healthcare worker awareness of birth dose administration guidelines.
The main aim of this pilot study is to assess the feasibility of immunizing newborns with BCG and OPV0 (and eventually HepB-BD) within 24 hours of birth by integrating routine immunization into maternity and immediate newborn care in 15 facilities in Cameroon.
Further, the specific objectives of this pilot study are to:
- Integrate birth dose immunizations into maternity and immediate newborn care services
- Measure the change in proportion of newborn receiving birth doses BCG and OPV0 within 24 hours compared to baseline data
- Measure the change in average age of babies receiving birth doses of BCG and OPV0
- Assess the operational feasibility and acceptability of interventions and describe any factors (barriers and enablers) that may influence further implementation of birth dose strategies
This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon. Overall, in 20 weeks an intervention phase will be followed by a final assessment. The approach will utilize quantitative data from healthcare worker surveys, the birth registry and immunization registry, and maternity unit reporting forms. The study findings will be used to inform strategy on HepB-BD introduction in Cameroon as well as interventions to strengthen service delivery structures for newborns.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Adamawa
-
Dibi、Adamawa、カメルーン
- CMA Dibi
-
-
Adamawe
-
Mbe、Adamawe、カメルーン
- CMA Mbe
-
-
Center
-
Biyem Assi、Center、カメルーン
- HD Biyem-Assi
-
Cite Verte、Center、カメルーン
- HD Cite Verte
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Djoungolo、Center、カメルーン
- CMMR Etoudi
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Efoulan、Center、カメルーン
- CMA Ahala
-
Mbalmayo、Center、カメルーン
- CSIU Mbalmayo II
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Mfou、Center、カメルーン
- CSC Nkoabang
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Nkolndongo、Center、カメルーン
- Hospital Nicolas Barre
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Obala、Center、カメルーン
- HD Obala
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West
-
Baham、West、カメルーン
- CSC Baham
-
Foumbot、West、カメルーン
- HD Foumbot
-
Mifi、West、カメルーン
- HD Mifi
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Facilities will be those that have both an immunization unit as well as a maternity ward
Exclusion Criteria:
- Facilities without both units
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：Intervention Arm
These facilities will be those selected to have the intervention carried out.
|
The purpose of the work is to integrate readily available birth dose vaccinations (Oral Polio and the Tuberculosis vaccine) currently given in a separate clinic into the maternity delivery services through improved training, checklist, and job aides.
|
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 |
|---|---|---|
|
Timeliness of birth dose vaccine administration
時間枠：20 weeks
|
Median hours between birth and administration of oral polio and/or the BCG vaccine
|
20 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Coverage of birth dose vaccines
時間枠：20 weeks
|
The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine
|
20 weeks
|
協力者と研究者
捜査官
- 主任研究者：Ankouane Andoulo Firmin、Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- 2020/09/1695/L/CNERSH/SP
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
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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