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Cameroon HepB Birth Dose Feasibility Pilot

2022年7月22日 更新者：Clinton Health Access Initiative Inc.

Improving Timeliness of Birth Dose Vaccines in 15 Health Facilities in Cameroon Through Integrating Immunizations Into Maternity and Newborn Care Services: A Feasibility Assessment

This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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:

  1. Integrate birth dose immunizations into maternity and immediate newborn care services
  2. Measure the change in proportion of newborn receiving birth doses BCG and OPV0 within 24 hours compared to baseline data
  3. Measure the change in average age of babies receiving birth doses of BCG and OPV0
  4. 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.

研究类型

介入性

注册 (实际的)

13

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 喀麦隆
    • Adamawa
      • Dibi、Adamawa、喀麦隆
        • CMA Dibi
    • Adamawe
      • Mbe、Adamawe、喀麦隆
        • CMA Mbe
    • Center
      • Biyem Assi、Center、喀麦隆
        • HD Biyem-Assi
      • Cite Verte、Center、喀麦隆
        • HD Cite Verte
      • Djoungolo、Center、喀麦隆
        • CMMR Etoudi
      • Efoulan、Center、喀麦隆
        • CMA Ahala
      • Mbalmayo、Center、喀麦隆
        • CSIU Mbalmayo II
      • Mfou、Center、喀麦隆
        • CSC Nkoabang
      • Nkolndongo、Center、喀麦隆
        • Hospital Nicolas Barre
      • Obala、Center、喀麦隆
        • HD Obala
    • West
      • Baham、West、喀麦隆
        • CSC Baham
      • Foumbot、West、喀麦隆
        • HD Foumbot
      • Mifi、West、喀麦隆
        • HD Mifi

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Facilities will be those that have both an immunization unit as well as a maternity ward

Exclusion Criteria:

  • Facilities without both units

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention Arm
These facilities will be those selected to have the intervention carried out.
其他：Integration of vaccination services into delivery services
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Timeliness of birth dose vaccine administration
大体时间：20 weeks
Median hours between birth and administration of oral polio and/or the BCG vaccine
20 weeks

次要结果测量

结果测量
措施说明
大体时间
Coverage of birth dose vaccines
大体时间：20 weeks
The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine
20 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Clinton Health Access Initiative Inc.

合作者

Bill and Melinda Gates Foundation
Cameroon Expanded Program on Immunization

调查人员

  • 首席研究员：Ankouane Andoulo Firmin、Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月10日

初级完成 (实际的)

2021年12月11日

研究完成 (实际的)

2021年12月31日

研究注册日期

首次提交

2021年3月17日

首先提交符合 QC 标准的

2021年5月17日

首次发布 (实际的)

2021年5月19日

研究记录更新

最后更新发布 (实际的)

2022年7月25日

上次提交的符合 QC 标准的更新

2022年7月22日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2020/09/1695/L/CNERSH/SP

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Data on individual participant data will not be shared with other researchers. All reports will have data aggregated to the facility level. No personal identifiers will be gathered.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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