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Millennium Villages Project in Sub-Saharan Africa (MVP)

2017年4月20日 更新者:Sonia Sachs、Columbia University

A Pair-matched Community Intervention Trial to Assess the Impact of an Integrated Health and Development Intervention on Child Survival and the Millennium Development Goals in 10 Sub- Saharan African Countries

The Millennium Villages Project involves the coordinated and simultaneous delivery of a package of proven interventions in health, agriculture, infrastructure and education. The project works in partnership with governments in 10 African countries in areas where progress towards achieving the Millennium Development Goals has been insufficient.

The Project evaluation will test the following hypotheses:

  1. That after 5 years of operation, villages exposed to the MVP intervention will have a lower rate of under-5 mortality and parallel gains in MDG-related secondary outcomes when compared to similar villages not receiving the intervention.
  2. That the coordinated delivery a multi-sector package of health and development interventions implemented through a broad-based local partnership is feasible in a diversity of sub-Saharan African contexts, and;
  3. The intervention package can be delivered at a scalable cost of $40 per person per year in the health sector and $110 per person per year in total

研究概览

详细说明

Design and population The design is a pair-matched community intervention trial. Village clusters with high levels of malnutrition were selected from rural areas in ten sub-Saharan African countries to reflect a diverse range of agro-ecological zones, farming systems, disease profiles, and infrastructure challenges. MVP sites represent 80 villages in 14 clusters across 10 countries, covering nearly 500,000 people. For each intervention cluster, a matched comparison cluster has been selected at random to participate in the evaluation.

Outcomes The primary outcome is the under-5 mortality rate. Secondary outcomes are levels of coverage with essential maternal-child health interventions and related MDG indicators for poverty, nutrition, education, and environmental health.

Sample size calculation The assessment follows 6000 households across intervention and matched comparison villages at baseline, and after 3 and 5 years of intervention exposure. With 10 paired clusters, the study is powered to detect a 40% difference in the U5MR between the two groups.

Analysis plan The analysis will use a two-staged pair-matched cluster level analysis, and will be complemented with multilevel modeling. Reporting will adhere to Transparent Reporting of Evaluations with Non-randomized Designs (TREND) guidelines.

Implementation science A portfolio of qualitative implementation science (process evaluation) will complement the quantitative assessment, and involves interviews with implementers, partners, and project beneficiaries. This analysis will address questions about: the feasibility of the interventions; the timing and sequence of their introduction; key contextual barriers and facilitators to implementation; and potential synergies achieved from the integrated multisector approach.

Economic costing study One project hypothesis is that an annual per capita investment of $110 is required to achieve the MDGs. The aim of the economic costing study is to document the absolute and relative contribution of project partners (MVP, government, donors, and the community) to all priced and non-priced cluster-level activities, as well as the sector-specific breakdown of these inputs.

研究类型

介入性

注册 (实际的)

65000

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

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

15年 及以上 (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:

  • Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria:

  • Those not consenting to participate

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:预防
  • 分配:非随机化
  • 介入模型:阶乘赋值
  • 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:MVP village
Wealth stratified and randomly selected households residing in a village exposed to the Millennium Villages Project intervention (or health and development intervention package)
The timing and sequence of intervention vary by site, but include improved access to seed-fertilizer to increase agricultural production; improved market and capital access; proven maternal-newborn-child health interventions delivered free of cost at the point of service; improvements to school number and quality; and access to basic infrastructure including safe water, sanitation, electricity, transport and communication.
其他名称:
  • 最有价值球员
  • maternal-newborn-child health interventions
有源比较器:Comparison village
Villages receiving routine services through established programs
Routine services and programs currently being administered using prevailing resources, at the current pace and with established partnerships. There is no attempt to limit the introduction of new interventions or agencies into comparison sites.
其他名称:
  • standard of care services

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
Child Mortality Rate
大体时间:5 years
Under 5 Mortality Rate
5 years

次要结果测量

结果测量
措施说明
大体时间
Prevalence of Stunting
大体时间:5 years
Proportion of under 5s who are stunted; Stunted = low height for age Z-score
5 years
Prevalence of Diarrhea
大体时间:5 years
Proportion of under 5's with diarrhea in past 2 weeks
5 years
Prevalence of Malaria
大体时间:5 years
Prevalence of malaria among under 5s at the time of survey
5 years
Prevalence of antenatal care
大体时间:5 years
Proportion of women who receive at least 4 ANC visits
5 years
Survival rate to last grade of primary education (School Quality)
大体时间:5 years
5 years
Prevalence of improved sanitation utilization
大体时间:5 years
Proportion of the population using an improved sanitation source
5 years
Duration or breast feeding (Child feeding practices)
大体时间:5 years
5 years
Age of introduction of complementary feeding (Child feeding practices)
大体时间:5 years
5 years
Prevalence of bed net utilization
大体时间:5 years
Proportion of under 5s sleeping under Longlasting insecticide treated bednets in the night prior to the survey
5 years
Prevalence of malaria treatment
大体时间:5 years
Proportion of under 5s with a fever in the past 2 weeks who receive appropriate anti-malarial treatment
5 years
Prevalence of measles immunization
大体时间:5 years
Proportion under 1s immunized against measles
5 years
Prevalence of diarrhea management
大体时间:5 years
Proportion of under 5s with diarrhea in the past 2 weeks who received oral rehydration therapy
5 years
Prevalence of pneumonia management
大体时间:5 years
Proportion of under 5s treated for pneumonia in the past 2 weeks
5 years
Prevalence of newborn care
大体时间:5 years
Proportion of newborns receiving a post-natal check in the first week of life
5 years
Proportion of pregnant women who received and HIV test
大体时间:5 years
This measures the prevention of vertical transmission of HIV
5 years
Prevalence of food insecurity
大体时间:5 years
Proportion of households reporting not enough food for 1 of past 12 months
5 years
Institutional delivery rate
大体时间:5 years
Proportion of births attended by skilled health personnel
5 years
Prevalence of underweight
大体时间:5 years
Proportion of under 5s who are underweight; Underweight= weight for age Z score
5 years
Prevalence of wasting
大体时间:5 years
Proportion of under 5s who are wasted; Wasting = weight for height Z score
5 years
Prevalence of low mid-upper arm circumference
大体时间:5 years
Proportion of under 5s with a low mid-upper arm circumference
5 years
Household Asset Index (Household poverty)
大体时间:5 years
Survey of fixed and non-fixed assets, including recent purchases
5 years
Prevalence of improved water source utilization
大体时间:5 years
Proportion of the population using an improved drinking water source
5 years

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。

调查人员

  • 学习椅:Jeffrey Sachs, PhD、The Earth Institute, Columbia University
  • 研究主任:Pedro Sanchez, PhD、The Earth Institute, Columbia University
  • 首席研究员:Cheryl Palm, PhD、The Earth Institute, Columbia University
  • 首席研究员:Sonia Sachs, MD, PhD、Director of Health, The Earth Institute, Columbia University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2005年1月1日

初级完成 (实际的)

2016年6月25日

研究完成 (实际的)

2016年6月25日

研究注册日期

首次提交

2010年5月12日

首先提交符合 QC 标准的

2010年5月17日

首次发布 (估计)

2010年5月18日

研究记录更新

最后更新发布 (实际的)

2017年4月21日

上次提交的符合 QC 标准的更新

2017年4月20日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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

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