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Millennium Villages Project in Sub-Saharan Africa

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01125618
Acronym
MVP
Enrollment
65000
Registered
2010-05-18
Start date
2005-01-31
Completion date
2016-06-25
Last updated
2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Survival

Keywords

child mortality, intervention, Poverty, Africa, Millennium Development Goal, Millennium Development Goals

Brief summary

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

Detailed description

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.

Interventions

OTHERHealth 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.

OTHERRoutine services

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.

Sponsors

United Nations
CollaboratorOTHER
Bill and Melinda Gates Foundation
CollaboratorOTHER
Columbia University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Resident in a Millennium Village and consenting to periodic assessments

Exclusion criteria

* Those not consenting to participate

Design outcomes

Primary

MeasureTime frameDescription
Child Mortality Rate5 yearsUnder 5 Mortality Rate

Secondary

MeasureTime frameDescription
Prevalence of Diarrhea5 yearsProportion of under 5's with diarrhea in past 2 weeks
Prevalence of Malaria5 yearsPrevalence of malaria among under 5s at the time of survey
Prevalence of antenatal care5 yearsProportion of women who receive at least 4 ANC visits
Survival rate to last grade of primary education (School Quality)5 years
Prevalence of improved sanitation utilization5 yearsProportion of the population using an improved sanitation source
Duration or breast feeding (Child feeding practices)5 years
Age of introduction of complementary feeding (Child feeding practices)5 years
Prevalence of bed net utilization5 yearsProportion of under 5s sleeping under Longlasting insecticide treated bednets in the night prior to the survey
Prevalence of malaria treatment5 yearsProportion of under 5s with a fever in the past 2 weeks who receive appropriate anti-malarial treatment
Prevalence of measles immunization5 yearsProportion under 1s immunized against measles
Prevalence of Stunting5 yearsProportion of under 5s who are stunted; Stunted = low height for age Z-score
Prevalence of pneumonia management5 yearsProportion of under 5s treated for pneumonia in the past 2 weeks
Prevalence of newborn care5 yearsProportion of newborns receiving a post-natal check in the first week of life
Proportion of pregnant women who received and HIV test5 yearsThis measures the prevention of vertical transmission of HIV
Prevalence of food insecurity5 yearsProportion of households reporting not enough food for 1 of past 12 months
Institutional delivery rate5 yearsProportion of births attended by skilled health personnel
Prevalence of underweight5 yearsProportion of under 5s who are underweight; Underweight= weight for age Z score
Prevalence of wasting5 yearsProportion of under 5s who are wasted; Wasting = weight for height Z score
Prevalence of low mid-upper arm circumference5 yearsProportion of under 5s with a low mid-upper arm circumference
Household Asset Index (Household poverty)5 yearsSurvey of fixed and non-fixed assets, including recent purchases
Prevalence of improved water source utilization5 yearsProportion of the population using an improved drinking water source
Prevalence of diarrhea management5 yearsProportion of under 5s with diarrhea in the past 2 weeks who received oral rehydration therapy

Countries

Ethiopia, Ghana, Kenya, Malawi, Mali, Nigeria, Rwanda, Senegal, Tanzania, Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026