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Completed

NCT Number: NCT01125618

Millennium Villages Project in Sub-Saharan Africa

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

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Key information

Conditions

Child Survival

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koraro, Ethiopia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Resident in a Millennium Village and consenting to periodic assessments

Exclusion criteria

  • Those not consenting to participate

Treatment and study plan

Health and development intervention package

Other

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.

Other names: maternal-newborn-child health interventions, MVP

Routine services

Other

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.

Other names: standard of care services

Primary outcomes

  1. Child Mortality Rate

    Time frame: 5 years

    Under 5 Mortality Rate

Secondary outcomes

  1. Prevalence of Stunting

    Time frame: 5 years

    Proportion of under 5s who are stunted; Stunted = low height for age Z-score

  2. Prevalence of Diarrhea

    Time frame: 5 years

    Proportion of under 5's with diarrhea in past 2 weeks

  3. Prevalence of Malaria

    Time frame: 5 years

    Prevalence of malaria among under 5s at the time of survey

  4. Prevalence of antenatal care

    Time frame: 5 years

    Proportion of women who receive at least 4 ANC visits

  5. Survival rate to last grade of primary education (School Quality)

    Time frame: 5 years

  6. Prevalence of improved sanitation utilization

    Time frame: 5 years

    Proportion of the population using an improved sanitation source

  7. Duration or breast feeding (Child feeding practices)

    Time frame: 5 years

  8. Age of introduction of complementary feeding (Child feeding practices)

    Time frame: 5 years

  9. Prevalence of bed net utilization

    Time frame: 5 years

    Proportion of under 5s sleeping under Longlasting insecticide treated bednets in the night prior to the survey

  10. Prevalence of malaria treatment

    Time frame: 5 years

    Proportion of under 5s with a fever in the past 2 weeks who receive appropriate anti-malarial treatment

  11. Prevalence of measles immunization

    Time frame: 5 years

    Proportion under 1s immunized against measles

  12. Prevalence of diarrhea management

    Time frame: 5 years

    Proportion of under 5s with diarrhea in the past 2 weeks who received oral rehydration therapy

  13. Prevalence of pneumonia management

    Time frame: 5 years

    Proportion of under 5s treated for pneumonia in the past 2 weeks

  14. Prevalence of newborn care

    Time frame: 5 years

    Proportion of newborns receiving a post-natal check in the first week of life

  15. Proportion of pregnant women who received and HIV test

    Time frame: 5 years

    This measures the prevention of vertical transmission of HIV

  16. Prevalence of food insecurity

    Time frame: 5 years

    Proportion of households reporting not enough food for 1 of past 12 months

  17. Institutional delivery rate

    Time frame: 5 years

    Proportion of births attended by skilled health personnel

  18. Prevalence of underweight

    Time frame: 5 years

    Proportion of under 5s who are underweight; Underweight= weight for age Z score

  19. Prevalence of wasting

    Time frame: 5 years

    Proportion of under 5s who are wasted; Wasting = weight for height Z score

  20. Prevalence of low mid-upper arm circumference

    Time frame: 5 years

    Proportion of under 5s with a low mid-upper arm circumference

  21. Household Asset Index (Household poverty)

    Time frame: 5 years

    Survey of fixed and non-fixed assets, including recent purchases

  22. Prevalence of improved water source utilization

    Time frame: 5 years

    Proportion of the population using an improved drinking water source

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • United Nations

Registry information

Official study title

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

Acronym: MVP

Important dates

Study start
2005
Primary completion
2016
Study completion
2016
First posted
May 18, 2010
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.