MVP: Millennium Villages Project in Sub-Saharan Africa

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT01125618
Collaborator
United Nations (Other), Bill and Melinda Gates Foundation (Other)
65,000
11
2
137.8
5909.1
42.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Health and development intervention package
  • Other: Routine services
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
65000 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Jun 25, 2016
Actual Study Completion Date :
Jun 25, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Other: 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.
Other Names:
  • maternal-newborn-child health interventions
  • MVP
  • Active Comparator: Comparison village

    Villages receiving routine services through established programs

    Other: Routine 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.
    Other Names:
  • standard of care services
  • Outcome Measures

    Primary Outcome Measures

    1. Child Mortality Rate [5 years]

      Under 5 Mortality Rate

    Secondary Outcome Measures

    1. Prevalence of Stunting [5 years]

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

    2. Prevalence of Diarrhea [5 years]

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

    3. Prevalence of Malaria [5 years]

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

    4. Prevalence of antenatal care [5 years]

      Proportion of women who receive at least 4 ANC visits

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

    6. Prevalence of improved sanitation utilization [5 years]

      Proportion of the population using an improved sanitation source

    7. Duration or breast feeding (Child feeding practices) [5 years]

    8. Age of introduction of complementary feeding (Child feeding practices) [5 years]

    9. Prevalence of bed net utilization [5 years]

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

    10. Prevalence of malaria treatment [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 [5 years]

      Proportion under 1s immunized against measles

    12. Prevalence of diarrhea management [5 years]

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

    13. Prevalence of pneumonia management [5 years]

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

    14. Prevalence of newborn care [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 [5 years]

      This measures the prevention of vertical transmission of HIV

    16. Prevalence of food insecurity [5 years]

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

    17. Institutional delivery rate [5 years]

      Proportion of births attended by skilled health personnel

    18. Prevalence of underweight [5 years]

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

    19. Prevalence of wasting [5 years]

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

    20. Prevalence of low mid-upper arm circumference [5 years]

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

    21. Household Asset Index (Household poverty) [5 years]

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

    22. Prevalence of improved water source utilization [5 years]

      Proportion of the population using an improved drinking water source

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Resident in a Millennium Village and consenting to periodic assessments
    Exclusion Criteria:
    • Those not consenting to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Koraro Koraro Ethiopia
    2 Bonsasso Bonsasso Ghana
    3 Sauri Sauri Kenya
    4 Mwandama Mwandama Malawi
    5 Tiby Tiby Mali
    6 Ikaram Ikaram Nigeria
    7 Pampaida Pampaida Nigeria
    8 Mayange Mayange Rwanda
    9 Potou Potou Senegal
    10 Mbola Mbola Tanzania
    11 Ruhiira Ruhiira Uganda

    Sponsors and Collaborators

    • Columbia University
    • United Nations
    • Bill and Melinda Gates Foundation

    Investigators

    • Study Chair: Jeffrey Sachs, PhD, The Earth Institute, Columbia University
    • Study Director: Pedro Sanchez, PhD, The Earth Institute, Columbia University
    • Principal Investigator: Cheryl Palm, PhD, The Earth Institute, Columbia University
    • Principal Investigator: Sonia Sachs, MD, PhD, Director of Health, The Earth Institute, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sonia Sachs, Director of Health, The Earth Institute, Columbia University
    ClinicalTrials.gov Identifier:
    NCT01125618
    Other Study ID Numbers:
    • AAAA8202
    First Posted:
    May 18, 2010
    Last Update Posted:
    Apr 21, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sonia Sachs, Director of Health, The Earth Institute, Columbia University

    Study Results

    No Results Posted as of Apr 21, 2017