The Millennium Villages Project: Assessing the Impact on Child Survival and the Millennium Development Goals in Sub-Saharan Africa

Brief Summary

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”

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

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
  • Study Primary Completion Date: June 2012

Detailed Clinical Trial 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 Used in this Clinical Trial

  • 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: Routine services
    • Interventions in comparison villages are 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: MVP village
    • Wealth stratified and randomly selected households residing in a village exposed to the Millennium Villages Project intervention
  • Active Comparator: Comparison village
    • Villages receiving routine services through established programs

Outcome Measures for this Clinical Trial

Primary Measures

  • Child Mortality
    • Time Frame: 5 years
      Safety Issue?: No

Secondary Measures

  • Stunting: Proportion of under 5s who are stunted
    • Time Frame: 5 years
      Safety Issue?: No
  • Diarrhea prevalence
    • Time Frame: 5 years
      Safety Issue?: No
  • Malaria prevalence
    • Time Frame: 5 years
      Safety Issue?: No
  • Antenatal care
    • Time Frame: 5 years
      Safety Issue?: No
  • School quality
    • Time Frame: 5 years
      Safety Issue?: No
  • Access to improved sanitation
    • Time Frame: 5 years
      Safety Issue?: No
  • Child feeding practices
    • Time Frame: 5 years
      Safety Issue?: No
  • Bed net utilization
    • Time Frame: 5 years
      Safety Issue?: No
  • malaria treatment
    • Time Frame: 5 years
      Safety Issue?: No
  • Measles immunization
    • Time Frame: 5 years
      Safety Issue?: No
  • Diarrhea management
    • Time Frame: 5 years
      Safety Issue?: No
  • Pneumonia management
    • Time Frame: 5 years
      Safety Issue?: No
  • Newborn care
    • Time Frame: 5 years
      Safety Issue?: No
  • Prevention of vertical transmission of HIV
    • Time Frame: 5 years
      Safety Issue?: No
  • Food security
    • Time Frame: 5 years
      Safety Issue?: No
  • Institutional delivery rate
    • Time Frame: 5 years
      Safety Issue?: No
  • Underweight: Proportion of under 5s who are underweight
    • Time Frame: 5 years
      Safety Issue?: No
  • Wasting: Proportion of under 5s who are wasted
    • Time Frame: 5 years
      Safety Issue?: No
  • Mid-upper arm circumference
    • Time Frame: 5 years
      Safety Issue?: No
  • Household poverty based on household asset index
    • Time Frame: 5 years
      Safety Issue?: No
  • Access to improved water source
    • Time Frame: 5 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria

  • Those not consenting to participate

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Columbia University
  • Collaborator
    • United Nations Development Program
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeffrey Sachs, PhD, Study Chair, The Earth Institute, Columbia University
    • Pedro Sanchez, PhD, Study Director, The Earth Institute, Columbia University
    • Cheryl Palm, PhD, Principal Investigator, The Earth Institute, Columbia University
    • Paul Pronyk, PhD, Principal Investigator, The Earth Institute, Columbia University
  • Overall Contact(s)
    • Paul Pronyk, PhD, 917 239 8171, ppronyk@ei.columbia.edu

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01125618