Millennium Villages Project in Sub-Saharan Africa (MVP)

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 Overview

• Status: Completed
• Conditions: Child Survival
• Intervention / Treatment: Other: Health and development intervention package; Other: Routine services

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 Type: Interventional
• Enrollment (Actual): 65000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Koraro, Ethiopia
    • Koraro
• Ghana
  • Bonsasso, Ghana
    • Bonsasso
• Kenya
  • Sauri, Kenya
    • Sauri
• Malawi
  • Mwandama, Malawi
    • Mwandama
• Mali
  • Tiby, Mali
    • Tiby
• Nigeria
  • Ikaram, Nigeria
    • Ikaram
  • Pampaida, Nigeria
    • Pampaida
• Rwanda
  • Mayange, Rwanda
    • Mayange
• Senegal
  • Potou, Senegal
    • Potou
• Tanzania
  • Mbola, Tanzania
    • Mbola
• Uganda
  • Ruhiira, Uganda
    • Ruhiira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria:

• Those not consenting to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: MVP; maternal-newborn-child health interventions
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Mortality Rate	Under 5 Mortality Rate	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Bill and Melinda Gates Foundation; United Nations
• 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

Publications and helpful links

General Publications

• Pronyk PM, Muniz M, Nemser B, Somers MA, McClellan L, Palm CA, Huynh UK, Ben Amor Y, Begashaw B, McArthur JW, Niang A, Sachs SE, Singh P, Teklehaimanot A, Sachs JD; Millennium Villages Study Group. The effect of an integrated multisector model for achieving the Millennium Development Goals and improving child survival in rural sub-Saharan Africa: a non-randomised controlled assessment. Lancet. 2012 Jun 9;379(9832):2179-88. doi: 10.1016/S0140-6736(12)60207-4. Epub 2012 May 8. Erratum In: Lancet. 2012 May 26;379(9830):1950. Lancet. 2012 May 26;379(9830):1946; discussion 1946-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Actual): June 25, 2016
• Study Completion (Actual): June 25, 2016

Study Registration Dates

• First Submitted: May 12, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: intervention; Africa; Poverty; child mortality; Millennium Development Goal; Millennium Development Goals
• Other Study ID Numbers: AAAA8202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No