Millennium Villages Project in Sub-Saharan Africa (MVP)

• ClinicalTrials.gov Identifier: NCT01125618
• Recruitment Status: Completed
• First Posted: May 18, 2010
• Last Update Posted: April 21, 2017
• Sponsor: Columbia University
• Collaborators: United Nations; Bill and Melinda Gates Foundation
• Information provided by (Responsible Party): Sonia Sachs, Columbia University

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
Child Survival	Other: Health and development intervention package; Other: Routine services	Not Applicable

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 (Clinical Trial)
• 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: January 2005
• Actual Primary Completion Date: June 25, 2016
• Actual Study Completion Date: June 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 Name: standard of care services

Outcome Measures

Primary Outcome Measures :

1. Child Mortality Rate [ Time Frame: 5 years ]
   Under 5 Mortality Rate

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria:

• Those not consenting to participate

Contacts and Locations

Locations

Ethiopia

Koraro

Koraro, Ethiopia

Ghana

Bonsasso

Bonsasso, Ghana

Kenya

Sauri

Sauri, Kenya

Malawi

Mwandama

Mwandama, Malawi

Mali

Tiby

Tiby, Mali

Nigeria

Ikaram

Ikaram, Nigeria

Pampaida

Pampaida, Nigeria

Rwanda

Mayange

Mayange, Rwanda

Senegal

Potou

Potou, Senegal

Tanzania

Mbola

Mbola, Tanzania

Uganda

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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: April 21, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• 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, Columbia University:

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