Millennium Villages Project in Sub-Saharan Africa

NCT ID: NCT01125618

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2016-06-25

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

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.

Conditions

Child Survival

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Health and development intervention package

Intervention Type: 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.

Comparison village

Villages receiving routine services through established programs

Group Type: ACTIVE_COMPARATOR

Routine services

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

maternal-newborn-child health interventions; MVP; standard of care services

Eligibility Criteria

Inclusion Criteria

• Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria

• Those not consenting to participate

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United Nations

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Sonia Sachs

Director of Health, The Earth Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Sachs, PhD

Role: STUDY_CHAIR

The Earth Institute, Columbia University

Pedro Sanchez, PhD

Role: STUDY_DIRECTOR

The Earth Institute, Columbia University

Cheryl Palm, PhD

Role: PRINCIPAL_INVESTIGATOR

The Earth Institute, Columbia University

Sonia Sachs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Director of Health, The Earth Institute, Columbia University

Locations

Koraro

Koraro, , Ethiopia

Bonsasso

Bonsasso, , Ghana

Sauri

Sauri, , Kenya

Mwandama

Mwandama, , Malawi

Tiby

Tiby, , Mali

Ikaram

Ikaram, , Nigeria

Pampaida

Pampaida, , Nigeria

Mayange

Mayange, , Rwanda

Potou

Potou, , Senegal

Mbola

Mbola, , Tanzania

Ruhiira

Ruhiira, , Uganda

Countries

Ethiopia; Ghana; Kenya; Malawi; Mali; Nigeria; Rwanda; Senegal; Tanzania; Uganda

References

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.

Reference Type: DERIVED

PMID: 22572602 (View on PubMed)

Other Identifiers

AAAA8202

Identifier Type: -

Identifier Source: org_study_id