NCT01125618

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. 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. 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. 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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
9 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2016

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

11.5 years

First QC Date

May 12, 2010

Last Update Submit

April 20, 2017

Conditions

Keywords

child mortalityinterventionPovertyAfricaMillennium Development GoalMillennium Development Goals

Outcome Measures

Primary Outcomes (1)

  • Child Mortality Rate

    Under 5 Mortality Rate

    5 years

Secondary Outcomes (22)

  • Prevalence of Stunting

    5 years

  • Prevalence of Diarrhea

    5 years

  • Prevalence of Malaria

    5 years

  • Prevalence of antenatal care

    5 years

  • Survival rate to last grade of primary education (School Quality)

    5 years

  • +17 more secondary outcomes

Study Arms (2)

MVP village

EXPERIMENTAL

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

Comparison village

ACTIVE COMPARATOR

Villages receiving routine services through established programs

Other: Routine services

Interventions

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.

Also known as: maternal-newborn-child health interventions, MVP
MVP village

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.

Also known as: standard of care services
Comparison village

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Resident in a Millennium Village and consenting to periodic assessments

You may not qualify if:

  • Those not consenting to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Koraro

Koraro, Ethiopia

Location

Bonsasso

Bonsasso, Ghana

Location

Sauri

Sauri, Kenya

Location

Mwandama

Mwandama, Malawi

Location

Tiby

Tiby, Mali

Location

Ikaram

Ikaram, Nigeria

Location

Pampaida

Pampaida, Nigeria

Location

Mayange

Mayange, Rwanda

Location

Potou

Potou, Senegal

Location

Mbola

Mbola, Tanzania

Location

Ruhiira

Ruhiira, Uganda

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Jeffrey Sachs, PhD

    The Earth Institute, Columbia University

    STUDY CHAIR
  • Pedro Sanchez, PhD

    The Earth Institute, Columbia University

    STUDY DIRECTOR
  • Cheryl Palm, PhD

    The Earth Institute, Columbia University

    PRINCIPAL INVESTIGATOR
  • Sonia Sachs, MD, PhD

    Director of Health, The Earth Institute, Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Health, The Earth Institute

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 18, 2010

Study Start

January 1, 2005

Primary Completion

June 25, 2016

Study Completion

June 25, 2016

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations