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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Columbia University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
United Nations Development Program
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01125618
First received: May 12, 2010
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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 Intervention
Child Survival
Other: Health and development intervention package
Other: Routine services

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Child Mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Under 5 Mortality Rate


Secondary Outcome Measures:
  • Stunting: Proportion of under 5s who are stunted [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Stunted = low height for age Z-score

  • Diarrhea prevalence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of under 5's with diarrhea in past 2 weeks

  • Malaria prevalence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Prevalence of malaria among under 5s at the time of survey

  • Antenatal care [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of women who receive at least 4 ANC visits

  • School quality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Survival rate to last grade of primary education

  • Access to improved sanitation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of the population using an improved sanitation source

  • Child feeding practices [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Duration or breast feeding; age of introduction of complementary feeding

  • Bed net utilization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of under 5s sleeping under Longlasting insecticide treated bednets in the night prior to the survey

  • malaria treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of under 5s with a fever in the past 2 weeks who receive appropriate anti-malarial treatment

  • Measles immunization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion under 1s immunized against measles

  • Diarrhea management [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proprortion of under 5s with diarrhea in the past 2 weeks who received oral rehydration therapy

  • Pneumonia management [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of under 5s treated for pneumonia in the past 2 weeks

  • Newborn care [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of newborns receiving a post-natal check in the first week of life

  • Prevention of vertical transmission of HIV [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of pregnant women who received and HIV test

  • Food security [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of households reporting not enough food for 1 of past 12 months

  • Institutional delivery rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of births attended by skilled health personnel

  • Underweight: Proportion of under 5s who are underweight [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Underweight= weight for age Z score

  • Wasting: Proportion of under 5s who are wasted [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Wasting = weight for height Z score

  • Mid-upper arm circumference [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of under 5s with a low mid-upper arm circumference

  • Household poverty based on household asset index [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Survey of fixed and non-fixed assets, including recent purchases

  • Access to improved water source [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Proportion of the population using an improved drinking water source


Estimated Enrollment: 6000
Study Start Date: June 2006
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MVP village
Wealth stratified and randomly selected households residing in a village exposed to the Millennium Villages Project intervention
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 Name: maternal-newborn-child health interventions
Active Comparator: Comparison village
Villages receiving routine services through established programs
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
Other Name: standard of care

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125618

Contacts
Contact: Paul Pronyk, PhD 917 239 8171 ppronyk@ei.columbia.edu
Contact: Cheryl Palm, PhD cpalm@ei.columbia.edu

Locations
Ethiopia
Koraro Recruiting
Koraro, Ethiopia
Contact: Alem Hadera Abay, PhD    Alem Hadera Abay    mdethiopia@yahoo.com   
Sub-Investigator: Alem H Abay, PhD         
Ghana
Bonsasso Recruiting
Bonsasso, Ghana
Contact: Joseph-Mensah Homiah, PhD       mensahhomiah@gmail.com   
Sub-Investigator: Joseph-Mensah Honmiah, PhD         
Kenya
Sauri Recruiting
Sauri, Kenya
Contact: Patrick Mutuo, PhD       p.mutuo@cgiar.org   
Sub-Investigator: Patrick Mutuo, PhD         
Malawi
Mwandama Recruiting
Mwandama, Malawi
Contact: Jonathan Mkumbira, PhD       jonathan.mkumbira@undp.org   
Sub-Investigator: Jonathan Mkumbira, PhD         
Mali
Tiby Recruiting
Tiby, Mali
Contact: Bocary Kaya, PhD       bocary.kaya@undp.org   
Sub-Investigator: Bocary Kaya, PhD         
Nigeria
Ikaram Recruiting
Ikaram, Nigeria
Contact: Niyi Onabanjo       niyi.onabanjo@undp.org   
Sub-Investigator: Niyi Onabanjo, PhD         
Pampaida Recruiting
Pampaida, Nigeria
Contact: Bala Yunusa, Phd       bala.yunusa@undp.org   
Sub-Investigator: Bala Y Yunusa, PhD         
Rwanda
Mayange Recruiting
Mayange, Rwanda
Contact: Donald Ndahiro, PhD       dn2162@columbia.edu   
Sub-Investigator: Donald Ndahiro, PhD         
Senegal
Potou Recruiting
Potou, Senegal
Contact: Serigne Kandji, PhD       skandji@gmail.com   
Sub-Investigator: Serigne Kandji, PhD         
Tanzania
Mbola Recruiting
Mbola, Tanzania
Contact: Gerson Nyadzi, PhD       gerson.nyadzi@undp.org   
Sub-Investigator: Gerson Nyadzi, PhD         
Uganda
Ruhiira Recruiting
Ruhiira, Uganda
Contact: David Siriri, PhD       david.siriri@undp.org   
Sub-Investigator: David Siriri, Phd         
Sponsors and Collaborators
Columbia University
United Nations Development Program
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: Paul Pronyk, PhD The Earth Institute, Columbia University
  More Information

Additional Information:
No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01125618     History of Changes
Other Study ID Numbers: AAAA8202
Study First Received: May 12, 2010
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
child mortality
intervention
Poverty
Africa
Millennium Development Goal
Millennium Development Goals

ClinicalTrials.gov processed this record on October 01, 2014