Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Millennium Villages Project in Sub-Saharan Africa (MVP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01125618
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : April 21, 2017
Sponsor:
Collaborators:
United Nations
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Sonia Sachs, Columbia University

Tracking Information
First Submitted Date  ICMJE May 12, 2010
First Posted Date  ICMJE May 18, 2010
Last Update Posted Date April 21, 2017
Actual Study Start Date  ICMJE January 2005
Actual Primary Completion Date June 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
Child Mortality Rate [ Time Frame: 5 years ]
Under 5 Mortality Rate
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
Child Mortality [ Time Frame: 5 years ]
Under 5 Mortality Rate
Change History Complete list of historical versions of study NCT01125618 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • Prevalence of Stunting [ Time Frame: 5 years ]
    Proportion of under 5s who are stunted; Stunted = low height for age Z-score
  • Prevalence of Diarrhea [ Time Frame: 5 years ]
    Proportion of under 5's with diarrhea in past 2 weeks
  • Prevalence of Malaria [ Time Frame: 5 years ]
    Prevalence of malaria among under 5s at the time of survey
  • Prevalence of antenatal care [ Time Frame: 5 years ]
    Proportion of women who receive at least 4 ANC visits
  • Survival rate to last grade of primary education (School Quality) [ Time Frame: 5 years ]
  • Prevalence of improved sanitation utilization [ Time Frame: 5 years ]
    Proportion of the population using an improved sanitation source
  • Duration or breast feeding (Child feeding practices) [ Time Frame: 5 years ]
  • Age of introduction of complementary feeding (Child feeding practices) [ Time Frame: 5 years ]
  • 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
  • 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
  • Prevalence of measles immunization [ Time Frame: 5 years ]
    Proportion under 1s immunized against measles
  • Prevalence of diarrhea management [ Time Frame: 5 years ]
    Proportion of under 5s with diarrhea in the past 2 weeks who received oral rehydration therapy
  • Prevalence of pneumonia management [ Time Frame: 5 years ]
    Proportion of under 5s treated for pneumonia in the past 2 weeks
  • Prevalence of newborn care [ Time Frame: 5 years ]
    Proportion of newborns receiving a post-natal check in the first week of life
  • Proportion of pregnant women who received and HIV test [ Time Frame: 5 years ]
    This measures the prevention of vertical transmission of HIV
  • Prevalence of food insecurity [ Time Frame: 5 years ]
    Proportion of households reporting not enough food for 1 of past 12 months
  • Institutional delivery rate [ Time Frame: 5 years ]
    Proportion of births attended by skilled health personnel
  • Prevalence of underweight [ Time Frame: 5 years ]
    Proportion of under 5s who are underweight; Underweight= weight for age Z score
  • Prevalence of wasting [ Time Frame: 5 years ]
    Proportion of under 5s who are wasted; Wasting = weight for height Z score
  • Prevalence of low mid-upper arm circumference [ Time Frame: 5 years ]
    Proportion of under 5s with a low mid-upper arm circumference
  • Household Asset Index (Household poverty) [ Time Frame: 5 years ]
    Survey of fixed and non-fixed assets, including recent purchases
  • Prevalence of improved water source utilization [ Time Frame: 5 years ]
    Proportion of the population using an improved drinking water source
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
  • Stunting: Proportion of under 5s who are stunted [ Time Frame: 5 years ]
    Stunted = low height for age Z-score
  • Diarrhea prevalence [ Time Frame: 5 years ]
    Proportion of under 5's with diarrhea in past 2 weeks
  • Malaria prevalence [ Time Frame: 5 years ]
    Prevalence of malaria among under 5s at the time of survey
  • Antenatal care [ Time Frame: 5 years ]
    Proportion of women who receive at least 4 ANC visits
  • School quality [ Time Frame: 5 years ]
    Survival rate to last grade of primary education
  • Access to improved sanitation [ Time Frame: 5 years ]
    Proportion of the population using an improved sanitation source
  • Child feeding practices [ Time Frame: 5 years ]
    Duration or breast feeding; age of introduction of complementary feeding
  • Bed net utilization [ Time Frame: 5 years ]
    Proportion of under 5s sleeping under Longlasting insecticide treated bednets in the night prior to the survey
  • malaria treatment [ Time Frame: 5 years ]
    Proportion of under 5s with a fever in the past 2 weeks who receive appropriate anti-malarial treatment
  • Measles immunization [ Time Frame: 5 years ]
    Proportion under 1s immunized against measles
  • Diarrhea management [ Time Frame: 5 years ]
    Proprortion of under 5s with diarrhea in the past 2 weeks who received oral rehydration therapy
  • Pneumonia management [ Time Frame: 5 years ]
    Proportion of under 5s treated for pneumonia in the past 2 weeks
  • Newborn care [ Time Frame: 5 years ]
    Proportion of newborns receiving a post-natal check in the first week of life
  • Prevention of vertical transmission of HIV [ Time Frame: 5 years ]
    Proportion of pregnant women who received and HIV test
  • Food security [ Time Frame: 5 years ]
    Proportion of households reporting not enough food for 1 of past 12 months
  • Institutional delivery rate [ Time Frame: 5 years ]
    Proportion of births attended by skilled health personnel
  • Underweight: Proportion of under 5s who are underweight [ Time Frame: 5 years ]
    Underweight= weight for age Z score
  • Wasting: Proportion of under 5s who are wasted [ Time Frame: 5 years ]
    Wasting = weight for height Z score
  • Mid-upper arm circumference [ Time Frame: 5 years ]
    Proportion of under 5s with a low mid-upper arm circumference
  • Household poverty based on household asset index [ Time Frame: 5 years ]
    Survey of fixed and non-fixed assets, including recent purchases
  • Access to improved water source [ Time Frame: 5 years ]
    Proportion of the population using an improved drinking water source
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Millennium Villages Project in Sub-Saharan Africa
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Child Survival
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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)
    Intervention: Other: Health and development intervention package
  • Active Comparator: Comparison village
    Villages receiving routine services through established programs
    Intervention: Other: Routine services
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. Erratum in: Lancet. 2012 May 26;379(9830):1946; discussion 1946-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2017)
65000
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2010)
6000
Actual Study Completion Date  ICMJE June 25, 2016
Actual Primary Completion Date June 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria:

  • Those not consenting to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi,   Ethiopia,   Ghana,   Kenya,   Mali,   Nigeria,   Rwanda,   Senegal,   Tanzania,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01125618
Other Study ID Numbers  ICMJE AAAA8202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sonia Sachs, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • United Nations
  • Bill and Melinda Gates Foundation
Investigators  ICMJE
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
PRS Account Columbia University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP