Clinical trial NCT01125618: Millennium Villages Project in Sub-Saharan Africa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Survival
Keywords: child mortality
intervention
Poverty
Africa
Millennium Development Goal
Millennium Development Goals
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: United Nations
name: Bill and Melinda Gates Foundation
First posted: 2010-05-18
Enrollment: 65000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria:

* Those not consenting to participate

Primary outcomes:
measure: Child Mortality Rate
timeFrame: 5 years
Secondary outcomes:
measure: Prevalence of Stunting
timeFrame: 5 years
measure: Prevalence of Diarrhea
timeFrame: 5 years
measure: Prevalence of Malaria
timeFrame: 5 years
measure: Prevalence of antenatal care
timeFrame: 5 years
measure: Survival rate to last grade of primary education (School Quality)
timeFrame: 5 years
measure: Prevalence of improved sanitation utilization
timeFrame: 5 years
measure: Duration or breast feeding (Child feeding practices)
timeFrame: 5 years
measure: Age of introduction of complementary feeding (Child feeding practices)
timeFrame: 5 years
measure: Prevalence of bed net utilization
timeFrame: 5 years
measure: Prevalence of malaria treatment
timeFrame: 5 years
measure: Prevalence of measles immunization
timeFrame: 5 years
measure: Prevalence of diarrhea management
timeFrame: 5 years
measure: Prevalence of pneumonia management
timeFrame: 5 years
measure: Prevalence of newborn care
timeFrame: 5 years
measure: Proportion of pregnant women who received and HIV test
timeFrame: 5 years
measure: Prevalence of food insecurity
timeFrame: 5 years
measure: Institutional delivery rate
timeFrame: 5 years
measure: Prevalence of underweight
timeFrame: 5 years
measure: Prevalence of wasting
timeFrame: 5 years
measure: Prevalence of low mid-upper arm circumference
timeFrame: 5 years
measure: Household Asset Index (Household poverty)
timeFrame: 5 years
measure: Prevalence of improved water source utilization
timeFrame: 5 years
Other outcomes:
Locations:
city: Koraro
country: Ethiopia
facility: Koraro
city: Bonsasso
country: Ghana
facility: Bonsasso
city: Sauri
country: Kenya
facility: Sauri
city: Mwandama
country: Malawi
facility: Mwandama
city: Tiby
country: Mali
facility: Tiby
city: Ikaram
country: Nigeria
facility: Ikaram
city: Pampaida
country: Nigeria
facility: Pampaida
city: Mayange
country: Rwanda
facility: Mayange
city: Potou
country: Senegal
facility: Potou
city: Mbola
country: Tanzania
facility: Mbola
city: Ruhiira
country: Uganda
facility: Ruhiira
Study officials:
affiliation: The Earth Institute, Columbia University
name: Jeffrey Sachs, PhD
role: STUDY_CHAIR
affiliation: The Earth Institute, Columbia University
name: Pedro Sanchez, PhD
role: STUDY_DIRECTOR
affiliation: The Earth Institute, Columbia University
name: Cheryl Palm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of Health, The Earth Institute, Columbia University
name: Sonia Sachs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.