Millennium Villages Project in Sub-Saharan Africa

Study Overview
=================
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: 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. 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; 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.

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

Conditions
-----------------
Child Survival

Intervention / Treatment
-----------------
* Other: Health and development intervention package
* Other: Routine services


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident in a Millennium Village and consenting to periodic assessments Exclusion Criteria: Those not consenting to participate

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MVP village<br>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<br>* 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.<br>* Other names: MVP;|
| Active Comparator: Comparison village<br>Villages receiving routine services through established programs | Other: Routine services<br>* 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.<br>* Other names: standard of care services;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Mortality Rate | Under 5 Mortality Rate | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Stunting | Proportion of under 5s who are stunted; Stunted = low height for age Z-score | 5 years | 
| Prevalence of Diarrhea | Proportion of under 5's with diarrhea in past 2 weeks | 5 years | 
| Prevalence of Malaria | Prevalence of malaria among under 5s at the time of survey | 5 years | 
| Prevalence of antenatal care | Proportion of women who receive at least 4 ANC visits | 5 years | 
| Survival rate to last grade of primary education (School Quality) |  | 5 years | 
| Prevalence of improved sanitation utilization | Proportion of the population using an improved sanitation source | 5 years | 
| Duration or breast feeding (Child feeding practices) |  | 5 years | 
| Age of introduction of complementary feeding (Child feeding practices) |  | 5 years | 
| Prevalence of bed net utilization | Proportion of under 5s sleeping under Longlasting insecticide treated bednets in the night prior to the survey | 5 years | 
| Prevalence of malaria treatment | Proportion of under 5s with a fever in the past 2 weeks who receive appropriate anti-malarial treatment | 5 years | 
| Prevalence of measles immunization | Proportion under 1s immunized against measles | 5 years | 
| Prevalence of diarrhea management | Proportion of under 5s with diarrhea in the past 2 weeks who received oral rehydration therapy | 5 years | 
| Prevalence of pneumonia management | Proportion of under 5s treated for pneumonia in the past 2 weeks | 5 years | 
| Prevalence of newborn care | Proportion of newborns receiving a post-natal check in the first week of life | 5 years | 
| Proportion of pregnant women who received and HIV test | This measures the prevention of vertical transmission of HIV | 5 years | 
| Prevalence of food insecurity | Proportion of households reporting not enough food for 1 of past 12 months | 5 years | 
| Institutional delivery rate | Proportion of births attended by skilled health personnel | 5 years | 
| Prevalence of underweight | Proportion of under 5s who are underweight; Underweight= weight for age Z score | 5 years | 
| Prevalence of wasting | Proportion of under 5s who are wasted; Wasting = weight for height Z score | 5 years | 
| Prevalence of low mid-upper arm circumference | Proportion of under 5s with a low mid-upper arm circumference | 5 years | 
| Household Asset Index (Household poverty) | Survey of fixed and non-fixed assets, including recent purchases | 5 years | 
| Prevalence of improved water source utilization | Proportion of the population using an improved drinking water source | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child mortality, intervention, Poverty, Africa, Millennium Development Goal, Millennium Development Goals