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Millennium Villages Project in Sub-Saharan Africa (MVP)

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Columbia University

Status

Completed

Conditions

Child Survival

Treatments

Other: Health and development intervention package
Other: Routine services

Study type

Interventional

Funder types

Other

Identifiers

NCT01125618
AAAA8202

Details and patient eligibility

About

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

Full 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.

Enrollment

65,000 patients

Sex

All

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Resident in a Millennium Village and consenting to periodic assessments

Exclusion criteria

  • Those not consenting to participate

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

65,000 participants in 2 patient groups

MVP village
Experimental group
Description:
Wealth stratified and randomly selected households residing in a village exposed to the Millennium Villages Project intervention (or health and development intervention package)
Treatment:
Other: Health and development intervention package
Comparison village
Active Comparator group
Description:
Villages receiving routine services through established programs
Treatment:
Other: Routine services

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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