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Millennium Villages Project in Sub-Saharan Africa (MVP)

20 de abril de 2017 actualizado por: Sonia Sachs, Columbia University

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

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

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

65000

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Koraro, Etiopía
        • Koraro
      • Bonsasso, Ghana
        • Bonsasso
      • Sauri, Kenia
        • Sauri
      • Mwandama, Malaui
        • Mwandama
      • Tiby, Malí
        • Tiby
      • Ikaram, Nigeria
        • Ikaram
      • Pampaida, Nigeria
        • Pampaida
      • Mayange, Ruanda
        • Mayange
      • Potou, Senegal
        • Potou
      • Mbola, Tanzania
        • Mbola
      • Ruhiira, Uganda
        • Ruhiira

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

15 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria:

  • Those not consenting to participate

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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)
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.
Otros nombres:
  • Jugador más valioso
  • maternal-newborn-child health interventions
Comparador activo: Comparison village
Villages receiving routine services through established programs
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.
Otros nombres:
  • standard of care services

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Child Mortality Rate
Periodo de tiempo: 5 years
Under 5 Mortality Rate
5 years

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Jeffrey Sachs, PhD, The Earth Institute, Columbia University
  • Director de estudio: Pedro Sanchez, PhD, The Earth Institute, Columbia University
  • Investigador principal: Cheryl Palm, PhD, The Earth Institute, Columbia University
  • Investigador principal: Sonia Sachs, MD, PhD, Director of Health, The Earth Institute, Columbia University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2005

Finalización primaria (Actual)

25 de junio de 2016

Finalización del estudio (Actual)

25 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2010

Primero enviado que cumplió con los criterios de control de calidad

17 de mayo de 2010

Publicado por primera vez (Estimar)

18 de mayo de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

20 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • AAAA8202

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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