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Millennium Villages Project in Sub-Saharan Africa (MVP)

20. april 2017 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Etiopien
      • Koraro, Etiopien
        • Koraro
  • Ghana
      • Bonsasso, Ghana
        • Bonsasso
  • Kenya
      • Sauri, Kenya
        • Sauri
  • Malawi
      • Mwandama, Malawi
        • Mwandama
  • Mali
      • Tiby, Mali
        • Tiby
  • Nigeria
      • Ikaram, Nigeria
        • Ikaram
      • Pampaida, Nigeria
        • Pampaida
  • Rwanda
      • Mayange, Rwanda
        • Mayange
  • Senegal
      • Potou, Senegal
        • Potou
  • Tanzania
      • Mbola, Tanzania
        • Mbola
  • Uganda
      • Ruhiira, Uganda
        • Ruhiira

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

15 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria:

  • Those not consenting to participate

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Andet: 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.
Andre navne:
  • MVP
  • maternal-newborn-child health interventions
Aktiv komparator: Comparison village
Villages receiving routine services through established programs
Andet: 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.
Andre navne:
  • standard of care services

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child Mortality Rate
Tidsramme: 5 years
Under 5 Mortality Rate
5 years

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Columbia University

Samarbejdspartnere

Bill and Melinda Gates Foundation
United Nations

Efterforskere

  • Studiestol: Jeffrey Sachs, PhD, The Earth Institute, Columbia University
  • Studieleder: Pedro Sanchez, PhD, The Earth Institute, Columbia University
  • Ledende efterforsker: Cheryl Palm, PhD, The Earth Institute, Columbia University
  • Ledende efterforsker: Sonia Sachs, MD, PhD, Director of Health, The Earth Institute, Columbia University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2005

Primær færdiggørelse (Faktiske)

25. juni 2016

Studieafslutning (Faktiske)

25. juni 2016

Datoer for studieregistrering

Først indsendt

12. maj 2010

Først indsendt, der opfyldte QC-kriterier

17. maj 2010

Først opslået (Skøn)

18. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • AAAA8202

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Child Survival

Kliniske forsøg med Health and development intervention package

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Medicinske tilstande

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Betingelser

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