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Millennium Villages Project in Sub-Saharan Africa (MVP)

20 april 2017 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

65000

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Resident in a Millennium Village and consenting to periodic assessments

Exclusion Criteria:

  • Those not consenting to participate

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)
Övrig: 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.
Andra namn:
  • MVP
  • maternal-newborn-child health interventions
Aktiv komparator: Comparison village
Villages receiving routine services through established programs
Övrig: 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.
Andra namn:
  • standard of care services

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Child Mortality Rate
Tidsram: 5 years
Under 5 Mortality Rate
5 years

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Columbia University

Samarbetspartners

Bill and Melinda Gates Foundation
United Nations

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2005

Primärt slutförande (Faktisk)

25 juni 2016

Avslutad studie (Faktisk)

25 juni 2016

Studieregistreringsdatum

Först inskickad

12 maj 2010

Först inskickad som uppfyllde QC-kriterierna

17 maj 2010

Första postat (Uppskatta)

18 maj 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 april 2017

Senast verifierad

1 april 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • AAAA8202

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

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Nej

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