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Child SurvivalMVPNCT01125618

Millennium Villages Project in Sub-Saharan Africa

A study testing Health and development intervention package and Routine services in people with Child Survival, run by Columbia University at 11 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Child Survival
What is being tested?
Health and development intervention package and Routine services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65,000 participants
Where
11 sitesin 10 countries
Study dates
Jan 2005to 25 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Resident in a Millennium Village and consenting to periodic assessments

Who cannot join

  • Those not consenting to participate

Trial locations and contacts

11 sites in 10 countries.

11 sites in 10 countries

Nigeria2 sites

  • Ikaram

    Ikaram

  • Pampaida

    Pampaida

Other trials in Nigeria

Ethiopia1 site

  • Koraro

    Koraro

Other trials in Ethiopia

Ghana1 site

  • Bonsasso

    Bonsasso

Other trials in Ghana

Kenya1 site

  • Sauri

    Sauri

Other trials in Kenya

Malawi1 site

  • Mwandama

    Mwandama

Other trials in Malawi

Mali1 site

  • Tiby

    Tiby

Other trials in Mali

Rwanda1 site

  • Mayange

    Mayange

Other trials in Rwanda

Senegal1 site

  • Potou

    Potou

Other trials in Senegal

Tanzania1 site

  • Mbola

    Mbola

Other trials in Tanzania

Uganda1 site

  • Ruhiira

    Ruhiira

Other trials in Uganda

About this study

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

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
Read the 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.

Conditions
Child Survival
Being tested
Health and development intervention package, Routine services
Keywords
child mortality, intervention, Poverty, Africa, Millennium Development Goal, Millennium Development Goals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health and development intervention packageOther

    Also called maternal-newborn-child health interventions, MVP

    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.

  • Routine servicesOther

    Also called standard of care 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.

Study groups in NCT01125618
Study groupRoleWhat they receive
MVP villageExperimentalWealth stratified and randomly selected households residing in a village exposed to the Millennium Villages Project intervention (or health and development intervention package)
Receives: Other: Health and development intervention package
Comparison villageActive comparatorVillages receiving routine services through established programs
Receives: Other: Routine services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child Mortality Rate

    Under 5 Mortality Rate

    Measured: 5 years

Secondary outcomes (22)

  1. Prevalence of Stunting

    Proportion of under 5s who are stunted; Stunted = low height for age Z-score

    Measured: 5 years

  2. Prevalence of Diarrhea

    Proportion of under 5's with diarrhea in past 2 weeks

    Measured: 5 years

  3. Prevalence of Malaria

    Prevalence of malaria among under 5s at the time of survey

    Measured: 5 years

  4. Prevalence of antenatal care

    Proportion of women who receive at least 4 ANC visits

    Measured: 5 years

  5. Survival rate to last grade of primary education (School Quality)

    Measured: 5 years

  6. Prevalence of improved sanitation utilization

    Proportion of the population using an improved sanitation source

    Measured: 5 years

  7. Duration or breast feeding (Child feeding practices)

    Measured: 5 years

  8. Age of introduction of complementary feeding (Child feeding practices)

    Measured: 5 years

  9. Prevalence of bed net utilization

    Proportion of under 5s sleeping under Longlasting insecticide treated bednets in the night prior to the survey

    Measured: 5 years

  10. Prevalence of malaria treatment

    Proportion of under 5s with a fever in the past 2 weeks who receive appropriate anti-malarial treatment

    Measured: 5 years

  11. Prevalence of measles immunization

    Proportion under 1s immunized against measles

    Measured: 5 years

  12. Prevalence of diarrhea management

    Proportion of under 5s with diarrhea in the past 2 weeks who received oral rehydration therapy

    Measured: 5 years

  13. Prevalence of pneumonia management

    Proportion of under 5s treated for pneumonia in the past 2 weeks

    Measured: 5 years

  14. Prevalence of newborn care

    Proportion of newborns receiving a post-natal check in the first week of life

    Measured: 5 years

  15. Proportion of pregnant women who received and HIV test

    This measures the prevention of vertical transmission of HIV

    Measured: 5 years

  16. Prevalence of food insecurity

    Proportion of households reporting not enough food for 1 of past 12 months

    Measured: 5 years

  17. Institutional delivery rate

    Proportion of births attended by skilled health personnel

    Measured: 5 years

  18. Prevalence of underweight

    Proportion of under 5s who are underweight; Underweight= weight for age Z score

    Measured: 5 years

  19. Prevalence of wasting

    Proportion of under 5s who are wasted; Wasting = weight for height Z score

    Measured: 5 years

  20. Prevalence of low mid-upper arm circumference

    Proportion of under 5s with a low mid-upper arm circumference

    Measured: 5 years

  21. Household Asset Index (Household poverty)

    Survey of fixed and non-fixed assets, including recent purchases

    Measured: 5 years

  22. Prevalence of improved water source utilization

    Proportion of the population using an improved drinking water source

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2010 (estimated)
  2. Study startJan 2005
  3. Primary completion25 Jun 2016
  4. Study completion25 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
65,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01125618
Sponsor's protocol ID
AAAA8202
Acronym
MVP
Status last verified
Apr 2017
First submitted
12 May 2010
Last updated
21 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pronyk PM, Muniz M, Nemser B, Somers MA, McClellan L, Palm CA, Huynh UK, Ben Amor Y, Begashaw B, McArthur JW, Niang A, Sachs SE, Singh P, Teklehaimanot A, Sachs JD; Millennium Villages Study Group. The effect of an integrated multisector model for achieving the Millennium Development Goals and improving child survival in rural sub-Saharan Africa: a non-randomised controlled assessment. Lancet. 2012 Jun 9;379(9832):2179-88. doi: 10.1016/S0140-6736(12)60207-4. Epub 2012 May 8.

    PubMed 22572602

Questions about this trial

What is this clinical trial studying?

A study testing Health and development intervention package and Routine services in people with Child Survival, run by Columbia University at 11 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Nigeria, Ethiopia, Ghana, Kenya, Malawi and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Mortality Rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01125618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.

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