Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT01125618
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2010-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Millennium Villages Project in Sub-Saharan Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2010-05-12', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Mortality Rate', 'timeFrame': '5 years', 'description': 'Under 5 Mortality Rate'}], 'secondaryOutcomes': [{'measure': 'Prevalence of Stunting', 'timeFrame': '5 years', 'description': 'Proportion of under 5s who are stunted; Stunted = low height for age Z-score'}, {'measure': 'Prevalence of Diarrhea', 'timeFrame': '5 years', 'description': "Proportion of under 5's with diarrhea in past 2 weeks"}, {'measure': 'Prevalence of Malaria', 'timeFrame': '5 years', 'description': 'Prevalence of malaria among under 5s at the time of survey'}, {'measure': 'Prevalence of antenatal care', 'timeFrame': '5 years', 'description': 'Proportion of women who receive at least 4 ANC visits'}, {'measure': 'Survival rate to last grade of primary education (School Quality)', 'timeFrame': '5 years'}, {'measure': 'Prevalence of improved sanitation utilization', 'timeFrame': '5 years', 'description': 'Proportion of the population using an improved sanitation source'}, {'measure': 'Duration or breast feeding (Child feeding practices)', 'timeFrame': '5 years'}, {'measure': 'Age of introduction of complementary feeding (Child feeding practices)', 'timeFrame': '5 years'}, {'measure': 'Prevalence of bed net utilization', 'timeFrame': '5 years', 'description': 'Proportion of under 5s sleeping under Longlasting insecticide treated bednets in the night prior to the survey'}, {'measure': 'Prevalence of malaria treatment', 'timeFrame': '5 years', 'description': 'Proportion of under 5s with a fever in the past 2 weeks who receive appropriate anti-malarial treatment'}, {'measure': 'Prevalence of measles immunization', 'timeFrame': '5 years', 'description': 'Proportion under 1s immunized against measles'}, {'measure': 'Prevalence of diarrhea management', 'timeFrame': '5 years', 'description': 'Proportion of under 5s with diarrhea in the past 2 weeks who received oral rehydration therapy'}, {'measure': 'Prevalence of pneumonia management', 'timeFrame': '5 years', 'description': 'Proportion of under 5s treated for pneumonia in the past 2 weeks'}, {'measure': 'Prevalence of newborn care', 'timeFrame': '5 years', 'description': 'Proportion of newborns receiving a post-natal check in the first week of life'}, {'measure': 'Proportion of pregnant women who received and HIV test', 'timeFrame': '5 years', 'description': 'This measures the prevention of vertical transmission of HIV'}, {'measure': 'Prevalence of food insecurity', 'timeFrame': '5 years', 'description': 'Proportion of households reporting not enough food for 1 of past 12 months'}, {'measure': 'Institutional delivery rate', 'timeFrame': '5 years', 'description': 'Proportion of births attended by skilled health personnel'}, {'measure': 'Prevalence of underweight', 'timeFrame': '5 years', 'description': 'Proportion of under 5s who are underweight; Underweight= weight for age Z score'}, {'measure': 'Prevalence of wasting', 'timeFrame': '5 years', 'description': 'Proportion of under 5s who are wasted; Wasting = weight for height Z score'}, {'measure': 'Prevalence of low mid-upper arm circumference', 'timeFrame': '5 years', 'description': 'Proportion of under 5s with a low mid-upper arm circumference'}, {'measure': 'Household Asset Index (Household poverty)', 'timeFrame': '5 years', 'description': 'Survey of fixed and non-fixed assets, including recent purchases'}, {'measure': 'Prevalence of improved water source utilization', 'timeFrame': '5 years', 'description': 'Proportion of the population using an improved drinking water source'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child mortality', 'intervention', 'Poverty', 'Africa', 'Millennium Development Goal', 'Millennium Development Goals'], 'conditions': ['Child Survival']}, 'referencesModule': {'references': [{'pmid': '22572602', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe Project evaluation will test the following hypotheses:\n\n1. 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.\n2. 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;\n3. 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', 'detailedDescription': '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.\n\nOutcomes 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.\n\nSample 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.\n\nAnalysis 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.\n\nImplementation 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.\n\nEconomic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident in a Millennium Village and consenting to periodic assessments\n\nExclusion Criteria:\n\n* Those not consenting to participate'}, 'identificationModule': {'nctId': 'NCT01125618', 'acronym': 'MVP', 'briefTitle': 'Millennium Villages Project in Sub-Saharan Africa', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AAAA8202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MVP village', 'description': 'Wealth stratified and randomly selected households residing in a village exposed to the Millennium Villages Project intervention (or health and development intervention package)', 'interventionNames': ['Other: Health and development intervention package']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison village', 'description': 'Villages receiving routine services through established programs', 'interventionNames': ['Other: Routine services']}], 'interventions': [{'name': 'Health and development intervention package', 'type': 'OTHER', 'otherNames': ['maternal-newborn-child health interventions', 'MVP'], 'description': '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.', 'armGroupLabels': ['MVP village']}, {'name': 'Routine services', 'type': 'OTHER', 'otherNames': ['standard of care services'], 'description': '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.', 'armGroupLabels': ['Comparison village']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Koraro', 'country': 'Ethiopia', 'facility': 'Koraro'}, {'city': 'Bonsasso', 'country': 'Ghana', 'facility': 'Bonsasso'}, {'city': 'Sauri', 'country': 'Kenya', 'facility': 'Sauri'}, {'city': 'Mwandama', 'country': 'Malawi', 'facility': 'Mwandama'}, {'city': 'Tiby', 'country': 'Mali', 'facility': 'Tiby'}, {'city': 'Ikaram', 'country': 'Nigeria', 'facility': 'Ikaram'}, {'city': 'Pampaida', 'country': 'Nigeria', 'facility': 'Pampaida'}, {'city': 'Mayange', 'country': 'Rwanda', 'facility': 'Mayange', 'geoPoint': {'lat': -2.1928, 'lon': 30.1221}}, {'city': 'Potou', 'country': 'Senegal', 'facility': 'Potou', 'geoPoint': {'lat': 15.71667, 'lon': -16.5}}, {'city': 'Mbola', 'country': 'Tanzania', 'facility': 'Mbola'}, {'city': 'Ruhiira', 'country': 'Uganda', 'facility': 'Ruhiira'}], 'overallOfficials': [{'name': 'Jeffrey Sachs, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Earth Institute, Columbia University'}, {'name': 'Pedro Sanchez, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Earth Institute, Columbia University'}, {'name': 'Cheryl Palm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Earth Institute, Columbia University'}, {'name': 'Sonia Sachs, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Health, The Earth Institute, Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United Nations', 'class': 'OTHER'}, {'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Health, The Earth Institute', 'investigatorFullName': 'Sonia Sachs', 'investigatorAffiliation': 'Columbia University'}}}}