Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-20 @ 10:11 AM
Study NCT ID:
NCT01397851
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2011-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stimulating Private Sector Malaria Control
Sponsor:
Organization:
Raw JSON
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Odds ratios calculated in accordance with NIH guidance: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/', 'unitOfMeasure': 'odds ratio', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Increase in Maize Productivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'OG000'}, {'value': '720', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment: Insecticide-treated Net', 'description': 'Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net\n\nInsecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season'}, {'id': 'OG001', 'title': 'Control', 'description': 'Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '6', 'groupId': 'OG000'}, {'value': '59', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2009-2010 and 2010-2011 seasons (up to 2 years)', 'description': 'Increase in self-reported maize productivity (yield on maize plots divided by size of maize plots), collected through validation survey; calculated as maize productivity 2010-11 minus maize productivity 2009-10, measured in bags (ordinarily 50kg bags; however, kg measure not specified)', 'unitOfMeasure': 'bags (not further specified)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of study population selected for validation survey'}, {'type': 'SECONDARY', 'title': 'Self-reported Malaria Prevalence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'OG000'}, {'value': '720', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment: Insecticide-treated Net', 'description': 'Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net\n\nInsecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season'}, {'id': 'OG001', 'title': 'Control', 'description': 'Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000'}, {'value': '1.72', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2010-2011 season (up to 1 year)', 'description': 'Over two weeks before interview, collected through validation survey. Odds ratio calculated in accordance with NIH guidance http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/', 'unitOfMeasure': 'odds ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of study population selected for validation survey'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control'}, {'id': 'FG001', 'title': 'Treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41634'}, {'groupId': 'FG001', 'numSubjects': '39963'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41555'}, {'groupId': 'FG001', 'numSubjects': '39917'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '46'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39963', 'groupId': 'BG000'}, {'value': '41634', 'groupId': 'BG001'}, {'value': '81597', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment: Insecticide-treated Net', 'description': 'Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net\n\nInsecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season'}, {'id': 'BG001', 'title': 'Control', 'description': 'Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'not collected', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'not collected', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'not collected', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'not collected', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'not collected', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'not collected', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'not collected', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Zambia', 'categories': [{'measurements': [{'value': '39963', 'groupId': 'BG000'}, {'value': '41634', 'groupId': 'BG001'}, {'value': '81597', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81597}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2011-06-21', 'resultsFirstSubmitDate': '2014-11-20', 'studyFirstSubmitQcDate': '2011-07-18', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-07', 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cotton Yields', 'timeFrame': '2010-2011 season (up to 1 year)', 'description': "Farmer's cotton yields (kg delivered per household), as defined in the routine data collection system of the participating cotton outgrowing agribusiness"}], 'secondaryOutcomes': [{'measure': 'Contract Defaults', 'timeFrame': '2010-2011 season (up to 1 year)', 'description': 'Defaults on input loans, as defined in the routine data collection system of the participating cotton outgrowing agribusiness. Odds ratios calculated in accordance with NIH guidance: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/'}, {'measure': 'Increase in Maize Productivity', 'timeFrame': '2009-2010 and 2010-2011 seasons (up to 2 years)', 'description': 'Increase in self-reported maize productivity (yield on maize plots divided by size of maize plots), collected through validation survey; calculated as maize productivity 2010-11 minus maize productivity 2009-10, measured in bags (ordinarily 50kg bags; however, kg measure not specified)'}, {'measure': 'Self-reported Malaria Prevalence', 'timeFrame': '2010-2011 season (up to 1 year)', 'description': 'Over two weeks before interview, collected through validation survey. Odds ratio calculated in accordance with NIH guidance http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malaria']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.openscienceframework.org/project/vdS5m/node/253iA/', 'label': 'status update as of 2 April 2013'}]}, 'descriptionModule': {'briefSummary': 'Preliminary evidence from ongoing research provides strong indications that protecting farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan Africa. The study team invests in experimental research to investigate this conjecture in more detail.', 'detailedDescription': 'The study evaluates whether the sourcing of insecticide-treated nets and their distribution to smallholder farmers for free would be a profitable investment for a cotton outgrowing agribusiness in Zambia.\n\nThe study therefore carries out a major net distribution through the existing distribution channels of a cotton outgrowing agribusiness, evaluates the impact of this distribution on smallholder cotton yields, and values the profitability implications for the outgrowing agribusiness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Farmers who contracted with the participating cotton outgrowing company in the 2010-2011 season'}, 'identificationModule': {'nctId': 'NCT01397851', 'acronym': 'Outgrowers', 'briefTitle': 'Stimulating Private Sector Malaria Control', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'Stimulating Private Sector Malaria Control: The Outgrower Opportunity', 'orgStudyIdInfo': {'id': 'PATH Outgrowers'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment: Insecticide-treated net', 'description': 'Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net', 'interventionNames': ['Device: Insecticide-treated net (BASF Incerceptor)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning'}], 'interventions': [{'name': 'Insecticide-treated net (BASF Incerceptor)', 'type': 'DEVICE', 'description': 'One per farmer, once during the 2010-2011 season', 'armGroupLabels': ['Treatment: Insecticide-treated net']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'country': 'Zambia', 'facility': 'National Malaria Control Centre', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elizabeth Trias', 'investigatorAffiliation': 'PATH'}}}}