Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT05709457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-01
First Post:
2022-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Effects Of a Maternal Cash Transfer Experiment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of births that take place in a health facility', 'timeFrame': '4-5 years after RCT enrollment', 'description': 'Proportion of births that take place in a health facility'}, {'measure': 'Proportion of women that attended prenatal care during pregnancy', 'timeFrame': '4-5 years after RCT enrollment', 'description': 'Proportion of women that attended prenatal care during pregnancy'}, {'measure': 'Child survival', 'timeFrame': '4-5 years after RCT enrollment', 'description': 'Probability that child is alive'}, {'measure': 'Child health utilization', 'timeFrame': '4-5 years after RCT enrollment', 'description': 'Proportion of children taken to a health facility for care when sick'}, {'measure': 'Proportion of children receiving recommended immunizations', 'timeFrame': '4-5 years after RCT enrollment', 'description': 'Proportion of children receiving recommended immunizations'}], 'secondaryOutcomes': [{'measure': 'Maternal health', 'timeFrame': '4-5 years after RCT enrollment', 'description': 'Self-rated health'}, {'measure': 'Child weight', 'timeFrame': '4-5 years after RCT enrollment', 'description': 'Child weight measured at visit'}, {'measure': 'Child height', 'timeFrame': '4-5 years after RCT enrollment', 'description': 'Child height measured at visit'}, {'measure': 'Birth outcome', 'timeFrame': '4-5 years after RCT enrollment', 'description': 'Probability of a live birth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maternal Health Services', 'Outcome Assessment']}, 'descriptionModule': {'briefSummary': 'This is a follow-on study to a cluster randomized trial of maternal conditional incentives conducted in Nigeria. This study found that cash transfers, conditional on women obtaining facility-based prenatal, delivery, and postnatal care, resulted in large, significant effects on maternal and child outcomes (NICHD R01HD083444). This study will answer additional key policy questions. First, are the effects on maternal behavior temporary, or do they result in more sustained behavior change? Second, do measured short run (SR) child health effects persist over the long run? Third, did the program generate spillovers?', 'detailedDescription': 'This study will build on what the study investigators learned from the RCT and extend it in novel directions. Research assistants will return to the study communities approximately 5 years after enrollment in the RCT to collect data on utilization of maternal health care services for births to the trial participants after the intervention, and on long run child health outcomes including child weight and height. The research assistants will also collect data on the birth outcomes of non-incentivized childbearing women in the study clusters. Data will be collected through in-person surveys of study participants.\n\nThis study will provide valuable new evidence about the indirect and long run effects of demand-side incentives. This is of critical importance because accounting for only the direct effects may severely underestimate the full effect of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Households:\n\n* Resident in a community included in the RTC\n\nExclusion Criteria for Households:\n\n* None\n\nInclusion Criteria for Women:\n\n* Women must have participated in an earlier randomized trial of conditional incentives OR\n* They did not take part in the earlier trial but are resident in clusters that participated in the earlier trial and have given birth since 2018\n\nExclusion Criteria for Women:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05709457', 'briefTitle': 'Long Term Effects Of a Maternal Cash Transfer Experiment', 'organization': {'class': 'OTHER', 'fullName': 'RAND'}, 'officialTitle': 'Long Term Effects of an Intervention on Maternal Behavior, Child Health, and Community Influence', 'orgStudyIdInfo': {'id': 'R01HD102412', 'link': 'https://reporter.nih.gov/quickSearch/R01HD102412', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RCT Participants', 'description': 'Women and children who participated in the earlier study.', 'interventionNames': ['Behavioral: Cash transfer in prior study']}, {'type': 'NO_INTERVENTION', 'label': 'Non-RCT participants', 'description': 'Women and children in the same communities included in the earlier study who did not participate in that study.'}], 'interventions': [{'name': 'Cash transfer in prior study', 'type': 'BEHAVIORAL', 'description': 'Women were offered a cash transfer conditional on attending prenatal and postnatal visits and delivering in a facility', 'armGroupLabels': ['RCT Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kano', 'country': 'Nigeria', 'facility': 'Amino Kano Teaching Hospital', 'geoPoint': {'lat': 12.00012, 'lon': 8.51672}}], 'overallOfficials': [{'name': 'Edward N Okeke, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RAND'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'De-identified data will be shared after results are published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RAND', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}