Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 4:58 PM
Study NCT ID:
NCT04039932
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2019-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Faith Leaders Advocating for Maternal Empowerment (FLAME)
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': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized trial assigning facility catchment areas to intervention vs. standard of care'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2019-07-26', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facility delivery', 'timeFrame': 'Through study completion, an average of 18 months', 'description': 'The proportion of births attended by skilled health personnel among the women who attended ≥1 ANC visits'}], 'secondaryOutcomes': [{'measure': 'Any ANC', 'timeFrame': 'Through study completion, an average of 18 months', 'description': 'Number of women who attended ≥1 ANC visits'}, {'measure': 'Complete ANC', 'timeFrame': 'Through study completion, an average of 18 months', 'description': 'Number of women who attended ANC 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prenatal Care', 'Maternal Health Services', 'Perinatal Care']}, 'referencesModule': {'references': [{'pmid': '34737863', 'type': 'DERIVED', 'citation': 'Guthrie BL, Tsegaye AT, Rankin KC, Walson JL, Alemie GA. Partnering faith leaders with community health workers increases utilization of antenatal care and facility delivery services in Ethiopia: A cluster randomized trial. J Glob Health. 2021 Oct 30;11:04063. doi: 10.7189/jogh.11.04063. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': "In 2015, the average Ethiopian woman had a 1 in 64 lifetime risk of death due to complications of childbirth and 87,414 newborns died before their 28th day of life. Demand for MNCH services, however, remains low in Ethiopia's rural communities most at risk with only 16% of women delivering in a health facility.\n\nThe investigator's project responds to the challenge of creating demand for existing MNCH services in rural Ethiopia, which fell short of reaching Millennium Development Goal targets for reducing preventable maternal and neonatal deaths. This study addresses two strategic drivers to prevent maternal mortality identified by USAID including improving individual, household, and community behaviors and norms and increasing equity of access and use of services by the most vulnerable.\n\nThe primary objective of the study is to determine the impact of a behavior change intervention that partners Ethiopian Orthodox priests with members of the Health Development Army (HDA) and trains them to conduct maternal health outreach to increase births attended by skilled health personnel among women who attend ≥1 ANC visits."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Limited to pregnant women with female sex assigned at birth', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women\n* Willing to receive intervention counseling\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04039932', 'briefTitle': 'Faith Leaders Advocating for Maternal Empowerment (FLAME)', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Faith Leaders Advocating for Maternal Empowerment (FLAME)', 'orgStudyIdInfo': {'id': 'STUDY00001662'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: FLAME']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care'}], 'interventions': [{'name': 'FLAME', 'type': 'BEHAVIORAL', 'description': 'The FLAME intervention trains pairs of faith leaders and community health workers and deploys them to conduct behavior change outreach in their communities.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P.O. Box 126', 'city': 'Gonder', 'state': 'Amhara', 'country': 'Ethiopia', 'facility': 'University of Gondar', 'geoPoint': {'lat': 12.6, 'lon': 37.46667}}], 'overallOfficials': [{'name': 'Brandon Guthrie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Gondar', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, School of Public Health, Global Health', 'investigatorFullName': 'Brandon Guthrie', 'investigatorAffiliation': 'University of Washington'}}}}