Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-10 @ 11:48 AM
Study NCT ID:
NCT02936869
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2016-10-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Incentives for Postnatal Care Demand
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063130', 'term': 'Maternal Death'}, {'id': 'D066087', 'term': 'Perinatal Death'}], 'ancestors': [{'id': 'D063129', 'term': 'Parental Death'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adc785@mail.harvard.edu', 'phone': '9173712931', 'title': 'Dr. Adanna Chukwuma', 'organization': 'World Bank'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was concluded prior to schedule due to community conflict affecting the length of follow-up time; we relied on self-reports due to the poor information systems within the study context.'}}, 'adverseEventsModule': {'timeFrame': '5 months', 'description': 'At recruitment, participants were informed about potential adverse events in a consent form. During follow-up, enumerators were required to ask for these and other events. All reportable events were to be forwarded to the Harvard Longwood Medical Area Institutional Review Board within 5 days of the PI becoming aware of the situation as per the Office of Human Research Administration policy.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 0, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Referral Incentive Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.\n\nTraditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.\n\nPerformance-based monetary incentives', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maternal Postnatal Care Referral', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.'}, {'id': 'OG001', 'title': 'Referral Incentive Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.\n\nTraditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.\n\nPerformance-based monetary incentives'}], 'classes': [{'categories': [{'measurements': [{'value': '0.044', 'groupId': 'OG000', 'lowerLimit': '-0.009', 'upperLimit': '0.097'}, {'value': '0.154', 'groupId': 'OG001', 'lowerLimit': '0.079', 'upperLimit': '0.229'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 48 hours of delivery', 'description': 'The proportion of delivery clients that are successfully referred by the traditional birth attendant for postnatal care within 48 hours of delivery. For each delivery client that the traditional birth attendant reported, we visited at least three days after delivery to ascertain if they had been asked to visit the postnatal clinic, clarify if they had visited the clinic within 48 hours of delivery, and what care they had received (if yes). The team visited traditional birth attendants every two weeks to identify new clients. Where a new client was not up to three days post-delivery, the interview was postponed until the next visit by the team to the community. This occurred repeatedly, over a five-month frame.', 'unitOfMeasure': 'proportion of maternal clients referred', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis did not include information from the 7 TBAs lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Neonatal Postnatal Care Referral', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.'}, {'id': 'OG001', 'title': 'Referral Incentive Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.\n\nTraditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of maternal delivery clients to postnatal care within 48 hours of delivery in a facility if verified.\n\nPerformance-based monetary incentives'}], 'classes': [{'categories': [{'measurements': [{'value': '0.032', 'groupId': 'OG000', 'lowerLimit': '-0.015', 'upperLimit': '0.079'}, {'value': '0.126', 'groupId': 'OG001', 'lowerLimit': '0.059', 'upperLimit': '0.193'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 48 hours of delivery', 'description': 'Proportion of neonates delivered by the traditional birth attendant that are successfully referred for postnatal care within 48 hours of delivery', 'unitOfMeasure': 'proportion of neonates referred', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis did not include data from 7 TBAs lost to follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.'}, {'id': 'FG001', 'title': 'Referral Incentive Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.\n\nTraditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.\n\nPerformance-based monetary incentives'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Legal Case', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the community within 128 wards in Ebonyi State in August 2016.', 'preAssignmentDetails': 'Of the 269 TBAs identified through community leaders and facility heads that met the inclusion criteria and were recruited, 20 declined to participate and 27 could not be located at the given addresses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.'}, {'id': 'BG001', 'title': 'Referral Incentive Arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.\n\nTraditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.\n\nPerformance-based monetary incentives'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.42308', 'spread': '19.67241', 'groupId': 'BG000'}, {'value': '44.75728', 'spread': '16.23206', 'groupId': 'BG001'}, {'value': '48.10628', 'spread': '18.30641', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants lacking formal education', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Average income per pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '1790.962', 'spread': '1852.523', 'groupId': 'BG000'}, {'value': '2265.437', 'spread': '2992.071', 'groupId': 'BG001'}, {'value': '2027.053', 'spread': '2491.036', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Naira', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of participants offering postnatal care', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Monthly average of delivery clients', 'classes': [{'categories': [{'measurements': [{'value': '13.80769', 'spread': '97.70553', 'groupId': 'BG000'}, {'value': '9.553398', 'spread': '48.90622', 'groupId': 'BG001'}, {'value': '11.69082', 'spread': '77.21418', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'clients', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of participants that are literate in English', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants that are literate in non-English Language', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants who are leaders of any association', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants who are members of any association', 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants who are the main income earner in household', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-07', 'size': 1215876, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-03T12:32', 'hasProtocol': True}, {'date': '2016-07-07', 'size': 144390, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-03T12:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2016-10-14', 'resultsFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-22', 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Postnatal Care Referral', 'timeFrame': 'Within 48 hours of delivery', 'description': 'The proportion of delivery clients that are successfully referred by the traditional birth attendant for postnatal care within 48 hours of delivery. For each delivery client that the traditional birth attendant reported, we visited at least three days after delivery to ascertain if they had been asked to visit the postnatal clinic, clarify if they had visited the clinic within 48 hours of delivery, and what care they had received (if yes). The team visited traditional birth attendants every two weeks to identify new clients. Where a new client was not up to three days post-delivery, the interview was postponed until the next visit by the team to the community. This occurred repeatedly, over a five-month frame.'}], 'secondaryOutcomes': [{'measure': 'Neonatal Postnatal Care Referral', 'timeFrame': 'Within 48 hours of delivery', 'description': 'Proportion of neonates delivered by the traditional birth attendant that are successfully referred for postnatal care within 48 hours of delivery'}]}, 'conditionsModule': {'conditions': ['Maternal Death', 'Neonatal Death']}, 'referencesModule': {'references': [{'pmid': '9509629', 'type': 'BACKGROUND', 'citation': 'Itina SM. Characteristics of traditional birth attendants and their beliefs and practices in the Offot Clan, Nigeria. Bull World Health Organ. 1997;75(6):563-7.'}, {'pmid': '22895949', 'type': 'BACKGROUND', 'citation': 'Sibley LM, Sipe TA, Barry D. Traditional birth attendant training for improving health behaviours and pregnancy outcomes. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD005460. doi: 10.1002/14651858.CD005460.pub3.'}, {'type': 'BACKGROUND', 'citation': 'Oyebola, B. C., Muhammad, F., Otunomeruke, A., & Galadima, A. (2014). Effect of Performance-Based Incentives for Traditional Birth Attendants on Access to Maternal and Newborn Health-care Facilities in Gombe State, Nigeria: A Pilot Study. Meeting Abstract. Lancet.'}, {'type': 'BACKGROUND', 'citation': 'WHO. (2004). Making Pregnancy Safer: The Critical Role of the Skilled Attendant - A Joint Statement by WHO, ICM, and FIGO. Geneva: World Health Organization.'}, {'pmid': '31104629', 'type': 'DERIVED', 'citation': 'Chukwuma A, Mbachu C, McConnell M, Bossert TJ, Cohen J. The impact of monetary incentives on referrals by traditional birth attendants for postnatal care in Nigeria. BMC Pregnancy Childbirth. 2019 May 20;19(1):150. doi: 10.1186/s12884-019-2313-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify the causal impact of performance-based monetary incentives in increasing postnatal care (PNC) referrals by traditional birth attendants (TBAs), via a randomized controlled trial (RCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* community-based providers of antenatal and/or delivery care, and who are non-formally trained\n* must be resident within the community\n* must not plan to relocate over the intervention duration\n* identified in partnership with community leadership\n* be willing to participate fully in the study, including having their clients contacted for verification\n\nExclusion Criteria:\n\n* plan to relocate over the intervention duration\n* refusal to provide informed consent for the entire study protocol including agreeing to have their delivery clients contacted for verification'}, 'identificationModule': {'nctId': 'NCT02936869', 'briefTitle': 'Incentives for Postnatal Care Demand', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Incentives for Postnatal Care Demand', 'orgStudyIdInfo': {'id': 'HU-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.'}, {'type': 'EXPERIMENTAL', 'label': 'Referral incentive arm', 'description': 'Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.\n\nTraditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.', 'interventionNames': ['Behavioral: Performance-based monetary incentives']}], 'interventions': [{'name': 'Performance-based monetary incentives', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Referral incentive arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Adanna Chukwuma, MBBS, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Margaret McConnell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Jessica Cohen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Chinyere Mbachu, MBBS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Policy Research Group'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'The data on the Harvard Dataverse are available indefinitely as long as the website continues to host datasets.', 'ipdSharing': 'YES', 'description': 'De-identified data for this study including all the variables used for the analysis are available for download on the Harvard Dataverse.', 'accessCriteria': 'The data can be freely downloaded without permission.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral Candidate', 'investigatorFullName': 'Adanna Chukwuma', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}