Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-04 @ 11:35 PM
Study NCT ID:
NCT03188250
Status:
COMPLETED
Last Update Posted:
2017-06-15
First Post:
2017-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chama Cha MamaToto: a Pilot Study of Peer Support Groups in Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 515}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-14', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facility delivery', 'timeFrame': '22 months', 'description': 'Proportion of women giving birth in a health facility based on questionnaire'}], 'secondaryOutcomes': [{'measure': '4 ANC visits', 'timeFrame': '22 months', 'description': 'attendance at 4 or more ANC visits in pregnancy based on questionnaire'}, {'measure': 'CHV homevisit', 'timeFrame': '22 months', 'description': 'CHW homevisit within 48 hours of birth based on questionnaire'}, {'measure': 'Exclusive breastfeeding', 'timeFrame': '22 months', 'description': 'Initiation of solids to the infant after 6 months based on questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related', 'Group, Peer']}, 'referencesModule': {'references': [{'pmid': '32398156', 'type': 'DERIVED', 'citation': 'Maldonado LY, Songok JJ, Snelgrove JW, Ochieng CB, Chelagat S, Ikemeri JE, Okwanyi MA, Cole DC, Ruhl LJ, Christoffersen-Deb A. Promoting positive maternal, newborn, and child health behaviors through a group-based health education and microfinance program: a prospective matched cohort study in western Kenya. BMC Pregnancy Childbirth. 2020 May 12;20(1):288. doi: 10.1186/s12884-020-02978-w.'}]}, 'descriptionModule': {'briefSummary': 'Preventing maternal and newborn deaths remain high on the global agenda. To address this, the Academic Model Providing Access to Healthcare (AMPATH), in partnership with the Government of Kenya, launched Chama cha MamaToto, a community-led peer-support model that groups women together in pregnancy and infancy. Central to the chama approach is the integration of health, social and financial literacy education with a savings/loans program.', 'detailedDescription': 'To evaluate the feasibility of chamas, we analysed group attendance rates, GISE participation, membership retention, and continuation of the groups beyond the one year. To evaluate the effect of chamas, the investigators compared data from a prospective cohort of women in chamas with a group of controls who did not belong to a chama, matched for age, parity, and location of prenatal care. To evaluate the acceptability of chamas, FGDs were carried out with chama and non-chama participants, health providers and community health workers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women in communities where chamas were taking place\n* Any woman attending chama\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03188250', 'briefTitle': 'Chama Cha MamaToto: a Pilot Study of Peer Support Groups in Kenya', 'organization': {'class': 'OTHER', 'fullName': 'Moi University'}, 'officialTitle': 'Increasing Pregnancy Health Services Uptake Through Integrated Peer Support Groups in Kenya: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'UMoi3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chama cha MamaToto', 'description': 'Pregnant women in communities where chama cha mamatoto is taking place will be invited to join and participate in bi-weekly group meetings for a year', 'interventionNames': ['Behavioral: Chama cha Mamtoto']}, {'type': 'NO_INTERVENTION', 'label': 'Referent', 'description': 'Pregnant women attending at least one prenatal visit in communities where chama cha mamatoto was implemented three months later served as the comparison'}], 'interventions': [{'name': 'Chama cha Mamtoto', 'type': 'BEHAVIORAL', 'description': 'Chama cha Mamatoto is a community-based model of peer support group in pregnancy and infancy that combines health education, relationship building and a savings and loans program, led by community health workers', 'armGroupLabels': ['Chama cha MamaToto']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Astrid Christoffersen-Deb, MDCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moi University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grand Challenges Canada', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Visiting Lecturer', 'investigatorFullName': 'Astrid Christoffersen-Deb', 'investigatorAffiliation': 'Moi University'}}}}