Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06654505
Status:
RECRUITING
Last Update Posted:
2024-10-28
First Post:
2024-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Village Health Volunteers/Workers Working As Male-Female Pairs Improve the Use of Postnatal Care Services in the Lao People's Democratic Republic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 302}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-10-15', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of second postnatal care visit', 'timeFrame': '6 weeks after delivery', 'description': 'Second postnatal visit within 6 weeks after delivery in a health facility reported in maternal and child health handbook'}], 'secondaryOutcomes': [{'measure': 'Lenght of facility-based postpartum stay', 'timeFrame': 'cutoff is 12 hours', 'description': 'Number of hours of stay in health facility after delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnant Women', 'Lactating Mother']}, 'descriptionModule': {'briefSummary': "The study aims to assess the effectiveness of male-female VHV/Ws working in pairs on women's uptake of second PNC visits in rural Sepone, Lao PDR.\n\nMethods A quasi-experimental cluster study will be conducted between July 2024 and October 2026 in 37 selected sites from two districts in southern Lao PDR. In 19 selected intervention villages in the Sepone district, female-male VHV/Ws pairs will promote postpartum services, whereas, in 18 similar control villages in the Vilabuly district, VHV/Ws will work as individuals."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Only women who delivered a baby within a define period', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women who gave birth within six weeks and twelve months before the study's baseline and end-line surveys.\n\nExclusion Criteria:\n\n* Women whose births resulted in a loss,\n* Women who do consent to participate in the surveys\n* Women who face a language barrier with surveyors will not be enrolled."}, 'identificationModule': {'nctId': 'NCT06654505', 'briefTitle': "Can Village Health Volunteers/Workers Working As Male-Female Pairs Improve the Use of Postnatal Care Services in the Lao People's Democratic Republic", 'organization': {'class': 'OTHER', 'fullName': 'University of the Ryukyus'}, 'officialTitle': "Effectiveness of Village Health Volunteers/Workers Working As Male-Female Pairs on Women's Use of Postnatal Care Services in Sepone District in Lao People's Democratic Republic: a Protocol for a Quasi-experimental Cluster Study", 'orgStudyIdInfo': {'id': '24-2329-00-00-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Villages where Village Health Volunteers/Workers work as individuals'}, {'type': 'EXPERIMENTAL', 'label': 'Villages where Community Health Workers work in pairs', 'interventionNames': ['Behavioral: Paired Community Health Workers']}], 'interventions': [{'name': 'Paired Community Health Workers', 'type': 'BEHAVIORAL', 'description': 'Community Health Workers will promote maternal and child health services as paired female and male', 'armGroupLabels': ['Villages where Community Health Workers work in pairs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Savannakhet', 'status': 'RECRUITING', 'country': 'Laos', 'contacts': [{'name': 'Tiengkham PONGVONGSA', 'role': 'CONTACT', 'email': 'tiengkhampvs@gmail.com', 'phone': '+8562055640403'}], 'facility': 'Sepon and Vilabouly districts', 'geoPoint': {'lat': 16.5703, 'lon': 104.7622}}], 'centralContacts': [{'name': 'Credo Ahissou, PhD', 'role': 'CONTACT', 'email': 'Adelphahiss@gmail.com', 'phone': '+818064827518'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Ryukyus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research fellow and Assistant Investigator', 'investigatorFullName': 'Credo Adelphe Ahissou', 'investigatorAffiliation': 'University of the Ryukyus'}}}}