Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-12 @ 11:38 AM
Study NCT ID:
NCT02619227
Status:
UNKNOWN
Last Update Posted:
2015-12-02
First Post:
2015-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Livelihood Intervention for Impoverished Women in Rural Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2015-08-15', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Household Food Insecurity Access Scale', 'timeFrame': '12 months', 'description': 'Scale items range from 0 (never) to 3 (more than 10 days in the past month)'}, {'measure': 'Hopkins Symptom Checklist Scale', 'timeFrame': '12 months', 'description': 'Scale items range from 1 (not at all) to 4 (very much)'}], 'secondaryOutcomes': [{'measure': 'Intimate Partner Violence Scale', 'timeFrame': '12 months', 'description': 'Experience (yes/no) of 12 different forms of emotional, sexual, or physical victimization by an intimate partner (range 0-12)'}, {'measure': 'Norms about Intimate Partner Violence Scale', 'timeFrame': '12 months', 'description': 'Agreement (yes/no) with 5 different statements about the acceptability of intimate partner violence under 5 different scenarios (range, 0-5)'}, {'measure': 'Self-Reported Health Scale', 'timeFrame': '12 months', 'description': 'Scale item ranges from 1 (very bad) to 4 (very good)'}, {'measure': 'Decision Making Power Scale', 'timeFrame': '12 months', 'description': 'Primary decision making (yes/no) on household expenditures in 7 different categories: food, livestock, health care, transport, social, educational, other household (range, 0-7)'}, {'measure': 'Social Integration Scale', 'timeFrame': '12 months', 'description': "Frequency of participation in 11 different community groups: vocational, positive living, local council, water, village health, agricultural extension, savings, religious, women's, gardening (range, 0-11)"}, {'measure': 'Social Capital Scale', 'timeFrame': '12 months', 'description': 'Agreement (yes/no) with 4 questions about social trust and social cohesion (range, 0-4)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Indigency']}, 'referencesModule': {'references': [{'pmid': '32525954', 'type': 'DERIVED', 'citation': 'Weil AA, Debela MD, Muyanja DM, Kakuhikire B, Baguma C, Bangsberg DR, Tsai AC, Lai PS. Gut carriage of antimicrobial resistance genes in women exposed to small-scale poultry farms in rural Uganda: A feasibility study. PLoS One. 2020 Jun 11;15(6):e0229699. doi: 10.1371/journal.pone.0229699. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine whether a livelihood intervention can improve economic and psychosocial wellbeing in rural Uganda.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-60 years (or emancipated minors aged 16-17 years) who live with at least one child under the age of 5 in the same household\n* Women aged 18-60 years (or emancipated minors aged 16-17 years) who agree to participate in the livelihood intervention training program\n* Women aged 18-60 years (or emancipated minors aged 16-17 years) who agree to participate in study data collection\n\nExclusion Criteria:\n\n* Men\n* Women who do not live in Nyakabare Parish\n* Women under 18 years of age (if not emancipated minors) or older than 60 years of age\n* Women who do not live with at least one child under the age of 5 in the same household\n* Women who decline to participate in the livelihood intervention training program\n* Women who decline to participate in study data collection\n* Women who live in the same household as another study participant'}, 'identificationModule': {'nctId': 'NCT02619227', 'briefTitle': 'A Livelihood Intervention for Impoverished Women in Rural Uganda', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Livelihood Intervention for Impoverished Women in Rural Uganda: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MH096620-S3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate treatment', 'description': 'Participants will receive a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises', 'interventionNames': ['Other: Livelihood intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Delayed treatment', 'description': 'Participants will receive no intervention but will be placed on a waitlist to receive the intervention after a 12-month delay.'}], 'interventions': [{'name': 'Livelihood intervention', 'type': 'OTHER', 'description': 'Participants will receive a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises.', 'armGroupLabels': ['Immediate treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mbarara', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Alexander Tsai, MD, PhD', 'role': 'CONTACT', 'email': 'actsai@partners.org', 'phone': '617-724-1120'}, {'name': 'Bernard Kakuhikire, MBA', 'role': 'CONTACT', 'email': 'baitwakaku@gmail.com', 'phone': '256-075-250-4030'}, {'name': 'Alexander C Tsai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bernard Kakuhikire, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mbarara University of Science and Technology', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'centralContacts': [{'name': 'Alexander C Tsai, MD, PhD', 'role': 'CONTACT', 'email': 'actsai@partners.org', 'phone': '617-724-1120'}, {'name': 'Bernard Kakuhikire, MBA', 'role': 'CONTACT', 'email': 'baitwakaku@gmail.com', 'phone': '256-075-250-4030'}], 'overallOfficials': [{'name': 'Alexander C Tsai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Bernard Kakuhikire, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mbarara University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mbarara University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry', 'investigatorFullName': 'Alexander Tsai', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}