Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-25 @ 3:19 AM
Study NCT ID:
NCT02619305
Status:
UNKNOWN
Last Update Posted:
2015-12-02
First Post:
2015-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Network Outcomes of 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': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-06', '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': '2017-06', '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': 'HIV Stigma Scale', 'timeFrame': '12 months', 'description': 'Agreement (yes/no) with 15 statements about persons living with HIV (range, 0-15), to be assessed among social network ties of HIV-positive study participants'}, {'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': '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']}, 'descriptionModule': {'briefSummary': 'The objective of our study is to determine whether a livelihood intervention can change economic and psychosocial outcomes of social network ties and geographically proximate neighbors of impoverished women in rural Uganda.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligibility will be limited to all adults living in Nyakabare Parish (i.e., aged 18 years and older), including emancipated minors. Emancipated minors will be defined as persons living below 18 years of age who are married, are pregnant, live with a biological child in the household, or are responsible for their own livelihood.\n\nExclusion Criteria:\n\n* Persons under the age of 18 (other than emancipated minors as described above) and persons who do not live within Nyakabare Parish will not be permitted to participate.'}, 'identificationModule': {'nctId': 'NCT02619305', 'briefTitle': 'Social Network Outcomes of a Livelihood Intervention for Impoverished Women in Rural Uganda', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Social Network Outcomes of a Livelihood Intervention for Impoverished Women in Rural Uganda: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MH096620-S5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate treatment', 'description': 'Participants will be social network ties of women receiving 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: Social network tie']}, {'type': 'NO_INTERVENTION', 'label': 'Delayed treatment', 'description': 'Participants will be social network ties of women receiving no intervention but who will be placed on a waitlist to receive the intervention after a 12-month delay.'}], 'interventions': [{'name': 'Social network tie', 'type': 'OTHER', 'description': 'Participants will be social network ties of women receiving 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 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'}, {'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'}}}}