Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-31 @ 8:25 PM
Study NCT ID:
NCT01226433
Status:
COMPLETED
Last Update Posted:
2013-03-29
First Post:
2010-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Planning Through Dairy Cooperatives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-28', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-21', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Services Research', 'timeFrame': '1 year', 'description': 'Unmet need for family planning among women attending Field Days aged 18-49'}], 'secondaryOutcomes': [{'measure': 'Health Services Research', 'timeFrame': '1 year', 'description': 'Interest in receiving health services through Field Day model'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AE adverse event', 'AIDS acquired immunodeficiency syndrome', 'ALT (SGPT) alanine aminotransferase', 'ART antiretroviral therapy', 'AST (SGOT) aspartate aminotransferase', 'DCF data collection forms', 'DMC Data Monitoring Committee', 'FDA (U.S.) Food and Drug Administration', 'GCP Good Clinical Practice guidelines', 'HB sAg Hepatitis B surface antigen', 'ICH International Conference of Harmonisation', 'IND Investigational New Drug Application', 'IRB Institutional Review Board', 'IU International units', 'mg milligram(s)', 'mm3 cubic millimeter(s)', 'PCR polymerase chain reaction', 'SAE serious adverse event', 'µg microgram', 'ULN upper limit of the normal range', 'WB Western Blot'], 'conditions': ['The Study Goal is to Assess the Introduction of Sustainable Family Planning/Reproductive Health Information and Services Through', "Land O' Lakes-supported Dairy Cooperatives"]}, 'descriptionModule': {'briefSummary': "This observational study will assess a model for providing family planning through quarterly events organized by dairy cooperatives supported by Land O'Lakes in Kenya.", 'detailedDescription': "Access to family planning and other reproductive health services remains difficult in much of rural Kenya. One option for improving rural access to family planning is to use existing community events outside of the health sector as platforms for delivering information and services. This study will assess a model for providing family planning through quarterly events organized by dairy cooperatives supported by Land O'Lakes in Kenya. During these events, known as Field Days, a healthcare provider will have a tent in which Field Day attendees can receive basic family health services free of charge. The services offered will be: family planning counseling and methods, immunizations, antenatal care, screening and treatment for sexually transmitted infections, and HIV counseling and testing. Since the services are no different than those that could be obtained at Ministry of Health or some private facilities, the service provision is not considered to be part of the research.\n\nWomen receiving any service from the health care provider will be recruited for an interview that will measure their demand for family planning and attitudes about receiving services during the field day. In addition, the study will track the number of different types of services provided, the total number of Field Day attendees, and the cost of the service model. The study will be carried out at five Field Days in Rift Valley and Central provinces.\n\nParticipants will not be tested for STI/HIV as part of this research; however, at their request, they may have received a test from the provider prior to the research interview. At the time of consent, they will have already received the test, so the consent form will not include anything specific to testing. In Kenya, all STI/HIV test results are reported to the national public health authorities. These reports are not used for contacting patients but for planning purposes."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females aged 18-49', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:females aged 18-49 receiving health services at a field day event -\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01226433', 'briefTitle': 'Family Planning Through Dairy Cooperatives', 'organization': {'class': 'OTHER', 'fullName': 'FHI 360'}, 'officialTitle': 'Providing Family Planning Services Sustainably Through Dairy Cooperatives in Kenya', 'orgStudyIdInfo': {'id': '10227'}}, 'contactsLocationsModule': {'locations': [{'city': 'Various', 'state': 'Rift Valley & Central', 'country': 'Kenya', 'facility': '5 Community Outreach Events'}], 'overallOfficials': [{'name': 'John Bratt, MPP, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FHI 360'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FHI 360', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}