Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 7:58 PM
Study NCT ID:
NCT03069235
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2017-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D001942', 'term': 'Breast Feeding'}], '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'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2017-02-27', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exclusive breastfeeding', 'timeFrame': 'six months', 'description': 'proportion of women who report exclusive breastfeeding to six months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Breast Feeding'], 'conditions': ['HIV-infection/Aids', 'Breast Feeding']}, 'descriptionModule': {'briefSummary': 'This study evaluates strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among HIV infected women in a resource limited setting.', 'detailedDescription': 'This is a single center, operational research study with two components. A formative component and randomized intervention trial. The study aims are to inform, promote and evaluate strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among HIV infected women in a resource limited settings.\n\nThe primary objective of the qualitative formative research which includes Focus Group Discussions (FGD) and Key Informant Interviews (KII) is to explore factors affecting decisions on EBF and continued breastfeeding among HIV infected women.\n\nThe primary objective for the Intervention phase is to compare either of two intervention strategies against the standard arm using Ministry of Health (MOH) messages aimed at promoting EBF for 6 month.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-positive pregnant women in their late second or third trimester\n* On antiretroviral therapy (ARVs) for PMTCT or meets MOH guidelines for ARV therapy\n* Intention to breast feed\n* Willingness to deliver at Mulago Hospital\n* Living within Kampala and planning to stay within Kampala district for months after delivery\n* Willingness to participate during post partum period\n* Willingness to be home visited\n* Willingness and ability to bring a close family member of choice to the clinic, who is ≥ 18 years, who will be able to be in touch with the at least three times a week and to give support on EBF\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03069235', 'acronym': 'EBF', 'briefTitle': 'Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Operational Research to Promote Breastfeeding Among HIV Infected Women Attending the Prevention of Mother to Child Transmission (PMTCT) Program in Mulago Hospital, Kampala, Uganda', 'orgStudyIdInfo': {'id': 'NA_00050616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'group/individual counselling.', 'interventionNames': ['Behavioral: standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'Family member / peer support', 'description': 'Structured family member / peer support.', 'interventionNames': ['Behavioral: Family member / peer support']}, {'type': 'EXPERIMENTAL', 'label': 'Special infant feeding counselor support', 'description': 'Enhanced intervention with counselor support', 'interventionNames': ['Behavioral: Family member / peer support', 'Behavioral: Enhanced intervention with counselor support']}], 'interventions': [{'name': 'Family member / peer support', 'type': 'BEHAVIORAL', 'description': 'supplemental individualized counselling', 'armGroupLabels': ['Family member / peer support', 'Special infant feeding counselor support']}, {'name': 'Enhanced intervention with counselor support', 'type': 'BEHAVIORAL', 'description': '"hands on" EBF demonstrations', 'armGroupLabels': ['Special infant feeding counselor support']}, {'name': 'standard of care', 'type': 'BEHAVIORAL', 'description': 'one on one and in-group counselling', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joyce Matovu, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MU-JHU CARE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MU-JHU CARE', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}