Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-22 @ 4:30 PM
Study NCT ID:
NCT04033718
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2019-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inpatient Package to Reduce HIV and AIDS-related Death in Zambia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D003453', 'term': 'Cryptococcosis'}], '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': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D009181', 'term': 'Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2019-07-23', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coinfection diagnosis', 'timeFrame': 'Through hospital discharge, an average of 2 weeks', 'description': 'Positive test for tuberculosis or cryptococcus on admission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV/AIDS', 'Transitions of Care', 'Hospitalization', 'Tuberculosis', 'HIV Testing', 'Cryptococcosis']}, 'descriptionModule': {'briefSummary': 'Early post-discharge mortality is high among HIV-infected Zambians admitted to the hospital. Likely this is in part due to missed opportunities to identify lethal coinfections and optimize HIV care during admission (and before discharge). In this study the investigators will develop and pilot a new approach to inpatient HIV care that follows international guidelines for management of advanced HIV disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18+ years old\n* HIV-positive (by self-report or DCT result in UTH file)\n* Resident of Lusaka\n* Admitted to the hospital\n\nExclusion Criteria:\n\n* Too sick to provide informed consent (based on clinician opinion)\n* Likely to be discharged in the next 48 hours (based on clinician opinion)'}, 'identificationModule': {'nctId': 'NCT04033718', 'acronym': 'IPADZ', 'briefTitle': 'Inpatient Package to Reduce HIV and AIDS-related Death in Zambia', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Inpatient Package to Reduce HIV and AIDS-related Death in Zambia', 'orgStudyIdInfo': {'id': '300003461'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inpatient lab bundling plus navigation', 'description': 'Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach. Additional inpatient support from a patient navigator', 'interventionNames': ['Diagnostic Test: Inpatient lab bundling', 'Behavioral: Inpatient navigation']}, {'type': 'EXPERIMENTAL', 'label': 'Inpatient lab bundling alone', 'description': 'Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach.', 'interventionNames': ['Diagnostic Test: Inpatient lab bundling']}], 'interventions': [{'name': 'Inpatient lab bundling', 'type': 'DIAGNOSTIC_TEST', 'description': 'The investigators will provide patients a package of diagnostic tests at the time of admission to comprehensively assess for HIV coinfections and treatment failure. These labs are all recommended in advanced HIV guidelines but in this study we will provide all tests as a bundle rather than step-by-step as suggested in guidelines.', 'armGroupLabels': ['Inpatient lab bundling alone', 'Inpatient lab bundling plus navigation']}, {'name': 'Inpatient navigation', 'type': 'BEHAVIORAL', 'description': 'Participants will be assigned a patient navigator who will support the patient and bedsider (treatment supporter/guardian) during the hospitalization. The navigator will be an HIV counselor who can provide counseling and health education, as well as support specimen transport, obtaining results, booking tests in other departments, linkages to ART clinic, and discharge planning', 'armGroupLabels': ['Inpatient lab bundling plus navigation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'country': 'Zambia', 'facility': 'University Teaching Hospital', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Michael J Vinikoor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Teaching Hospital', 'class': 'UNKNOWN'}, {'name': 'University of Maryland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Vinikoor', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}