Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-28 @ 4:11 AM
Study NCT ID:
NCT07119359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating HIV Prevention With TB Household Contact Evaluation in Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'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': 'D007239', 'term': 'Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Household randomized implementation study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2480}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP uptake', 'timeFrame': 'From enrollment to the one-month follow-up visit', 'description': 'Uptake of PrEP among eligible household members, measured as the proportion initiating PrEP by 1 month and found to have detectable tenofovir use at the one-month visit'}], 'secondaryOutcomes': [{'measure': 'PrEP continuation', 'timeFrame': 'From enrollment to six-month follow-up visit', 'description': 'Proportion of participants initiating PrEP with detectable tenofovir in urine samples at three- and six-month visits'}, {'measure': 'HIV testing coverage', 'timeFrame': 'From enrollment to six-month follow-up visit', 'description': 'Proportion of participants known to be living with HIV or have tested HIV-negative among all participants'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uganda', 'TB contact tracing', 'HIV', 'Tuberculosis', 'PrEP', 'Household'], 'conditions': ['Tuberculosis (TB)', 'Human Immunodeficiency Virus (HIV) Prophylaxis']}, 'descriptionModule': {'briefSummary': 'This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care (modified SOC) household TB contact investigation in Uganda. It uses qualitative methods to evaluate the process of implementing the intervention and a health economic evaluation to assess the financial sustainability of this strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person with pulmonary TB OR live in a household with someone with pulmonary TB being treated at one of the participating health facilities\n* Household includes ≥2 persons\n* Age 15 years and older\n* Willingness to participate in study procedures\n\nExclusion Criteria:\n\n* Lives in a congregate setting (e.g., dormitory or jail)\n* Lives outside the study area\n* Any other condition that, in the opinion of the Investigator/designee, could preclude informed consent, make study participation unsafe, or otherwise interfere with achieving study objectives'}, 'identificationModule': {'nctId': 'NCT07119359', 'acronym': 'TB PrEP', 'briefTitle': 'Integrating HIV Prevention With TB Household Contact Evaluation in Uganda', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Integrating HIV Prevention With TB Household Contact Evaluation in Uganda (TB PrEP)', 'orgStudyIdInfo': {'id': 'STUDY00020907'}, 'secondaryIdInfos': [{'id': 'R01MH134685', 'link': 'https://reporter.nih.gov/quickSearch/R01MH134685', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home-based HIV self-testing and PrEP initiation', 'description': 'Home-based HIV self-testing and PrEP initiation (for eligible participants) integrated into routine TB household contact investigation', 'interventionNames': ['Other: Home-based HIV self-testing', 'Other: Home-based initiation of PrEP']}, {'type': 'NO_INTERVENTION', 'label': 'Modified standard of care', 'description': 'Referral to health facility for HIV testing and PrEP initiation'}], 'interventions': [{'name': 'Home-based HIV self-testing', 'type': 'OTHER', 'description': 'Integration of HIV self-testing into TB household contact investigation', 'armGroupLabels': ['Home-based HIV self-testing and PrEP initiation']}, {'name': 'Home-based initiation of PrEP', 'type': 'OTHER', 'description': 'Integration of PrEP initation into TB household contact investigation', 'armGroupLabels': ['Home-based HIV self-testing and PrEP initiation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'country': 'Uganda', 'facility': 'Infectious Diseases Institute', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'centralContacts': [{'name': 'Jennifer M Ross, MD, MPH', 'role': 'CONTACT', 'email': 'jross3@uw.edu', 'phone': '206 543-9192'}], 'overallOfficials': [{'name': 'Jennifer M Ross, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Select IPD will be available through the NIMH data archive', 'accessCriteria': 'Data will be shared through the NIMH Data Archive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Infectious Diseases Institute, Uganda', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Medicine, Division of Allergy and Infectious Diseases', 'investigatorFullName': 'Jennifer Ross', 'investigatorAffiliation': 'University of Washington'}}}}