Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT05285202
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2022-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinic-based Versus Hotspot-focused Active TB Case Finding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D014376', 'term': 'Tuberculosis'}], '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': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Twelve clusters or study regions (of which eight will be randomized to receive interventions) will be defined according to the catchment areas of twelve participating Ugandan district hospitals/major health centers. Eight study areas will receive a total of six 4-month intervention periods (alternating between the facility-based and the hotspot focused strategy, for three periods of each type) over a four-year period, with a 4-month wash-out period after each intervention period. Four additional areas will be used as control sites; the only involvement of participants in these sites will be through retrospective collection of de-identified data.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary bacteriologically confirmed TB notifications, hotspot vs facility', 'timeFrame': 'From the start to two weeks after the end of each four-month intervention period', 'description': 'Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing periods in which regions performed hotspot-focused ACF/TPT to those in which facility-based ACF/TPT was performed.'}], 'secondaryOutcomes': [{'measure': 'TPT initiations, hotspot vs facility', 'timeFrame': 'From the start to two weeks after the end of each four-month intervention period', 'description': 'Number of study region residents initiating TPT during intervention periods, comparing periods in which regions performed hotspot-focused ACF/TPT to those in which facility-based ACF/TPT was performed.'}, {'measure': 'Pulmonary bacteriologically confirmed TB notifications, ACF/TPT vs control', 'timeFrame': '48 months from start of interventions in each "triplet" of clusters', 'description': 'Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing intervention regions to control regions.'}, {'measure': 'Notification trend (intervention vs control) as assessed by Average percent change in number of TB notifications', 'timeFrame': 'First 16 months following start of interventions in a cluster "triplet", versus final 16 months of the interventions (including 4 months of washout after the final intervention) in each triplet', 'description': 'Average percent change in number of TB notifications, from the first 16 months of intervention to the final 16 months of intervention, comparing intervention clusters to control clusters.'}, {'measure': 'Study-initiated TB notifications, hotspot vs facility', 'timeFrame': 'From the start to two weeks after the end of each four-month intervention period', 'description': 'Number of people diagnosed with TB through study participation and initiating treatment for TB, hotspot-focused and facility-based ACF/TPT.'}, {'measure': 'Number screened by study', 'timeFrame': 'During four-month intervention periods (6 periods per cluster over 48 months)', 'description': 'Total number of people screened for TB with each intervention.'}, {'measure': 'Number diagnosed by study', 'timeFrame': 'During four-month intervention periods (6 periods per cluster over 48 months)', 'description': 'Number of study participants found to have Xpert-positive sputum.'}, {'measure': 'Cost effectiveness (hotspot vs facility) as assessed by cost per disability-adjusted life year averted', 'timeFrame': 'From the start to two weeks after the end of each four-month intervention period', 'description': 'Incremental cost per disability-adjusted life year (DALY) averted, comparing the more to the less effective ACF/TPT intervention (if an effectiveness difference is found).'}, {'measure': 'Cost effectiveness (ACF/TPT vs no intervention) as assessed by cost per disability-adjusted life year averted', 'timeFrame': 'From the start to two weeks after the end of each four-month intervention period', 'description': 'Incremental cost per disability-adjusted life year (DALY) averted, comparing ACF/TPT to no ACF/TPT.'}, {'measure': 'Number evaluated for latent tuberculosis infection (LTBI) with tuberculin skin testing (TST)', 'timeFrame': 'During four-month intervention periods (6 periods per cluster over 48 months)', 'description': 'Total number of people completing TST placement and reading by the study'}, {'measure': 'Number referred for TPT', 'timeFrame': 'During four-month intervention periods (6 periods per cluster over 48 months)', 'description': 'Number of participants referred for TB preventive therapy based on TST result or other eligibility criteria'}, {'measure': 'Contacts screened', 'timeFrame': 'During four-month intervention periods (6 periods per cluster over 48 months)', 'description': 'Number of people screened for TB who are identified as contacts of a person diagnosed with TB through the study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis, Pulmonary', 'Mycobacterium Tuberculosis Infection']}, 'descriptionModule': {'briefSummary': 'This five-year study will evaluate two strategies for conducting tuberculosis (TB) active case finding (ACF) and linkage to TB treatment or TB preventive therapy (TPT) in peri-urban Uganda. The two strategies differ in the location where ACF activities are performed: A "facility-based" ACF/TPT strategy will perform ACF, plus linkage to TPT, in the immediate vicinity of a large public health facility and will primarily recruit individuals who are attending the health facility, irrespective of TB suspicion or symptoms. Alternatively, a "hotspot-based" strategy will use routine notification data and local expertise to identify local TB hotspots - defined as the geographic areas though to have the highest burden of undiagnosed TB per estimated population. The same infrastructure (personnel, equipment, supplies, etc.) for ACF/TPT will then be placed in those zones for a period of four months at a time, and the general population will be recruited for screening and linkage to TPT.\n\nThe two interventions will be compared in a Type 1 hybrid effectiveness-implementation trial with a cluster-randomized, multiple-period crossover design. The study will evaluate whether hotspot-focused ACF/TPT results in a greater number of TB patients diagnosed and linked to care, and a greater number of individuals started on preventive therapy, than facility-based ACF/TPT. Secondarily, it will also compare the two interventions in terms of number of people initiated on TPT, and it will compare TB cases detected in regions performing ACF/TPT (either approach) against cases detected in regions that continue to perform the standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥15 years, OR age 5-14 and a close contact of someone diagnosed with TB,\n* Provision of oral informed consent, or, if age \\<18 years and not legally emancipated, oral informed assent (if ages 8-17) and parental informed consent (ages 5-17) to participate in the study\n* Ability to communicate with study staff in English or Luganda, or availability of a capable interpreter who is acceptable to the participant\n\nExclusion Criteria:\n\n* On treatment for, or diagnosed with but not yet treated for, active TB'}, 'identificationModule': {'nctId': 'NCT05285202', 'acronym': 'CHASE-TB', 'briefTitle': 'Clinic-based Versus Hotspot-focused Active TB Case Finding', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial', 'orgStudyIdInfo': {'id': 'IRB00300939'}, 'secondaryIdInfos': [{'id': '2R01HL138728', 'link': 'https://reporter.nih.gov/quickSearch/2R01HL138728', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hotspot-focused ACF/TPT', 'description': 'ACF/TPT intervention will be delivered in a community setting, in geographic areas judged likely to have a high burden of undiagnosed TB', 'interventionNames': ['Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)']}, {'type': 'EXPERIMENTAL', 'label': 'Facility-based ACF/TPT', 'description': 'ACF/TPT intervention will be delivered on the grounds of a health facility (hospital or large public health center)', 'interventionNames': ['Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention'}], 'interventions': [{'name': 'Active TB case finding with linkage to preventive therapy (ACF/TPT)', 'type': 'OTHER', 'description': 'ACF/TPT in both intervention arms will consist of TB screening by mobile chest X-ray (with artificial intelligence-based reading, followed by confirmatory sputum testing with Xpert MTB/RIF Ultra for participants with abnormal x-rays), and linkage to preventive therapy for those who are TB-negative and eligible for TPT (limited in April 2024 to those with close TB contact or known HIV infection).', 'armGroupLabels': ['Facility-based ACF/TPT', 'Hotspot-focused ACF/TPT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Achilles Katamba', 'role': 'CONTACT', 'email': 'amkatamba@gmail.com', 'phone': '256-414-530-021,'}, {'name': 'Achilles Katamba, MBChB PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Walimu', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'centralContacts': [{'name': 'Emily A Kendall, MD PhD', 'role': 'CONTACT', 'email': 'ekendall@jhmi.edu', 'phone': '410-502-8234'}, {'name': 'David W Dowdy, MD PhD', 'role': 'CONTACT', 'email': 'ddowdy1@jhmi.edu'}], 'overallOfficials': [{'name': 'Emily Kendall, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data that underlie results in publications will be deposited into a publicly available data repository at the time of publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Walimu', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}