CHASE-TB: Clinic-based Versus Hotspot-focused Active TB Case Finding
Study Details
Study Description
Brief Summary
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.
The 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hotspot-focused ACF/TPT ACF/TPT intervention will be delivered in a community setting, in geographic areas judged likely to have a high burden of undiagnosed TB |
Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)
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 for eligible for TPT (interested after counseling and either positive tuberculin skin test or known HIV infection).
|
| Experimental: Facility-based ACF/TPT ACF/TPT intervention will be delivered on the grounds of a health facility (hospital or large public health center) |
Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)
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 for eligible for TPT (interested after counseling and either positive tuberculin skin test or known HIV infection).
|
| No Intervention: No intervention
|
Outcome Measures
Primary Outcome Measures
- Pulmonary bacteriologically confirmed TB notifications, hotspot vs facility [From the start to two weeks after the end of each four-month intervention period]
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.
Secondary Outcome Measures
- TPT initiations, hotspot vs facility [From the start to two weeks after the end of each four-month intervention period]
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.
- Pulmonary bacteriologically confirmed TB notifications, ACF/TPT vs control [48 months from start of interventions in each "triplet" of clusters]
Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing intervention regions to control regions.
- Notification trend (intervention vs control) as assessed by Average percent change in number of TB notifications [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]
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.
- Study-initiated TB notifications, hotspot vs facility [From the start to two weeks after the end of each four-month intervention period]
Number of people diagnosed with TB through study participation and initiating treatment for TB, hotspot-focused and facility-based ACF/TPT.
- Number screened by study [During four-month intervention periods (6 periods per cluster over 48 months)]
Total number of people screened for TB with each intervention.
- Number diagnosed by study [During four-month intervention periods (6 periods per cluster over 48 months)]
Number of study participants found to have Xpert-positive sputum.
- Cost effectiveness (hotspot vs facility) as assessed by cost per disability-adjusted life year averted [From the start to two weeks after the end of each four-month intervention period]
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).
- Cost effectiveness (ACF/TPT vs no intervention) as assessed by cost per disability-adjusted life year averted [From the start to two weeks after the end of each four-month intervention period]
Incremental cost per disability-adjusted life year (DALY) averted, comparing ACF/TPT to no ACF/TPT.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥15 years
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Provision of oral informed consent, or, if age <18 years and not legally emancipated, oral informed assent and parental informed consent to participate in the study
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Ability to communicate with study staff in English or Luganda, or availability of a capable interpreter who is acceptable to the participant
Exclusion Criteria:
- On treatment for, or diagnosed with but not yet treated for, active TB
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Walimu | Kampala | Uganda |
Sponsors and Collaborators
- Johns Hopkins University
- National Heart, Lung, and Blood Institute (NHLBI)
- Walimu
Investigators
- Principal Investigator: Emily Kendall, MD PhD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00300939
- 2R01HL138728