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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
150,000
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).
Walimu
Kampala, Uganda
RECRUITINGPulmonary bacteriologically confirmed TB notifications, hotspot vs facility
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.
Time frame: From the start to two weeks after the end of each four-month intervention period
TPT initiations, hotspot vs facility
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.
Time frame: From the start to two weeks after the end of each four-month intervention period
Pulmonary bacteriologically confirmed TB notifications, ACF/TPT vs control
Number of study region residents notified as initiating treatment for bacteriologically confirmed new or relapsed pulmonary TB, comparing intervention regions to control regions.
Time frame: 48 months from start of interventions in each "triplet" of clusters
Notification trend (intervention vs control) as assessed by Average percent change in number of TB notifications
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.
Time frame: 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
Study-initiated TB notifications, hotspot vs facility
Number of people diagnosed with TB through study participation and initiating treatment for TB, hotspot-focused and facility-based ACF/TPT.
Time frame: From the start to two weeks after the end of each four-month intervention period
Number screened by study
Total number of people screened for TB with each intervention.
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Number diagnosed by study
Number of study participants found to have Xpert-positive sputum.
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Cost effectiveness (hotspot vs facility) as assessed by cost per disability-adjusted life year averted
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).
Time frame: From the start to two weeks after the end of each four-month intervention period
Cost effectiveness (ACF/TPT vs no intervention) as assessed by cost per disability-adjusted life year averted
Incremental cost per disability-adjusted life year (DALY) averted, comparing ACF/TPT to no ACF/TPT.
Time frame: From the start to two weeks after the end of each four-month intervention period
Number evaluated for latent tuberculosis infection (LTBI) with tuberculin skin testing (TST)
Total number of people completing TST placement and reading by the study
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Number referred for TPT
Number of participants referred for TB preventive therapy based on TST result or other eligibility criteria
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
Contacts screened
Number of people screened for TB who are identified as contacts of a person diagnosed with TB through the study
Time frame: During four-month intervention periods (6 periods per cluster over 48 months)
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