Clinic-based Versus Hotspot-focused Active TB Case Finding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥15 years, OR age 5-14 and a close contact of someone diagnosed with TB,
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
Ability to communicate with study staff in English or Luganda, or availability of a capable interpreter who is acceptable to the participant
Disqualifiers
On treatment for, or diagnosed with but not yet treated for, active TB
Trial design
Design model
Crossover
Treatments tested in this trial
Active TB case finding with linkage to preventive therapy (ACF/TPT)
Other interventionACF/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).
Treatment groups
150,000 Participants
are divided into 3 treatment groupsGroup A: Hotspot-focused ACF/TPTExperimental treatment 1 intervention
Group B: Facility-based ACF/TPTExperimental treatment 1 intervention
Group C: No interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pulmonary 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 periodSecondary outcomes
1
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 period2
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 clusters3
TB notification trend (intervention vs control)
Trend in TB notification rate over the span of study intervention involvement, comparing intervention clusters to control clusters
Time frame
Approximately 38 to 46 months per cluster (5 to 6 four-month intervention periods, plus intervening washout periods)4
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 periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Walimu
Collaborator
Source ClinicalTrials.gov