Clinic-based Versus Hotspot-focused Active TB Case Finding

Recruiting now · Not applicable

Conditions studied: Tuberculosis, Pulmonary, Mycobacterium Tuberculosis Infection

In brief

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.

Key facts

Study ID: NCT05285202
Run by: Johns Hopkins University
People needed: 150000
Starts: 2022-06-01
Expected to finish: 2026-11-01
Last updated by the study team: 2026-06-01

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

On treatment for, or diagnosed with but not yet treated for, active TB

Where it is running

Walimu — Kampala, Uganda (enrolling)

Full record on ClinicalTrials.gov

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