Clinic-based Versus Hotspot-focused Active TB Case Finding (CHASE-TB)

Johns Hopkins University

Status: Enrolling

Conditions: Mycobacterium Tuberculosis Infection; Tuberculosis, Pulmonary

Treatments: Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05285202

2R01HL138728 (U.S. NIH Grant/Contract)

IRB00300939

Details and patient eligibility

About

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.

Enrollment: 150,000 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150,000 participants in 3 patient groups

Hotspot-focused ACF/TPT

Experimental group

Description:

ACF/TPT intervention will be delivered in a community setting, in geographic areas judged likely to have a high burden of undiagnosed TB

Treatment:

Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)

Facility-based ACF/TPT

Experimental group

Description:

ACF/TPT intervention will be delivered on the grounds of a health facility (hospital or large public health center)

Treatment:

Other: Active TB case finding with linkage to preventive therapy (ACF/TPT)

No intervention

No Intervention group