Actively Recruiting

Phase Not Applicable
Age: 5Years +
All Genders
Healthy Volunteers
NCT05285202

Clinic-based Versus Hotspot-focused Active TB Case Finding

Led by Johns Hopkins University · Updated on 2026-03-05

150000

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Clinic-based Versus Hotspot-focused Active TB Case Finding

Who Can Participate

Age: 5Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 15 years or older, OR age 5-14 years and a close contact of someone diagnosed with TB
  • Provide oral informed consent, or, if under 18 and not legally emancipated, provide oral informed assent (ages 8-17) plus parental informed consent (ages 5-17)
  • Ability to communicate with study staff in English or Luganda, or have an acceptable interpreter available
Not Eligible

You will not qualify if you...

  • Currently on treatment for active TB
  • Diagnosed with active TB but not yet treated

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Walimu

Kampala, Uganda

Actively Recruiting

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Research Team

E

Emily A Kendall, MD PhD

CONTACT

D

David W Dowdy, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SCREENING

Number of Arms

3

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