Clinic-based Versus Hotspot-focused Active TB Case Finding

Last updated: February 27, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Lung Disease

Treatment

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

Clinical Study ID

NCT05285202
IRB00300939
2R01HL138728
  • Ages > 5
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

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 legallyemancipated, 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 acapable interpreter who is acceptable to the participant

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 150000
Treatment Group(s): 1
Primary Treatment: Active TB case finding with linkage to preventive therapy (ACF/TPT)
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Walimu

    Kampala,
    Uganda

    Active - Recruiting

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