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RECRUITINGINTERVENTIONAL

Clinic-based Versus Hotspot-focused Active TB Case Finding

Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥15 years, OR age 5-14 and a close contact of someone diagnosed with TB, - Provision of oral willing to sign a consent form, or, if age \<18 years and not legally emancipated, oral informed assent (if ages 8-17) and parental willing to sign a consent form (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 Who Should NOT Join This Trial: - On treatment for, or diagnosed with but not yet treated for, active TB Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

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

ACF/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).

Locations (1)

Walimu
Kampala, Uganda