NCT05285202Completed
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 146539 (actual)
- First submitted
- 9 Mar 2022
- Start date
- 1 Jun 2022
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- Johns Hopkins University
- Diseases
- Tuberculosis
- NCT number
- NCT05285202
What you commit to
- Study type: Interventional
- Participants enrolled: 146539
- From 1 Jun 2022 to the primary completion date, 30 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- On treatment for, or diagnosed with but not yet treated for, active TB
Who the study is looking for
- 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
Age in the registry: 5 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Walimu Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.