Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05285202
Study type Interventional
Source Johns Hopkins University
Contact Emily A Kendall, MD PhD
Phone 410-502-8234
Email ekendall@jhmi.edu
Status Recruiting
Phase N/A
Start date June 1, 2022
Completion date January 31, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT06084715 - The INSTITUT Study
Terminated NCT03028129 - Prevention of Tuberculosis in Prisons Phase 4
Not yet recruiting NCT06253715 - Shortened Regimen for Drug-susceptible TB in Children Phase 3
Withdrawn NCT03862248 - Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More Phase 3
Completed NCT03271567 - Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
Completed NCT03199313 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid Phase 1
Active, not recruiting NCT04919239 - Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB) Phase 2
Active, not recruiting NCT03251196 - TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
Recruiting NCT05926466 - BTZ-043 Dose Evaluation in Combination and Selection Phase 2
Recruiting NCT04752592 - Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB N/A
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Not yet recruiting NCT04968886 - TuBerculosis Viability Interregional Study and Agreement on Biological Tests
Not yet recruiting NCT04485156 - Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3) Phase 3
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Completed NCT01364324 - Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
Active, not recruiting NCT04179500 - A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers Phase 2
Completed NCT05899400 - A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
Completed NCT04938596 - Airborne Preventive Measures to Reduce New TB Infections in Household Contacts N/A
Recruiting NCT05455112 - Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis Phase 2
Completed NCT03044158 - GeneXpert Performance Evaluation for Linkage to Tuberculosis Care N/A