Tuberculosis, Pulmonary Clinical Trial
Official title:
Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF/TPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover 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.
n/a
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Withdrawn |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 |