N/A
N=10,579
Kharituwe TB Contact Tracing Study
Tuberculosis · Hiv
Bottom Line
View on ClinicalTrials.gov: NCT04520113 ↗Enrolled (actual)
10,579
Serious AEs
—
Results posted
Feb 2025
Primary outcome: Primary: Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm — 1.7; 1.2; 2.3; 2.4 mean secondary TB cases
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Household contact tracing (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm |
1.7; 1.2; 2.3; 2.4 | — |
| SECONDARY The TB Prevalence Ratio, Comparing Highly Mobile to Less Mobile Index Patients |
— | — |
| SECONDARY TB Strain Relatedness Using Maximum Likelihood Transmission Trees. |
— | — |
| SECONDARY Relative Acceptability of Each Novel Strategy Compared to Standard Contact Investigation |
— | — |
| SECONDARY Feasibility of Each Strategy: Proportion of Potentially Eligible Index Cases for Whom a Household Visit Was Conducted |
— | — |
| SECONDARY Relative Fidelity of Each Novel Strategy Compared to Standard Contact Investigation |
— | — |
| SECONDARY Sustainability of Each Novel Strategy Relative to Standard Contact Tracing |
— | — |
| SECONDARY Incremental Cost-effectiveness Ratio for Each Novel Strategy Relative to Standard Contact Tracing |
— | — |
Summary
The purpose of this study is to characterize the role of human mobility in fueling TB epidemics and estimate the potential impact of innovative case finding interventions tailored to mobile populations
Eligibility Criteria
TB index cases:
Inclusion criteria
- Age 0-99 years (Including those recently deceased)
- Diagnosed with pulmonary TB at a study hospital or clinic (microbiological and/or chest x-ray diagnosis)
Exclusion criteria
- Unwilling/unable to provide informed consent (including next of kin, for those recently deceased)
- Plan not to pursue TB treatment within the study district
- Unwilling/unable to comply with study procedures
Contacts:
Inclusion criteria
- Age 0-99 years
- Currently resides with or visiting eligible TB index case
Exclusion Criteria
- Unwilling/unable to provide informed consent
- Unwilling/unable to comply with study procedures
Data sourced from ClinicalTrials.gov (NCT04520113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.