NCT04520113

Kharituwe TB Contact Tracing Study

Completed NA Results posted Last updated 8 April 2025

What this trial tests

NA trial testing Household contact tracing in Tuberculosis in 10,579 participants. Completed in 31 March 2025.

Timeline

1 September 2020

Primary endpoint
30 August 2023

31 March 2025

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	10,579
Start date	1 September 2020
Primary completion	30 August 2023
Estimated completion	31 March 2025
Sites	2 locations across South Africa

Drugs / interventions tested

• Household contact tracing

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →
• Hiv — all drugs for Hiv →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

Under 99, any sex, with Tuberculosis or Hiv. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm Primary · Up to 35 months

The mean number of secondary TB cases identified and started on treatment per index case for each arm.

Group	Value	95% CI
Standard Tracing- Limpopo	1.7	0.9 – 2.5
Holiday Tracing	1.2	0.5 – 1.9
Evening / Weekend Tracing	2.3	1.0 – 3.2
Standard Tracing- Soshanguve	2.4	1.8 – 3.0

Sponsor's own description

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

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perceived stigma among people with TB and household contacts.
   Machavariani E, Nonyane BAS, Lebina L, Mmolawa L, et al · · 2023 · cited 12× · PMID 37608483 · DOI 10.5588/ijtld.22.0670
2. The impact of ethical implications intertwined with tuberculosis household contact investigation: A qualitative study.
   Mlambo LM, Milovanovic M, Hanrahan CF, Motsomi K, et al · · 2026 · PMID 41911256 · DOI 10.1371/journal.pone.0306848
3. Timing of household contact investigation for tuberculosis among rural and urban populations in South Africa (Kharituwe study): a pragmatic individually randomized controlled trial.
   Hanrahan CF, Nonyane BAS, Biche P, Mohlamonyane M, et al · · 2026 · PMID 41607590 · DOI 10.1016/j.eclinm.2025.103744
4. Non-Communicable Disease and Depressive Symptoms Among Participants of the Kharituwe Case Finding Trial
   Yeboah ED, Martinson N, Hanrahan C, Dowdy DW, et al · · 2026 · DOI 10.21203/rs.3.rs-8329023/v1
5. Innovative timing strategies for tuberculosis household contact investigation: cost-effectiveness analysis from a randomized trial in rural and urban South Africa (Kharituwe Study).
   Young N, Biché P, Mohlamonyane M, Morolo M, et al · · 2025 · PMID 40503514 · DOI 10.1016/j.eclinm.2025.103259
6. The impact of ethical implications intertwined with tuberculosis household contact investigation: a qualitative study
   Mlambo L, Milovanovic M, Hanrahan C, Motsomi K, et al · · 2024 · DOI 10.1101/2024.06.27.24309538