Clinical Trials Directory

Trials / Completed

CompletedNCT04520113

Kharituwe TB Contact Tracing Study

Innovative Contact Tracing Strategies for Detecting TB in Mobile Rural and Urban South African Populations

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10,579 (actual)
Sponsor
Johns Hopkins Bloomberg School of Public Health · Academic / Other
Sex
All
Age
99 Years
Healthy volunteers
Accepted

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

Detailed description

The investigators propose a randomized trial of two novel TB case-finding interventions among household members of patients diagnosed with active TB: holiday-based screening in a rural South African province (Limpopo) and off-peak (weekend/evening) screening in an urban settlement into which many residents of Limpopo migrate for work. The investigators will enroll index cases of TB plus their household contacts in each setting and randomize them to novel versus standard contact investigation. In Specific Aim 1, investigators will use whole genome sequencing of all cases, overlaying transmission trees with data on human movement, to evaluate associations between mobility and TB transmission in this population. In Specific Aim 2, investigators will employ a multidisciplinary approach to compare novel versus standard contact investigation in each setting along the following dimensions: (a) effectiveness (number of secondary TB cases diagnosed and starting treatment); (b) implementation (reach, fidelity, and maintenance of contact investigation outside of business hours); (c) cost-effectiveness (cost per disability-adjusted life year) and budget impact; and (d) projected population-level impact on TB incidence. Successful completion of these aims will have long-term impact by characterizing the role of mobility in fueling TB epidemics and testing two tailored approaches to improve TB control in highly mobile populations - an underserved group that is increasingly recognized as playing a major role in global TB transmission.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHousehold contact tracingHousehold contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.

Timeline

Start date
2020-09-01
Primary completion
2023-08-30
Completion
2025-03-31
First posted
2020-08-20
Last updated
2025-04-08
Results posted
2025-02-10

Locations

2 sites across 1 country: South Africa

Source: ClinicalTrials.gov record NCT04520113. Inclusion in this directory is not an endorsement.