Skip to main content
OpenTrials
Completed

NCT Number: NCT04520113

Kharituwe TB Contact Tracing Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perinatal HIV Research Unit (PHRU), Johannesburg, South Africa

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Household contact tracing

Behavioral

Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.

Primary outcomes

  1. Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm

    Time frame: Up to 35 months

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

Secondary outcomes

  1. The TB Prevalence Ratio, Comparing Highly Mobile to Less Mobile Index Patients

    Time frame: Duration of study (30 months)

    The TB prevalence ratio, comparing highly mobile to less mobile individuals, measuring mobility on two scales (neighborhood/intra-urban and regional/intra-national). For the analysis: amount of time spent in transit, truncating long excursions at 50km (one hour).

  2. TB Strain Relatedness Using Maximum Likelihood Transmission Trees.

    Time frame: Duration of study (30 months)

    TB natural history, epidemiological, and whole genome sequencing (WGS)-derived phylogenetic data will be integrated into a statistical modeling framework to draw probabilistic conclusions about the likelihood of transmission between persons. "Transmitters" will be defined as individuals from whom at least one secondary case most likely originated.

  3. Relative Acceptability of Each Novel Strategy Compared to Standard Contact Investigation

    Time frame: Duration of study (30 months)

    Relative acceptability of each novel strategy, compared against routine contact investigation. Acceptability of the intervention will be measured among index cases and contacts using a short questionnaire given to a randomly selected participant at a randomly selected 15% of the households visited. The interview will cover acceptability of the visit timing, notification, visit activities (TB screening, HIV testing) and study team interaction among others.

  4. Feasibility of Each Strategy: Proportion of Potentially Eligible Index Cases for Whom a Household Visit Was Conducted

    Time frame: Duration of study (30 months(

    Feasibility of each strategy as the proportion of potentially eligible index cases for whom a household visit was conducted. All reasons why visits were unable to be conducted will be recorded (e.g. could not find household, no one ever home, visit not conducted during expected off-peak period).

  5. Relative Fidelity of Each Novel Strategy Compared to Standard Contact Investigation

    Time frame: Duration of study (30 months)

    Relative fidelity of each novel strategy using a process checklist for each index case and household, including whether the household visit was offered and accepted, whether the visit was attempted, whether the visit was successful (i.e., enrolled at least one contact), whether symptom screening and sputum collection were completed and whether newly identified TB cases were notified and referred for treatment.

  6. Sustainability of Each Novel Strategy Relative to Standard Contact Tracing

    Time frame: Duration of study (30 months)

    Sustainability of each novel strategy by reporting the primary outcome and fidelity measures according to six-month time period over the course of the study.

  7. Incremental Cost-effectiveness Ratio for Each Novel Strategy Relative to Standard Contact Tracing

    Time frame: Duration of study (30 months)

    Defined as (cost of contact tracing strategy 2 - cost of strategy 1)/(effectiveness of strategy 2 - effectiveness of strategy 1), where effectiveness is modeled as the number of disability-adjusted life years (DALYs) averted by the intervention. The primary cost-effectiveness measures will be the incremental cost per DALY averted using novel strategies (holiday and off-hours contact tracing) compared to routine contact tracing in each setting separately.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Perinatal HIV Research Unit of the University of the Witswatersrand
  • Setshaba Research Centre
  • The National Institute for Communicable Diseases

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Aug 20, 2020
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.