AzTrials
AzTrials

TuberculosisNCT04520113

Kharituwe TB Contact Tracing Study

A study testing Household contact tracing in people with Tuberculosis and Hiv, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages Up to 99 yearsHealthy volunteers can take part
Conditions the study is for
Tuberculosis, Hiv
What is being tested?
Household contact tracing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,579 participants
Where
2 sitesSouth Africa
Study dates
1 Sep 2020to 31 Mar 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)
  • Age 0-99 years
  • Currently resides with or visiting eligible TB index case

Who cannot join

  • 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:
  • Unwilling/unable to provide informed consent
  • Unwilling/unable to comply with study procedures

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

  • Perinatal HIV Research Unit (PHRU)

    Johannesburg

  • Setshaba Research Centre

    Soshanguve

Other trials in South Africa

About this study

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

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

Read the 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
Tuberculosis, Hiv
Being tested
Household contact tracing
Medical subject headings
Tuberculosis, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Household contact tracingBehavioural

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

Study groups in NCT04520113
Study groupRoleWhat they receive
Standard TracingActive comparatorHouseholds of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.
Receives: Behavioral: Household contact tracing
Holiday TracingExperimentalHouseholds of tuberculosis index patients in rural South Africa receive household contact tracing during holidays (Christmas and Easter).
Receives: Behavioral: Household contact tracing
Evening / Weekend TracingExperimentalHouseholds of tuberculosis index patients in urban South Africa receive household contact tracing during evenings and weekends.
Receives: Behavioral: Household contact tracing

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to 35 months

Secondary outcomes (7)

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

    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).

    Measured: Duration of study (30 months)

  2. TB Strain Relatedness Using Maximum Likelihood Transmission Trees.

    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.

    Measured: Duration of study (30 months)

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

    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.

    Measured: Duration of study (30 months)

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

    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).

    Measured: Duration of study (30 months(

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

    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.

    Measured: Duration of study (30 months)

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

    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.

    Measured: Duration of study (30 months)

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

    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.

    Measured: Duration of study (30 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start1 Sep 2020
  3. Primary completion30 Aug 2023
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
10,579 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04520113
Sponsor's protocol ID
R01AI147681
Other IDs
IRB00011124
Status last verified
Apr 2025
First submitted
7 Aug 2020
Last updated
8 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mlambo LM, Milovanovic M, Hanrahan CF, Motsomi K, Morolo MT, Mohlamonyane MM, Albaugh NW, Ahmed K, Martinson N, Dowdy DW, West NS. The impact of ethical implications intertwined with tuberculosis household contact investigation: A qualitative study. PLoS One. 2026 Mar 30;21(3):e0306848. doi: 10.1371/journal.pone.0306848. eCollection 2026.

    PubMed 41911256

  • Hanrahan CF, Nonyane BAS, Biche P, Mohlamonyane M, Morolo M, Omar SV, Ahmed K, Martinson N, Dowdy DW. Timing of household contact investigation for tuberculosis among rural and urban populations in South Africa (Kharituwe study): a pragmatic individually randomized controlled trial. EClinicalMedicine. 2026 Jan 16;91:103744. doi: 10.1016/j.eclinm.2025.103744. eCollection 2026 Jan.

    PubMed 41607590

  • Young N, Biche P, Mohlamonyane M, Morolo M, Maholwana B, Ahmed K, Martinson N, Hanrahan CF, Dowdy DW. Innovative timing strategies for tuberculosis household contact investigation: cost-effectiveness analysis from a randomized trial in rural and urban South Africa (Kharituwe Study). EClinicalMedicine. 2025 May 26;84:103259. doi: 10.1016/j.eclinm.2025.103259. eCollection 2025 Jun.

    PubMed 40503514

  • Mlambo LM, Milovanovic M, Hanrahan CF, Motsomi KW, Morolo MT, Mohlamonyane MP, Albaugh NW, Ahmed K, Martinson NA, Dowdy DW, West NS. The impact of ethical implications intertwined with tuberculosis household contact investigation: a qualitative study. medRxiv [Preprint]. 2024 Jun 28:2024.06.27.24309538. doi: 10.1101/2024.06.27.24309538.

    PubMed 38978659

Questions about this trial

What is this clinical trial studying?

A study testing Household contact tracing in people with Tuberculosis and Hiv, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm (time frame: Up to 35 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04520113, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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