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Latent TuberculosisNCT02119130

Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa

A study testing QGIT in people with Latent Tuberculosis and HIV, run by Johns Hopkins University at 14 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 use a cluster randomized trial to compare the effectiveness of linking the Quantiferon-gold in-tube test (QGIT) with routine CD4 testing to the routine use of the tuberculin skin test (TST), the current standard of care for diagnosing latent tuberculosis infection (LTBI) in South… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Latent Tuberculosis, HIV
What is being tested?
QGIT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,506 participants
Where
14 sitesSouth Africa
Study dates
1 Nov 2014to May 2019
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-infected
  • >= 18 years of age
  • attending one of the 14 clinics during the duration of the study
  • eligible to receive TST or IPT according to South Africa guidelines

Who cannot join

  • diagnosed with active tuberculosis
  • not eligible to receive TST or IPT according to South Africa guidelines

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

South Africa14 sites

  • Bothabelo CHC

    Klerksdorp, North West

  • Grace Mokhomo

    Klerksdorp, North West

  • Jouberton

    Klerksdorp, North West

  • Marcus Zenzile

    Klerksdorp, North West

  • NM Pretorious Gateway

    Klerksdorp, North West

  • Orkney

    Klerksdorp, North West

  • Park Street

    Klerksdorp, North West

  • Stilfontein

    Klerksdorp, North West

  • Tshepong Wellness Clinic

    Klerksdorp, North West

  • Tsholofelo

    Klerksdorp, North West

  • Boiki Tihapi

    Potchefstroom, North West

  • Potchefstroom Gateway

    Potchefstroom, North West

  • Potchefstroom

    Potchefstroom, North West

  • Steve Tshwete

    Potchefstroom, North West

Other trials in South Africa

About this study

Official title: Quantiferon Gold Test for Detecting TB Infection in HIV/AIDS Patients in South Africa

The purpose of this study is to use a cluster randomized trial to compare the effectiveness of linking the Quantiferon-gold in-tube test (QGIT) with routine CD4 testing to the routine use of the tuberculin skin test (TST), the current standard of care for diagnosing latent tuberculosis infection (LTBI) in South Africa. The investigators hypothesize that QGIT clinics will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher proportion of patients and in a significantly faster timeframe. The cost-effectiveness of linking QGIT with routine CD4 compared to routine TST will also be evaluated, and the process of implementation of QGIT into the routine cluster of differentiation 4 (CD4) blood draw will be evaluated using a mixed method approach to identify steps that can be modified for future scale-up of the intervention.

Read the detailed description

The investigators propose a cluster randomized trial in 16 HIV clinics in South Africa to compare time to determine LTBI status in patients in clinics using QGIT and TST and those with TST only. The investigators will take advantage of the excellent HIV services provided in South Africa and link QGIT with CD4 blood collection and provide the first evidence of an operational comparison between QGIT and TST in HIV-infected patients in a country that accounts for one-third of the HIV-related TB in the world. The QGIT study will contribute to the understanding of QGIT performance and implementation in HIV-infected individuals. Careful evaluation of the implementation and operational aspects of the program will provide useful knowledge for future scale-up in this and other HIV clinic settings.

Being tested
QGIT
Keywords
cluster randomized trial, interferon-gamma, tuberculin test, operational comparison, cost effectiveness, qualitative evaluation
Medical subject headings
Latent Tuberculosis

What participants receive

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

  • QGITDevice

    Seven pairs of clinics will be included in this study. One clinic in each pair will be selected by a computerized randomization program to be the standard of care arm (TST only) and the other will be in the QGIT arm.

Study groups in NCT02119130
Study groupRoleWhat they receive
TST onlyNo interventionTuberculin skin test for all eligible patients, to be placed and read by clinic staff. Thereafter, for 2 years, annual TST provided for patients with TST negative/unknown history. IPT to be provided to patients with a positive TST for whom active TB has been ruled out.
QGITExperimentalQGIT for all eligible patients, to be done at routine CD4 blood draw. Thereafter, for 2 years, annual QGIT at CD4 blood draw for patients with QGIT negative/unknown history. IPT to be provided to patients with a positive QGIT for whom active TB has been ruled out.
Receives: Device: QGIT

What is being measured

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

  1. Impact of linking QGIT with CD4 blood collection and the current standard of care process of TST in HIV clinics in South Africa on operational metrics

    Measured: Participants will be followed for the duration of the study, an expected average of 2 years

  2. Time to known latent TB infection status in clinics integrating QGIT with CD4 blood draw versus clinics with current standard of care (TST only)

    Measured: Participants will be followed for the duration of the study, an expected average of 2 years

  3. Time to provision of IPT for eligible patients in QGIT versus TST-only clinics

    Measured: Participants will be followed for the duration of the study, an expected average of 2 years

  4. Proportion of patients with known LTBI status in QGIT and TST-only clinics

    Measured: Participants will be followed for the duration of the study, an expected average of 2 years

  5. Proportion of eligible patients receiving IPT between QGIT and TST-only clinics

    Measured: Participants will be followed for the duration of the study, an expected average of 2 years

  6. Proportion of eligible patients receiving a second TST or QGIT following an initial negative test

    Measured: Participants will be followed for the duration of the study, an expected average of 2 years

  7. Patient-, provider-, and clinic-level factors that impact outcomes within and between arms

    Measured: Participants will be followed for the duration of the study, an expected average of 2 years

Secondary outcomes (8)

  1. Cost effectiveness of implementing QGIT versus TST-only

    Costs and effectiveness (quality-adjusted life years) of LTBI screening and treatment with QGIT versus TST standard of care. Looking at the impact on the HIV-associated TB epidemic in South Africa under each strategy and scenarios under which QGIT is cost-effective relative to TST, and vice versa.

    Measured: 1 year

  2. Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of key clinic personnel

    Knowledge, attitudes and practices of clinic personnel, along with consensus regarding key factors linked to successful screening

    Measured: up to 6 months

  3. Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients

    Patients' understandings and experiences with TB screening approaches, along with consensus regarding key factors linked to successful screening

    Measured: up to 6 months

  4. Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of clinic personnel

    Knowledge, attitudes and practices of clinic personnel, along with consensus regarding key factors linked to successful screening

    Measured: 1 year

  5. Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients

    Patients' understandings and experiences with TB screening approaches, along with consensus regarding key factors linked to successful screening

    Measured: 1 year

  6. Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of clinic personnel

    Knowledge, attitudes and practices of clinic personnel, along with consensus regarding key factors linked to successful screening

    Measured: 2 years

  7. Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients

    Patients' understandings and experiences with TB screening approaches, along with consensus regarding key factors linked to successful screening

    Measured: 2 years

  8. Cost effectiveness of implementing QGIT versus TST-only

    Costs and effectiveness (quality-adjusted life years) of LTBI screening and treatment with QGIT versus TST standard of care. Looking at the impact on the HIV-associated TB epidemic in South Africa under each strategy and scenarios under which QGIT is cost-effective relative to TST, and vice versa.

    Measured: 2 years

Timeline

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

  1. First posted21 Apr 2014 (estimated)
  2. Study start1 Nov 2014
  3. Primary completionJun 2018
  4. Study completionMay 2019

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
None (open label)
Enrolment
3,506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02119130
Sponsor's protocol ID
NA_00085133
Other IDs
R01AI095041
Status last verified
Oct 2019
First submitted
10 Apr 2014
Last updated
3 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • Jarrett BA, Shearer K, Motlhaoleng K, Chon S, Letuba GG, Qomfo C, Moulton LH, Cohn S, Lebina L, Chaisson RE, Variava E, Martinson NA, Golub JE. Comparison of QuantiFERON Gold In-Tube Versus Tuberculin Skin Tests on the Initiation of Tuberculosis Preventive Therapy Among Patients Newly Diagnosed With HIV in the North West Province of South Africa (the Teko Study): A Cluster Randomized Trial. Clin Infect Dis. 2024 Sep 26;79(3):751-760. doi: 10.1093/cid/ciae268.

    PubMed 39036871

  • Kerrigan D, Tudor C, Motlhaoleng K, Lebina L, Qomfu C, Variava E, Chon S, Martinson N, Golub JE. Relevance and acceptability of using the Quantiferon gold test (QGIT) to screen CD4 blood draws for latent TB infection among PLHIV in South Africa: formative qualitative research findings from the TEKO trial. BMC Health Serv Res. 2018 Apr 16;18(1):288. doi: 10.1186/s12913-018-3088-8.

    PubMed 29661197

Questions about this trial

What is this clinical trial studying?

A study testing QGIT in people with Latent Tuberculosis and HIV, run by Johns Hopkins University at 14 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 2 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 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Impact of linking QGIT with CD4 blood collection and the current standard of care process of TST in HIV clinics in South Africa on operational metrics (time frame: Participants will be followed for the duration of the study, an expected average of 2 years). The study lists 7 primary outcomes in all. 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 NCT02119130, which also lists 2 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 3 Oct 2019.

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