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Completed

NCT Number: NCT02119130

Quantiferon Gold Test for Detecting Tuberculosis (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.

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Key information

Conditions

Latent Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections HIV Infections Latent Infection Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bothabelo CHC, Klerksdorp, North West, South Africa

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

QGIT

Device

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.

Primary outcomes

  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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary outcomes

  1. Cost effectiveness of implementing QGIT versus TST-only

    Time frame: 1 year

    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.

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

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

    Time frame: 1 year

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

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

    Time frame: 1 year

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

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

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  8. Cost effectiveness of implementing QGIT versus TST-only

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of Witwatersrand, South Africa

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Apr 21, 2014
Registry last updated
Oct 3, 2019

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.

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