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

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ClinicalTrials.gov Identifier: NCT02119130
Recruitment Status : Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : December 26, 2017
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Latent Tuberculosis HIV Device: QGIT Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantiferon Gold Test for Detecting TB Infection in HIV/AIDS Patients in South Africa
Actual Study Start Date : November 1, 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: TST only
Tuberculin 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.
Experimental: QGIT
QGIT 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.
Device: QGIT
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119130


Locations
South Africa
Bothabelo CHC
Klerksdorp, North West, South Africa
Grace Mokhomo
Klerksdorp, North West, South Africa
Jouberton
Klerksdorp, North West, South Africa
Marcus Zenzile
Klerksdorp, North West, South Africa
NM Pretorious Gateway
Klerksdorp, North West, South Africa
Orkney
Klerksdorp, North West, South Africa
Park Street
Klerksdorp, North West, South Africa
Stilfontein
Klerksdorp, North West, South Africa
Tshepong Wellness Clinic
Klerksdorp, North West, South Africa
Tsholofelo
Klerksdorp, North West, South Africa
Boiki Tihapi
Potchefstroom, North West, South Africa
Potchefstroom Gateway
Potchefstroom, North West, South Africa
Potchefstroom
Potchefstroom, North West, South Africa
Steve Tshwete
Potchefstroom, North West, South Africa
Sponsors and Collaborators
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
University of Witwatersrand, South Africa
Investigators
Principal Investigator: Jonathan E Golub, PhD Johns Hopkins University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02119130     History of Changes
Other Study ID Numbers: NA_00085133
R01AI095041 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Keywords provided by Johns Hopkins University:
cluster randomized trial
interferon-gamma
tuberculin test
operational comparison
cost effectiveness
qualitative evaluation

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections