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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Johns Hopkins University
Sponsor:
Collaborators:
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
Jonathan E Golub, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02119130
First received: April 10, 2014
Last updated: July 22, 2014
Last verified: June 2014
  Purpose

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 Intervention
Latent Tuberculosis
HIV
Device: QGIT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantiferon Gold Test for Detecting TB Infection in HIV/AIDS Patients in South Africa

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost effectiveness of implementing QGIT versus TST-only [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Knowledge, attitudes and practices of clinic personnel, along with consensus regarding key factors linked to successful screening

  • 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 ] [ Designated as safety issue: No ]
    Patients' understandings and experiences with TB screening approaches, along with consensus regarding key factors linked to successful screening

  • Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of clinic personnel [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Knowledge, attitudes and practices of clinic personnel, along with consensus regarding key factors linked to successful screening

  • Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patients' understandings and experiences with TB screening approaches, along with consensus regarding key factors linked to successful screening

  • Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of clinic personnel [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Knowledge, attitudes and practices of clinic personnel, along with consensus regarding key factors linked to successful screening

  • Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Patients' understandings and experiences with TB screening approaches, along with consensus regarding key factors linked to successful screening

  • Cost effectiveness of implementing QGIT versus TST-only [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 3000
Study Start Date: July 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119130

Contacts
Contact: Sandy Chon, MHS 410-955-2886 schon2@jhmi.edu

Locations
South Africa
Tshepong Wellness Clinic Not yet recruiting
Klerksdorp, North West, South Africa
Contact: Neil Martinson, MBBCh    +27 (11) 989-9836      
Principal Investigator: Neil Martinson, MBBCh         
Bothabelo CHC Not yet recruiting
Klerksdorp, North West, South Africa
Jouberton Not yet recruiting
Klerksdorp, North West, South Africa
Stilfontein Not yet recruiting
Klerksdorp, North West, South Africa
Orkney Not yet recruiting
Klerksdorp, North West, South Africa
Majara Sephapho Not yet recruiting
Klerksdorp, North West, South Africa
Marcus Zenzile Not yet recruiting
Klerksdorp, North West, South Africa
Tsholofelo Not yet recruiting
Klerksdorp, North West, South Africa
NM Pretorious Gateway Not yet recruiting
Klerksdorp, North West, South Africa
Grace Mokhomo Not yet recruiting
Klerksdorp, North West, South Africa
Park Street Not yet recruiting
Klerksdorp, North West, South Africa
Steve Tshwete Not yet recruiting
Potchefstroom, North West, South Africa
Boiki Tihapi Not yet recruiting
Potchefstroom, North West, South Africa
Potchefstroom Gateway Not yet recruiting
Potchefstroom, North West, South Africa
Potchefstroom Not yet recruiting
Potchefstroom, North West, South Africa
Sponsors and Collaborators
Johns Hopkins University
University of Witwatersrand, South Africa
Investigators
Principal Investigator: Jonathan E Golub, PhD The Johns Hopkins University School of Medicine
  More Information

No publications provided

Responsible Party: Jonathan E Golub, Associate Professor, Medicine, Epidemiology and International Health, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02119130     History of Changes
Other Study ID Numbers: 3358597, R01AI095041
Study First Received: April 10, 2014
Last Updated: July 22, 2014
Health Authority: South Africa: Human Research Ethics Committee
South Africa: National Health Research Ethics Council
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014