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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119130
• Other study ID #: NA_00085133
• Secondary ID: R01AI095041
• Status: Completed
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: May 2019

Study information

• Verified date: October 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3506
• Est. completion date: May 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Latent Tuberculosis
• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
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	Potchefstroom	North West
South Africa	Potchefstroom Gateway	Potchefstroom	North West
South Africa	Steve Tshwete	Potchefstroom	North West

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Allergy and Infectious Diseases (NIAID), University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Participants will be followed for the duration of the study, an expected average of 2 years
Primary	Time to known latent TB infection status in clinics integrating QGIT with CD4 blood draw versus clinics with current standard of care (TST only)		Participants will be followed for the duration of the study, an expected average of 2 years
Primary	Time to provision of IPT for eligible patients in QGIT versus TST-only clinics		Participants will be followed for the duration of the study, an expected average of 2 years
Primary	Proportion of patients with known LTBI status in QGIT and TST-only clinics		Participants will be followed for the duration of the study, an expected average of 2 years
Primary	Proportion of eligible patients receiving IPT between QGIT and TST-only clinics		Participants will be followed for the duration of the study, an expected average of 2 years
Primary	Proportion of eligible patients receiving a second TST or QGIT following an initial negative test		Participants will be followed for the duration of the study, an expected average of 2 years
Primary	Patient-, provider-, and clinic-level factors that impact outcomes within and between arms		Participants will be followed for the duration of the study, an expected average of 2 years
Secondary	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.	1 year
Secondary	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	up to 6 months
Secondary	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	up to 6 months
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	2 years
Secondary	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	2 years
Secondary	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.	2 years