Clinical trial NCT02119130: Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa
Official title: Quantiferon Gold Test for Detecting TB Infection in HIV/AIDS Patients in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Latent Tuberculosis
HIV
Keywords: cluster randomized trial
interferon-gamma
tuberculin test
operational comparison
cost effectiveness
qualitative evaluation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of Witwatersrand, South Africa
First posted: 2014-04-21
Enrollment: 3506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
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
timeFrame: Participants will be followed for the duration of the study, an expected average of 2 years
measure: Time to known latent TB infection status in clinics integrating QGIT with CD4 blood draw versus clinics with current standard of care (TST only)
timeFrame: Participants will be followed for the duration of the study, an expected average of 2 years
measure: Time to provision of IPT for eligible patients in QGIT versus TST-only clinics
timeFrame: Participants will be followed for the duration of the study, an expected average of 2 years
measure: Proportion of patients with known LTBI status in QGIT and TST-only clinics
timeFrame: Participants will be followed for the duration of the study, an expected average of 2 years
measure: Proportion of eligible patients receiving IPT between QGIT and TST-only clinics
timeFrame: Participants will be followed for the duration of the study, an expected average of 2 years
measure: Proportion of eligible patients receiving a second TST or QGIT following an initial negative test
timeFrame: Participants will be followed for the duration of the study, an expected average of 2 years
measure: Patient-, provider-, and clinic-level factors that impact outcomes within and between arms
timeFrame: Participants will be followed for the duration of the study, an expected average of 2 years
Secondary outcomes:
measure: Cost effectiveness of implementing QGIT versus TST-only
timeFrame: 1 year
measure: Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of key clinic personnel
timeFrame: up to 6 months
measure: Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients
timeFrame: up to 6 months
measure: Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of clinic personnel
timeFrame: 1 year
measure: Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients
timeFrame: 1 year
measure: Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of clinic personnel
timeFrame: 2 years
measure: Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients
timeFrame: 2 years
measure: Cost effectiveness of implementing QGIT versus TST-only
timeFrame: 2 years
Other outcomes:
Locations:
city: Klerksdorp
country: South Africa
facility: Bothabelo CHC
state: North West
city: Klerksdorp
country: South Africa
facility: Grace Mokhomo
state: North West
city: Klerksdorp
country: South Africa
facility: Jouberton
state: North West
city: Klerksdorp
country: South Africa
facility: Marcus Zenzile
state: North West
city: Klerksdorp
country: South Africa
facility: NM Pretorious Gateway
state: North West
city: Klerksdorp
country: South Africa
facility: Orkney
state: North West
city: Klerksdorp
country: South Africa
facility: Park Street
state: North West
city: Klerksdorp
country: South Africa
facility: Stilfontein
state: North West
city: Klerksdorp
country: South Africa
facility: Tshepong Wellness Clinic
state: North West
city: Klerksdorp
country: South Africa
facility: Tsholofelo
state: North West
city: Potchefstroom
country: South Africa
facility: Boiki Tihapi
state: North West
city: Potchefstroom
country: South Africa
facility: Potchefstroom Gateway
state: North West
city: Potchefstroom
country: South Africa
facility: Potchefstroom
state: North West
city: Potchefstroom
country: South Africa
facility: Steve Tshwete
state: North West
Study officials:
affiliation: Johns Hopkins University
name: Jonathan E Golub, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.