Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa
- Conditions
- Latent TuberculosisHIV
- Interventions
- Device: QGIT
- Registration Number
- NCT02119130
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3506
- 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
- diagnosed with active tuberculosis
- not eligible to receive TST or IPT according to South Africa guidelines
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QGIT 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.
- Primary Outcome Measures
Name Time Method 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 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 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 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 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 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 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 Outcome Measures
Name Time Method Cost effectiveness of implementing QGIT versus TST-only 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.
Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of key clinic personnel up to 6 months 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 2 years 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 2 years Knowledge, attitudes and practices of clinic personnel, along with consensus regarding key factors linked to successful screening
Trial Locations
- Locations (14)
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
Stilfontein
🇿🇦Klerksdorp, North West, South Africa
Orkney
🇿🇦Klerksdorp, North West, South Africa
Park Street
🇿🇦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
Steve Tshwete
🇿🇦Potchefstroom, North West, South Africa
Potchefstroom Gateway
🇿🇦Potchefstroom, North West, South Africa
Potchefstroom
🇿🇦Potchefstroom, North West, South Africa