Quantiferon Gold Test for Detecting TB Infection in HIV/AIDS Patients in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,506
- 试验地点
- 14
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •diagnosed with active tuberculosis
- •not eligible to receive TST or IPT according to South Africa guidelines
研究组 & 干预措施
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.
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.
干预措施: QGIT (Device)
结局指标
主要结局
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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Participants will be followed for the duration of the study, an expected average of 2 years
Proportion of eligible patients receiving a second TST or QGIT following an initial negative test
时间窗: 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
时间窗: Participants will be followed for the duration of the study, an expected average of 2 years
次要结局
- Cost effectiveness of implementing QGIT versus TST-only(2 years)
- 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)
- Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients(2 years)
- Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of clinic personnel(2 years)