HIV, Latent Tuberculosis
Conditions
Keywords
cluster randomized trial, interferon-gamma, tuberculin test, operational comparison, cost effectiveness, qualitative evaluation
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.
Interventions
DEVICEQGIT
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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of Witwatersrand, South Africa
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 6 months | 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 | 1 year | Knowledge, attitudes and practices of clinic personnel, along with consensus regarding key factors linked to successful screening |
| Cost effectiveness of implementing QGIT versus TST-only | 1 year | 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. |
Countries
South Africa
Outcome results
None listed