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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,506

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach

1 country

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.5 years study duration

First Submitted

Initial submission to the registry

April 10, 2014

Completed

11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed

6 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed

Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

3.6 years

First QC Date

April 10, 2014

Last Update Submit

October 2, 2019

Conditions

Latent Tuberculosis HIV

Keywords

cluster randomized trialinterferon-gammatuberculin testoperational comparisoncost effectivenessqualitative evaluation

Outcome Measures

Primary Outcomes (7)

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
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
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 Outcomes (8)

Cost effectiveness of implementing QGIT versus TST-only
1 year
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
up to 6 months
Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of clinic personnel
1 year
Attitudinal and operational factors influencing the successful implementation of QGIT versus TST diagnostic practices from the perspective of patients
1 year
+3 more secondary outcomes

Study Arms (2)

TST only

NO INTERVENTION

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

EXPERIMENTAL

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.

Device: QGIT

Interventions

QGITDEVICE

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.

QGIT

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

diagnosed with active tuberculosis
not eligible to receive TST or IPT according to South Africa guidelines

Contact the study team to confirm eligibility.