Test and Treat TB: A Proof of Concept Trial in South Africa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4815 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-11-30

Brief Summary

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The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of a "Test \& Treat TB" strategy on a mobile HIV screening unit in South Africa and (2) to assess the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for maximizing linkage to TB care and treatment completion.

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Detailed Description

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Conditions

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Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual Care

Patients in the usual care arm will be screened for tuberculosis (TB) on a mobile unit and referred for treatment according to the current standard of care in South Africa

Group Type NO_INTERVENTION

No interventions assigned to this group

Test-and-Treat Intervention

Patients in the intervention arm will partake in a Test-and-Treat TB strategy involving mobile GeneXpert MTB/RIF testing, facilitated TB treatment initiation, SMS reminders for clinic visits, and cashless incentives.

Group Type ACTIVE_COMPARATOR

Test-and-Treat TB

Intervention Type OTHER

Interventions

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Test-and-Treat TB

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* English or Zulu speaking
* presenting for screening at mobile unit
* voluntarily undergoing HIV testing
* able and willing to give informed consent
* willing to share HIV and TB test results
* willing to attend one of six local clinics for treatment
* access to a mobile phone