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

Mass General Brigham

Status: Completed

Conditions: Tuberculosis

Treatments: Other: Test-and-Treat TB

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02298309

R21AI110264 (U.S. NIH Grant/Contract)

2014P001173/MGH

Details and patient eligibility

About

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.

Enrollment: 4,815 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• pregnant

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,815 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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

Test-and-Treat Intervention

Active Comparator group

Description:

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.

Treatment:

Other: Test-and-Treat TB