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

Study Overview
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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.

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

Conditions
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Tuberculosis

Intervention / Treatment
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* Other: Test-and-Treat TB


Participation Criteria
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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 Exclusion Criteria: pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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 | |
| Active Comparator: Test-and-Treat Intervention<br>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. | Other: Test-and-Treat TB<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who complete tuberculosis treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of mobile testers screened for tuberculosis |  | 20 months | 
| Proportion of eligible participants able to produce sputum samples |  | 20 months | 
| Prevalence of TB among those tested |  | 20 months | 
| Prevalence of tuberculosis and rifampin resistance | The GeneXpert test can detect rifampin resistant strains of tuberculosis | 20 months | 
| Distribution of TB symptoms ascertained from TB symptom screen questionnaire |  | 20 months | 
| Proportion returning to the mobile tester for TB test result |  | 20 months | 
| Linkage to TB care (first visit to a local TB treatment site ascertained from clinic record) |  | 1 month | 
| ART initiation date as documented by clinic record for those HIV co-infected |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, TB, Test and Treat, Linkage