Test and Treat TB: A Proof of Concept Trial in South Africa
Not Applicable
Completed
- Conditions
- Tuberculosis
- Registration Number
- NCT02298309
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4815
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of patients who complete tuberculosis treatment 6 months
- Secondary Outcome Measures
Name Time Method Proportion of mobile testers screened for tuberculosis 20 months Prevalence of tuberculosis and rifampin resistance 20 months The GeneXpert test can detect rifampin resistant strains of tuberculosis
Distribution of TB symptoms ascertained from TB symptom screen questionnaire 20 months Proportion of eligible participants able to produce sputum samples 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 Prevalence of TB among those tested 20 months ART initiation date as documented by clinic record for those HIV co-infected 6 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the Test-and-Treat TB intervention's impact on TB transmission in South Africa?
How does the mobile Test-and-Treat TB strategy compare to standard-of-care in terms of treatment adherence and outcomes for drug-sensitive TB patients?
What biomarkers are associated with successful linkage to TB care in the NCT02298309 clinical trial setting?
What are the potential adverse events of rapid TB diagnostic tests used in the Test-and-Treat TB mobile screening program?
How does the cost-effectiveness of integrated HIV/TB mobile screening compare to traditional clinic-based approaches in high TB incidence regions?
Trial Locations
- Locations (1)
iThembalabantu Clinic/AIDS Healthcare Foundation
🇿🇦Durban, KwaZulu-Natal, South Africa
iThembalabantu Clinic/AIDS Healthcare Foundation🇿🇦Durban, KwaZulu-Natal, South Africa