Tuberculosis
Conditions
Keywords
TB, HIV, Test and Treat, Linkage
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.
Interventions
OTHERTest-and-Treat TB
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
AIDS Healthcare Foundation
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who complete tuberculosis treatment | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 20 months | The GeneXpert test can detect rifampin resistant strains of tuberculosis |
| Proportion of mobile testers screened for tuberculosis | 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 | — |
| Distribution of TB symptoms ascertained from TB symptom screen questionnaire | 20 months | — |
Countries
South Africa
Outcome results
None listed