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| ID | Type | Description | Link |
|---|---|---|---|
| R21AI110264 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| AIDS Healthcare Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test-and-Treat TB | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who complete tuberculosis treatment | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid V Bassett, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| iThembalabantu Clinic/AIDS Healthcare Foundation | Durban | KwaZulu-Natal | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30717693 | Derived | Bassett IV, Forman LS, Govere S, Thulare H, Frank SC, Mhlongo B, Losina E. Test and Treat TB: a pilot trial of GeneXpert MTB/RIF screening on a mobile HIV testing unit in South Africa. BMC Infect Dis. 2019 Feb 4;19(1):110. doi: 10.1186/s12879-019-3738-4. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2017 | Apr 2, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| 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 |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |