Tuberculosis Clinical Trial
— SiyasizaOfficial title:
Test and Treat TB: A Proof of Concept Trial in South Africa
Verified date | April 2018 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4815 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
South Africa | iThembalabantu Clinic/AIDS Healthcare Foundation | Durban | KwaZulu-Natal |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | AIDS Healthcare Foundation, National Institute of Allergy and Infectious Diseases (NIAID) |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients who complete tuberculosis treatment | 6 months | ||
Secondary | Proportion of mobile testers screened for tuberculosis | 20 months | ||
Secondary | Proportion of eligible participants able to produce sputum samples | 20 months | ||
Secondary | Prevalence of TB among those tested | 20 months | ||
Secondary | Prevalence of tuberculosis and rifampin resistance | The GeneXpert test can detect rifampin resistant strains of tuberculosis | 20 months | |
Secondary | Distribution of TB symptoms ascertained from TB symptom screen questionnaire | 20 months | ||
Secondary | Proportion returning to the mobile tester for TB test result | 20 months | ||
Secondary | Linkage to TB care (first visit to a local TB treatment site ascertained from clinic record) | 1 month | ||
Secondary | ART initiation date as documented by clinic record for those HIV co-infected | 6 months |
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