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

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ClinicalTrials.gov Identifier: NCT02298309
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : April 4, 2018
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
AIDS Healthcare Foundation
Information provided by (Responsible Party):
Ingrid V. Bassett, MD, MPH, 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.

Condition or disease Intervention/treatment Phase
Tuberculosis Other: Test-and-Treat TB Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4815 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Test and Treat TB: A Proof of Concept Trial in South Africa
Actual Study Start Date : April 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
No Intervention: Usual Care
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
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



Primary Outcome Measures :
  1. Number of patients who complete tuberculosis treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Proportion of mobile testers screened for tuberculosis [ Time Frame: 20 months ]
  2. Proportion of eligible participants able to produce sputum samples [ Time Frame: 20 months ]
  3. Prevalence of TB among those tested [ Time Frame: 20 months ]
  4. Prevalence of tuberculosis and rifampin resistance [ Time Frame: 20 months ]
    The GeneXpert test can detect rifampin resistant strains of tuberculosis

  5. Distribution of TB symptoms ascertained from TB symptom screen questionnaire [ Time Frame: 20 months ]
  6. Proportion returning to the mobile tester for TB test result [ Time Frame: 20 months ]
  7. Linkage to TB care (first visit to a local TB treatment site ascertained from clinic record) [ Time Frame: 1 month ]
  8. ART initiation date as documented by clinic record for those HIV co-infected [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298309


Locations
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South Africa
iThembalabantu Clinic/AIDS Healthcare Foundation
Durban, KwaZulu-Natal, South Africa
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
AIDS Healthcare Foundation
Investigators
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Principal Investigator: Ingrid V Bassett, MD, MPH Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Ingrid V. Bassett, MD, MPH, Massachusetts General Hospital:
Study Protocol  [PDF] May 26, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ingrid V. Bassett, MD, MPH, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02298309     History of Changes
Other Study ID Numbers: 2014P001173/MGH
R21AI110264 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ingrid V. Bassett, MD, MPH, Massachusetts General Hospital:
TB
HIV
Test and Treat
Linkage

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections