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Completed

NCT Number: NCT02298309

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

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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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

iThembalabantu Clinic/AIDS Healthcare Foundation

Durban, KwaZulu-Natal, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test-and-Treat TB

Other

Primary outcomes

  1. Number of patients who complete tuberculosis treatment

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • AIDS Healthcare Foundation
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Acronym: Siyasiza

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2014
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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