A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Primary endpoint(s) modified Show 9 more changesShow less
    • Results posted: Oct 6, 2026
    • Trial completed
    • Final enrollment: 2844 participants (planned 3600)
    • Study completion date changed from estimate of Jul 2026 to Dec 2025
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints revised (3)
    • Site details revised at 1 of 15 sites
    • Publications: details revised at 43 of 61 entries
    • Study description expanded, about 3 words
  2. Study completion date: Mar 2026 to Jul 2026v20
  3. Primary completion date: Nov 2020 to Mar 2021
    • Study completion date: Dec 2025 to Mar 2026
    v19
  4. Study completion date: Jun 2025 to Dec 2025v18
  5. Study completion date: Dec 2024 to Jun 2025v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study completion date: May 2024 to Dec 2024v16
  2. Study completion date: May 2023 to May 2024v15
  3. Study completion date: Dec 2022 to May 2023v14
  4. Primary completion date changed from estimate of Dec 2021 to Nov 2020
    • Study completion date: Dec 2021 to Dec 2022
    v13
  5. Re-verified, no change to tracked fieldsv12
  6. Primary completion date: Dec 2018 to Dec 2021v11 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 3000 to 3600
    • Study completion date: Dec 2019 to Dec 2021
    • Site details revised at 15 of 15 sites
  7. 2 versions Re-verified since Jan 14, 2019, no change to tracked fieldsv9-v10
  8. Site details revised at 3 of 15 sitesv8
  9. Re-verified, no change to tracked fieldsv7
  10. Study sites: 13 to 15v6
  11. 2 versions Re-verified since Mar 23, 2016, no change to tracked fieldsv4-v5
  12. Site details revised at 6 of 13 sitesv3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2014 to Oct 2014
    • Site details revised at 13 of 13 sites
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs. The patients need to take these drugs for up to two years. Certain hospitals have already agreed to participate in this research project, half of the hospitals will be assigned a nurse case manager and the other half will not. The researchers are studying the benefits of having a nurse case manager to improve treatment response for patients with drug resistant TB. The researchers believe that nurse case management (NCM) in the intervention sites will increase MDR-TB cure and completion rates (i.e. treatment success) in comparison to usual care (UC), i.e. standardized programmatic management alone, in patients with and without HIV co-infection. To do this, the researchers will review the medical information collected at the hospital as part of the patient's treatment after obtaining the patient's permission.
Trial Details
NCT Number NCT02129244
Lead Sponsor Johns Hopkins University
Collaborators: National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa
Conditions
(from sponsor)		 MDR-TB, HIV
Related terms Tuberculosis, Multidrug-Resistant
Enrollment 2,844 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov