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NCT02129244Completed

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

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
2844 (actual)
First submitted
29 Apr 2014
Start date
1 Oct 2014
Primary completion date
31 Mar 2021
Lead sponsor
Johns Hopkins University
Diseases
HIV
NCT number
NCT02129244

What you commit to

  • Study type: Interventional
  • Participants enrolled: 2844
  • From 1 Oct 2014 to the primary completion date, 31 Mar 2021
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Persons who present to the MDR-TB ward who have started MDR-TB treatment prior to admission.

Other illness

  • Any patient enrolled in another clinical trial that changes standard MDR- TB or HIV care.

Age

  • Children, less than 13 years of age; only one participating center has an MDR-TB wards for children under 13.

Other

  • Persons who are unable or unwilling to provide informed consent for participation

Who the study is looking for

  • Center (Cluster Level)
    • MDR-TB Centers in KwaZulu-Natal (KZN) or Eastern Cape (EC), South Africa providing standardized
    • MDR-TB regimen according to National Department of Health guidelines
    • Facility has provided MDR-TB care for a minimum of 6 months at study initiation
    • MDR-TB Centers with facility-based access to anti-retroviral therapy
    • Facility willingness to participate in the study
  • Individual (Patient Level)
    • Patients 18 years of age and older, with microbiologically confirmed MDR- TB, admitted to receive inpatient care at a participating hospital who signs informed consent within 7 days of admission.
    • Patients 13 - 17 years of age, with microbiologically confirmed MDR- TB, who provide consent for study team to contact parent or legal guardian and when patient is willing and parent or legal guardian provides approval for study participation within 7 days of admission.

Age in the registry: 13 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Catherine Booth Hospital
Coordinator of this site? Confirm its status
aMatikuluSouth AfricaUnknown status
King George V Hospital
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DurbanSouth AfricaUnknown status
Don McKenzie
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DurbanSouth AfricaUnknown status
Fort Gray Hospital
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East LondonSouth AfricaUnknown status
Dunstan Farrell Hospital
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HibberdeneSouth AfricaUnknown status
Hlabisa Hospital
Coordinator of this site? Confirm its status
HlabisaSouth AfricaUnknown status
Manguzi
Coordinator of this site? Confirm its status
ManguziSouth AfricaUnknown status
Nkqubela
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MdantsaneSouth AfricaUnknown status
Fosa Hospital
Coordinator of this site? Confirm its status
Newlands WestSouth AfricaUnknown status
Doris Goodwin Hospital
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PietermaritzburgSouth AfricaUnknown status
Marjorie Parrish Hospital
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Port AlfredSouth AfricaUnknown status
Jose Pearson Hospital
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Port ElizabethSouth AfricaUnknown status
Murchison Hospital
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Port ShepstoneSouth AfricaUnknown status
St Margaret's MDR-TB Hopsital
Coordinator of this site? Confirm its status
UmzimkuluSouth AfricaUnknown status
Regus Primary Office
Coordinator of this site? Confirm its status
WestvilleSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.