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Nurse support boosts TB treatment in south africa

NCT ID NCT02129244

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether having a nurse case manager helps people with multidrug-resistant tuberculosis (MDR-TB) and HIV complete their long treatment. About 3,600 patients in South Africa are involved. Half of the clinics have a nurse case manager to guide care, while the other half follow standard procedures. Researchers will compare treatment success rates between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nurse case management
What this could lead to
If successful, this approach could improve cure rates for drug-resistant TB, especially in patients also living with HIV.
What could go wrong
This is an observational study comparing existing care models, not testing a new drug. Results may vary by location and patient adherence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2014

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Center (Cluster Level) 1. MDR-TB Centers in KwaZulu-Natal (KZN) or Eastern Cape (EC), South Africa providing standardized 2. MDR-TB regimen according to National Department of Health guidelines 3. Facility has provided MDR-TB care for a minimum of 6 months at study initiation 4. MDR-TB Centers with facility-based access to anti-retroviral therapy 5. Facility willingness to participate in the study * Individual (Patient Level) 1. 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. 2. 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. Exclusion Criteria (Individual Patient Level): * Persons who present to the MDR-TB ward who have started MDR-TB treatment prior to admission. * Children, less than 13 years of age; only one participating center has an MDR-TB wards for children under 13. * Persons who are unable or unwilling to provide informed consent for participation * Any patient enrolled in another clinical trial that changes standard MDR- TB or HIV care.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease multidrug-resistant tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV MDR-TB

Contacts and locations

Locations

  • Catherine Booth Hospital

    aMatikulu, KwaZulu-Natal, South Africa

  • Don McKenzie

    Durban, South Africa

  • Doris Goodwin Hospital

    Pietermaritzburg, South Africa

  • Dunstan Farrell Hospital

    Hibberdene, South Africa

  • Fort Gray Hospital

    East London, South Africa

  • Fosa Hospital

    Newlands West, South Africa

  • Hlabisa Hospital

    Hlabisa, South Africa

  • Jose Pearson Hospital

    Port Elizabeth, South Africa

  • King George V Hospital

    Durban, South Africa

  • Manguzi

    Manguzi, South Africa

  • Marjorie Parrish Hospital

    Port Alfred, South Africa

  • Murchison Hospital

    Port Shepstone, South Africa

  • Nkqubela

    Mdantsane, South Africa

  • Regus Primary Office

    Westville, Durban, 3629, South Africa

  • St Margaret's MDR-TB Hopsital

    Umzimkulu, South Africa

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