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

NCT02129244 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3600

Last updated 2026-03-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

NCM-Plus

The NCM will follow the domains of the chronic care model by: 1. Assuring effective, efficient clinical care and self-management support 2. Promoting clinical care consistent with scientific evidence and patient preferences 3. Organizing data to facilitate efficient, effective care 4. Empowering and preparing patients to manage their health and health-care needs 5. Mobilizing community resources to meet the needs of patients

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Medical Research Council, South Africa

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Jason E Farley, PhD, MPH, NP · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2021-03-31
Completion
2026-07-31

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02129244 on ClinicalTrials.gov