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

NCT02129244 | Active Not Recruiting DMC

• 2 other identifiers: NA_00078899RO1 104488-01A1
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 15

Brief 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

MDR-TB; HIV

Keywords

MDR-TB; HIV; Nurse Case Management (NCM)

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who experience successful treatment outcomes

  General Estimating Equations (GEE) Regression Analysis

  24-36 months

Secondary Outcomes (3)

• Proportion of patients who experience successful treatment outcomes based on HIV co-infection

  24 to 36 months

• Proportion of patients who experience successful treatment outcomes based on sex and gender

  24-36 months

• Proportion of patients who experience successful treatment outcomes based on age

  24-36 months

Study Arms (2)

NCM Plus Intervention

ACTIVE COMPARATOR

The researchers designed the NCM-Plus intervention by integrating the domains of the Chronic Care Model with added attention to linkage to care, building on evidence-based guidelines and the team's pilot findings. In the NCM bundle, the researchers provide extensive details on both proximal and distal outcome variables. Nurse case managers will be hired and trained to improve disease management for patients with MDR-TB and HIV. Specific measurable responsibilities will be implemented by each NCM at sites randomized to receive the intervention. The NCM-patient interaction will occur at the MDR-TB treatment inpatient or outpatient facility.

Other: NCM-Plus

Standard/Usual Care

NO INTERVENTION

Usual care is defined as standardized programmatic management of MDR-TB/HIV without care coordination. Nurses are present as part of the team, but with no special coordination role, leaving the MDR-TB physician solely responsible for treatment outcomes with little support. Physicians see patients weekly during the intensive phase and the patient receives basic daily nursing care without coordination of care, active monitoring of Adverse Drug Reactions (ADR)s or HIV care integration. This care transitions to monthly visits with the physician in the continuation phase, again with very little nursing involvement in care coordination.

Interventions

NCM-Plus OTHER

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

NCM Plus Intervention

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Medical Research Council, South Africa: collaborator
• Johns Hopkins University: lead

Study Sites (15)

Regus Primary Office

Westville, Durban, 3629, South Africa

Location

Catherine Booth Hospital

aMatikulu, KwaZulu-Natal, South Africa

Location

Don McKenzie

Durban, South Africa

Location

King George V Hospital

Durban, South Africa

Location

Fort Gray Hospital

East London, South Africa

Location

Dunstan Farrell Hospital

Hibberdene, South Africa

Location

Hlabisa Hospital

Hlabisa, South Africa

Location

Manguzi

Manguzi, South Africa

Location

Nkqubela

Mdantsane, South Africa

Location

Fosa Hospital

Newlands West, South Africa

Location

Doris Goodwin Hospital

Pietermaritzburg, South Africa

Location

Marjorie Parrish Hospital

Port Alfred, South Africa

Location

Jose Pearson Hospital

Port Elizabeth, South Africa

Location

Murchison Hospital

Port Shepstone, South Africa

Location

St Margaret's MDR-TB Hopsital

Umzimkulu, South Africa

Location

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MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

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

Study Officials

• Jason E Farley, PhD, MPH, NP

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 2, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2021
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (15)