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

June 6, 2023 updated by: Johns Hopkins University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Mycobacterium tuberculosis (TB) remains the leading cause of death among persons living with Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) in southern Africa. This syndemic places an overwhelming burden on healthcare workers and the health system. Drug-resistant TB remains a growing threat to public health despite advances in treatment and diagnosis over the past decade. South Africa has the world's highest rate of TB/HIV co-infection and ranks fourth worldwide for both multi-drug resistant (MDR) TB incidence and HIV prevalence. Treatment of MDR-TB, defined as resistance to isoniazid and rifampin, remains challenging and its treatment course complex. Success of second line treatment regimens is considerably less likely than first line treatment with significantly more adverse drug reactions (ADRs). Prospective cohort studies from South Africa report less than 50% treatment success (i.e. cure or completion) and significant differences in patients with and without HIV are noted. Differences in sex and gender as well as age are rarely evaluated. In addition to the management complexity and length of treatment, systems level factors such as access to care and healthcare capacity contribute to poorer treatment outcomes. Insufficient numbers of trained physicians capable and clinically competent to manage the challenges of integrated MDR-TB/HIV care are commonplace. These circumstances place a heavy burden on the most abundant healthcare resource in South Africa, the nurse. Nurses with proficiency in care models for both diseases are essential to improve treatment outcomes. The investigators experience dictates, however, that patients endure lengthy treatment with little assessment, support or guidance from nursing professionals due to a lack of training as well as lack of evidence-based interventions and delineated models of care for MDR-TB patients.

Nurse case management (NCM) models in which a registered nurse facilitates and coordinates treatment plans to ensure that timely, evidence-based care is given improves treatment outcomes. Presently, there is little evidence to describe such models in TB/HIV co-infected patients globally, and specifically less evidence for MDR-TB/HIV in sub-Saharan Africa. Many studies, however, have demonstrated substantial improvements in disease outcomes utilizing nurse case managers. Complex diseases such as heart failure, diabetes, HIV and drug susceptible TB are among these. Substantial gaps remain, however, in the investigators understanding of the impact of such interventions among co-infected patients, the influence of such models among different age groups or the cost-benefit in under resourced settings. Prior studies provide strong evidence that interventions must be multi-faceted and foster system level approaches to improve treatment outcomes (i.e. NCM patient-centered care services coupled with systems level approaches to care coordination). The Chronic Care Model identifies essential elements of a health care system that encourage high-quality chronic disease care in such a systems approach. These elements provide the conceptual model and implementation structure for the proposed NCM plus health systems strengthening (i.e. NCM-plus) intervention, a multi-faceted health systems and patient-centered intervention to improve MDR-TB/HIV treatment outcomes. The proposed 5-year cluster randomized trial, will evaluate the NCM-plus intervention on MDR-TB treatment outcomes in South Africa, the epicenter of the MDR-TB/HIV epidemic.

Primary Aim:

To determine the impact of a NCM model (i.e. NCM-Plus) on MDR-TB outcomes in patients with and without HIV co-infection in South Africa through a cluster randomized trial.

Hypothesis:

Nurse case management (NCM) in 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.

Secondary Aims:

  1. To conduct sub-group analysis by a) HIV co-infection; b) sex and gender; and c) age
  2. To compare the frequency and time to identification of adverse drug events between intervention and control sites.
  3. To conduct a costing analysis and a cost-effectiveness evaluation of the intervention.

Study Type

Interventional

Enrollment (Estimated)

3600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Durban, South Africa
        • King George V Hospital
      • East London, South Africa
        • Fort Gray Hospital
      • Ethekwini, South Africa
        • Don McKenzie
      • Hibberdene, South Africa
        • Dunstan Farrell Hospital
      • Hlabisa, South Africa
        • Hlabisa Hospital
      • Manguzi, South Africa
        • Manguzi
      • Mdantsane, South Africa
        • Nkqubela
      • Newlands West, South Africa
        • Fosa Hospital
      • Pietermaritzburg, South Africa
        • Doris Goodwin Hospital
      • Port Alfred, South Africa
        • Marjorie Parrish Hospital
      • Port Elizabeth, South Africa
        • Jose Pearson Hospital
      • Port Shepstone, South Africa
        • Murchison Hospital
      • Umzimkulu, South Africa
        • St Margaret's MDR-TB Hopsital
    • Durban
      • Westville, Durban, South Africa, 3629
        • Regus Primary Office
    • KwaZulu-Natal
      • Amatikulu, KwaZulu-Natal, South Africa
        • Catherine Booth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NCM Plus Intervention
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

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
No Intervention: Standard/Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who experience successful treatment outcomes
Time Frame: 24-36 months
General Estimating Equations (GEE) Regression Analysis
24-36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who experience successful treatment outcomes based on HIV co-infection
Time Frame: 24 to 36 months
Multivariate Analysis using binomial or Poisson-based GEE models
24 to 36 months
Proportion of patients who experience successful treatment outcomes based on sex and gender
Time Frame: 24-36 months
Multivariate Analysis using binomial or Poisson-based GEE models
24-36 months
Proportion of patients who experience successful treatment outcomes based on age
Time Frame: 24-36 months
Multivariate Analysis using binomial or Poisson-based GEE models
24-36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Medical Research Council, South Africa

Investigators

  • Principal Investigator: Jason E Farley, PhD, MPH, NP, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2020

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimated)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00078899
  • RO1 104488-01A1 (Other Grant/Funding Number: NIH/NAID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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