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

Primary Purpose

MDR-TB, HIV

Status
Active
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
NCM-Plus
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for MDR-TB focused on measuring MDR-TB, HIV, Nurse Case Management (NCM)

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Regus Primary Office
  • Catherine Booth Hospital
  • King George V Hospital
  • Fort Gray Hospital
  • Don McKenzie
  • Dunstan Farrell Hospital
  • Hlabisa Hospital
  • Manguzi
  • Nkqubela
  • Fosa Hospital
  • Doris Goodwin Hospital
  • Marjorie Parrish Hospital
  • Jose Pearson Hospital
  • Murchison Hospital
  • St Margaret's MDR-TB Hopsital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NCM Plus Intervention

Standard/Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of patients who experience successful treatment outcomes
General Estimating Equations (GEE) Regression Analysis

Secondary Outcome Measures

Proportion of patients who experience successful treatment outcomes based on HIV co-infection
Multivariate Analysis using binomial or Poisson-based GEE models
Proportion of patients who experience successful treatment outcomes based on sex and gender
Multivariate Analysis using binomial or Poisson-based GEE models
Proportion of patients who experience successful treatment outcomes based on age
Multivariate Analysis using binomial or Poisson-based GEE models

Full Information

First Posted
April 29, 2014
Last Updated
June 6, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT02129244
Brief Title
A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
Official Title
A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MDR-TB, HIV
Keywords
MDR-TB, HIV, Nurse Case Management (NCM)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NCM Plus Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard/Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
NCM-Plus
Intervention Description
The NCM will follow the domains of the chronic care model by: Assuring effective, efficient clinical care and self-management support Promoting clinical care consistent with scientific evidence and patient preferences Organizing data to facilitate efficient, effective care Empowering and preparing patients to manage their health and health-care needs Mobilizing community resources to meet the needs of patients
Primary Outcome Measure Information:
Title
Proportion of patients who experience successful treatment outcomes
Description
General Estimating Equations (GEE) Regression Analysis
Time Frame
24-36 months
Secondary Outcome Measure Information:
Title
Proportion of patients who experience successful treatment outcomes based on HIV co-infection
Description
Multivariate Analysis using binomial or Poisson-based GEE models
Time Frame
24 to 36 months
Title
Proportion of patients who experience successful treatment outcomes based on sex and gender
Description
Multivariate Analysis using binomial or Poisson-based GEE models
Time Frame
24-36 months
Title
Proportion of patients who experience successful treatment outcomes based on age
Description
Multivariate Analysis using binomial or Poisson-based GEE models
Time Frame
24-36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason E Farley, PhD, MPH, NP
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regus Primary Office
City
Westville
State/Province
Durban
ZIP/Postal Code
3629
Country
South Africa
Facility Name
Catherine Booth Hospital
City
Amatikulu
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
King George V Hospital
City
Durban
Country
South Africa
Facility Name
Fort Gray Hospital
City
East London
Country
South Africa
Facility Name
Don McKenzie
City
Ethekwini
Country
South Africa
Facility Name
Dunstan Farrell Hospital
City
Hibberdene
Country
South Africa
Facility Name
Hlabisa Hospital
City
Hlabisa
Country
South Africa
Facility Name
Manguzi
City
Manguzi
Country
South Africa
Facility Name
Nkqubela
City
Mdantsane
Country
South Africa
Facility Name
Fosa Hospital
City
Newlands West
Country
South Africa
Facility Name
Doris Goodwin Hospital
City
Pietermaritzburg
Country
South Africa
Facility Name
Marjorie Parrish Hospital
City
Port Alfred
Country
South Africa
Facility Name
Jose Pearson Hospital
City
Port Elizabeth
Country
South Africa
Facility Name
Murchison Hospital
City
Port Shepstone
Country
South Africa
Facility Name
St Margaret's MDR-TB Hopsital
City
Umzimkulu
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No
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A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes

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