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

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ClinicalTrials.gov Identifier: NCT02129244
Recruitment Status : Recruiting
First Posted : May 2, 2014
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Medical Research Council, South Africa
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
MDR-TB HIV Other: NCM-Plus Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
Study Start Date : October 2014
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.



Primary Outcome Measures :
  1. Proportion of patients who experience successful treatment outcomes [ Time Frame: 24-36 months ]
    General Estimating Equations (GEE) Regression Analysis


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129244


Contacts
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Contact: Kelly Lowensen, RN, MSN 410-502-3101 klowens1@jhu.edu

Locations
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South Africa
Regus Primary Office Not yet recruiting
Westville, Durban, South Africa, 3629
Contact: Kelly Lowensen, RN, MSN    410-502-3101    klowens1@jhu.edu   
Principal Investigator: Jason E Farley, PhD, MPH, NP         
Catherine Booth Hospital Active, not recruiting
Amatikulu, KwaZulu-Natal, South Africa
King George V Hospital Recruiting
Durban, South Africa
Fort Gray Hospital Active, not recruiting
East London, South Africa
Don McKenzie Recruiting
Ethekwini, South Africa
Dunstan Farrell Hospital Not yet recruiting
Hibberdene, South Africa
Hlabisa Hospital Recruiting
Hlabisa, South Africa
Manguzi Active, not recruiting
Manguzi, South Africa
Nkqubela Recruiting
Mdantsane, South Africa
Fosa Hospital Not yet recruiting
Newlands West, South Africa
Doris Goodwin Hospital Recruiting
Pietermaritzburg, South Africa
Marjorie Parrish Hospital Recruiting
Port Alfred, South Africa
Jose Pearson Hospital Recruiting
Port Elizabeth, South Africa
Murchison Hospital Active, not recruiting
Port Shepstone, South Africa
St Margaret's MDR-TB Hopsital Recruiting
Umzimkulu, South Africa
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Medical Research Council, South Africa
Investigators
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Principal Investigator: Jason E Farley, PhD, MPH, NP Johns Hopkins University

Publications:
World Health Organization. Global Tuberculosis Control. WHO/HTM/TB/2010.7. 2010. Geneva, Switzerland.
World Health Organization. Multidrug and extensively drug-resistant TB (M/XDR-TB): 2010 global report on surveillance and response. [WHO/HTM/TB/2010.3]. 2010. World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland, WHO Press.
National Department of Health, South Africa. Decentralized Management of Multi-Drug Resistant Tuberculosis: A Policy Framework for South Africa. 2011.
Institute of Medicine. Preparing for the Future of HIV/AIDS in Africa: A Shared Responsibility. 11-29-2010. Washington, D.C., The National Academies Press.
Joint United Nations Programme on HIV/AIDS (UNAIDS). Global Report: UNAIDS Report on the Global AIDS Epidemic, 2010. UNAIDS/10.11E | JC1958E. 2010.
National Department of Health, South Africa. Decentalized Management of Multi-Drug Resistant Tuberculosis: A Policy Framework for South Africa. 2010.
Department of Labour. The shortage of Medical Doctors in South Africa: Scarce and critical skills research project. 1-30-2009.
National Department of Health, South Africa. Programmatic Management of Multi-Drug Resistant Tuberculosis: Emergency Update. 2008.
Department of Health. Management of Drug Resistant Tuberculosis: Policy Guidelines. i-151. 8-1-2012.
Department of Health. National Strategic Plan on HIV, STIs and TB (2012-2016). 1-78. 12-1-2012.
National Department of Health, South Africa. The South African Antiretroviral Treatement Guidelines 2010. 2010. 2010.
National Department of Health, South Africa. Decentralized Management of Multi-Drug Resistant Tuberculosis: A Policy Framework for South Africa (Draft). 2010.
World Health Organization. Guidelines for the Programmatic Management of Drug Resistant Tuberculosis; Emergency Update, 2008. WHO/HTM/TB/2008.402. 2008.
World Health Organization. Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis: 2011 Update. [WHO/HTM/TB/2011.6], i-33. 2012.
Institute of Healthcare Improvement. Improving HIV Care: A Modular Quality Improvement Curriculum. Institue of Healthcare Improvemnet . 6-15-2011.
Farley JE, Alwood K, Davis JG, Stellenberg E, and van der Walt M. Development and Pilot Testing of MDR-TB/HIV In-Service Training in Rural KwaZulu Natal. National Education Association and Foundation of Nursing University Deans of South Africa Annual Conference . 10-15-2010.

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02129244     History of Changes
Other Study ID Numbers: NA_00078899
RO1 104488-01A1 ( Other Grant/Funding Number: NIH/NAID )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
MDR-TB
HIV
Nurse Case Management (NCM)

Additional relevant MeSH terms:
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Coinfection
Tuberculosis, Multidrug-Resistant
HIV Infections
Infection
Virus Diseases
Parasitic Diseases
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases