Clinical trial NCT02129244: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: MDR-TB
HIV
Keywords: MDR-TB
HIV
Nurse Case Management (NCM)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Medical Research Council, South Africa
First posted: 2014-05-02
Enrollment: 3600
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients who experience successful treatment outcomes
timeFrame: 24-36 months
Secondary outcomes:
measure: Proportion of patients who experience successful treatment outcomes based on HIV co-infection
timeFrame: 24 to 36 months
measure: Proportion of patients who experience successful treatment outcomes based on sex and gender
timeFrame: 24-36 months
measure: Proportion of patients who experience successful treatment outcomes based on age
timeFrame: 24-36 months
Other outcomes:
Locations:
city: Westville
country: South Africa
facility: Regus Primary Office
state: Durban
city: Amatikulu
country: South Africa
facility: Catherine Booth Hospital
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: King George V Hospital
city: East London
country: South Africa
facility: Fort Gray Hospital
city: Ethekwini
country: South Africa
facility: Don McKenzie
city: Hibberdene
country: South Africa
facility: Dunstan Farrell Hospital
city: Hlabisa
country: South Africa
facility: Hlabisa Hospital
city: Manguzi
country: South Africa
facility: Manguzi
city: Mdantsane
country: South Africa
facility: Nkqubela
city: Newlands West
country: South Africa
facility: Fosa Hospital
city: Pietermaritzburg
country: South Africa
facility: Doris Goodwin Hospital
city: Port Alfred
country: South Africa
facility: Marjorie Parrish Hospital
city: Port Elizabeth
country: South Africa
facility: Jose Pearson Hospital
city: Port Shepstone
country: South Africa
facility: Murchison Hospital
city: Umzimkulu
country: South Africa
facility: St Margaret's MDR-TB Hopsital
Study officials:
affiliation: Johns Hopkins University
name: Jason E Farley, PhD, MPH, NP
role: PRINCIPAL_INVESTIGATOR
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