A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
MDR-TB, HIV
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
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.
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
Active Comparator
No Intervention
NCM Plus Intervention
Standard/Usual Care
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.