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

Active Not RecruitingNA

Sponsor: Johns Hopkins University

Conditions: MDR-TB, HIV

Interventions: NCM-Plus

Countries: South Africa

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.

Eligibility overview

Sex: ALL

Age: 13 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (15)

Westville, Durban, South Africa
aMatikulu, KwaZulu-Natal, South Africa
Durban, South Africa
Durban, South Africa
East London, South Africa
Hibberdene, South Africa
Hlabisa, South Africa
Manguzi, South Africa
Mdantsane, South Africa
Newlands West, South Africa
Pietermaritzburg, South Africa
Port Alfred, South Africa
Port Elizabeth, South Africa
Port Shepstone, South Africa
Umzimkulu, South Africa