Active — Not RecruitingNot Applicable

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

South Africa3,600 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range13 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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.

What they're measuring

Proportion of patients who experience successful treatment outcomes

Timeframe: 24-36 months

Trial details

NCT IDNCT02129244

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03

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