CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 3,600 target
Drug / intervention
NCM-Plusother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02129244
NCT02129244N/AActiveUpdate OverdueUpdated 3mo ago · Completion was 64mo ago
Enrollment Stalled

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

Johns Hopkins University·interventional·Posted May 2, 2014·Updated Mar 18, 2026

In Brief

A clinical study evaluating NCM-Plus for MDR-TB and HIV. Active but no longer recruiting, targeting 3,600 participants across 15 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMDR-TB, HIV
CountriesSouth Africa

Timeline

N/AActiveOverdue
2014201520162017201820192020202120222023202420252026
First PostedMay 2, 2014
Enrollment StartOct 1, 2014
Primary CompletionMar 1, 2021
Study CompletionJul 1, 2026
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 12.2 years ago

Interventions

NCM-Plusother

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