Summary
Background: Nurse case management (NCM) models have improved outcomes in chronic disease and HIV, but evidence in multidrug-resistant TB (MDR-TB) is limited. We therefore evaluated whether NCM could improve MDR-TB outcomes.
Methods: This pragmatic, cluster-randomised trial was conducted at 10 district hospitals in KwaZulu-Natal and Eastern Cape, South Africa.
Results: Between 13 November 2014 and 5 September 2019, 2,844 were enrolled. A total of 2,134 were analysed (1,093 NCM, 1,041 usual care). Among 1,236 men (57.9%) and 898 women (42.1%), mean age was 37.4 years (standard deviation 12.2). Treatment success occurred in 706 (64.5%) of NCM group and 645 (61.9%) in usual care (P = 0.62). Treatment failure occurred in 28 (2.6%) of NCM group and 47 (4.5%) of usual care. NCM did not improve the proportion of successful treatment (adjusted odds ratio [aOR] = 0.79, P = 0.17, and 95% confidence interval [CI]: 0.56, 1.12). In secondary analysis, NCM reduced the odds of treatment failure by 44% (aOR 0.56, 95% CI: 0.31-0.99), which improved to 49% (aOR 0.51, 95% CI: 0.26-0.99) in sensitivity analysis. Differences for other outcomes were not significant.
Conclusion: NCM did not improve MDR-TB treatment success. Yet, NCM was associated with reduced odds of treatment failure. The intervention alone was insufficient to overcome barriers associated with loss to follow-up, or delayed presentation.
Keywords: MDR-TB outcomes; South Africa; chronic care model; nursing; treatment; tuberculosis.