Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial.
Expanded access to combination antiretroviral therapy in resource-poor settings is dependent on task shifting from doctors to other health-care providers. This study compared outcomes of nurse versus doctor management of antiretroviral therapy care for HIV-infected patients. A randomised non-inferiority trial was undertaken at two South African primary-care clinics. HIV-positive individuals with a CD4 cell count of less than 350 cells per microL or WHO stage 3 or 4 disease were randomly assigned to nurse-monitored or doctor-monitored antiretroviral therapy care. Patients were randomly assigned by stratified permuted block randomisation, and neither the patients nor those analysing the data were masked to assignment. The primary objective was a composite endpoint of treatment-limiting events, incorporating mortality, viral failure, treatment-limiting toxic effects, and adherence to visit schedule. Analysis was by intention to treat. Non-inferiority of the nurse versus doctor group for cumulative treatment failure was pre-specified as an upper 95% confidence interval for the hazard ratio that was less than 1.40. 408 patients were assigned to doctor-monitored antiretroviral therapy care and 404 to nurse-monitored antiretroviral therapy care; all participants were analysed. 371 (46%) patients reached an endpoint of treatment failure: 192 (48%) in the nurse group and 179 (44%) in the doctor group. The hazard ratio for composite failure was 1.09 (95% CI 0.89-1.33), which was within the limits for non-inferiority. After a median follow-up of 120 weeks (IQR 60-144), deaths (10 vs 11), virological failures (44 vs 39), toxicity failures (68 vs 66), and programme losses (70 vs 63) were similar in nurse and doctor groups, respectively. The authors conclude that nurse-monitored antiretroviral therapy is not inferior to doctor-monitored therapy.
A noninferiority trial is conducted when it would be unethical to use a placebo arm because an accepted treatment or approach already exists. Such trials are designed to determine that the effect of a new strategy/treatment is not worse than that of a currently accepted approach by more than a specified margin. The arm receiving the standard approach is sometimes called the active control arm. In this study, all 812 patients were started on antiretroviral therapy by physicians in busy primary care clinics in Masiphumelele, Cape Town and Soweto, Johannesburg. They were then randomised to be followed by doctors or by nurses within 6 weeks of starting treatment. The finding that nurse-monitored therapy was not inferior to physician-monitored therapy over a 24-month period supports observational data on successful task-shifting in HIV therapy in both resource-constrained and resource-rich countries, as well as for other diseases. These results suggest that countries such as South Africa in which only physicians can prescribe antiretroviral therapy, health care workers are in short supply, and HIV treatment needs are high, should move rapidly toward nurse-led models of antiretroviral therapy delivery
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