Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): A randomised non-inferiority trial

Background Expanded access to combination antiretroviral therapy (ART) in resource-poor settings is dependent on task shifting from doctors to other health-care providers. We compared outcomes of nurse versus doctor managementof ART care for HIV-infected patients.Methods This randomised non-inferiority trial was undertaken at two South African primary-care clinics. HIV- positiveindividuals with a CD4 cell count of less than 350 cells per μL or WHO stage 3 or 4 disease were randomly assignedo nurse-monitored or doctor-monitored ART care. Patients were randomly assigned by stratifi ed permuted block randomisation, and neither the patients nor those analysing the data were masked to assignment. The primaryobjective was a composite endpoint of treatment-limiting events, incorporating mortality, viral failure, treatmentlimitingtoxic eff ects, and adherence to visit schedule. Analysis was by intention to treat. Non-inferiority of the nurseversus doctor group for cumulative treatment failure was prespecifi ed as an upper 95% CI for the hazard ratio thatwas less than 1·40. This study is registered with ClinicalTrials.gov, number NCT00255840.Findings 408 patients were assigned to doctor-monitored ART care and 404 to nurse-monitored ART care; allparticipants were analysed. 371 (46%) patients reached an endpoint of treatment failure: 192 (48%) in the nurse groupand 179 (44%) in the doctor group. The hazard ratio for composite failure was 1·09 (95% CI 0·89-1·33), which waswithin the limits for non-inferiority. After a median follow-up of 120 weeks (IQR 60-144), deaths (ten vs 11), virologicalfailures (44 vs 39), toxicity failures (68 vs 66), and programme losses (70 vs 63) were similar in nurse and doctorgroups, respectively.Interpretation Nurse-monitored ART is non-inferior to doctor-monitored therapy. Findings from this study lendsupport to task shifting to appropriately trained nurses for monitoring of ART.Funding National Institutes of Health; United States Agency for International Development; National Institute of Allergy and Infectious Diseases.