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 management of ART care for HIV-infected patients.


METHODS
This 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 ART 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 prespecified as an upper 95% CI for the hazard ratio that was less than 1.40. This study is registered with ClinicalTrials.gov, number NCT00255840.


RESULTS
408 patients were assigned to doctor-monitored ART care and 404 to nurse-monitored ART 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 (ten 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.


CONCLUSIONS
Nurse-monitored ART is non-inferior to doctor-monitored therapy. Findings from this study lend support to task shifting to appropriately trained nurses for monitoring of ART.


BACKGROUND
National Institutes of Health; United States Agency for International Development; National Institute of Allergy and Infectious Diseases.
Sanne
Ian
I
Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Orrell
Catherine
C
Fox
Matthew P
MP
Conradie
Francesca
F
Ive
Prudence
P
Zeinecker
Jennifer
J
Cornell
Morna
M
Heiberg
Christie
C
Ingram
Charlotte
C
Panchia
Ravindre
R
Rassool
Mohammed
M
Gonin
René
R
Stevens
Wendy
W
Truter
Handré
H
Dehlinger
Marjorie
M
van der Horst
Charles
C
McIntyre
James
J
Wood
Robin
R
D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016903:Drug Monitoring / Q000451:nursing*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000401:mortality / Q000451:nursing*; D015497:HIV-1; D006801:Humans; D008297:Male; D010820:Physicians; D013019:South Africa; D017211:Treatment Failure
D044966:Anti-Retroviral Agents