title: Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial.
abstract: 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.
authors.affiliation: Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Ian
authors.initials: I
authors.lastname: Sanne
authors.forename: Catherine
authors.initials: C
authors.lastname: Orrell
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Fox
authors.forename: Francesca
authors.initials: F
authors.lastname: Conradie
authors.forename: Prudence
authors.initials: P
authors.lastname: Ive
authors.forename: Jennifer
authors.initials: J
authors.lastname: Zeinecker
authors.forename: Morna
authors.initials: M
authors.lastname: Cornell
authors.forename: Christie
authors.initials: C
authors.lastname: Heiberg
authors.forename: Charlotte
authors.initials: C
authors.lastname: Ingram
authors.forename: Ravindre
authors.initials: R
authors.lastname: Panchia
authors.forename: Mohammed
authors.initials: M
authors.lastname: Rassool
authors.forename: René
authors.initials: R
authors.lastname: Gonin
authors.forename: Wendy
authors.initials: W
authors.lastname: Stevens
authors.forename: Handré
authors.initials: H
authors.lastname: Truter
authors.forename: Marjorie
authors.initials: M
authors.lastname: Dehlinger
authors.forename: Charles
authors.initials: C
authors.lastname: van der Horst
authors.forename: James
authors.initials: J
authors.lastname: McIntyre
authors.forename: Robin
authors.initials: R
authors.lastname: Wood
mesh_terms: 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
chemical_list: D044966:Anti-Retroviral Agents