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Cited by 248HIV/AIDS Research and InterventionsHIV/AIDS drug development and treatmentNursing Roles and Practices

The DOI matches its Crossref record; 33 of the 34 references it cites were found in a registry or an index.

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

Open access
Sanne, Ian, Orrell, Catherine, Fox, Matthew P, Conradie, Francesca, Ive, Prudence, Zeinecker, Jennifer, Cornell, Morna, Heiberg, Christie, Ingram, Charlotte, Panchia, Ravindre, Rassool, Mohammed, Gonin, René, Stevens, Wendy, Truter, Handré, Dehlinger, Marjorie, van der Horst, Charles, McIntyre, James, Wood, Robin·2010·The Lancet
DOI 10.1016/s0140-6736(10)60894-xPMC PMC3145152
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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.Findings 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.Interpretation 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.Funding National Institutes of Health; United States Agency for International Development; National Institute of Allergy and Infectious Diseases.

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Authors
Sanne, I., Orrell, C., Fox, M. P., Conradie, F., Ive, P., Zeinecker, J., Cornell, M., Heiberg, C., Ingram, C., Panchia, R., Rassool, M., Gonin, R., Stevens, W., Truter, H., Dehlinger, M., van der Horst, C., McIntyre, J., & Wood, R.
Affiliations
  • University of the Witwatersrand (ZA)
  • University of Cape Town (ZA)
  • Boston University (US)
  • Westat (United States) (US)
  • National Institute of Allergy and Infectious Diseases (US)
Corresponding author
Orrell, Catherine
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2010-07
Volume
376
Issue
9734
Pages
33-40
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(10)60894-x
PMC
PMC3145152
OpenAlex
W2169980588
Cited by
248
References
34
Citations by year
2026: 1 · 2025: 2 · 2024: 7 · 2023: 3 · 2022: 2 · 2021: 7 · 2020: 12 · 2019: 9 · 2018: 10 · 2017: 17 · 2016: 14 · 2015: 13 · 2014: 32 · 2013: 35 · 2012: 45
FWCI
24.59
Type
journal article
Language
en
Update notices
erratum (2010-09-25)
Open access
Licence
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • United States Agency for International Development
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
  • National Institute of Allergy and Infectious Diseases (1U19 AI53217-01, P30 AI50410, U19AI053217, K01AI083097, P30AI050410)
Topics
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
  • Health Sciences › Health Professions › General Health Professions › Nursing Roles and Practices
Keywords
HIV infection, antiretroviral therapy, nurse-led care, task shifting, non-physician health workers, primary care, treatment failure, virological failure, drug toxicity, patient adherence, resource-limited settings, South Africa
MeSH terms
Adult, Drug Therapy, Combination, Female, Humans, Male, Physicians, South Africa, HIV-1, HIV Infections, Drug Monitoring, Treatment Failure, Anti-Retroviral Agents

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