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Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial
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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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“In the field of HIV/AIDS, task shifting has been deemed imperative with evidence that nurses can prescribe antiretroviral treatments just as effectively as physicians”
From Global Burden of Skin Disease: Inequities and Innovations (2017) · cites this paper as [51]
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Metadata
- 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
- 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
- green
- www.ncbi.nlm.nih.gov
- 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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