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Nurse management is not inferior to doctor management of ARV patients: the CIPRA South Africa randomized trial
R. Wood1, M. Fox2, F. Conradie3, M. Cornell1, M. Dehlinger4, C. Heiberg1, C. Ingram3, P. Ive3, C. Orrell1, R. Panchia3, M. Rassool3, W. Stevens3, H. Truter3, C. van der Horst5, J. Zeinekcer1, J. Mcintyre3, I. Sanne3
1University of Cape Town, Cape Town, South Africa, 2Boston University School of Public Health, Center for International Health and Development, Boston, United States, 3University of the Witwatersrand, Johannesburg, South Africa, 4National Institutes for Allergy and Infectious Diseases, Bethesda, United States, 5University of North Carolina - Chapel Hill, Chapel Hill, United States
Background: In sub-Saharan Africa there are not enough doctors to monitor HIV treatment. This CIPRA-SA study tested the hypothesis that doctor-initiated NURSE monitored antiretroviral treatment is not inferior to DOCTOR monitored treatment.
Methods: We randomized 812 ART-naïve participants with CD4+< 350, no active OI, or treatment limiting toxicity to nurse or doctor monitored ART followed for at least 96 weeks. The primary endpoint was a composite of treatment failure < 1.5 log drop by 12 weeks or 2 consecutive VL >1000), death, loss to follow-up, toxicity, 3 consecutive missed visits and withdrawn consent. Analysis was by intention-to-treat using Cox proportional hazard regression.
Results: Among participants, 70% (569/812) were women and 64% (517/812) had a baseline CD4+ < 200. Baseline characteristics were similar between NURSE and DOCTOR arms (median CD4+: 157 vs 161cells/mm3; mean log viral load: 5.09 vs. 4.99, CDC C: 33.2% vs. 36.8%). Common reasons for failure were toxicity (16.5%), virologic (10.2%) and defaulting (8.6%). Cumulative failure was similar between NURSE and DOCTOR arms (47.5% vs. 43.9%) with NURSE monitored patients being 1.09 (0.89 - 1.33) times more likely to fail. Our upper confidence limit (1.33) was within our pre-specified non-inferiority margin (1.40).
| | Nurse | Doctor | HR (95% CI) | | CUMULATIVE FAILURE | 192/404 (47.5%) | 179/408 (43.9%) | 1.09 (0.89 - 1.33) | | Virologic failure | 44/404 (10.9%) | 39/408 (9.6%) | 1.15 (0.75 - 1.76) | | Toxicity failure | 68/404 (16.8%) | 66/408 (16.2%) | 1.04 (0.74 - 1.45) | | Withdrew consent | 18/404 (4.5%) | 21/408 (5.1%) | 0.87 (0.46 - 1.63) | | Default | 38/404 (9.4%) | 32/408 (7.8%) | 1.21 (0.76 - 1.93) | | Lost to follow-up | 14/404 (3.5%) | 10/408 (2.5%) | 1.42 (0.63 - 3.20) | | Death | 10/404 (2.5%) | 11/408 (2.7%) | 0.92 (0.39 - 2.17) |
Conclusions: These results demonstrate that nurses are non-inferior to doctors when monitoring the treatment of HIV patients on ART and should be considered as a strategy for ART delivery.
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