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Nurses may be as qualified as doctors to initiate ART
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Similar treatment failure rates were observed among patients with HIV on antiretroviral therapy who were receiving nurse-monitored care and those receiving doctor-monitored care, according to findings published recently in The Lancet.
Researchers conducted a randomized prospective trial in Cape Town and Johannesburg, South Africa, to evaluate the outcomes in HIV patients who were starting treatment with a previous AIDS-defining illness or CD4 T-cell counts of less than 350 cells/mcL. The researchers hypothesized that nurse-delivered care would not be inferior to doctor-delivered care, with a preset non-inferiority margin of an upper 95% CI, for an HR that was less than 1.40.
ART was initially administered by a doctor. Patients were then randomly assigned to have their condition monitored by teams of two doctors or two primary care nurses. There were 408 participants in the doctor cohort and 404 participants in the nurse cohort.
The initial primary outcome was treatment failure. Analysis was conducted using a composite endpoint of treatment-limiting events that incorporated mortality, viral failure, treatment-limiting toxic effects and adherence to visit schedule.
During 120 weeks of follow-up, 371 patients (46%) experienced treatment failure; there were 192 treatment failures in the nurse-monitored group (48%) and 179 in the doctor-monitored group (44%).
The 10 deaths, 44 virological failures, 68 toxicity failures and 70 withdrawals from the study in the nurse-monitored group were comparable with the 11 deaths, 39 virological failures, 66 toxicity failures and 63 withdrawals in the doctor-monitored group. The HR for composite treatment failure in the nurse vs. the doctor group was 1.09 (95% CI, 0.89-1.33), which was within the preset non-inferiority limits, according to the results.
“Findings from this study lend support to task shifting to appropriately trained nurses for monitoring of ART,” the researchers wrote.
Mark Boyd, MD, of St. Vincent’s Hospital in Sydney, Australia, and Chidi Nwizu, MBBS, of the University of Maryland School of Medicine in Baltimore, wrote an accompanying editorial. “The results confirm data from cohort studies that this strategy is safe and effective,” they wrote. “It is marvelous to see the results of a practical and innovative study [that] helps propel the field forward and improves our collective confidence that despite all obstacles, we can succeed.”
Sanne I. Lancet. 2010;doi:10.1016/S0140-6736(10)60894-X.