Trained nurses can monitor HIV care in poorer countries with the same results as achieved by doctors, researchers said.
The finding, from a randomized prospective trial in South Africa, offers a possible solution to the shortage of trained medical personnel in resource-poor regions, according to Catherine Orrell, MMed, of the University of Cape Town in South Africa, and colleagues.
It's the first randomized trial to test so-called "task-shifting" in the care of HIV patients being treated with combination antiretroviral therapy, Orrell and colleagues said online in The Lancet.
The researchers reported outcomes from 812 HIV patients in two primary care clinics in Cape Town and Johannesburg who were starting treatment with either a previous AIDS-defining illness or a CD4 T-cell count of less than 350.
After antiretroviral therapy was initiated by a doctor, patients in each clinic were randomly assigned to have their condition monitored by teams consisting of two doctors or two primary care nurses. The teams also included practitioners without extensive HIV-related experience, but who had undergone a short course in HIV care and the use of antiretroviral therapy.
The primary outcome was treatment failure, using a composite endpoint of treatment-limiting events, incorporating mortality, viral failure, treatment-limiting toxic effects, and adherence to visit schedule. The study was intended to test the hypothesis that nurse-delivered care would not be inferior to doctor-delivered care, with a preset noninferiority margin of an upper 95% confidence interval for the hazard ratio that was less than 1.40.
Overall, after a median follow-up of 120 weeks, 371 patients experienced treatment failure -- 192 (or 48%) in the nurse-monitored group and 179 (or 44%) in the doctor-monitored group, the researchers said.
That yielded a hazard ratio for composite failure of 1.09, with a 95% confidence interval from 0.89 to 1.33, whose upper limit was lower than the 1.40 bar set for noninferiority, they said.
The elements of the composite endpoint were also similar in the nurse-led and doctor-led groups, respectively:
- 10 deaths versus 11
- 44 virological failures compared with 39
- 68 toxicity failures versus 66
- 70 all loss (withdrew consent, failed to keep appointments, or were lost to follow-up) compared with 63
The investigators noted that use of stavudine in the treatment regimen might have increased toxicity in both groups but stated that this drug is still often used in resource-poor areas.
The researchers cautioned that the study "did not necessarily replicate the typical conditions under which therapy is delivered in resource-poor settings," which may limit how widely it can be applied. The results also can't be applied to situations where multiple treatment options can be used, which might limit the incidence of treatment-limited toxicity, they said.
Nonetheless, the "result confirms data from cohort studies that this strategy is safe and effective," according to 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, in an accompanying commentary.
They noted that the study design might have minimized some differences between the arms, since the teams and the patients were potentially able to mingle. As well, both teams had access to an experienced clinical safety team that included doctors, with which they could discuss case management.
In spite of that, they said, "it is marvelous to see the results of a practical and innovative study which helps propel the field forward and improves our collective confidence that despite all the obstacles we can succeed."
Primary source: The Lancet
Source reference: Sanne I, et al "Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial" Lancet 2010; DOI: 10.1016/S0140-6736(10)60894-X.
Additional source: The Lancet
Source reference: Boyd MA, Nwizu CA "Operational research in HIV priority areas: the African way" Lancet 2010; DOI: 10.1016/ S0140-6736(10)60972-5.