The monitoring of antiretroviral therapy (ART) by trained nurses in primary healthcare seems to be as similarly safe and effective as doctor-monitored care, according to an article published in this week's edition of The Lancet.
The results of this randomised trial* add to the observational evidence of successful "task-shifting" in HIV care that could help ease the critical shortage of healthcare workers while expanding access to ART for the millions in urgent need of treatment.
A worldwide shortage of 4.3 million healthcare workers means that many people do not have access to the HIV therapy they need. In order to meet universal access targets by 2010, the World health Organization (WHO) proposed "task-shifting" from doctors to other lower level health-care workers, enabling nurses and community workers to deliver ART, so that more patients might be treated.
There are 22•4 million people living with HIV in sub-Saharan Africa, with an estimated 3•8 million in urgent need of treatment.
According to Prof. Ian Sanne, lead author of the paper, Associate Professor of Infectious Diseases at Wits University and Director of the Clinical HIV Research Unit, South Africa has the world's largest national ART programme but has just 17.4 medical practitioners per 100 000 people. "To tackle this shortage, South Africa is planning large-scale task shifting, where it plans to increasingly use nurses for HIV care and the monitoring of ART. However, prior to this study, there was not much research undertaken to investigate if this approach is safe and effective."
To provide more evidence, the Comprehensive International Program for Research in AIDS in South Africa (CIPRA-SA) study team, supported by the South African National Department of Health and the National Institute for Health (USA), compared the outcomes of nurse versus doctor management of doctor-initiated ART care** for HIV patients in two South-African primary care clinics - one in Masiphumelele in Cape Town and another in Soweto, Johannesburg. Between 2005 and 2007, 812 HIV patients were randomly assigned to nurse-managed ART care (408) or doctor-managed ART care (404). The composite endpoint was defined as failure of the treatment strategy to maintain patients on ART and measured using death rate, viral failure, treatment-limiting toxic effects and whether patients attended scheduled visits.
Overall, 192 patients (48%) experienced treatment failure in the nurse group and 179 (44%) in the doctor group.
After two years, deaths (10 vs 11), viral failure (44 vs 39), toxicity failures (68 vs 66) and programme losses (70 vs 63) were found to be similar between the nurse and doctor groups.
Prof. Ian Sanne says: "The findings lend support to the strategy of task shifting and suggests that HIV management by nurses can be safe and effective, probably even for those starting therapy with advanced HIV infection. However, widespread task shifting will need increased training, a redefinition of scope of practice for nurses and a clinical support structure."
In an accompanying comment, Mark Boyd from St Vincent's Hospital, Sydney, Australia, states: "There have been many calls for clinical and operational research to help to better inform policy and guidelines for routine HIV care. In view of the enormous amount of resources ploughed into the effort to achieve universal access to HIV care, including antiretroviral therapy, it is marvellous 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."
The CIPRA-SA project is a collaboration between the University of the Witwatersrand, the University of Cape Town, the National Health Laboratory Services (NHLS), the University of North Carolina (USA) and Boston University. The study was funded by the National Institute for Health (USA) and supported by the South African National Department of Health that provided the necessary antiretroviral therapy for the study.
* A randomised trial is a type of scientific experiment most commonly used in testing the efficacy or effectiveness of healthcare services or health technologies. It involves the random allocation of different interventions (treatments or conditions) to patients and it eliminates selection bias in the assignment of treatments.
**The study did not examine nurse-initiated ART because South African law requires the prescription of drugs by doctors.
