The results of the study came just as the national Department of Health is reviewing its exclusively doctor-led management of AIDS patients. The study involved just over 800 patients and it was what is known as a randomized trial, which means that one half of the subjects were assigned to doctors and the other to nurses. Both nurses and doctors monitored the patients over a period of 24 months from their first day of taking treatment. The outcome showed virtually no differences in either health care worker category’s ability to successfully monitor and manage patients taking ARVs.
‘We focused our study on factors that would limit the treatment administration of antiretroviral therapy. In other words, we focused on mortality ‘ overall death in the study ‘ 10 in the one arm and 11 in the other. We focused on antiretroviral therapy toxicity ‘ both the recognition, thereof, as well as the response to it, which is to switch treatment, and, again, nurses performed just as well as doctors did. And we focused on dose-limiting loss, what I would call loss to follow-up – any patient that missed three scheduled visits was considered lost and met an end-point in the study. And in all of those categories were found to be not inferior, in statistical terms, to doctor-monitored treatment’, Prof Ian Sanne, Associate Professor of Infectious Diseases at Wits University and Director of the Clinical HIV Research Unit, in Johannesburg, and Principal Investigator of the study.
The study was conducted in clinics in Soweto, south-west of Johannesburg and in Masiphumelele, outside Cape Town. Prof. Sanne added that the trial involved ordinary nurses and that both doctors and nurses received similar training to be part of the study.
‘The nurses that we engaged were so-called primary health care nurses in South Africa. That means that they would have gone through nurse training and then have conducted at least, one year of clinical training thereafter. They then, together with the doctors who were newly qualified doctors ‘ those who had completed their community services or were just two years out of completing their doctor training ‘ were taken through approximately two weeks of didactic lectures in antiretroviral therapy, diagnosis, opportunistic infections and TB and, then, they were asked to join one of our sites and were trained clinically so we could, in fact, make sure that they were clinically-competent for a period of anything between 3 ‘ 6 months, depending on when they came into the study cycle. The training period was equal for both groups’, he said.
In a country where one million people are on ARV treatment, yet more than five million are estimated to be living with HIV, which means that many more are in urgent need of treatment, the outcome of the study is important. The finding is also important in a country that has a shortage of public doctors.
Prof. Sanne explained that if nurses are as competent as doctors in monitoring patients on antiretroviral therapy, then the country’s doctor-centred approach of AIDS treatment needs to change.
‘We probably need to continue to grow the treatment programme to in excess of three million patients on treatment. We know that, in fact, we’re unable to do that with the current available doctor resources. We know that we have to do the task-shifting. This study really gives us confidence that, in fact, we can do that. It also gives confidence to the regulators that they can change the regulatory environment ‘ things like the scope of practice of nurses, the Central Drug List to include antiretroviral therapy and some of the other regulations that are required for nurses to, in fact, initiate antiretroviral therapy’, he said.
The national Department of Health welcomed the study outcome, saying it ‘backed up the government’s decision to devolve HIV care to nurses to enable more people to get treatment’. It said ‘the government had begun training nurses to initiate and monitor HIV treatment with doctor support. The critical thing is to ensure that the Department provides the necessary support to nurses’.