Fast track — ArticlesNurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial
Introduction
Combination drug therapy has had a remarkable effect on the reduction of AIDS-related morbidity and mortality.1 In industrialised countries, antiretroviral management is administered by specialist physicians who prescribe from the full range of available antiretroviral drugs, supported by frequent laboratory monitoring including resistance testing.2 Finding from several studies in industrialised settings have shown that outpatients have better outcomes when cared for by a physician with HIV expertise than do those without such a physician, including quality of care and survival,3, 4, 5, 6, 7 which could be an indicator of the complexities of HIV infection and its management.2 By contrast with the small epidemic in resource-rich countries, there are 22·4 million people living with HIV in sub-Saharan Africa,8 with an estimated 3·8 million in urgent need of treatment.9 Globally, there is a shortage of 4·3 million health workers (doctors, midwives, nurses, and support workers);9 in South Africa there are only 17·4 medical practitioners per 100 000 people, who are largely concentrated in urban areas.10, 11
By contrast with the individualised approach to HIV care in developed countries, WHO has proposed a public health approach to antiretroviral therapy (ART) to enable scaling up of access to treatment for large numbers of HIV-positive adults and children in developing countries.12 An approach using standardised simplified treatment protocols and decentralised service delivery was developed to enable lower level health-care workers to deliver care.13 Models of care have investigated task shifting to clinical officers14 and a combination of nurses and community workers;15 however, nurse-led models of antiretroviral delivery have been one of the most widely implemented models of HIV care in poor-resourced African settings.15, 16, 17, 18 Findings from a trial have shown that work-site treatment of hypertension by specially trained nurses led to significantly improved blood pressure control and drug adherence.19 So far no randomised prospective study has been published to show the effectiveness of nurse-monitored ART. The HIV/AIDS strategic plan of South Africa, a middle-income country with the world's largest national ART programme, envisions increasing reliance on nurses for monitoring of ART.20 With increasing deployment of nurses for HIV care, operational research is urgently needed to establish whether nurse-led models of care are safe and effective.
We therefore compared outcomes of nurse versus doctor management of doctor-initiated ART care for HIV-infected patients.
Section snippets
Study design and population
This prospective, unblinded, randomised controlled study was a community-based ART strategy trial done as part of the Comprehensive International Program for Research in AIDS in South Africa (CIPRA-SA).21 The trial was undertaken between Feb 25, 2005, and Jan 20, 2009, at two primary health-care sites in South African townships: Masiphumelele in Cape Town and Soweto in Johannesburg. The CIPRA-SA study compared two treatment monitoring strategies. Participants were allocated to receive either
Results
Figure 1 shows the trial profile. 917 participants were screened for study enrolment, of whom 828 met eligibility criteria and 812 consented and were randomly assigned. Of the 89 patients excluded from the study, 32 did not meet the ART initiation criteria, 22 had acute medical conditions, 18 were considered unsuitable by investigators or did not return, eight had laboratory results out of eligible range, and nine were unable to take oral drugs or were receiving excluded drugs. 804 (99%) study
Discussion
This study reports the findings of a prospective, randomised, controlled study comparing nurse-managed versus doctor-managed ART. A composite endpoint indicative of multiple aspects of ART delivery showed that nurse monitored therapy was not inferior to doctor monitored therapy. These findings lend support to observational data from other treatment programmes reporting successful use of task shifting in HIV care in both resource-limited (South Africa, Rwanda, and Lesotho)28, 29, 30, 31 and
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