Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial

Summary

Background

Expanded access to combination antiretroviral therapy (ART) in resource-poor settings is dependent on task shifting from doctors to other health-care providers. We compared outcomes of nurse versus doctor management of ART care for HIV-infected patients.

Methods

This randomised non-inferiority trial was undertaken at two South African primary-care clinics. HIV-positive individuals with a CD4 cell count of less than 350 cells per μL or WHO stage 3 or 4 disease were randomly assigned to nurse-monitored or doctor-monitored ART care. Patients were randomly assigned by stratified permuted block randomisation, and neither the patients nor those analysing the data were masked to assignment. The primary objective was a composite endpoint of treatment-limiting events, incorporating mortality, viral failure, treatment-limiting toxic effects, and adherence to visit schedule. Analysis was by intention to treat. Non-inferiority of the nurse versus doctor group for cumulative treatment failure was prespecified as an upper 95% CI for the hazard ratio that was less than 1·40. This study is registered with ClinicalTrials.gov, number NCT00255840.

Findings

408 patients were assigned to doctor-monitored ART care and 404 to nurse-monitored ART care; all participants were analysed. 371 (46%) patients reached an endpoint of treatment failure: 192 (48%) in the nurse group and 179 (44%) in the doctor group. The hazard ratio for composite failure was 1·09 (95% CI 0·89–1·33), which was within the limits for non-inferiority. After a median follow-up of 120 weeks (IQR 60–144), deaths (ten vs 11), virological failures (44 vs 39), toxicity failures (68 vs 66), and programme losses (70 vs 63) were similar in nurse and doctor groups, respectively.

Interpretation

Nurse-monitored ART is non-inferior to doctor-monitored therapy. Findings from this study lend support to task shifting to appropriately trained nurses for monitoring of ART.

Funding

National Institutes of Health; United States Agency for International Development; National Institute of Allergy and Infectious Diseases.

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.