Study protocol

Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol

Lara R Fairall^1,2 , Max O Bachmann³ , Merrick F Zwarenstein⁴ , Carl J Lombard⁵ , Kerry Uebel¹ , Cloete van Vuuren⁶ , Dewald Steyn⁶ , Andrew Boulle⁷ and Eric D Bateman^1,2

¹Knowledge Translation Unit, University of Cape Town Lung Institute, PO Box 34560, Groote Schuur 7937, South Africa

²Department of Medicine, University of Cape Town, PO Box 34560, Groote Schuur 7937, South Africa

³School of Medicine, Health Policy & Practice, University of East Anglia, Norwich NR47TJ, UK

⁴Li Ka Shing Knowledge Institute, St Michaels Hospital, Department of Health, Policy, Management and Evaluation, University of Toronto, Toronto, Canada

⁵Medical Research Council, Francie van Zijl Drive, Parowvallei, PO Box 19070, Tygerberg 7505, South Africa

⁶Department of Medicine, University of the Free State, P.O. Box 339, Bloemfontein 9300, South Africa

⁷School of Public Health and Family Medicine, University of Cape Town, Observatory 7925, South Africa

author email corresponding author email

Trials 2008, 9:21doi:10.1186/1745-6215-9-21

Published:	23 April 2008

Abstract

Background

A major barrier to accessing free government-provided antiretroviral treatment (ART) in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults.

Methods/design

This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART) for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a) 7400 registering with the programme with CD4 counts of ≤ 350 cells/mL (mainly to evaluate treatment initiation) and b) 4900 already receiving ART (to evaluate ongoing treatment and monitoring). The primary outcomes will be time to death (in the first group) and viral suppression (in the second group). Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register.

Trial registration

Controlled Clinical Trials ISRCTN46836853