Streamlining tasks and roles to expand treatment and care for HIV : randomised controlled trial protocol
Date
2008
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central, London, GB
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.
Description
item.page.type
Journal Article (peer-reviewed)
item.page.format
Text
Keywords
EVALUATION, TASK SHIFTING, AIDS, HIV TREATMENT, INFORMATION TECHNOLOGY, MEDICAL RECORDS, SOUTH AFRICA