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

 

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dc.contributor.author Fairall, Lara en_ZA
dc.contributor.author Bachmann, Max en_ZA
dc.contributor.author Zwarenstein, Merrick en_ZA
dc.contributor.author Lombard, Carl en_ZA
dc.contributor.author Uebel, Kerry en_ZA
dc.contributor.author van Vuuren, Cloete en_ZA
dc.contributor.author Steyn, Dewald en_ZA
dc.contributor.author Boulle, Andrew en_ZA
dc.contributor.author Bateman, Eric en_ZA
dc.date.accessioned 2015-10-28T06:53:16Z
dc.date.available 2015-10-28T06:53:16Z
dc.date.issued 2008 en_ZA
dc.identifier.citation Fairall, L. R., Bachmann, M. O., Zwarenstein, M. F., Lombard, C. J., Uebel, K., van Vuuren, C., ... & Bateman, E. D. (2008). Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol. Trials, 9(1), 21. en_ZA
dc.identifier.uri http://hdl.handle.net/11427/14435
dc.identifier.uri http://dx.doi.org/10.1186/1745-6215-9-21
dc.description.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 [less than or equal to] 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 en_ZA
dc.language.iso eng en_ZA
dc.publisher BioMed Central Ltd en_ZA
dc.rights This is an Open Access article distributed under the terms of the Creative Commons Attribution License en_ZA
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en_ZA
dc.source Trials en_ZA
dc.source.uri http://www.trialsjournal.com/ en_ZA
dc.subject.other HIV en_ZA
dc.subject.other Vaccine trials en_ZA
dc.title Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol en_ZA
dc.type Journal Article en_ZA
dc.rights.holder 2008 Fairall et al; licensee BioMed Central Ltd. en_ZA
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Division of Pulmonology en_ZA
uct.type.filetype Text
uct.type.filetype Image
dc.identifier.apacitation Fairall, L., Bachmann, M., Zwarenstein, M., Lombard, C., Uebel, K., van Vuuren, C., ... Bateman, E. (2008). Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol. <i>Trials</i>, http://hdl.handle.net/11427/14435 en_ZA
dc.identifier.chicagocitation Fairall, Lara, Max Bachmann, Merrick Zwarenstein, Carl Lombard, Kerry Uebel, Cloete van Vuuren, Dewald Steyn, Andrew Boulle, and Eric Bateman "Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol." <i>Trials</i> (2008) http://hdl.handle.net/11427/14435 en_ZA
dc.identifier.vancouvercitation Fairall L, Bachmann M, Zwarenstein M, Lombard C, Uebel K, van Vuuren C, et al. Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol. Trials. 2008; http://hdl.handle.net/11427/14435. en_ZA
dc.identifier.ris TY - Journal Article AU - Fairall, Lara AU - Bachmann, Max AU - Zwarenstein, Merrick AU - Lombard, Carl AU - Uebel, Kerry AU - van Vuuren, Cloete AU - Steyn, Dewald AU - Boulle, Andrew AU - Bateman, Eric AB - 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 [less than or equal to] 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 DA - 2008 DB - OpenUCT DO - 10.1186/1745-6215-9-21 DP - University of Cape Town J1 - Trials LK - https://open.uct.ac.za PB - University of Cape Town PY - 2008 T1 - Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol TI - Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol UR - http://hdl.handle.net/11427/14435 ER - en_ZA


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