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

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dc.contributor.authorFairall, Laraen_ZA
dc.contributor.authorBachmann, Maxen_ZA
dc.contributor.authorZwarenstein, Merricken_ZA
dc.contributor.authorLombard, Carlen_ZA
dc.contributor.authorUebel, Kerryen_ZA
dc.contributor.authorvan Vuuren, Cloeteen_ZA
dc.contributor.authorSteyn, Dewalden_ZA
dc.contributor.authorBoulle, Andrewen_ZA
dc.contributor.authorBateman, Ericen_ZA
dc.date.accessioned2015-10-28T06:53:16Z
dc.date.available2015-10-28T06:53:16Z
dc.date.issued2008en_ZA
dc.description.abstractBACKGROUND: 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 ISRCTN46836853en_ZA
dc.identifier.apacitationFairall, 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/11427/14435en_ZA
dc.identifier.chicagocitationFairall, 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/11427/14435en_ZA
dc.identifier.citationFairall, 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.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
dc.identifier.urihttp://hdl.handle.net/11427/14435
dc.identifier.urihttp://dx.doi.org/10.1186/1745-6215-9-21
dc.identifier.vancouvercitationFairall 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.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDivision of Pulmonologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2008 Fairall et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceTrialsen_ZA
dc.source.urihttp://www.trialsjournal.com/en_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherVaccine trialsen_ZA
dc.titleStreamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocolen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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