Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial
Summary Background Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Role...
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| Veröffentlicht in: | The Lancet (British edition) 2012-09, Vol.380 (9845), p.889-898 |
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| creator | Fairall, Lara, PhD Bachmann, Max O, Prof Lombard, Carl, PhD Timmerman, Venessa, MSc Uebel, Kerry, MBChB Zwarenstein, Merrick, PhD Boulle, Andrew, PhD Georgeu, Daniella, Dip Nursing Colvin, Christopher J, PhD Lewin, Simon, PhD Faris, Gill, Dip General Nursing Cornick, Ruth, MBChB Draper, Beverly, MBChB Tshabalala, Mvula, MBChB Kotze, Eduan, PhD van Vuuren, Cloete, MBChB Steyn, Dewald, MBChB Chapman, Ronald, MMed Bateman, Eric, Prof |
| description | Summary Background Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care. Methods We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads ( |
| doi_str_mv | 10.1016/S0140-6736(12)60730-2 |
| format | Article |
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We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care. Methods We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (<400 copies per mL) 12 months after enrolment (equivalence analysis, prespecified difference <6%). Patients and clinicians could not be masked to group assignment. The interim analysis was blind, but data analysts were not masked after the database was locked for final analysis. Analyses were done by intention to treat. This trial is registered, number ISRCTN46836853. Findings 5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group, and 3862 in cohort 1 and 3202 in cohort 2 were in the control group. Median follow-up was 16·3 months (IQR 12·2–18·0) in cohort 1 and 18·0 months (18·0–18·0) in cohort 2. In cohort 1, 997 (20%) of 4943 patients analysed in the intervention group and 747 (19%) of 3862 in the control group with known vital status at the end of the trial had died. Time to death did not differ (hazard ratio [HR] 0·94, 95% CI 0·76–1·15). In a preplanned subgroup analysis of patients with baseline CD4 counts of 201–350 cells per μL, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54–1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76–1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI −2·4 to 4·6). Interpretation Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality. Funding UK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(12)60730-2</identifier><identifier>PMID: 22901955</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adult ; adults ; Anti-HIV Agents - therapeutic use ; Antiretroviral agents ; Biological and medical sciences ; biomedical research ; CD4 Lymphocyte Count ; Clinical trials ; death ; Delivery of Health Care - organization & administration ; Drug Prescriptions - nursing ; Drug therapy ; Female ; General aspects ; Health participants ; HIV ; HIV Infections - drug therapy ; HIV Infections - immunology ; HIV Infections - mortality ; HIV Infections - nursing ; Hospitals ; Human immunodeficiency virus ; Humans ; Internal Medicine ; Intervention ; Male ; Medical personnel ; Medical research ; Medical sciences ; Middle Aged ; Mortality ; nurses ; outreach ; patients ; physicians ; Primary Care Nursing - methods ; Primary Health Care - organization & administration ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; risk ; South Africa - epidemiology ; therapeutics ; Treatment Outcome ; Viral Load</subject><ispartof>The Lancet (British edition), 2012-09, Vol.380 (9845), p.889-898</ispartof><rights>Elsevier Ltd</rights><rights>2012 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2012 Elsevier Ltd. All rights reserved.</rights><rights>2012 Elsevier Ltd. All rights reserved. 2012 Elsevier Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c689t-c83d2c376c4f8bd00cae6035f7fdf1b9ce18cfecb1b2f0465d43f52fd8f1bd313</citedby><cites>FETCH-LOGICAL-c689t-c83d2c376c4f8bd00cae6035f7fdf1b9ce18cfecb1b2f0465d43f52fd8f1bd313</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1082451106?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>230,314,777,781,882,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26345383$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22901955$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fairall, Lara, PhD</creatorcontrib><creatorcontrib>Bachmann, Max O, Prof</creatorcontrib><creatorcontrib>Lombard, Carl, PhD</creatorcontrib><creatorcontrib>Timmerman, Venessa, MSc</creatorcontrib><creatorcontrib>Uebel, Kerry, MBChB</creatorcontrib><creatorcontrib>Zwarenstein, Merrick, PhD</creatorcontrib><creatorcontrib>Boulle, Andrew, PhD</creatorcontrib><creatorcontrib>Georgeu, Daniella, Dip Nursing</creatorcontrib><creatorcontrib>Colvin, Christopher J, PhD</creatorcontrib><creatorcontrib>Lewin, Simon, PhD</creatorcontrib><creatorcontrib>Faris, Gill, Dip General Nursing</creatorcontrib><creatorcontrib>Cornick, Ruth, MBChB</creatorcontrib><creatorcontrib>Draper, Beverly, MBChB</creatorcontrib><creatorcontrib>Tshabalala, Mvula, MBChB</creatorcontrib><creatorcontrib>Kotze, Eduan, PhD</creatorcontrib><creatorcontrib>van Vuuren, Cloete, MBChB</creatorcontrib><creatorcontrib>Steyn, Dewald, MBChB</creatorcontrib><creatorcontrib>Chapman, Ronald, MMed</creatorcontrib><creatorcontrib>Bateman, Eric, Prof</creatorcontrib><title>Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care. Methods We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (<400 copies per mL) 12 months after enrolment (equivalence analysis, prespecified difference <6%). Patients and clinicians could not be masked to group assignment. The interim analysis was blind, but data analysts were not masked after the database was locked for final analysis. Analyses were done by intention to treat. This trial is registered, number ISRCTN46836853. Findings 5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group, and 3862 in cohort 1 and 3202 in cohort 2 were in the control group. Median follow-up was 16·3 months (IQR 12·2–18·0) in cohort 1 and 18·0 months (18·0–18·0) in cohort 2. In cohort 1, 997 (20%) of 4943 patients analysed in the intervention group and 747 (19%) of 3862 in the control group with known vital status at the end of the trial had died. Time to death did not differ (hazard ratio [HR] 0·94, 95% CI 0·76–1·15). In a preplanned subgroup analysis of patients with baseline CD4 counts of 201–350 cells per μL, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54–1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76–1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI −2·4 to 4·6). Interpretation Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality. Funding UK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency.</description><subject>Adult</subject><subject>adults</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral agents</subject><subject>Biological and medical sciences</subject><subject>biomedical research</subject><subject>CD4 Lymphocyte Count</subject><subject>Clinical trials</subject><subject>death</subject><subject>Delivery of Health Care - organization & administration</subject><subject>Drug Prescriptions - nursing</subject><subject>Drug therapy</subject><subject>Female</subject><subject>General aspects</subject><subject>Health participants</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - mortality</subject><subject>HIV Infections - nursing</subject><subject>Hospitals</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Intervention</subject><subject>Male</subject><subject>Medical personnel</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>nurses</subject><subject>outreach</subject><subject>patients</subject><subject>physicians</subject><subject>Primary Care Nursing - methods</subject><subject>Primary Health Care - organization & administration</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>risk</subject><subject>South Africa - epidemiology</subject><subject>therapeutics</subject><subject>Treatment Outcome</subject><subject>Viral Load</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkl1rFDEUhgdR7Fr9CWpAhC10NJ8zs15USvELCoK7Be9CNjnZTTszWZPMQv-JP9fsh1vtTa_mIs955rzJWxQvCX5HMKneTzHhuKxqVo0JPalwzXBJHxUjwmteCl7_fFyMDshR8SzGa4wxr7B4WhxROsFkIsSo-D1T8QbFpbPJ9QvkLVJ9cgFS8GsXVItSAJU66BOywXfIeJ18iCh5tAquU-G21CoA6ocQISLXo6kf0hKd2-C0QuPp7Men2cXXkw9I5QG16FRy-hStVHa30J4i3Q4xQSiD6o3vXASTf-lU-7x4YlUb4cX-e1xcfd6YysvvX75dnF-WumomqdQNM1SzutLcNnODsVZQYSZsbY0l84kG0mgLek7m1Ob4wnBmBbWmyaeGEXZcnO28q2HegdE5aV5N7sNJr5z8_6R3S7nwa8k4p5SyLBjvBcH_GiAmmVNoaFvVgx-iJIQKShtW84dRzCaYNUSIjL65h177IfT5JjLVUC4IwVWmxI7SwccYwB72JlhuaiK3NZGbDkhC5bYmkua5V_-GPkz97UUG3u4BFbVqbX4d7eIdVzEuWLMJ_3rHWeWlWoTMXE0pJgJjQicNw5n4uCMgP-LaQZBRO-g1mNwynaTx7sFlz-4ZdOv63K72Bm4h3t2LjFTinWTjIHRroOwPWiD6Ng</recordid><startdate>20120908</startdate><enddate>20120908</enddate><creator>Fairall, Lara, PhD</creator><creator>Bachmann, Max O, Prof</creator><creator>Lombard, Carl, PhD</creator><creator>Timmerman, Venessa, MSc</creator><creator>Uebel, Kerry, MBChB</creator><creator>Zwarenstein, Merrick, PhD</creator><creator>Boulle, Andrew, PhD</creator><creator>Georgeu, Daniella, Dip Nursing</creator><creator>Colvin, Christopher J, PhD</creator><creator>Lewin, Simon, PhD</creator><creator>Faris, Gill, Dip General Nursing</creator><creator>Cornick, Ruth, MBChB</creator><creator>Draper, Beverly, MBChB</creator><creator>Tshabalala, Mvula, MBChB</creator><creator>Kotze, Eduan, PhD</creator><creator>van Vuuren, Cloete, MBChB</creator><creator>Steyn, Dewald, MBChB</creator><creator>Chapman, Ronald, MMed</creator><creator>Bateman, Eric, Prof</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</general><general>Lancet Publishing Group</general><scope>6I.</scope><scope>AAFTH</scope><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TT</scope><scope>0TZ</scope><scope>0U~</scope><scope>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88C</scope><scope>88E</scope><scope>88G</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>KB~</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope><scope>7U1</scope><scope>7U2</scope><scope>5PM</scope></search><sort><creationdate>20120908</creationdate><title>Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial</title><author>Fairall, Lara, PhD ; Bachmann, Max O, Prof ; Lombard, Carl, PhD ; Timmerman, Venessa, MSc ; Uebel, Kerry, MBChB ; Zwarenstein, Merrick, PhD ; Boulle, Andrew, PhD ; Georgeu, Daniella, Dip Nursing ; Colvin, Christopher J, PhD ; Lewin, Simon, PhD ; Faris, Gill, Dip General Nursing ; Cornick, Ruth, MBChB ; Draper, Beverly, MBChB ; Tshabalala, Mvula, MBChB ; Kotze, Eduan, PhD ; van Vuuren, Cloete, MBChB ; Steyn, Dewald, MBChB ; Chapman, Ronald, MMed ; Bateman, Eric, Prof</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c689t-c83d2c376c4f8bd00cae6035f7fdf1b9ce18cfecb1b2f0465d43f52fd8f1bd313</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>adults</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretroviral agents</topic><topic>Biological and medical sciences</topic><topic>biomedical research</topic><topic>CD4 Lymphocyte Count</topic><topic>Clinical trials</topic><topic>death</topic><topic>Delivery of Health Care - organization & administration</topic><topic>Drug Prescriptions - nursing</topic><topic>Drug therapy</topic><topic>Female</topic><topic>General aspects</topic><topic>Health participants</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - immunology</topic><topic>HIV Infections - mortality</topic><topic>HIV Infections - nursing</topic><topic>Hospitals</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Intervention</topic><topic>Male</topic><topic>Medical personnel</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>nurses</topic><topic>outreach</topic><topic>patients</topic><topic>physicians</topic><topic>Primary Care Nursing - methods</topic><topic>Primary Health Care - organization & administration</topic><topic>Public health. 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Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><collection>Risk Abstracts</collection><collection>Safety Science and Risk</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fairall, Lara, PhD</au><au>Bachmann, Max O, Prof</au><au>Lombard, Carl, PhD</au><au>Timmerman, Venessa, MSc</au><au>Uebel, Kerry, MBChB</au><au>Zwarenstein, Merrick, PhD</au><au>Boulle, Andrew, PhD</au><au>Georgeu, Daniella, Dip Nursing</au><au>Colvin, Christopher J, PhD</au><au>Lewin, Simon, PhD</au><au>Faris, Gill, Dip General Nursing</au><au>Cornick, Ruth, MBChB</au><au>Draper, Beverly, MBChB</au><au>Tshabalala, Mvula, MBChB</au><au>Kotze, Eduan, PhD</au><au>van Vuuren, Cloete, MBChB</au><au>Steyn, Dewald, MBChB</au><au>Chapman, Ronald, MMed</au><au>Bateman, Eric, Prof</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2012-09-08</date><risdate>2012</risdate><volume>380</volume><issue>9845</issue><spage>889</spage><epage>898</epage><pages>889-898</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care. Methods We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (<400 copies per mL) 12 months after enrolment (equivalence analysis, prespecified difference <6%). Patients and clinicians could not be masked to group assignment. The interim analysis was blind, but data analysts were not masked after the database was locked for final analysis. Analyses were done by intention to treat. This trial is registered, number ISRCTN46836853. Findings 5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group, and 3862 in cohort 1 and 3202 in cohort 2 were in the control group. Median follow-up was 16·3 months (IQR 12·2–18·0) in cohort 1 and 18·0 months (18·0–18·0) in cohort 2. In cohort 1, 997 (20%) of 4943 patients analysed in the intervention group and 747 (19%) of 3862 in the control group with known vital status at the end of the trial had died. Time to death did not differ (hazard ratio [HR] 0·94, 95% CI 0·76–1·15). In a preplanned subgroup analysis of patients with baseline CD4 counts of 201–350 cells per μL, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54–1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76–1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI −2·4 to 4·6). Interpretation Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality. Funding UK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>22901955</pmid><doi>10.1016/S0140-6736(12)60730-2</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2012-09, Vol.380 (9845), p.889-898 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3442223 |
| source | MEDLINE; Elsevier ScienceDirect Journals; ProQuest Central UK/Ireland |
| subjects | Adult adults Anti-HIV Agents - therapeutic use Antiretroviral agents Biological and medical sciences biomedical research CD4 Lymphocyte Count Clinical trials death Delivery of Health Care - organization & administration Drug Prescriptions - nursing Drug therapy Female General aspects Health participants HIV HIV Infections - drug therapy HIV Infections - immunology HIV Infections - mortality HIV Infections - nursing Hospitals Human immunodeficiency virus Humans Internal Medicine Intervention Male Medical personnel Medical research Medical sciences Middle Aged Mortality nurses outreach patients physicians Primary Care Nursing - methods Primary Health Care - organization & administration Public health. Hygiene Public health. Hygiene-occupational medicine risk South Africa - epidemiology therapeutics Treatment Outcome Viral Load |
| title | Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial |
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