Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland's public sector health system: study protocol for a stepped-wedge randomized trial.
Identifieur interne : 000B98 ( PubMed/Curation ); précédent : 000B97; suivant : 000B99Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland's public sector health system: study protocol for a stepped-wedge randomized trial.
Auteurs : Fiona J. Walsh [États-Unis] ; Till B Rnighausen [États-Unis] ; Wim Delva [Afrique du Sud] ; Yvette Fleming [Pays-Bas] ; Gavin Khumalo [Swaziland] ; Charlotte L. Lejeune [Swaziland] ; Sikhathele Mazibuko [Swaziland] ; Charmaine Khudzie Mlambo [Swaziland] ; Ria Reis [Pays-Bas] ; Donna Spiegelman [États-Unis] ; Mandisa Zwane [Zimbabwe] ; Velephi Okello [Swaziland]Source :
- Trials [ 1745-6215 ] ; 2017.
Abstract
There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as "treatment as prevention" or "universal test and treat") is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's public sector health system.
DOI: 10.1186/s13063-017-2128-8
PubMed: 28821264
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Walsh</name><affiliation wicri:level="1"><nlm:affiliation>Clinton Health Access Initiative, Boston, MA, USA. fwalsh@clintonhealthaccess.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Clinton Health Access Initiative, Boston, MA</wicri:regionArea></affiliation></author><author><name sortKey="B Rnighausen, Till" sort="B Rnighausen, Till" uniqKey="B Rnighausen T" first="Till" last="B Rnighausen">Till B Rnighausen</name><affiliation wicri:level="1"><nlm:affiliation>Harvard T.H. Chan School of Public Health, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Harvard T.H. Chan School of Public Health, Boston, MA</wicri:regionArea></affiliation></author><author><name sortKey="Delva, Wim" sort="Delva, Wim" uniqKey="Delva W" first="Wim" last="Delva">Wim Delva</name><affiliation wicri:level="1"><nlm:affiliation>The South African Department of Science and Technology - National Research Foundation (DST-NRF) Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>The South African Department of Science and Technology - National Research Foundation (DST-NRF) Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch</wicri:regionArea></affiliation></author><author><name sortKey="Fleming, Yvette" sort="Fleming, Yvette" uniqKey="Fleming Y" first="Yvette" last="Fleming">Yvette Fleming</name><affiliation wicri:level="1"><nlm:affiliation>aidsfonds, Amsterdam, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>aidsfonds, Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Khumalo, Gavin" sort="Khumalo, Gavin" uniqKey="Khumalo G" first="Gavin" last="Khumalo">Gavin Khumalo</name><affiliation wicri:level="1"><nlm:affiliation>Swaziland National Network of People Living with HIV/AIDS (SWANNEPHA), Mbabane, Swaziland.</nlm:affiliation><country xml:lang="fr">Swaziland</country><wicri:regionArea>Swaziland National Network of People Living with HIV/AIDS (SWANNEPHA), Mbabane</wicri:regionArea></affiliation></author><author><name sortKey="Lejeune, Charlotte L" sort="Lejeune, Charlotte L" uniqKey="Lejeune C" first="Charlotte L" last="Lejeune">Charlotte L. Lejeune</name><affiliation wicri:level="1"><nlm:affiliation>Clinton Health Access Initiative, Mbabane, Swaziland.</nlm:affiliation><country xml:lang="fr">Swaziland</country><wicri:regionArea>Clinton Health Access Initiative, Mbabane</wicri:regionArea></affiliation></author><author><name sortKey="Mazibuko, Sikhathele" sort="Mazibuko, Sikhathele" uniqKey="Mazibuko S" first="Sikhathele" last="Mazibuko">Sikhathele Mazibuko</name><affiliation wicri:level="1"><nlm:affiliation>Ministry of Health, Mbabane, Swaziland.</nlm:affiliation><country xml:lang="fr">Swaziland</country><wicri:regionArea>Ministry of Health, Mbabane</wicri:regionArea></affiliation></author><author><name sortKey="Mlambo, Charmaine Khudzie" sort="Mlambo, Charmaine Khudzie" uniqKey="Mlambo C" first="Charmaine Khudzie" last="Mlambo">Charmaine Khudzie Mlambo</name><affiliation wicri:level="1"><nlm:affiliation>Clinton Health Access Initiative, Mbabane, Swaziland.</nlm:affiliation><country xml:lang="fr">Swaziland</country><wicri:regionArea>Clinton Health Access Initiative, Mbabane</wicri:regionArea></affiliation></author><author><name sortKey="Reis, Ria" sort="Reis, Ria" uniqKey="Reis R" first="Ria" last="Reis">Ria Reis</name><affiliation wicri:level="1"><nlm:affiliation>University of Amsterdam, Amsterdam, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>University of Amsterdam, Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Spiegelman, Donna" sort="Spiegelman, Donna" uniqKey="Spiegelman D" first="Donna" last="Spiegelman">Donna Spiegelman</name><affiliation wicri:level="1"><nlm:affiliation>Harvard T.H. Chan School of Public Health, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Harvard T.H. Chan School of Public Health, Boston, MA</wicri:regionArea></affiliation></author><author><name sortKey="Zwane, Mandisa" sort="Zwane, Mandisa" uniqKey="Zwane M" first="Mandisa" last="Zwane">Mandisa Zwane</name><affiliation wicri:level="1"><nlm:affiliation>SAfAIDS, Harare, Zimbabwe.</nlm:affiliation><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>SAfAIDS, Harare</wicri:regionArea></affiliation></author><author><name sortKey="Okello, Velephi" sort="Okello, Velephi" uniqKey="Okello V" first="Velephi" last="Okello">Velephi Okello</name><affiliation wicri:level="1"><nlm:affiliation>Ministry of Health, Mbabane, Swaziland.</nlm:affiliation><country xml:lang="fr">Swaziland</country><wicri:regionArea>Ministry of Health, Mbabane</wicri:regionArea></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as "treatment as prevention" or "universal test and treat") is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's public sector health system.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28821264</PMID><DateCreated><Year>2017</Year><Month>08</Month><Day>19</Day></DateCreated><DateRevised><Year>2017</Year><Month>08</Month><Day>22</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>18</Volume><Issue>1</Issue><PubDate><Year>2017</Year><Month>Aug</Month><Day>18</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland's public sector health system: study protocol for a stepped-wedge randomized trial.</ArticleTitle><Pagination><MedlinePgn>383</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-017-2128-8</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as "treatment as prevention" or "universal test and treat") is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's public sector health system.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This is a three-year stepped-wedge randomized design with open enrollment for all adults aged 18 years and older across 14 government-managed health facilities in Swaziland's Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, patient satisfaction, and cost per patient per year. Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each four-month step. This design will result in approximately one half of the total observation time to accrue in the intervention arm and the other half in the control arm. Our estimated enrolment number, which is supported by conservative power calculations, is 4501 patients over the course of the 36-month study period. A multidisciplinary, mixed-methods approach will be adopted to supplement the randomized controlled trial and meet the study aims. Additional study components include implementation science, social science, economic evaluation, and predictive HIV incidence modeling.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">A stepped-wedge randomized design is a causally strong and robust approach to determine if providing antiretroviral treatment for all HIV-positive individuals is a feasible intervention in a resource-limited, public sector health system. We expect our study results to contribute to health policy decisions related to the HIV response in Swaziland and other countries in sub-Saharan Africa.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov, NCT02909218 . Registered on 10 July 2016.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Walsh</LastName><ForeName>Fiona J</ForeName><Initials>FJ</Initials><AffiliationInfo><Affiliation>Clinton Health Access Initiative, Boston, MA, USA. fwalsh@clintonhealthaccess.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bärnighausen</LastName><ForeName>Till</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Harvard T.H. Chan School of Public Health, Boston, MA, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Africa Health Research Institute (AHRI), Mtubatuba, South Africa.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Institute of Public Health, University of Heidelberg, Heidelberg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Delva</LastName><ForeName>Wim</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>The South African Department of Science and Technology - National Research Foundation (DST-NRF) Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Hasselt University, Center for Statistics, Diepenbeek, Belgium.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Ghent University, International Centre for Reproductive Health, Gent, Belgium.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>KU Leuven, Rega Institute for Medical Research, Leuven, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fleming</LastName><ForeName>Yvette</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>aidsfonds, Amsterdam, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Khumalo</LastName><ForeName>Gavin</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Swaziland National Network of People Living with HIV/AIDS (SWANNEPHA), Mbabane, Swaziland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lejeune</LastName><ForeName>Charlotte L</ForeName><Initials>CL</Initials><AffiliationInfo><Affiliation>Clinton Health Access Initiative, Mbabane, Swaziland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mazibuko</LastName><ForeName>Sikhathele</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Ministry of Health, Mbabane, Swaziland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mlambo</LastName><ForeName>Charmaine Khudzie</ForeName><Initials>CK</Initials><AffiliationInfo><Affiliation>Clinton Health Access Initiative, Mbabane, Swaziland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Reis</LastName><ForeName>Ria</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>University of Amsterdam, Amsterdam, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Leiden University Medical Center, Leiden, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Children's Institute, University of Cape Town, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Spiegelman</LastName><ForeName>Donna</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Harvard T.H. Chan School of Public Health, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zwane</LastName><ForeName>Mandisa</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>SAfAIDS, Harare, Zimbabwe.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Okello</LastName><ForeName>Velephi</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Ministry of Health, Mbabane, Swaziland.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>08</Month><Day>18</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2015 Aug 27;373(9):795-807</RefSource><PMID Version="1">26192873</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2012 Oct 4;367(14):1355-60</RefSource><PMID Version="1">23034025</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Trials. 2013 Jul 23;14:230</RefSource><PMID Version="1">23880306</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2011 Aug 11;365(6):493-505</RefSource><PMID Version="1">21767103</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMC Public Health. 2015 Mar 01;15:209</RefSource><PMID Version="1">25880823</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2013 Oct 15;8(10):e77101</RefSource><PMID Version="1">24143205</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMJ Open. 2016 Mar 06;6(3):e009656</RefSource><PMID Version="1">26948960</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMJ. 2012 Sep 04;345:e5661</RefSource><PMID Version="1">22951546</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Contemp Clin Trials. 2007 Feb;28(2):182-91</RefSource><PMID Version="1">16829207</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Trials. 2014 Feb 13;15:57</RefSource><PMID Version="1">24524229</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Epidemiology. 2000 Sep;11(5):561-70</RefSource><PMID Version="1">10955409</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>AIDS. 2016 Aug 24;30(13):2009-20</RefSource><PMID Version="1">27314176</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMJ. 2015 Feb 06;350:h391</RefSource><PMID Version="1">25662947</PMID></CommentsCorrections></CommentsCorrectionsList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Antiretroviral treatment</Keyword><Keyword MajorTopicYN="N">HIV/AIDS</Keyword><Keyword MajorTopicYN="N">Prevention</Keyword><Keyword MajorTopicYN="N">Swaziland</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>11</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>07</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>8</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>8</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>8</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28821264</ArticleId><ArticleId IdType="doi">10.1186/s13063-017-2128-8</ArticleId><ArticleId IdType="pii">10.1186/s13063-017-2128-8</ArticleId><ArticleId IdType="pmc">PMC5563033</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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