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TitleSame-day HIV testing with initiation of antiretroviral therapy versus standard care for persons
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RESEARCHARTICLESame-dayHIVtestingwithinitiationofantiretroviraltherapyversusstandardcareforpersonslivingwithHIV:ArandomizedunblindedtrialSerenaP.Koenig1,2,NancyDorvil1,JessyG.DeÂvieux3,BethanyL.Hedt-Gauthier4,CynthiaRiviere1,MikerlyneFaustin1,KerlyneLavoile1,ChristianPerodin1,AlexandraApollon1,LimatheDuverger1,MargaretL.McNairy5,6,KellyA.Hennessey1,AriadneSouroutzidis7,Pierre-YvesCremieux7,PatriceSevere1,JeanW.Pape1,51HaitianStudyGroupforKaposi'sSarcomaandOpportunisticInfections(GHESKIO),Port-au-Prince,Haiti,2DivisionofGlobalHealthEquity,BrighamandWomen'sHospital,Boston,Massachusetts,UnitedStatesofAmerica,3AIDSPreventionProgram,FloridaInternationalUniversity,Miami,Florida,UnitedStatesofAmerica,4DepartmentofGlobalHealthandSocialMedicine,HarvardMedicalSchool,HarvardUniversity,Boston,Massachusetts,UnitedStatesofAmerica,5CenterforGlobalHealth,DepartmentofMedicine,WeillCornellMedicalCollege,CornellUniversity,NewYork,NewYork,UnitedStatesofAmerica,6DivisionofGeneralInternalMedicine,DepartmentofMedicine,WeillCornellMedicalCollege,CornellUniversity,NewYork,NewYork,UnitedStatesofAmerica,7AnalysisGroup,Boston,Massachusetts,UnitedStatesofAmerica
[email protected]dfromHIVtestingtoantiretroviraltherapy(ART)initiationishighworldwide.Weassessedwhethersame-dayHIVtestingandARTinitiationimprovesreten-tionandvirologicsuppression.MethodsandfindingsWeconductedanunblinded,randomizedtrialofstandardARTinitiationversussame-dayHIVtestingandARTinitiationamongeligibleadults18yearsoldwithWorldHealthOrgani-zationStage1or2diseaseandCD4count500cells/mm3.ThestudywasconductedamongoutpatientsattheHaitianGroupfortheStudyofKaposi'sSarcomaandOpportunisticinfections(GHESKIO)ClinicinPort-au-Prince,Haiti.Participantswererandomlyassigned(1:1)tostandardARTinitiationorsame-dayHIVtestingandARTinitiation.ThestandardgroupinitiatedART3weeksafterHIVtesting,andthesame-daygroupinitiatedARTonthedayoftesting.Theprimarystudyendpointwasretentionincare12monthsafterHIVtestingwithHIV-1RNA
50copies/ml.Weassessedtheimpactoftreatmentarmwithamodifiedintention-to-treatanalysis,usingmultivariablelogisticregressioncontrollingforpotentialcon-founders.BetweenAugust2013andOctober2015,762participantswereenrolled;59partic-ipantstransferredtootherclinicsduringthestudyperiod,andwereexcludedasperprotocol,leaving356inthestandardand347inthesame-dayARTgroups.InthestandardARTPLOSMedicine|https://doi.org/10.1371/journal.pmed.1002357July25,20171/15a1111111111a1111111111a1111111111a1111111111a1111111111

Citation:KoenigSP,DorvilN,DeÂvieuxJG,Hedt-GauthierBL,RiviereC,FaustinM,etal.(2017)Same-dayHIVtestingwithinitiationofantiretroviraltherapyversusstandardcareforpersonslivingwithHIV:Arandomizedunblindedtrial.PLoSMed14(7):e1002357.https://doi.org/10.1371/journal.pmed.1002357AcademicEditor:ElvinH.Geng,UniversityofCalifornia,SanFrancisco,UNITEDSTATESReceived:January24,2017Accepted:June16,2017Published:July25,2017Copyright:
2017Koenigetal.ThisisanopenaccessarticledistributedunderthetermsoftheCreativeCommonsAttributionLicense,whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalauthorandsourcearecredited.DataAvailabilityStatement:WehaveincludedtheanonymizeddatasetasaSupportingInformationfile(S1Data).Funding:ThisprojectwassupportedbytheNationalInstituteofAllergyandInfectiousDiseases,grantnumberR01AI104344.Thefunderhadnoroleinstudydesign,datacollectionandanalysis,decisiontopublish,orpreparationofthemanuscript.


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group,156(44%)participantswereretainedincarewith12-monthHIV-1RNA
50copies,and184(52%)had
1,000copies/ml;20participants(6%)died.Inthesame-dayARTgroup,184(53%)participantswereretainedwithHIV-1RNA
50copies/ml,and212(61%)had
1,000copies/ml;10(3%)participantsdied.Theunadjustedriskratio(RR)ofbeingretainedat12monthswithHIV-1RNA
50copies/mlwas1.21(95%CI:1.04,1.38;p=0.015)forthesame-dayARTgroupcomparedtothestandardARTgroup,andtheunadjustedRRforbeingretainedwithHIV-1RNA
1,000copieswas1.18(95%CI:1.04,1.31;p=0.012).Themainlimitationofthisstudyisthatitwasconductedatasingleurbanclinic,andthegeneraliz-abilitytoothersettingsisuncertain.ConclusionsSame-dayHIVtestingandARTinitiationisfeasibleandbeneficialinthissetting,asitimprovesretentionincarewithvirologicsuppressionamongpatientswithearlyclinicalHIVdisease.TrialregistrationThisstudyisregisteredwithClinicalTrials.govnumberNCT01900080AuthorsummaryWhywasthisstudydone?·Multiplevisitsforcounseling,laboratorytesting,andotherprocedurestopreparepatientsforinitiationofantiretroviraltherapy(ART)areburdensomeandcontributetothehighrateofattritionduringtheperiodfromHIVtestingtoARTinitiation.·TheWorldHealthOrganization(WHO)recentlychangedtheirguidelinestorecom-mendARTforallpersonslivingwithHIV,facilitatingARTinitiation.·ThisstudywasconductedtodetermineifARTinitiationonthedayofHIVdiagnosiscouldimprovetreatmentinitiationrates,retentionincare,andHIVviralsuppressionforpatientswithasymptomaticorminimallysymptomaticHIVdisease.Whatdidtheresearchersdoandfind?·WerandomlyassignedpatientswhopresentedforHIVtestingataclinicinPort-au-Prince,HaititostandardARTinitiationorsame-dayHIVtestingandARTinitiation(356inthestandardand347inthesame-daygroups).·Thestandardgrouphad3weeklyvisitswithasocialworkerandphysicianandthenstartedART21daysafterthedateofHIVdiagnosis;thesame-dayARTgroupinitiatedARTonthedayofHIVdiagnosis.·Allparticipantsinthesame-dayARTgroupand92%ofparticipantsinthestandardgroupinitiatedART.Same-dayHIVtestingandantiretroviraltherapyinitiationPLOSMedicine|https://doi.org/10.1371/journal.pmed.1002357July25,20172/15Competinginterests:Theauthorshavedeclaredthatnocompetinginterestsexist.Abbreviations:ART,antiretroviraltherapy;GHESKIO,HaitianGroupfortheStudyofKaposi'sSarcomaandOpportunisticinfections;IQR,interquartilerange;LTFU,losttofollow-up;PPD,purifiedproteinderivative;RR,riskratio;SEARCH,SustainableEastAfricaResearchonCommunityHealth;UNAIDS,TheJointUnitedNationsProgrammeonHIV/AIDS;WHO,WorldHealthOrganization.


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(primaryendpoint),retainedwithHIV-1RNA<1,000copies/ml,retainedregardlessofHIV-1RNA,initiatedART,anddied(secondaryendpoints)at12monthsafterenrollmentusingachi-squaretest.WeconductedmultivariablelogisticregressionincludingallcovariateslistedinTable1tocontrolforanyresidualconfounding.Wepresentunadjustedandadjustedriskratios(RR)with95%confidenceintervals.Becauseofthechangeinenrollmentcriteriamid-study,weconductedasensitivityanalysisthatincludedonlytheparticipantswhomettheorig-inalenrollmentcriteriaofCD4count350cells/mm3.Inresponsetoareviewer'srequest,wealsoplottedretentionincare,regardlessofviralload,forbothgroupsandcomparedthedistri-butionswiththelog-ranktest.ThestudyisregisteredwithClinicalTrials.govnumberNCT01900080.ResultsAtotalof821patientswerescreened,and762wereenrolledinthestudyandunderwentran-domization(Fig2).Afterrandomization,59participants(28inthestandardARTand31insame-dayARTgroup)transferredtoanotherclinicandwereexcludedfromallanalyses,asperprotocol.Themedianagewas37yearsold(IQR:30±45years),347(49%)werewomen,andthemedianCD4countwas248cells/mm3(IQR:148,345).Ofthe356participantsinthestandardgroup,256(72%)wereretainedincare,20(6%)died,and80(23%)wereLTFU(Table2).Amongthe256participantsretainedinthestandardARTgroup,156(61%ofretainedand44%overall)hadHIV-1RNA<50copies/ml.Ofthe347participantsinthesame-dayARTgroup,277(80%)wereretainedincare,10(3%)died,and60(17%)wereLTFU.Amongthe277participantsretainedinthesame-dayARTgroup,184Table1.Baselinecharacteristicsofstudyparticipantsbygroup.CharacteristicStandardGroup(n=356)Same-DayARTGroup(n=347)Age(years)ÐMedian(IQR)37(30,45)37(29,46)FemalesexÐno.(%)181(51)166(48)EducationÐno.(%)Noschool90(25)93(27)Primaryschool110(31)111(32)Secondaryschoolormore156(44)143(41)IncomeÐno.(%)Noincome92(26)90(26)
$0to$1/day176(49)159(46)
$1to$2/day67(19)76(22)
$2/day21(6)22(6)MaritalstatusÐno.(%)Single71(20)71(20)Currentlymarried/livingwithpartner222(62)211(61)Formerlymarried63(18)65(19)WHOStageÐno.(%)WHOStage1117(33)101(29)WHOStage2239(67)246(71)CD4count(cells/mm3)ÐMedian(IQR)247(150,349)249(143,336)BodymassindexÐMedian(IQR)
21.6(19.7,23.9)20.9(19.3,23.5)
Bodymassindexdifferedsignificantlybetweenthe2groups(p=0.025).ART,antiretroviraltherapy;IQR,interquartilerange,WHO,WorldHealthOrganization.https://doi.org/10.1371/journal.pmed.1002357.t001Same-dayHIVtestingandantiretroviraltherapyinitiationPLOSMedicine|https://doi.org/10.1371/journal.pmed.1002357July25,20177/15


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(66%ofretainedand53%overall)hadHIV-1RNA<50copies/ml.TheunadjustedRRofbeingretainedincareat12monthsandachievingHIV-1RNA<50copies/mlwas1.21(95%CI:1.04,1.38;
=0.015)forthesame-dayARTgroupcomparedtothestandardgroup(Table3);theadjustedRRforthiscomparisonwas1.24(95%CI:1.06,1.41;
=0.008).Fig2.Screening,randomization,andfollow-up.https://doi.org/10.1371/journal.pmed.1002357.g002Same-dayHIVtestingandantiretroviraltherapyinitiationPLOSMedicine|https://doi.org/10.1371/journal.pmed.1002357July25,20178/15


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