eC

EUROPEANCENTREFORDISEASEPREVENTION

ANDCONTROL

EuropeanstandardsofHIV

preventionandcare:

Moduleonpre-exposure

prophylaxis

ECDCOPERATIONALSUPPORT

EuropeanstandardsofHIVpreventionandcare:Moduleonpre-exposureprophylaxis

ii

ThisreportbytheEuropeanCentreforDiseasePreventionandControl(ECDC)wascoordinatedbyTeymurNoori.ThedraftversionwasproducedunderaspecificcontractwiththeEuropeanCentreforDiseasePreventionand

Control(ECDC).TheEuropeanAIDSClinicalSociety(EACS)wasawardedthisspecificcontractunder‘EuropeanstandardsofHIVcare’(servicecontractnumber:ECDC/2022/0210)

ThisreportonstandardsofcareforPre-ExposureProphylaxisisoneinaseriesofstandardsforHIVcare.Other

reportsintheseriescanbefoundonECDC’swebsiteat

https://www.ecdc.europa.eu/en/infectious-disease-

topics/hiv-infection-and-aids/ecdceacs-standards-hiv-care

ECDCwouldliketoacknowledgethesupport,guidance,andqualityassurancethroughoutthedurationofthe

projectprovidedbymembersoftheStandardsofCareAdvisorygroup:AlmaCicic(Montenegro),CarolineHurley(Ireland),CianánRussell(ILGA-Europe),CristinaMussini(Italy),CristianaOprea(Romania),DenizG?kengin

(Türkiye),DominiqueVanBeckhoven(Belgium),FerencBagyinszky(Germany),GeorgBehrens(Germany),JoseBernardino(Spain),OmarSyarif(GNP+),TeymurNoori(ECDC).

ECDCwouldalsoliketothankthetechnicalwritinggroupfortheirtime,energy,andtechnicalexpertiseinthe

draftingoftheStandardsofCare:WritinggroupLeadMitoszParczewski(Poland),AlmaCicic(Montenegro),AnnaKoval(Ukraine),AnnSullivan(UK),BartoszSzetela(Poland),BoguszAksak-W?s(Poland),CarolineHurley

(Ireland),CianánRussell(ILGA-Europe),DenizG?kengin(Türkiye),EvaOrviz(Spain),FerencBagyinszky(Germany),FionaBurns(UK),GeorgBehrens,(Germany),Jean-MichelMolina(France),JessikaDeblonde(Belgium),OmarSyarif(GNP+),PepColl(Spain),SimeZekan(Croatia).

ECDCwouldalsoliketothanktheSoCprojectCoreGroupmembersfortheirdedicatedsupporttopreparingtheapplicationforthisproject,providingday-to-daysupporttotheworkingprocess;AnnSullivan(ExpertEACS),

DanielSim?es(ExpertCommunity),DortheRaben(CHIP),EstebanMartinez(ExpertEACS),FionaBurns(Expert

EACS),JürgenRockstroh(ExpertEACS),JoelleVerluyten(EACS),MitoszParczewski(ExpertEACS),SanjayBhagani(ExpertEACS).

ECDCwouldalsoliketothanktheEuropeanStandardofCareCoordinationteaminEACSandCHIPforjointly

coordinatingtheworkandensuringsupporttoallphasesoftheproject.TheprojectteamconsistsofJoelle

Verluyten(EACS)andDortheRaben(CHIP)includingprojectcoordinators,AnneRaahauge,SusanneOlejas(CHIP)andOlgaFursa(CHIP).

Suggestedcitation:EuropeanCentreforDiseasePreventionandControl.EuropeanstandardsofHIVprevention

andcare:Moduleonpre-exposureprophylaxis.Stockholm:ECDC;2025.

Stockholm,June2025

ISBN978-92-9498-806-5

doi:10.2900/4677371

CataloguenumberTQ-01-25-036-EN-N

?EuropeanCentreforDiseasePreventionandControl,2025

Reproductionisauthorised,providedthesourceisacknowledged

OPERATIONALSUPPORTEuropeanstandardsofHIVpreventionandcare:Moduleonpre-exposureprophylaxis

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Contents

Abbreviations iv

Backgroundandintroduction 5

Methodology 6

1.Accesstopre-exposurePrEP 7

prophylaxis()

2.PrEPaspects 8

initiation,includingsafety

3.Continuumofpre-exposurecareadherenceandpost-exposure 10

prophylaxis(includingprophylaxis)

4.Pre-exposureandcombination 11

prophylaxisdelivery,integratedservices,prevention

5 13

Stafftraining

6.Monitoringandevaluation 14

Applyingthestandards 14

References 15

Annex1.Contributorstotheofthestandards 18

development

Annex2.Overviewofstatements,andtargets 19

qualityindicators,

Tables

Table1.Qualitystatements,andtargetsfor1‘AccesstoPrEP’ 7

indicators,topic

Table2.Qualitystatements,andtargetsfor2‘PrEP 8

indicators,topicinitiation,includingsafetyaspects’

Table3.Qualitystatements,andtargetsfor3‘ContinuumofPrEPcare’ 10

indicators,topic

Table4.Qualitystatements,andservicesandcombinationon’.11

indicators,targetsfortopic4‘PrEPdelivery,integratedpreventi

Table5.Qualitystatements,andtargetsfor5‘Staff 13

indicators,topictraining’

Table6.Qualitystatements,andtargetsfor3‘Monitoringandevaluation’ 14

indicators,topic

EuropeanstandardsofHIVpreventionandcare:Moduleonpre-exposureprophylaxisOPERATIONALSUPPORT

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Abbreviations

AGAdvisoryGroup

ARTAntiretroviraltherapy

CHIPCentreofExcellenceforHealth,Immunity,andInfections

CSOCivilSocietyOrganisation

DOIDeclarationofinterest

EATGEuropeanAIDSTreatmentGroup

ECDCEuropeanCentreforDiseasePreventionandControl

EACSEuropeanAIDSClinicalSociety

EU/EEAEuropeanUnion/EuropeanEconomicArea

FTFFace-To-Face

FTCEmtricitabine

GBMSMGay,bisexual,andothermenwhohavesexwithmen

GNP+GlobalNetworkofPeoplelivingwithHIV

HCPHealthcareprovider

HIV/AIDSHumanImmunodeficiencyVirus/AcquiredImmunodeficiencySyndrome

HAVHepatitisAvirus

HBVHepatitisBvirus

HCVHepatitisCvirus

HPVHumanPapillomaVirus

HMISHealthManagementInformationSystems

IIndicators

IDInfectiousDiseases

iPREXPreexposureProphylaxisInitiative

LAIPrEPLong-actinginjectablePrEP

MpoxMpoxvirus(formerlyMonkeypox)

NFPNationalFocalPoint

NGONon-governmentalorganisation

PLHIVPeoplelivingwithHIV

PrEPPre-exposureprophylaxis

QSQualityStatement

SDGSustainableDevelopmentGoals

SoCStandardsofcare

SRHSexualandReproductiveHealth

STIsSexuallytransmittedinfections

TDFTenofovirDisoproxilFumarate

TDxTenofovirDisoproxil

TAFTenofovirAlafenamide

WHOWorldHealthOrganization

3TCLamivudine

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Backgroundandintroduction

Anestimated2334662peoplearelivingwithHIVinEuropeandCentralAsia,1944695ofwhom(83%;range65–100%)havebeendiagnosed[1].In2023,110486peoplewerediagnosedwithHIVintheWHOEuropeantheregion[2].Ofthesenewdiagnoses,54%weremadeatalatestageofinfection(CD4cellcount<350cells/mm3atthetimeofdiagnosis),including34%withadvancedHIVinfection(CD4cellcount<200cells/mm3)[2].EarlyidentificationofrecentHIVinfectionhelpsdetectpeopleduringaperiodofincreasedtransmissibilityandreducestheriskofspreadofonwardstransmission[3].

Pre-exposureprophylaxis(PrEP)withantiretroviralmedicationsisahighlyeffectivetoolinpreventingnewHIV

infections[4-7].Roll-outoforaltenofovirdisoproxil/emtricitabine(TDx/FTC)basedPrEPeffectivelyreduced

incidenceamongkeypopulationsatsubstantialriskofHIVacquisitionthroughsexualexposure[8-10],butwiderscaleimplementationofPrEPisnecessarytoaccelerateprogresstowardstheUNsustainabledevelopmentgoal3.3ofendingtheAIDSepidemicby2030.

TheimplementationofHIVPrEPhasimprovedsubstantiallysince2016,butthereisstillagreatdealofvariationintheimplementationacrosscountries.In2023,thirty-twocountriesreportedthat203362peoplereceivedPrEPatleastonceinthelast12months.Also,inthisperiod30countriesinEuropeandCentralAsiahaddevelopedand

implementednationalPrEPguidelines,andsystem-fundedPrEPwasavailablethroughthehealthcaresystemof15countries[11].Evenwithinthesecountries,PrEPisnotalwaysfullyavailable,andsomecountriesalsohave

restrictionsaroundeligibility.Forcertainkeypopulations(prisoners,peoplewhoinjectdrugsandundocumentedmigrants),PrEPoftenremainsinaccessibleoronlyavailablethroughprivateclinicsorat-cost.Thiscreatesa

financialbarriertocareforthesepopulations[12].

Bytheendof2023,13countriesinEuropeandCentralAsiahadnotyetformallyimplementedPrEPthroughtheirhealthcaresystems.In15countries,PrEPwasavailableforfreeatpublicfacilitiesandin4countriesPrEPwasfreeiftheindividualhadinsurance.In14countriesPrEPwasavailableatcost[11].PrEPistypicallyprovidedinclinicalsettings,suchasinfectiousdiseaseclinicsandsexualhealthclinics,andinmostcountriesintheWHOEuropean

regionrequiresaprescriptionfromamedicaldoctor.In2022,doctorswereabletoprescribePrEPin36countries,butfourofthesecountriesspecifiedthattheprescribingdoctorhadtobeaninfectiousdiseasespecialist.MembersofthenursingprofessionwereonlyabletoprescribePrEPintwocountries,andpharmacistswerenotableto

prescribePrEPinanyEuropeancountry.Thismaycreatebarrierstoaccessforkeygroups[13].

WhatarestandardsofcareforHIV?

Thestandardsofcare(SoC)forHIVdefinetheexpected,ordesired,qualityofprevention,treatment,andcareforpeopleatriskofHIVacquisitionorlivingwithHIV.

Thestandardsarebasedonascientificrationale,aswellastheresponsibilitiesofeachstakeholderandensurethatpeoplereceiveappropriate,high-qualitypreventionandcarethatalignswiththemostup-to-datemedicalknowledgeandethicalstandards.

TheEuropeanCentreforDiseasePreventionandControl(ECDC)inpartnershipwiththeEuropeanAIDSClinicalSociety(EACS)havedevelopedstandardsofcareintheareasofHIVtesting,pre-exposureprophylaxis(PrEP),antenatalscreening,commencementofART,andHIVandco-morbidities(addlinkstoSoCmodules).

Eachstandardisbasedonthefollowingstructure:

1.briefdescriptionoftherationaleforthestandard.

2.qualitystatementsdescribingbestpracticebasedoncurrentguidelines,evidence,andexpertopinion.

3.relatedmeasurableandauditableoutcomeindicatorsusedtoassessthequalityandeffectivenessoftheservices.

4.numericvaluesfordefinedtargets.

Thestandardsareperson-centredintheirapproachwithaspecificfocusonbeingequitable,non-discriminatory,relevant,appropriate,andaccessibleforpeopleatriskoforlivingwithHIV.

Whoistheintendedaudienceofthestandardsofcare?

Thesestandardsofcarearedesignedforthreedistinctaudiences:

?peopleatriskofacquiringHIVorpeoplewhoarelivingwithHIV;

?peopleresponsiblefortheprovisionanddeliveryofHIV-relatedservices(serviceproviders);

?peoplewhohaveresponsibilityforpolicy,guidancedevelopmentandcommissioningorfundingofHIVservices(Commissionersandpublichealthinstitutes).

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Methodology

Anadvisorygroupandtopic-specificwritinggroupsconsistingofrepresentativesfromclinicalcareproviders,publichealthpractitioners,communityorganisationsandpeoplelivingwithHIVfromacrossEuropewereestablished(seeAnnex1).Theadvisorygroupprovidedoverarchingadvicethroughoutthedurationoftheproject,supportedtheprioritisationofmoduleselection,prioritisationofqualitystatementsandindicatorsandreviewedtheSoCmodule.Thetopic-specificwritinggroupshavedevelopedthequalitystatements,indicators,andtargets(underthe

guidanceofanEACSexpertleadwriter),andalsoreviewedthefinalSoCtestingmodule.

Indevelopingthestandard,acombinationofconsensus-buildingtechniques,suchastheRAND/UCLA

AppropriatenessmethodandtheDelphimethod,wereused.TheRANDmethodisaformalconsensustechniquethatcombinesscientificevidencewithexpertopinionstocreateguidelines,recommendations,andquality

indicators,particularlyinhealthcaresettings–thismethodwasusedtoidentifytopicsfortheSoCsandfor

developingqualitystatementsandindicators.TheDelphimethodisastructuredcommunicationprocessthat

gathersexpertopinionsandfacilitatesconsensusthroughmultipleroundsofquestionsandfeedback–thismethodwasusedaspartofthewritinggroupmeetings.

ThemethodologyhasbeendescribedinmoredetailinthemethodpaperonECDC’swebsiteat:

https://www.ecdc.europa.eu/en/infectious-disease-topics/hiv-infection-and-aids/ecdceacs-standards-hiv-care

Qualitystatements,indicators,andtargets

TheSoCforPrEPisdividedintotopicsunderwhichqualitystatementsandindicatorshavebeendeveloped.Thetopicsarelistedbelowfollowedbytherationalesandqualitystatementsdescribingbestpractisesandthe

minimumserviceandcarethatapersonatriskofHIVshouldexpecttobeabletoaccessrelativetoHIVriskorstatusandacrossthelife-course.

Topics

1.AccesstoPrEP

2.PrEPinitiation,includingsafetyaspects

3.ContinuumofPrEPcare(includingadherenceandpost-exposureprophylaxis)

4.PrEPdelivery,integratedservices,andcombinationprevention

5.Stafftraining

6.Monitoringandevaluation

Foreachofthequalitystatementslistedbelow,indicatorsandtargetshavebeendevelopedtosupportmonitoringofthevariousqualitystatements.

Adetailedoverviewofqualitystatements,indicators,numerator,denominator,targets,anddatasourcecanbefoundinAnnex2.

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1.Accesstopre-exposureprophylaxis(PrEP)

Rationale

Pre-exposureprophylaxis(PrEP)access,deliverymethodsandimplementationpracticesarenotablydifferentandnotfullyequitableacrosscountriesrangingfromfullysystem-funded,topartiallyreimbursedtofullypayableor

withlimitedavailability[20,21].Largescale,real-lifeanalysesindicatethatlong-termprotectionprovidedbyPrEPisneededtoreachtheSDGofendingAIDSby2030.However,thereremainsalargeunmetneedforPrEP

implementationwithinthesystem-fundedprogrammesacrosscountriesinEurope[15,16,22].OnlyexpandingequitableaccesstoreachallindividualsinneedofPrEPwouldallowtomeettheUNAIDS2025PrEPtarget,whichiscriticaltoreachingtheSDGgoalof‘endingAIDS’by2030[23,24].

Table1.Qualitystatements,indicators,andtargetsfortopic1‘AccesstoPrEP’

Qualitystatement

1.1AllpeopleatriskofacquiringHIVshouldbeofferedandhaveequitableaccesstoPrEP

Indicator*

1.1PercentageofcountriesofferingPrEP

Target

100%

1.2PercentageofcountriesacrossEuropeprovidingsystem-fundedPrEP.

Target

100%

1.3NumberofcurrentPrEPusersinacountry

Target

Targetstobeestablishedanddefinedfollowingimplementationofaudits

1.4NumberofnewPrEPusersinacountry

Target

Targetstobeestablishedanddefinedfollowingimplementationofaudits

1.5Percentageofcountrieswithavailabilityoflong-actinginjectablePrEP

Target

Targetstobeestablishedanddefinedfollowingimplementationofaudits

1.6PrEP-to-needratio(PnR)foracountryacrosskeypopulations

Target

Targetstobeestablishedanddefinedfollowingimplementationofaudits

*Indicatorshighlightedinboldhavebeenselectedforprioritisationinordertomaximiseacceptabilityandfeasibilityofadoptionandreportingagainstthestandards.

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2.PrEPinitiation,includingsafetyaspects

Rationale

SafetyandavoidingharminpeopleusingPrEPremainsahighpriority[8-10,15]andisamarkerofexcellenceinhealthcarecare.PriortoinitiatingPrEP,itiscriticaltoconsidertheexposurehistoryandriskofrecentlyacquiredHIVinfection.Therefore,itisessentialtoexcludeundiagnosedinfectionsbothatPrEPinitiationandduringfollow-upcare.Forthispurpose,appropriateHIVtestingshouldbeundertakenforthosewithsuspectedorprobable

acuteinfectionusingantigen/antibodycombinationassaysornucleicacidamplificationtesting[8,25-27].Timelydetectionofacute/recentlyacquiredHIVinfectionandinitiationofantiretroviraltherapy(ART),aswellas

identificationofdrug-resistantvariants,isessentialfrombothapopulationandindividualperspective.Suchan

approachaimstoreducetheriskofonwardtransmissionandpreserveeffectivePrEPoptions[28].

Furthermore,delayeddetectionofHIVinfectionwhileonPrEPhasbeenassociatedwithincreasedriskofdrug

resistance,limitingARToptions[29].PrEPusersmayalsobevulnerabletocontractinghepatitisBvirus(HBV),

eventhoughtenofovirbasedagent-useisassociatedwithdecreasedriskofHBVinfection[30].VaccinationagainstHBVremainsawell-establishedandsuccessfulmethodforHBVpreventionandshouldbeaccessibletoallPrEP

users[31].Ontheotherhand,amongpeoplelivingwithchronicHBV,PrEPuseappearssafewhenatriskofnon-adherenceordiscontinuation[32].Also,duetorisk(albeitlow)oftoxicities,especiallyrelatedtokidneyandboneaspectsincasesofTDxuse,relevantbiochemicaltestingstrategiesshouldbeavailableatpredefinedintervalsinadditiontoalternativePrEPoptions(e.g.TAFinindividualswithimpairedkidneyfunction)[8,33].Lastly,TDx/FTChasaprovensafetyprofileinpregnancyandduringthebreastfeedingperiod[34,35].

Table2.Qualitystatements,indicators,andtargetsfortopic2‘PrEPinitiation,includingsafetyaspects’

Qualitystatement

2.1PrEPshouldbeinitiatedwithfullconsiderationofclinicalsafetyincludingreliableexclusionofHIVinfection.

Indicator

2.1Percentageofcountriesfollowinginternational(e.g.EACS)ornationalPrEPsafetyguidelines,thatincludeoptionforalternativePrEPregimensforsafetyreasons

Target

100%

2.2PercentageofPrEPusersolderthan50yearsandwithbaselineeGFR<90withkidneyfunctionassessedatleastannually

Target

90%

2.3PercentageofPrEPuserswithreliable*exclusionofHIVinfectionpriortoinitiatingPrEP

*BaselinenegativeHIVtestforpeoplewithoutrecentriskexposure,repeatedtestingforpeoplewithrecentriskexposureatbaseline

Target

95%

Qualitystatement

3.1AllPrEPusersshouldbetestedforhepatitisBandifnon-immune,effectivelyimmunised.

Indicator

3.1Percentageofcountrieswithsystem-fundedHBVvaccinationavailabletoPrEPusers

Target

100%

3.2PercentageofPrEPuserswithHBVstatusverifiedusing:

a)HBsAg(activereplication),or

b)anti-HBc(past/activeinfection)

Target

90%

80%

3.3PercentageofPrEPuserstestedHBsAbnegativeimmunisedwithHBVvaccination

Target

80%

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Qualitystatement

4.1ClearpathwaysforrapidandreliablediagnosisofHIVaswellasantiretroviraltreatmentinitiationshouldbeensuredforPrEPusers.

Indicator

4.1PercentageofPrEPserviceswithestablishedpathwaysforrapididentificationofHIVinfectionamongPrEPusers

Target

80%

4.2PercentageofPrEPuserswithrecentlyacquiredHIVinfection

Target

--

4.3PercentageofPrEPuserswithrecentlyacquiredHIVinfectioninitiatedonART

Target

95%

Qualitystatement

5.1PriorityresistancetestingforPrEPusersrecentlyinfectedwithHIVshouldbeavailable.

Indicator

5.1PercentageofcountrieswithresistancetestingavailableforPrEPuserswithrecentlyacquiredHIVinfection

Target

100%

5.2PercentageofPrEPuserswithrecentlyacquiredHIVinfectionwhoundergoresistancetestingpriortoARTinitiation

Target

80%

*Indicatorshighlightedinboldhavebeenselectedforprioritisationinordertomaximiseacceptabilityandfeasibilityofadoptionandreportingagainstthestandards.

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3.Continuumofpre-exposureprophylaxis

care(includingadherenceandpost-exposureprophylaxis)

Rationale

SupportingthepatientjourneyalongthecontinuumofPrEPcareandreducingbarrierstoPrEPaccesscontributestoadherenceandpersistenceinPrEPuse.Retentionstrategiesshouldbeoptimised,asPrEPdiscontinuationratesareusuallyhigh[36,37].MajorbarrierstoPrEPpersistenceincludesubstanceuse(includingchemsex),mentalhealthandhousingissues,cost,insurance,andaccesstohealthcare[38].LowPrEPadherenceandcondomlesssexualexposuresmayleadtoHIVacquisition,andmostcasesofHIVacquisitioninpeopletakingPrEPoccurduetoincorrectdrugdosingand/ortoleranceissues.Topromoteoptimaldosing,adherenceshouldbemonitoredandfactorsinfluencingadherence,suchastoleranceissues,shouldbediscussedandaddressed[39].

Non-adherentpopulationsmaybenefitfrompost-exposureprophylaxis(PEP)asanadditionalpreventivemeasure[8].SuboptimalTDx/FTCPrEPadherenceisclearlydefinedacrossguidelines,allowingfortheidentificationofnon-adherentPrEPuserswhoshouldbeofferedPEPassoonaspossible,butnotlaterthan72hoursafterexposure.PEPinitiationinPrEP-na?veindividualsshouldbeseenasanopportunitytofollowPEPimmediatelywithaPrEP

offer.TofacilitatePrEPuse,bothon-demandanddailyTDx/FTCdosingstrategiesmaybeusedinterchangeablyamongcisgendermenbasedonindividualrisk,tolerance,medicalhistory,andfinancialcapabilities.BothdosingstrategieshavebeenproventobehighlyeffectiveinreducingtheratesofHIVacquisition[40].However,for

transgenderpopulations,optimaldosingstrategies(on-demandorcontinuous)shouldbedecidedindividuallybasedontheactualpersonalriskandconcomitantuseofgender-affirmingtherapies.

Table3.Qualitystatements,indicators,andtargetsfortopic3‘ContinuumofPrEPcare’

Qualitystatement

6.1PrEPadherenceshouldbeassessedandaddressedroutinelywheneverPrEPisdispensed.

Indicator

6.1PercentageofpeopleonPrEPwithdocumentationofadherenceassessment

Target

80%

Qualitystatement

7.1Formen,continuousdailyandon-demandPrEPdosingshouldbeavailableinterchangeablyandindividualisedinlinewithrelevantguidelines.

Indicator

7.1Percentageofcountrieswithavailabilityofbothcontinuousandon-demandPrEP

Target

100%

Qualitystatement

8.1Intheeventofhigh-risksexualexposurewithoutappropriatePrEPuse,systemfundedHIVpost-exposureprophylaxis(PEP)shouldbeimmediatelyavailable.

Indicator

8.1PercentageofcountrieswithavailabilityofsystemfundedPEPforhigh-risksexualexposures

Target

100%

*Indicatorshighlightedinboldhavebeenselectedforprioritisationinordertomaximiseacceptabilityandfeasibilityofadoptionandreportingagainstthestandards.

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4.Pre-exposureprophylaxiscaredelivery,integratedservices,andcombination

prevention

Rationale

CombinationpreventionapproacheshaveresultedinanincreaseofPrEPuse[15].ToexpandeffectivePrEPuse,itisvitaltoimplementcombinationpreventionintegratingavarietyofsexualhealth-relatedservices,including

testing,vaccination,counselling,simplifyingandindividualisingaccesswithconsiderationofthelocalpopulation

needs.AwidearrayofmodelsforPrEPdeliveryhavebeensuccessfullyestablishedworldwide.Theseinclude,butarenotlimitedto,deliveryinspecialistclinics(infectiousdiseaseandHIVunits,STI/genitourinaryclinics),primarycarecentres,sexualhealthcentres,community-basedorganisations(checkpoints).Inmostsettings,however,PrEPishighlymedicalised.Thereisasignificantbenefitfromawideofferofdeliveryapproachesthatcommonlyhaveconvenientopeninghours[41,42].Integrationwithsexualandreproductivehealth(SRH)serviceshasalsobeenshowntoimproveeffectiveuseofPrEP[16,21].Suchintegrationbringsexpandedskillsdevelopmentanda

reductioninworkload[15]andthereforeimprovedefficiency.

NovelPrEPdeliverymethods,suchastheuseoftelemedicineandonlinecommunicationtechnologiestocreate

virtualplatformsfordeliveringPrEPservices,havethepotentialtoremovebarriersforPrEPuptakeandpersistenceandsupportitseffectiveuse[43].Onlyvirtualtoolsthataresecure,ensureconfidentialityandhavebeenfully

evaluatedinrelationtoaccessanduseshouldbeimplemented.Theprinciplesofgoodclinicalpracticeneedtobemaintainedregardlessofwhichpathwayofdeliveryischosen.Inordertooptimiseclinicalandpublichealth

outcomesforHIVandotherSTIsduringthefollow-upperiod,relevantSTItestingshouldbeintegratedinPrEP

carestrat