OPTIONSCountrySituationAnalysisInterimFindings:Kenya

FSGinpartnershipwithLVCTHealth

FEBRUARY2017

2FEBRUARY2017

OPTIONSIntroductionOneoffivecooperativeagreementsawardedbyUSAIDwithPEPFARfundingthroughRoundThreeoftheAnnualProgramStatement(APS)forMicrobicideResearch,Development,andIntroduction.

TheOPTIONSConsortiumobjectiveistoprovidetargetedsupporttohelpexpediteandsustainaccesstonewARV-basedHIVpreventionproductsincountriesandamongpopulationswheremostneeded.

OPTIONSConsortiumMembers

KENYA

SOUTHAFRICA

ZIMBABWE

3FEBRUARY2017

OPTIONS ConsortiumAims

Developevidence-basedbusinesscasesandacoordinatedinvestmentstrategy forARV-basedpreventionproductintroductiontoensuretimelyglobal,nationalandprivatesectoractiononpriorityareas

AIM1 AIM2 AIM3 AIM4

Providetechnicalassistanceandsupportforhealthsystemsstrengthening(HSS) withrapiduseofdatatoidentifyandaddressimplementationbottlenecksthroughoutthevaluechain

Supportcountrylevel regulatoryapproval,policydevelopment,programplanning,marketingandimplementationstrategiesforARV-basedpreventionproductintroduction

Facilitateandconductimplementationscience(IS)toadvancetheintroductionofandaccesstomicrobicidesandARV-basedpreventiontechnologies

OPTIONScanprovidetargetedsupportacrossitsfourprojectaims:

4FEBRUARY2017

OPTIONSHowWeWork• OPTIONSisnotaservicedelivery project;weapplysystemsthinkingto

supportandaccelerateproductintroduction

• OursupportisflexibleandisdesignedtoberesponsivetonationalcountryprioritiesandplansandwillbeguidedbynationalleadershipthroughNASCOP

• Wehaveastronglocalpartner,LVCTHealth,withsignificantexperienceworkingonHIVpreventionintheKenyacontext

• InadditiontoLVCT,ourconsortiumisabletobringmulti-disciplinaryexpertisetotheefforttointroducefemale-controlledHIVpreventionproductsinKenya

• Wearetakingsignificantstepstoensurewedonotreplicateexistingorongoingwork– ourmissionistofillgapsandhelpanswerkeyquestionsasoutlinedbythenationalgovernment,theUSAIDcountrymission,andotherkeylocalstakeholders

5FEBRUARY2017

• This document includes interim findings from the OPTIONS situation analysis for Kenya,completed by FSG with significant input and consultation from LVCT Health

• The situation analysis aims to take a comprehensive and robust approach to assessing the“state of the field” for PrEP in Kenya, including opportunities and resources as well as gapsand expected challenges

• The situation analysis serves multiple purposes: it provides a basis for country consultationsand stakeholder engagement, it serves as a tool to clarify the roles, activities and investmentsneeded for the successful roll-out of PrEP, and it will inform the development of the OPTIONSinvestment cases for PrEP

• This document reflects findings from secondary research and in-country consultations withkey stakeholders

• This is designed as a “living document,” to serve as a repository for information regardingthe situation of PrEP in Kenya to be updated on an ongoing basis as additional informationbecomes available and progress is made towards the roll-out of PrEP

• If you have any updates, additional information, or follow-up questions regarding thissituation analysis, please email Neeraja Bhavaraju at Neeraja.Bhavaraju@fsg.org

AbouttheSituationAnalysis

6FEBRUARY2017

ExecutiveSummary• Kenyahasmadesignificantstridestowardcreatingpositiveinitialconditionsfortheroll-outofPrEP,:

– PrEPisincludedinKenya’smostrecentKenyaAIDSStrategicFramework(KASF),thePreventionRevolutionRoadmap,andKenya’sFast-trackPlantoendHIVandAIDSamongAdolescentsandYoungPeople

– ThePharmacyandPoisonsBoardhasregisteredTruvada(oralPrEP)forHIVprevention,andPrEPisincludedintheNationalARVGuidelines

– GovernmententitiessuchasNASCOPandNACCaretakingaproactiveroleingeneratinglocal-levelbuy-inforPrEP,engagingdiversesectorsinPrEPplanning,andcooperatingwithkeystakeholdersinthedevelopmentofpoliciesandpracticesforPrEP. AnationalTWGforPrEPandvariousPrEPsub-committeesareinplace

– Potentialtargetpopulationshavebeeninitiallydefined:femalesexworkers(FSW),menhavingsexwithmen(MSM),sero-discordantcouples,adolescentgirlsandyoungwomen(AGYW),amongothers.However,KenyaismotivatedtoprovidePrEPtoallthoseassubstantialongoingriskandhasdevelopedariskassessmentframeworktodefinesuchrisk

– BeginningJanuary2017,PrEPwillbedeliveredthroughBridgetoScaleandDREAMS.ThenationalPrEPprogramwilllaunchofficiallyinMarch2017

• Kenya,throughNASCOPleadership,developedtestandtreatguidelinesin2016thatincludePrEP. Implementation guidelinesareunderdevelopmentandexpectedtobecompletedbyMarch2017andinvolvemulti-sectorparticipation

• ThecurrentstateofthePrEPdiscussionrevolvesaroundimplementationconsiderations:– DesigningandprovidinghealthcareworkertrainingtosupportPrEPdelivery,monitoring,andadherence– FindingkeydeliverychannelsforreachingtargetpopulationswithPrEP(e.g.,comprehensivecarecentersandother

ARTsites,DREAMSdistricts,sexualandreproductivehealth(SHR)sites)– IncreasinguptakewillnecessitateunderstandingtargetpopulationuserpreferencesandPrEPaccessneeds, and

deployingasuccessful nationalcommunicationscampaignforPrEP– DeterminingthecostandimpactofaddingPrEPtopreventionstrategiesfortargetpopulations– Assessingcapacity-buildingneedsfortheintegrationofPrEPintohealthservicesandotherchannels– MonitoringandevaluationofPrEP programanddefiningcommoditysecuritysystemstoensureuninterruptedsupply

• ThemostsignificantcurrentconcernsaboutPrEP include:– Howtoaddressstigmathroughpolicies,communications,andscale-upprocedures– Obtainingdonorcommitmenttosustainablyfundscale-upofPrEP

7FEBRUARY2017

GeographyHighlyconcentratedepidemic- 65%ofnewinfectionsoccurringin9outofthe47counties1:

TrendsHIVincidencehassteadilybeendecreasingatalowrate

HIVinKenyaContext• Kenyahastheworld’sfourthlargestHIVburden,withanestimated1.5millionpeoplelivingwithHIV(prevalenceof5.9%)¹• ~900,000peopleonantiretroviraltherapy(ART)bytheendof2015²,a40%increasefrom20131• NewHIVinfectionsinKenyawerereducedby19%between2013and2015.77,647newinfectionsoccurredin2015• HighlygeographicallyconcentratedHIVburden,thusGovernmentandPEPFAR’sresponsetoHIVisfocusedatthecountylevel

DemographicsKenya’sHIVincidenceisdrivenbyabroadsetofpopulations,includingsignificantcontributionsfromsero-discordantcouplesandadolescentgirlsandyoungwomen(AGYW):NewHIVinfections,20151

AdultHIVincidencerateovertime3

Sources:(1)KenyaAIDSResponseProgressReport,MinistryofHealth,2016;(2)GuidelinesonUseofAntiretroviralDrugsforTreatingandPreventingHIVInfectionsinKenya- 2016Edition;((3)KenyaHIVEstimates2015,NationalAidsControlCouncil,2016

8FEBRUARY2017

RemainingChallenges

• Despitegrowinginvestment,Kenyaisstrugglingwithfinancialsustainability forHIVtreatmentandprevention,andhasbeguntodevelopadditionaldomesticfundingsourcesinlightofsubstantialfundinggapsinrecentyears

• Thecurrenthealthservicesystem faceschallengesinplanning,coordination,andinadequateinfrastructureinvestment,leadingtocapacityconstraintsinHIV-AIDSclinicssuchasashortagesofstaffing,insufficientspace/facilityinfrastructure,andshortagesintestingkits

• PLHIV continuetofacehighlevelsofstigma throughoutthecountry.Thisindicatorhasnotimprovedsince2003

• Currentmessaginganddistributionchannelsareinsufficientforreachingkeypopulations;theGoK willneedtocontinuetoadjustcurrentstrategiesinordertoserveat-riskpopulations,andinvestinyouth-friendlyservices/facilities

• Riskperceptionislowamongcertaintargetpopulations,whichmakespreventionuptakeaconstantchallenge

Context• Throughaheightenedlevelofinvestmentandafocusoncombinationprevention,thegovernmenthasmadesignificantprogressin

reducingthenumberofnewinfections:49%decreaseamongchildren;19%amongadultsbetween2013and2015¹.Infectionsamongyoungpeopleareincreasing- 51%ofadultinfectionsoccurringamongthose15-24comparedto29%in20131

• Giventhesmallerreductioninadultinfections,Kenya’smostcurrentstrategyhasshiftedtowardsfocusingonprioritygeographieswithhigh-incidence,andintegratingthosewhoaredisproportionatelyaffectedbytheepidemic:girls,womenandkeypopulationssuchasFSW,MSM,peoplewhoinjectdrugs(PWID),sero-discordantcouples,andpeopleinprison²

CurrentEfforts

• HighHIV/AIDStreatmentcoverage²in~2000ARTsites:- Mothertochild(78%)- Men(80%)- Women(77%)- Infants/children(42%)

• HighreachofHIVtestingandcounsellingforhigh-riskpopulations,with lowerratesforgeneralpublic²through~5000testingsites:- FSW(68%)- MSM(74%)- PWID(60%)- Women- general(47.3%)- Men- general(35.8%)

• Similarpercentofkeypopulationsnotreceivingtargetedinterventions1:- FSW(33%)- MSM(31%)- PWID(26%)

HIVPrevention&TreatmentinKenya

Sources:(1)(1)KenyaAIDSResponseProgressReport,MinistryofHealth,2016;(2)KenyaPreventionRevolutionRoadmap,MinistryofHealth,2014

9FEBRUARY2017

KeyConsiderationsforPrEP• Achieving national targets: Kenya has committed to addressing the

HIV/AIDS epidemic by setting a high goal for prevention: a 75% reductionin new infections by 2020.¹ However, the rate of reduction for adult HIVtransmission is slow, seeing only a 7% decrease from 2007-2013.¹ At thisrate, Kenya will not meet its goals. The number of new infections will notdecrease unless Kenya targets at-risk populations who are most severelyaffected: FSW, MSM, sero-discordant couples, PWID, AGYW, people inprison, and other marginalized populations.² PrEP could provide aneffective method for these populations who do not use other preventionoptions.

• Combination prevention: Impact models suggest that PrEP use by keypopulations in combination with the currently available set ofinterventions (behaviour change, early ART, male circumcision) wouldavert the highest number of infections. ²

• Equity and human rights: Kenya’s national plan states that “the success ofthe HIV response is dependent on protecting and promoting the rights ofthose who are socially excluded, marginalised and vulnerable.” ¹ Several ofthe high-risk populations for whom PrEP is most appropriate are alsomost discriminated against by Kenyan society. Currently, demonstrationprojects have shown promising results for the demand for PrEP amongthese populations, particularly among MSM and FSW. ³

• PrEP offers a gender-sensitive option for prevention:Women continue tobe disproportionately affected by HIV/AIDS, in particular AGYW ages 15-24. If implemented effectively, PrEP could give women the choice toprotect themselves against infection, regardless of their partner’spreference for sexual activity.

WhyPrEPisunderconsiderationinKenya ContextandquestionsaroundPrEP• Kenya’snationalplans(KASF,Revolution

Roadmap,andFast-trackplans)includeprovisionofPrEPtohigh-riskpopulations

• ThePharmacyandPoisonsBoardapprovedPrEPinDecember2015,nationaltreatmentguidelinesareinplace,andimplementationguidelinesexpected inMarch2017

• AlthoughnationalplansandpoliciesincludeprovisionsforPrEP,questionsremainonconcreteplanstodeliverPrEPtotargetpopulations,planstoencourageandsupportuptake,andfundingforPrEP,especiallyatthecountylevel

• RemainingquestionsaboutthemosteffectivedeliverychannelsforPrEP,aswellasthehealthcaresystemcapacitytoreachkeypopulationsandprovideadditionalPrEP-relatedservices

• FundingforPrEPisstillunclear,yetdonorssuchasGatesandPEPFARhaveshowninitialcommitmentstofundPrEPintroductioninKenya

• PlanningforPrEPwillbeinitiallyfocusedoncountieswithcurrentandplannedPrEPdemonstrationprojects

Sources:(1)KenyaAidsStrategicFramework2014/15-2018/19,MinistryofHealth,2014;(2) KenyaPreventionRevolutionRoadmap,MinistryofHealth,2014;(3)SafetyandAdherencetoIntermittentPre-ExposureProphylaxis(PrEP)forHIV-1inAfricanMenWhoHaveSexwithMenandFemaleSexWorkers,Plos One,2012

10FEBRUARY2017

PlandevelopedtoimplementWHOPrEPguidelinesfortargeted

populations

PrEPproduced,purchased,anddistributedin

sufficientquantitytomeetprojecteddemand

PrEPservicesdeliveredbyappropriatechannelswithaccesstotarget

populations

TargetpopulationsseekandareabletoaccessPrEPandbeginuse

TargetpopulationadherestoPrEPatrecommendedfrequencyand forideal

timeperiod

PLANNINGANDBUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

What’sNeededtoIntroducePrEPOPTIONSaimstotakearobustandcomprehensiveapproachtoanalyzingthesituationaroundPrEP. ThegoalofthisexerciseistoidentifykeybottlenecksandopportunitiestointroduceandscalePrEPeffectively ineachOPTIONScountry.Thisinformationwilleventuallyfeedintotheinvestmentcasesandwillbeusedtoinformandcapturecountryprogress.

Toidentifywhat’sneededforPrEPintroduction,wehaveorganizedtherestofthesituationanalysisalongthePrEPvaluechain,introducedbelow.

ValueChainforPrEP

11FEBRUARY2017

ValueChainAnalysesThefollowingslidesholdthreeanalysesalongthevaluechain

• Resourcesthatexistin-countrytosupportandacceleratePrEPintroduction

• GapsinresourcesthatcouldactasbarrierstoeffectivePrEPintroduction

• Keyconsiderations toinformcomprehensivein-countryplanningforPrEPintroduction

• Alistofspecificfactorsthatneedtobein-placetoeffectivelyintroducePrEPforeachcomponentofthevaluechainalongwithprogressto-dateforeachfactor

• Detailsoncurrentsituation,keyactors,responsibilities,timelinesandprogresstowardseachactivityareincludedintheappendix

• Remainingquestionstoinformin-countrydiscussionsandplanning

• Remainingquestionstoinformongoingmodelling,researchandanalysisefforts

• OpportunitiesforotherpartnerstosupportaccelerationofPrEPintroduction

12FEBRUARY2017

ResourcesandGapsforPrEPinKenya

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

ExpectedStrengths

EmergingKeyConsiderations

•PrEPcoulduseexistingsupplychainsystemsforARVs,butnewdeliverychannelswouldrequireadditionalplanning•Countycoordination andtargetingwillrequireconsideration

•Healthsystemwillneedadditionalcapacity(e.g.,staff,equipment)todeliverPrEP

•ChannelsforPrEP willneedtobeidentifiedfortargetpopulationsincludingAGYW

•OngoingtestingforPrEPusersmayputadditionalstrainonhealthsystemcapacity•Strategiesareneededtoencourageeffectiveuseforeachtargetpopulation

• StigmaisamajorconcernforuptakeinAGYWandsero-discordantcouples

• Awareness/demand forPrEPisunknown;willrequireinvestmentindemandgeneration

• Needforbroad-reachingcommunicationscampaignforPrEP

• ImplicationsofPrEPforAGYWremainuncertain;demonstrationprojectswillprovideadditionaldataandinsights

• Unclearhowmodelingoutputswillinformstrategy

• Sourcesoffinancing forPrEPareuncertain

• Nationalplans callforusingPrEPwithincurrentcombinationpreventionforindividualsatsubstantialongoingriskofHIVinfection

• NASCOP scheduledtolaunchnationalrollout inMarch2017

•Truvadaisregisteredforprevention•PrEPimplementationguidelinesexpectedinMarch2017•ProcurementprocesseshaveeffectivelysuppliedARVswithoutshortagesthroughastronge-system

•CurrentdistributionchannelsforHIVtestingandcounsellingarewidespreadanddiverse•Healthsystemhas highreachofsomeat-riskgroups

•NationalHIVM&Eplantomeasureprogressisinplace.NASCOPandpartnersplantodevelopanationalPrEPM&Eplan•Demoprojectsaregeneratinginsightsoneffectiveuseconcerns

• HighreachandusageofHIVtesting/counsellingservicesforat-riskpopulations

• DemonstrationprojectswillprovideinsightonuserneedsandpreferencesforPrEP

13FEBRUARY2017

Impact, costandcost-effectivenessanalysesforPrEP aspartofcomprehensiveHIVpreventionportfolio

IdentificationandquantificationoftargetpopulationsforPrEP

InclusionofPrEPandfemale-controlledmethodsincurrentorupcomingnationalHIVpreventionplans

Timelineandplan forPrEPintroductionandscale-up

Abudget forPrEProll-outtotargetpopulations

Sufficientfunding toachievetargets

Regulatoryapprovalofform(s)oforalPrEPbyauthorities

EffectivedemandandsupplyforecastingmechanismsforPrEP

ManufactureridentificationandcontractnegotiationtopurchasePrEP

Productandpackagingdesigntomeettargetpopulation needsandpreferences

DevelopmentofdistributionplanforPrEPtoreachtargetpopulations

Effectivedistributionmechanisms toavoidPrEPstock-outsinpriorityfacilities

Issuanceofstandardclinicalguidelinesforprescription anduseofPrEP

Sufficientinfrastructure andhumanresourcestoconductinitialHIVtestsandprescribePrEPinprioritychannelsPlantoengagehealthcareworkers onPrEPanddeliverytotargetpopulations(includingmitigatingstigma)

ToolstohelppotentialclientsandHCWunderstandwhoshouldusePrEP havebeencreated

Sufficientresourcestoroll-outplansforhealthcareworkerengagement

ClearandinformativecommunicationsonPrEPforgeneralpublicaudiences

Developmentofdemandgenerationstrategiestargetedtouniqueneedsofdifferentpopulations

Linkages betweenHTC,PrEPprescription,andPrEPaccesstoenablePrEPuptake

Information forclientsonhowtoeffectivelyusePrEPforalltargetpopulations

EstablishedplanstosupporteffectiveuseandregularHIV,creatininetestingthatreflecttheuniqueneedsoftargetpopulations

CapacitytoprovideongoingHIV andcreatinineleveltestingforPrEPusersaccessibletotargetpopulations

Monitoringsystemtosupportdatacollectionforongoinglearning(e.g.,rateofpatientsreturningfor2ndvisit,non-HIVSTIrates)

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

TowardsIntroductionofPrEPinKenya

Significantprogressand/ormomentum

Earlyprogress

Initialconversationsongoing

COLORKEY

14FEBRUARY2017

KeyQuestionsforPrEPinKenya

• WhatistheincrementalcostandimpactofaddingPrEPtocombinationpreventionforvariouspopulationsinkeygeographies?

• Towhatextentaretargetpopulationswillingandabletopay forPrEP?

• HowwilltheintroductionofPrEPbefinanced?

• WhowillmanufacturePrEP?Howwillitbepriced/packaged?Whatalternativescouldbeused?

• HowwillPrEPprocurementanddistributionbemanagedbetweenthenationalandcountylevels,particularlyforpotentialchannelsthatarenotdeliveringARVs?

• Whatwillbeconsidered“effectiveuse”foreachpopulationandhowwillitbeencouraged?

• TowhatextentwillongoingtestingneedsforPrEPusersfurtherstrainhealthsystemscapacity?

• Howwillongoingmonitoring bemanaged?

• WhatarethemosteffectivechannelstoreachtargetpopulationswithPrEP(e.g.,healthfacilities,communitychannels)?

• Howwillhealthcareworkers,includingcommunityhealthworkers,beengagedandsupportedtodeliverPrEP?

• WhatisthecurrentdemandgenerationandcommunicationsstrategiesforPrEP?

• HowwillstigmabeaddressedbothtoensuretargetpopulationscaneffectivelyaccessPrEPandtoensurethatusebysome(e.g.,FSW)doesnotstigmatizePrEPforothers(e.g.,AGYW)?

PLANNINGANDBUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

15FEBRUARY2017

Nationa

lstakeho

lders

KenyaMinistryofHealth- createsnationalplans/priorities,andoverseesthefollowingHIV-specificdivisions

NACC- strategysetting,datagathering,progressmonitoring,advocacy, coordinationofstakeholders, careforPLHIV

NASCOP- overseesimplementation,policy/guidelines,coordinatestechnicalHIVprogramming,managessupplychainsandcapacity-building, M&E

Nationaltechnicalworkinggroups- provideleadershipandstrategicguidanceforimplementation

CDC- involvedinguidelinecreation

CDC- supplies laboratorycapacitysupport

Professionalregulators- (MedicalPract.&DentistsBoard,NursingCouncil)- giveslicensureto healthproviders,andmonitorsethicalpracticeofhealthworkers

PharmacyandPoisonsBoard-approvesallnewmedications

Gilead- registeredTruvada forprevention inKenya

KenyaMedicalSuppliesAuthority- centralprocurementagency

NationalHIVReferenceLaboratory- improvescountry’sHIV labcapacity

Implem

enters

County-levelgovernments-make decisionsregardingplanning,funding,procurement/distribution,andhealthfacilitycapacity-buildingforPrEP

Healthcarefacilities(community-basedclinics,SWOPclinics,comprehensivecareclinics,mobileclinics,HTCsites)- provide ARVSandotherHIV/AIDS-relatedservices

Communitybasedorganizations(non-profit, faith-based,advocacygroups)- trustedorganizationsthatcanreachtargetpopulationswithPrEPandgeneratedemand

Others Currentdonors(PEPFAR,GatesFoundation,andNikeFoundationaspartof DREAMS,CHAI,GlobalFund,UNAIDSandWHO)

Otherpotentialdonors(HNWIs,local philanthropicorganizations,UKAID,UNITAID)

KeyStakeholdersforPrEP

Specificorganizationswillbedetermineduponnationallevel

implementationplans

Currentlyinvolved

Potential/futureinvolvement

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

16FEBRUARY2017

County-levelHIVstructuresinKenyaCountygovernmentsareresponsiblefordevelopingHIVpreventionbudgetsandimplementationplansatthelocallevel,andthereforewillbecriticalpartnersinanyeffortstointroducePrEP inKenya.

County-levelgovernancestructuresforHIV

CountyExecutiveCommitteeoversees effectivedeliveryoftheHIVresponseatthecountylevel

CountyGovernment(Governor)implementsnationalpolicyandensuresresourceallocationfor

HIVprograms

CountyHIVCommitteeensures effectivedeliveryoftheHIVresponseatthecountylevel

CountyHIVCoordinationUnit(NACC)coordinates

implementationofthe KASF

CountyHIVInter-agencyCoordinatingCommittee

comprisedofstakeholderWorkingGroupsrepresentingthevariousconstituenciese.g.,CSO,FBOs,Youth,PWID,PLHIVcoordinatesandoverseesimplementationof

globalfundprojects

CountyKASFMonitoringCommittee

countymonitoringofKASFactivitiesacrossfive

StrategicDirectionareasofPrevention,Treatment,HumanRights,Systems

StrengtheningandResearch

Sub-County/ConstituencyHIVCommittees

membersoftheCountyHIVCommittee,responsiblefortheeffectivedeliveryoftheHIVresponseatthesub-

countylevel

CountyHealthManagementTeam

responsibleforensuringintegrationofHIVservices

atthecountylevel

NationalGovernmentcoordinatesfunctionsof

ministriesandgovernmentdepartmentstoreinforceNACC’srole;coordinatesallocationof

fundingtodistricts

NACCSecretariatfacilitatesdeliveryof

KASF,includingaccountabilityofsectorsandpartnersinvolved

andsustainablefinancing

Sources:KenyaAidsStrategicFramework2014/15-2018/19,MinistryofHealth,2014

17FEBRUARY2017

APPENDIXA.ValueChainDetailB.TimelineforPrEPC.References

18FEBRUARY2017

AppendixA:ValueChainDetail

ThefollowingslidesprovideadditionaldetailoneachsectionofthePrEP valuechaininKenya

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PlanningKeyStakeholders• MoH - createsnationalplans/priorities,andoverseesthefollowingHIV-

specificdivisions:• NACC- helpsimplementstrategicplans,coordinatesstakeholders,and

providescareforPLHIV• NASCOP- hasoversightonpolicyandguidelines,coordinatestechnical

HIVprogramming,managescapacity-building,andperformsM&E• Nationaltechnicalworkinggroups- runbyNASCOPandNACC,provide

leadershipandstrategicguidanceforimplementation

KeyStrengthsandOpportunities• Targetpopulationsandtargetgeographies forPrEP aredefined• Governmentisleadingeffortstofurtherdisaggregatedatatosegment

youthpopulation,includingAGYW• PreventionRevolutionRoadmapmakesthecaseforgeographic

targetingandcombinationpreventionincludingPrEP fortargetpopulations.ARVtreatmentguidelinesincludeguidanceonPrEP

• NASCOPisengagingkeystakeholderssuchascounty-levelgovernments,civilsocietyandadvocacygroups

• CostmodelsexistandarebeingrefinedfordeliveringandscalingPrEPtoFSWandMSM

KeyEmergingConsiderations• Moreprep-specificinformationisneededfortargetpopulations:

preferences,needsforaccessandsupport,effectiveuse(somewillbeavailablethroughdemoprojectandPopulationCouncilresearch)

• Translatinganationalstrategyintocounty-levelactionwillrequiresignificantguidanceandincentives(financialandtechnicalsupport,leadershipofothercounties)

• Nationalfundingisinsufficient forprovidingandsustainingPrEP;Kenyawillneeddonorstoscale-upPrEP

ReadinessforPrEPIntroductionReadinessFactor ProgressImpact, costandcost-effectivenessanalyses forPrEP aspartofcomprehensiveHIVpreventionportfolio

• Modellingstudiesunderwaytorefineimpactandcost-effectivenessestimates (ImperialCollegeofLondon,HealthPolicyProject,Avenir)

• Costingstudiesunderway (CHAI/LVCTHealth);expectedmid2017

IdentificationandquantificationoftargetpopulationsforPrEP

• TargetpopulationsinRevolutionRoadmapincludeFSW,MSM,PWID,sero-discordantcouples,variesbycounty

• PlansforAGYWremainuncertain

InclusionofPrEPandfemale-controlledmethodsincurrentorupcomingnationalHIVpreventionplans

• PrEPisincorporatedintotheKenyanHIVPreventionRevolutionRoadmapandisalsoidentifiedasanevidence-basedinterventioninthemostrecentKenyaNationalStrategicFramework(KASF).PrEPisalsoincludedintheGuidelinesonuseofARVdrugsfortreatingandpreventingHIVinfections

Timelineandplan forPrEPintroductionandscale-up

• NASCOPandpartnersaredevelopingaPrEPintroductionplan.DeliverywillbegininJanuary2017throughDREAMSandB2S.AnationalcampaignedtobelaunchedinMarch

Abudget forPrEProll-outtotargetpopulations

• Earlybudgetconsiderationsandthinking happeningaspartofbroaderPrEPplanning

Sufficientfunding toachievetargets

• DREAMShasresourcesdedicatedtoPrEPforAGYW

• GatesFoundationisfundingBridgetoScale,toacceleratePrEPscale-up

20FEBRUARY2017

PotentialTargetPopulationsforPrEPAdolescentgirlsandyoungwomen(AGYW)

Sero-discordantcouples FemaleSexWorkers(FSW)

PeopleWhoInjectDrugs(PWID)

Menwhohavesexwithmen(MSM)

KeyIndicators

• ~4.1MtotalAGYW(ages15-24)inKenya,basedon2009Census¹

• 21%ofnewadultinfectionsperyearareamongAGYW³

• 4.5%prevalence;byage24therateforAGYWisalmost4timeshigherthanforyoungboys²

• ~90%ofyoungwomentestforHIVatleastoncebythetimetheyareage24²

• ~260,000couples³or5-6%⁴ofcouplesareHIVsero-discordant

• 44.1% ofnewadultinfectionsfromsero-discordantcouples³

• UnknownlevelofaccesstotestingandtargetedHIV/AIDSinterventionservices

• Lowawarenessofpartnerstatus(48%forwomen;61%formen)⁵

• Unknownnumber,butestimatedat~1000,000⁴*

• 29.3% HIVprevalence⁴• 14.1% ofnewadultinfectionsperyearareamongsexworkersandtheirclients³

• 68%testedforHIVinthepastyearandknowtheirstatus⁶

• 70% receivetargetedinterventionservices³

• UnknownnumberoftotalPWID*

• 18.3% prevalence³• 3.8% ofnewadultinfectionsperyear³

• 60%testedforHIVinpastyearandknowtheirstatus⁶

• 24% receivetargetedinterventionservices³

• UnknownnumberoftotalMSM*

• 18.2%prevalence³• 15.2% ofnewadultinfectionsperyearfromMSMandprison³

• 74% testedforHIVinthepastyearandknowtheirstatus⁶

• 55%receivetargetedinterventionservices³

Prioritiza

tion

• NationalplansdefineAGYWasaprioritypopulationforprevention;sometimesmentionedastargetsforPrEP

• Demonstrationprojects:ConfidenceProject,MP3-Youth,POWER,IPCP

• Includedinnationalplansasprioritypopulationforprevention

• MentionedastargetsforPrEP

• Demonstrationprojects:Fem-PrEP,PartnersPrEPOle

• NationalplansdefineFSWasaprioritypopulationforprevention;mentionedastargetsforPrEP

• Demonstrationproject:IPCP

• ExistingstudyoncostofPrEPscale-upforFSW

• NationalplansdefinePWIDasaprioritypopulationforprevention

• MentionedastargetsforPrEP

• NationalplansdefineMSMasaprioritypopulationforprevention

• MSMmentionedastargetsforPrEP

• Demonstrationproject:IPCP

Que

stions

• WhatmessageswillbeappropriateforencouraginguseofPrEP withoutstigma?

• WhichchannelswillbeeffectiveforPrEP delivery?

• WhatadditionalcommunitysupportmechanismsneedtobeinplaceforPrEP’s effectiveuse?

• HowmuchdemandwilltherebeforPrEP,especiallyrelativetootherpreventionoptionsinthepipeline?

Sources:1-KenyaPopulationandHousingCensus,KenyaNationalBureauofStatistics,2009;2-KenyaFastTrackPlantoendHIV/AIDSinAdolescentsandYoungPeople,MinistryofHealth,2009;3-KenyaPreventionRevolutionRoadmap,MinistryofHealth,2014;4-KenyaHIVResponseandmodesoftransmissionanalysis,MinistryofHealth,2009;5-KenyaAidsStrategicFramework2014/15-2018/19,MinistryofHealth,2014;6-KenyaAIDSResponseProgressReport,NationalAidsControlCouncil,2014

21FEBRUARY2017

Budgeting

CurrentFunding• PEPFAR,GatesFoundation,andNike

currentlyfundPrEP-relatedefforts($39.5mallocatedtoDREAMS)¹

• PrEP researchhasbeenfundedbyBMGF,USAID,andNMHI/NIH

• MainfundsourcesforHIV/AIDS²:• >62%Bilateralfunds(PEPFAR,UK)• >15%PublicFunds(GoK)• >4%Internationalnonprofits(CHAI)

• Currentfundinggoestoward³:

RemainingGapsandChallenges• ItislikelythatPrEP willnotbefunded

byGoK,spellingtheneedforadditionalfundingfromexternaldonorssuchasPEPFAR

• TheoverallHIV/AIDSfundinggap (in$USDM)willcontinueuntil2019³:

PotentialNewFundingSources• FunderssuchastheGatesFoundation

haveshowninitialcommitmentstofurther fundPrEPthroughBridgetoScaleandrequestsforproposals

• TheNationalHospitalInsuranceFund(NHIF)willfinancetheKenyangovernment’suniversalhealthcare.KenyaseekstoincreasethenumberofcontributorstothisfundtocovercostsofART,andpotentiallyfundadditionalHIVservices

• KenyaHIVTrust/InvestmentFundwillraisenational/countyresourcesthatwillsubsidizegovernmentHIVcosts

• DeterminingtheabilityandwillingnesstopayforPrEPinaprivatehealthcaresettingmightenablesomecost-recovery

Summary• Kenya’sHIV/AIDStotalexpenditureshaverisenovertime,accountingfor2%oftotal

countryGDP.Over68% offundingcomingfromexternalsources³• Thecountryhasprojectedfundinggapstoimplementthenewstrategicplan(KASF),

includingthescaleupofUTT• Kenyawillstrivetoclosefundinggapsbymaximizingprogramefficiencytoreduce

costs,andincreasingdomesticfinancingby50%by2019

Nationalbudget

$956.2McostsforHIV$210.3MofwhichispreventionTBDwhatiscommittedtoPrEP

Treatment& Care 52%

Prevention 21%

Socialinclusion,humanrights&gender 13%

Leadership&governance 7%

Healthsystems 4%

Year 2015 2017 2019

Baselinefunding $829M $797M $724M

Proposedfunding $829M $852M $940M

Resourceneeds $956M $948M $833M

Gap -13% -10% +13%

Sources:(1)“ProjecttocutnewHIVcasesingirls,womenlaunched”,SciDevNet,2015;(2)KenyaNationalAidsSpendingAssessment,ReportfortheFinancialYears2009/10-2011/12,NACC,MOH,andUNAIDSKenya,2014;(3)KenyaAidsStrategicFramework2014/15-2018/19,MinistryofHealth,2014

22FEBRUARY2017

Procurement&DistributionKeyStakeholders• GileadlicensesTruvadamanufacturingglobally.Itsregionalbusiness

partnerinKenya iscurrentlyPhillipsPharmaceuticalsLimited• PharmacyandPoisonsBoard- approvesallnewmedications• KenyaMedicalSuppliesAuthority(KEMSA)- centralprocurement

agencyundertheMoH;partnerswithdonors,countygovernmentsandcommunity-basedorganizations(CBOs)toestablisheffectivesupplychains.WillberesponsibleforsupplyforecastingforPrEP

• CBOsandcountylevelgovernments- willberesponsibleforthelocalsupplychainofPrEP

KeyStrengthsandOpportunities

• StrongsupplychainforARVs,withlimitedinstancesofshortages• StrongE- MedicalRecordSystem(EMR) toensureARTcoordination

andqualitymanagementsystem inplace

• AlthoughthedetailsonwhowillprocurePrEParestillunclear,theGoK hascommittedtosupportingprocurementforPrEP tomakeitavailablewhereverneeded(pharmacies,HIVclinics)

KeyEmergingConsiderations• Needforadditionaldataontargetpopulationsdemandestimates

anduserpreferencestoinformdemandforecasts• LackofclarityonwhowillmanufactureanddistributePrEP– likely

notachallengewhenhandledbycurrentARVchannelsbutquestionsremainaboutadditionaldeliverychannelsnotadministeringART

• NeedprocurementplanthroughKEMSAandcentralcoordination,establishtherelevantHIVcommoditymanagementsystems

• HighpriceofTruvada – couldshiftwithemergenceofalternativesoralPrEPdrugs

ReadinessforPrEPIntroductionReadinessFactor ProgressRegulatoryapprovalofform(s)oforalPrEPbyauthorities

• Truvada approvedforpreventionbythePharmacyandPoisonsBoard

• OtherformsoforalPrEPinpipeline

EffectivedemandandsupplyforecastingmechanismsforPrEP

• StrongsupplychainmanagementinplaceforARVs,whichwilllikelytranslatetoPrEPreadiness

• CHAIisconductingdemandforecasting

ManufactureridentificationandcontractnegotiationtopurchasePrEP

• ManufacturerssupplyingPrEPinclude: Gilead,Cipla,Aurobindo,Hetero,andCosmos(adomesticmanufacturer)

Productandpackagingdesigntomeettargetpopulation needsandpreferences

• Currently aplasticpillbottle,toberefilledmonthly;unknownifformatwillbeconsistentforotherformsoforalPrEP

• MylanandPSKareexploringdifferentpackagingpreferencesandoptions

DevelopmentofdistributionplanforPrEPtoreachtargetpopulations

• NACCandotherentitiesdeterminingmosteffectivechannelsandaccompanyingdistributionplans

• NASCOP’s RFPsforimplementationofPreventionRevolutionRoadmapwillprovideinsightondistribution

Effectivedistributionmechanisms toavoidPrEPstock-outsinpriorityfacilities

• KenyahashistoricallymaintainedastrongsupplychainforARVs,withlimitedinstancesofshortages.LikelytotranslatetoPrEP

23FEBRUARY2017

PrEPDeliveryPlatformsKeyStakeholders• PrEPTWG– informidentificationandplanningfordeliverychannels• Comprehensivecareclinics(currentARVchannels)- coulddistributePrEP

alongsideHIVtestingandtreatment• Community-basedorganizations- cansupportdemandgeneration,distribution,

andprovidesupportforPrEPatthelocallevel• County-levelgovernments– createcounty-levelHIVplansaspartofKASF

deliverythatwouldneedtoincorporatePrEP• Keypopulationclinics- provideHIVservicestokeypopulationsdirectly

KeyStrengthsandOpportunities• ARVclinicshaveawidereachthrough~2000sitessuchascomprehensivecare

centersandCBO-runclinics.ThesecouldbeleveragedforPrEPdelivery• AdditionaldistributionplansarecurrentlybeingdevelopedbyNACC, takinginto

accountthevoiceofcommunities(viafocusgroups) toidentifyaccessneeds,preferences,andsupportmechanismsnecessaryforeffectivedistributionofPrEPtotargetpopulations

• ConsidertheabilityandwillingnesstopayforPrEPthroughprivatehealthchannels,somealreadyreachingkeypopulations(e.g.,FHI’sGoldStarNetwork)

KeyEmergingConsiderations• HealthworkersinmanysettingsarenotequippedtodistributePrEPtotarget

populations,oraddressstigma.Aplanandcurriculumfor trainingisneeded• HIVtestingkitshortagescouldimpedePrEPprescription/access• NeedbetterunderstandingoffulllandscapeofpotentialPrEPdistribution

channels inordertomosteffectivelyreachtargetpopulations• Capacity-buildingwillbeneededinordertoequipnon-ARVdeliverychannelsas

PrEPdelivery/referralsites,includingcapacitytointegratewithothercareoutlets(e.g.,hospitals)toprovideliverandkidneytestingneededalongsidePrEP

• Noear-markedfundingforPrEPisavailableforcapacity-building

ReadinessforPrEPIntroductionReadinessFactor ProgressIssuanceofstandardclinicalguidelinesforprescription anduseofPrEP

• PrEPClinicalguidelines includedin2016ARVguidance

Sufficientinfrastructure andhumanresourcestoconductinitialHIVtestsandprescribePrEPinprioritychannels

• HighreachofHTC forhigh-riskpopulations,withlowerratesforgeneralpublic,through~5000testingsites.

• Humanresourcesneedslikelytobedetermined tomeetPrEPguidelines

Plantoengagehealth careworkersonPrEPanddeliverytotargetpopulations(includingmitigatingstigma)

• PrEPTWGworkingondevelopingspecificPrEPmodulestostackontothecurrentguidelineslikeKPanddevelopingacomprehensivetrainingfordifferentlevelsofstaff

ToolstohelppotentialclientsandHCWunderstandwhoshouldusePrEPhavebeencreated

• Somematerialsalreadyexistfromdemonstrationprojects

• LVCTHealthsupportingNASCOPtodevelopariskassessmenttoolforPrEP usethroughtheservicedeliverysub-committee

Sufficientresourcestoroll-outplansforhealthcareworkerengagement

• Serviceprovider toolkitsarebeingdeveloped

24FEBRUARY2017

CurrentPrEPDeliveryChannelsDemonstrationProjectsandOpenLabel Extensions DREAMS

Backgrou

nd

• PrEPdemonstrationprojectsthroughoutKenyahavedeliveredPrEPthroughanumberofprojects.Theseprojectsinclude:ConfidenceProject;Fem-PrEPwithadultwomen;LVCTandSWOPIPCPdemoprojectwithFSW,youngwomen,andMSM;MP3-Youthwithyouth15-24yearsold;PartnersPrEPdemoprojectandOLEwithserodiscordant couples.

• TheDREAMS initiative(Determined, Resilient, Empowered,AIDS-free, Mentored,and Safewomen)willprovidePrEPtoyoungwomeninthedistrictsofHoma Bay,Siaya,KisumuandNairobibeginningin2016/2017.OralPrEPintheformofTruvadawillbedonatedbyGileadforusebyDREAMS.

KeyStreng

ths

• DemoprojectsalreadyreachingindividualsfromtargetpopulationsathighriskofcontractingHIV(e.g.,AGYW,FSW,MSM)• ExistingaccesstoPrEPandassociatedtesting,monitoring,andextensivecounsellingandadherencesupportservices• ExperiencedstaffhighlyknowledgeableaboutPrEP• Valuableinsightsfromrecruitmentandretentioneffortsthusfar• LowlevelsofstigmaamongstaffworkingwithPrEPusers

• Targetedprogramreachinghigh-risk(asidentifiedbycommunity-ledcriteria)adolescentgirlstostart2016/17• PrEPdeliverycoupledwithbehaviorchangeactivitiesandextensivecounseling• FundingforPrEPsecured(TruvadadonatedbyGilead,programcostsfromDREAMSfunding)• PotentialtoexpandPrEPthroughoutthesedistrictsgivenotherinvestmentstomakePrEPavailabletoDREAMSparticipants,includinglogistics,procurement,demandgeneration,andcommunitybuy-inefforts• PopulationCouncilimplementationresearchwillinformhowtoidentifyandreachAGYW,linkthemtoservices,andprovidePrEP

Key

Challeng

es • PerceptionofPrEPaspartofan“experiment”deterspotentialusersfearingpoorsafetyandefficacyofdrug• Extensiveadherencesupportavailableindemoprojectsislikelytobeprohibitivelyexpensiveatscale• Highercostsofdeliveryindemonstrationprojectcontext

• DREAMS’PrEPcomponenttoreachonlyadolescentgirlsincommunitieswheremanyotherpopulationscouldbenefitfromPrEP• ReachlimitedtoHoma Bay,Siaya,KisumuandNairobi

25FEBRUARY2017

ComprehensiveCareCenters &otherARTsites SexualandReproductiveHealth(SRH)careproviders

Backgrou

nd

Public(Gov’t) NGO Private

• Publichospitals,clinics,andotherhealthcarecenters

• NGO-runclinics,carecenters,otherHIV serviceprogramsincludingthosespecificallyforkeypopulations(e.g.,SWOP,LVCTHealth,FHI,PSI)

• Private fee-for-serviceproviders(e.g.,FHI’sGoldStarNetwork)

• ArangeofSRHcareincludingfamilyplanning,post-abortioncareclinics,pre-natalcare&otherSRHproviders

KeyStreng

ths

• Mostvisibletogeneralpopulation

• Systemsguidedandlinkedwithcountyandnationalstandards/agendas

• Canprovidegreateraccesstokeypopulations(FSW,MSM,PWID)

• Effectivelyreachhigh-riskindividualswithlow/nostigmapresentincentersoramongstaff

• Frequentuseofpeer-educatorprograms,whichmightbecriticaltoeffectiveuseandincreaseddemandgeneration

• Opportunitiestodeliverthroughprivatechannelsaccessingkeypopulationssuchas FHI’sGoldStarNetworkclinicsinNairobi,thecoastalregion,andRiffValley

• DiscreteaccesstoPrEPwithoutstigmaforthosewhocanaffordit

• Notdependentonaid

• Providegreateraccesstosero-discordantwomenandAGYWinfemale-friendlyandtrustedsettings

• StaffmayhavelowerlevelsofstigmaagainstAGYWwhoseekfamilyplanningandHTCservices

• Post-abortioncareclinicshavethepotentialtoreachwomenatveryhighriskofHIVinfection

• LowcostofdemandgenerationsincewomenarealreadyvisitingSRHservices

• Over2000ARTsitesthroughoutKenya• Well-integratedprocurementanddeliverysystems• LaboratorycapacityfornecessaryPrEPmonitoringinplace• HTC-trainedstaff

Key

Challeng

es • HCWstigmaagainsttargetpopulationsdetersmanyfromaccessingcarethroughthesechannels

• Staffandresourcesperceivedtobestretchedthin,resultinginsuboptimalcare• Maynoteffectivelyreachtargetpopulationsathighestrisk

• PotentiallylimitedexperienceandtraininginHTClinkages

• Limited/nolaboratorycapacityfornecessaryPrEPmonitoring

• AGYWmayhavetroubleaccessing

PotentialPrEPDeliveryChannelsThisisanareaoffocus

forOPTIONS.Additionaldetailsexpectedto

emerge

26FEBRUARY2017

IndividualUptakeKeyStakeholders• NASCOP- overseethedevelopmentofcommunicationsstrategiesvia

TWGsandotherpartners• DREAMS- willpotentiallyhaveresearchandimplementationpracticefor

AGYWusingPrEPthatcanbeusedtoinformfurtherscale-up(managedbyGlobalCommunitiesinKenya)

• Community-basedandfaith-basedorganizations willplaykeyrolereachingtargetpopulationsandinfluencingcommunityPrEPbuy-in

• Localandnationalmedia- tohelpaccuratemessagingonPrEPasaneffectiveandsafepreventionoption

KeyStrengthsandOpportunities• SomeresearchexistsonuserpreferencesforPrEPinkeypopulations

(FSW,MSM,andsero-discordantcouples),including:dosagepatterns;willingnesstoconsiderusingPrEP;potentialdemandforPrEP

• NASCOPhasplansforadditionalresearchspecificallyondeliverychannelsandaccesspointsforPrEP

• Communicationssub-committeeofPrEPTWGhasbeenestablishedandiscoordinatingcommunicationsplanstoreachallpopulations

• ImplementationstakeholdersacknowledgetheimportanceofaddressingstigmainordertoreachAGYWandsero-discordantcouples

KeyEmergingConsiderations• Stigmaisamajorconcernforuptake.Thisincludesboththestigma

associatedwithHIVandthosenormallythoughtofas“highrisk”populations,aswellasstigmaagainstyoungwomenwhomightbesexuallyactiveandseekingSRHcare.ThereisastrongneedtonormalizePrEPandcreateasupportivecommunicationstrategyforitsuse

• Awareness/demand forPrEPisunknown;willrequireinvestmentindemandgeneration(CHAIiscurrentlydoinginitialdemandgenerationresearchtobecompletedbyQ4/16)

ReadinessforPrEPIntroductionReadinessFactor Progress

ClearandinformativecommunicationsonPrEPforgeneralpublicaudiences

• Thereisasub-committeeofthePrEP TWGfocusedoncommunications,advocacy,andcommunityengagement.Thissub-committeeisdevelopingacommunicationsstrategy

• PSKisconductingcommunicationsworkforDREAMSandJilindeprojects

Developmentofdemandgenerationstrategiestargetedtouniqueneedsofdifferentpopulations

• PSKandMcCannareworkingonearlystages of demandgenerationstrategies

Linkages betweenHTC,PrEPprescription,andPrEPaccesstoenablePrEPuptake

• Necessary PrEPdeliveryelementshavebeenoutlinedinPrEPtreatmentguidelines(initialandmonitoringtesting)

• TheactualcapacityofvariousdeliverychannelstoprovidePrEPin-houseorthroughlinkagestootherchannelsisyettobeassessedatscale

Information forclientsonhowtoeffectivelyusePrEPforalltargetpopulations

• Informationexistsforthoseparticipatingindemoprojects

• Patienteducationtoolkithasalreadybeendeveloped,andcurrentlyunderreview

27FEBRUARY2017

KeyConsiderations

Stigma

• Earlystigmalingers:makingPrEPwidelyavailablebeyondkeypopulationswouldhelpmitigatepreconceptionsofPrEPasanoptiononlyforFSWandMSM.Thisisimportantbecausemostdemoprojectshavebeendonewithkeypopulations.AnyPrEPcommunicationscampaignwillneedtodirectlyaddressthestigmaassociatedwiththosepopulations.

• Amonghealthworkers:thechallengesaretwofold- healthcareworkershavetheirownbiasesaboutwhoshouldbeaccessingbirthcontroloptionsandHIVpreventionservices,andtheyoftenlacktheappropriateinformationandtrainingtoeffectivelyprovidearangeofoptionsforindividualstomakeinformeddecisions.

• Youthandfemale-friendlyspacesarecriticalandneeded:centersthatarestigma-free,youthandfemale-friendlywillfacilitateuptake,butchangestofacilitieshavebeenslowandinsufficient.

DrugPreconceptions

• TherearefearsaboutdevelopingresistancetoARVswhileonPrEP,anddevelopingphysicalsideeffectsassociatedwithARVs.

• PeoplerecognizeTruvadaasanARVanddonotwanttobeseentakingitiftheyareHIVnegative.

Messengers• MessagesaroundPrEPneedtobeproactive,consistent,andcomefrommultipledirections.Importantmessengersinclude:nationalandcountygovernments,ministries,CBOs,celebrities,religiousleaders,healthcareworkers,peersandvariousformsofmedia(e.g.print,radio,online).

Messages

• Riskperception:youngwomeninKenyagenerallydonotseethemselvesathighriskforHIVtransmission.Theyaremorefocusedoneconomicopportunityandeducation

• PrEPaspower: PrEPcouldbeframedasanoptiontoprotectoneself and thecommunity. Alsoassomethingthatisempoweringandpositiveasopposedtoshamefulandincriminating.Ideasformessagingincluded statementssuchas:“Ourownchoice,ourownpower”

• “Mpango Wa Kando”:potentialtobuild-offofpreviousnationalcampaign abouttheconsequencesof extramaritalaffairstoappealtopotentialPrEPusersbyhighlightingtheriskassociatedwith theirown/theirpartners’conduct

• PrEPforall: ideasfor inclusivemessaging includedstatementssuchas“PrEPisforyou,PrEPisforme”and“PrEPisforallofus”

KeyEndUserThemesforPrEP

28FEBRUARY2017

EffectiveUse&MonitoringKeyStakeholders• MOH/NASCOP- developingDetailedmonitoringoforalPrEProlloutthrough

DREAMSandBridge-To-Scale(B2S)withsupportfromUCSF• NACC- holdscountry-wideresponsibilitytotrackKASFprogressandHIV-related

programsuccess• CDC- workscloselywithGOKandimplementingpartnerstosupportlabsystems

andnetworksstrengthening• NationalHIVReferenceLaboratory(NHRL)- leadspolicyandguidelines

formulationonHIV-relatedlabservicestostrengthencountry’slaboratorycapacity

KeyEmergingConsiderations• MechanismsforgatheringlocaldataonPrEPimpactarenotestablished• Planstoincreaseeffectiveusedonotexist;noroleshavebeenassignedfor

generatingthesupportsystemsneededtofostereffectiveuseatlarge• Interventionsusedtoencourageeffectiveuseamongdemoprojectparticipants

wouldlikelybetoocostlyinmanyreal-lifesettings(e.g.extensivecounselling,useofpeereducators)

• Frequent,ongoingmonitoringneedslikelytobothdriveupcostsofdeliveryanddiscourageongoinguseofPrEP

ReadinessforPrEPIntroductionReadinessFactor ProgressEstablishedplanstosupporteffectiveuseandregularHIV,creatininetestingthatreflecttheuniqueneedsoftargetpopulations

• Effectiveuseyettobedefined• EarlyconsiderationsforencouragingandsupportingeffectiveuseandadherencetoregulartestingareincludedinthenationalARVguidelines

CapacitytoprovideongoingHIV andcreatinineleveltestingforPrEPusersaccessibletotargetpopulations

• While thereisincreasingHTCcapacityforcurrentefforts,gapsremainparticularlyforreachingtargetpopulations

• TestingneedsfororalPrEPhavebeenidentifiedin2016nationaltestandtreatguidelines

Monitoringsystemtosupportdatacollectionforongoinglearning(e.g.,rateofpatientsreturningfor2ndvisit,non-HIVSTIrates)

• ThenationalMonitoringandEvaluationFramework2014/15-2018/19isthefoundationformonitoringprogresstowardHIVnationalgoals (keyindicatorsincludereducingstigmarelatedtoHIV-AIDS,andreducinginfectionswithinkeypopulations)

• PrEPandM&ETWGsareidentifyingkeyindicatorsfortrackingPrEPservicedeliveryatnationallevelthroughDHIS_2

• B2Sis leadingthelearningagendaprocess

KeyStrengthsandOpportunities• Nationalmonitoringandevaluationframework includesprioritiestoincrease

fundingtowardhealthcarecapacity-building,reducingstigma,andtargeting/prioritizingkeypopulationssuchasMSM,FSW,youth

• VarioussurveysexisttocollectnationaldataontheHIVepidemic,includingthesituationroomtoolwhichwillshowlive,localupdatesonHIVincidenceandmortality

• NASCOPleadingthedevelopmentofM&EplansviaTWGPrEPsubcommittee,USAIDSIteam,andUCSF

• Lessonsoneffectiveusefromdemoprojectstolearnfromandbuildonincludeconsistentregimens,structuredfollow-up,andcounselling/communitysupport

29FEBRUARY2017

AppendixB:TimelinesforPrEPQ1, 16 Q2, 16 Q3, 16 Q4, 16 Q1, 17 Q2, 17 Q3, 17 Q4, 17 2018 2019 2020

Research

IPCPKenya(LVCTHealthandSWOPKenya)studyonPrEPforAGYW,MSM,andFSW

PartnersDemonstration ProjectonPrEPforsero-discordantcouples

MP3-Youthstudy toevaluatecombinationpreventionforadolescentboysandgirls

POWERdemonstrationprojectsforadherence/deliverysupportforwomen

ConfidenceProjectstudy (LVCTHealthandLSHTM)onPrEPacceptabilityreports

DevelopmentofanationalresearchagendaforHIV

Plan

ning/

Implem

entatio

n DREAMSprogrammingimplementedinHoma Bay,Siaya, Kisumu, andNairobi

BridgetoScale(B2S)

Policy NextNationalAIDSStrategicFramework

(KASF)developed

Fina

ncing NASCOP RFPsforPreventionRevolution

Roadmapimplementation,includingPrEP

Mod

ellin

g

OPTIONSAGYWmodellingresultsexpected

B2Scostingstudy

B2Simpactandcost-effectivenessmodelling Exacttimelinestobeclarified

Exacttimelinestobeclarified

??

Exacttimelinestobeclarified

30FEBRUARY2017

AppendixC:References• KenyaAidsStrategicFramework2014/15-2018/19,MinistryofHealth,2014• KenyaPreventionRevolutionRoadmap,MinistryofHealth,2014• KenyaAIDSResponseProgressReport,NationalAidsControlCouncil,2014• KenyaAIDSResponseProgressReport,NationalAidsControlCouncil,2016• KenyaHIVEstimates2015,NationalAidsControlCouncil,2016• KenyaMonitoringandEvaluationFramework 2014/15-2018/19,MinistryofHealth,2014• NationalguidelinesonHIVtestingandcounselling,MinistryofHealth,2008• GuidelinesonUseofAntiretroviralDrugsforTreatingandPreventingHIVInfection,MinistryofHealth,2016• KenyaAidsIndicatorSurvey,MinistryofHealthandothers,2012• KenyaHIVResponseandmodesoftransmissionanalysis,MinistryofHealth,2009• KenyaFastTrackPlantoendHIV/AIDSinAdolescentsandYoungPeople,MinistryofHealth,2009• KenyaPopulationandHousingCensus,KenyaNationalBureauofStatistics,2009• KenyaNationalAidsSpendingAssessment,ReportfortheFinancialYears2009/10-2011/12,NACC,MOH,andUNAIDSKenya,

2014• Costofprovidingpre-exposureprophylaxistopreventHIVinfectionamongsexworkersinKenya,HealthPolicyProjectand

MinistryofHealth,2014• ConsiderationsforRollingOutOralPrEP toTargetPopulationsthroughSocialMarketing,FHI360andIRDO,2013• Barriersandfacilitatorstopre-exposureprophylaxis(PrEP)eligibilityscreeningandongoingHIVtestingamongtarget

populationsinBondo andRarieda,Kenya:Resultsofaconsultationwithcommunitystakeholders,BMCHealthServicesResearch,2014

• SafetyandAdherencetoIntermittentPre-ExposureProphylaxis(PrEP)forHIV-1inAfricanMenWhoHaveSexwithMenandFemaleSexWorkers,Plos One,2012

• PreferencesforandWillingnesstoUseAntiretroviralBasedHIV-1PreventionStrategiesamongKenyanHIV-1SerodiscordantCouples,NCBI,2012

• “ProjecttocutnewHIVcasesingirls,womenlaunched”,SciDevNet,2015• SouthAfricaandKenyaApprovalofOralPrEP ShouldSpurRollout,AVACblog,2015• http://www.prepwatch.org/,AVAC,2016