OPTIONSCountrySituationAnalysisInterimFindings:Kenya

FSGinpartnershipwithLVCTHealth

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OPTIONSIntroductionOneoffivecooperativeagreementsawardedbyUSAIDwithPEPFARfundingthroughRoundThreeoftheAnnualProgramStatement(APS)forMicrobicideResearch,Development,andIntroduction.

TheOPTIONSConsortiumobjectiveistoprovidetargetedsupporttohelpexpediteandsustainaccesstonewARV-basedHIVpreventionproductsincountriesandamongpopulationswheremostneeded.

OPTIONSConsortiumMembers

KENYA

SOUTHAFRICA

ZIMBABWE

3APRIL2016

OPTIONS ConsortiumAims

Developevidence-basedbusinesscasesandacoordinatedinvestmentstrategy forARV-basedpreventionproductintroduction toensuretimelyglobal,nationalandprivatesectoractiononpriorityareas

AIM1 AIM2 AIM3 AIM4

Provide technicalassistanceandsupportforhealthsystemsstrengthening(HSS) withrapiduseofdatatoidentifyandaddressimplementationbottlenecksthroughout thevaluechain

Support countrylevel regulatoryapproval,policydevelopment,programplanning,marketingandimplementationstrategiesforARV-basedpreventionproductintroduction

Facilitateandconductimplementationscience (IS)toadvancetheintroduction ofandaccesstomicrobicidesandARV-basedpreventiontechnologies

OPTIONScanprovidetargetedsupportacrossitsfourprojectaims:

4APRIL2016

OPTIONSHowWeWork• OPTIONSisnotaservicedelivery project;weapplysystemsthinkingto

supportandaccelerateproductintroduction

• OursupportisflexibleandisdesignedtoberesponsivetonationalcountryprioritiesandplansandwillbeguidedbynationalleadershipthroughNASCOP

• Wehaveastronglocalpartner,LVCTHealth,withsignificantexperienceworkingonHIVpreventionintheKenyacontext

• InadditiontoLVCT,ourconsortiumisabletobringmulti-disciplinaryexpertisetotheefforttointroducefemale-controlledHIVpreventionproductsinKenya

• Wearetakingsignificantstepstoensurewedonotreplicateexistingorongoingwork– ourmissionistofillgapsandhelpanswerkeyquestionsasoutlinedbythenationalgovernment,theUSAIDcountrymission,andotherkeylocalstakeholders

5APRIL2016

• 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 ismade 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

6APRIL2016

ExecutiveSummary• Kenyahasmadestridestowardcreatingpositive initialconditions fortheroll-outofPrEP:

– PrEPisincludedinKenya’smostrecentnationalplans forcombatingHIV/AIDSincludingtheKenyaAIDSStrategicFramework(KASF)andthePreventionRevolutionRoadmap

– ThePharmacyandPoisonsBoardhasregisteredTruvada(oralPrEP) forHIVprevention– GovernmententitiessuchasNASCOParetakingaproactiveroleingeneratinglocal-levelbuy-inforPrEP,engaging

diversesectorsinPrEPplanning,andcooperatingwithkeystakeholdersinthedevelopmentofpoliciesandpracticesforPrEP

– Potential targetpopulations havebeen initiallydefined:femalesexworkers(FSW),menhavingsexwithmen(MSM),sero-discordantcouples,adolescentgirlsandyoungwomen(AGYW),amongothers

• Currently, thereisnoofficialimplementation strategyforPrEP.Kenya,throughNASCOPandCDCleadership,isintheprocessoftranslatinghigh-levelWHOpolicyintotreatmentand implementation guidelines,whichareexpected tobecompletedbyJune2016andinvolvemulti-sectorparticipation

• ThecurrentstateofthePrEPdiscussionrevolvesaroundimplementationconsiderations:– Definingpriority targetpopulations forPrEP– FindingkeydeliverychannelsforreachingtargetpopulationswithPrEP(e.g.,comprehensivecarecentersandother

ARTsites,DREAMSdistricts,sexualandreproductivehealth(SHR)sites)– UnderstandingtargetpopulationuserpreferencesandPrEPaccessneeds, anddeployingasuccessful national

communicationscampaignforPrEP– Determiningthecostand impactofaddingPrEP topreventionstrategiesfortargetpopulations– Assessingcapacity-buildingneeds fortheintegrationofPrEPintohealthservicesandotherchannels

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

7APRIL2016

GeographyHighlyconcentrated epidemic- 65%ofnewinfectionsoccurringin9outofthe47counties²:

TrendsHIVincidencehassteadilybeendecreasingatalowrate

HIVinKenyaContext• Kenyahastheworld’sfourth largestHIVburden, withanestimated1.63millionpeople livingwithHIV(prevalenceof6%)¹• 100,000newinfectionsoccurannually,with21%ofadult infectionsoccurringamongyoungwomenages15-24²• HighlygeographicallyconcentratedHIVburden, thusGovernmentandPEPFAR’sresponsetoHIVisfocusedatthecounty level

0

20

40

60

80

100

120

140

2009 2010 2011 2012 2013

MaleFemaleTotal

DemographicsKenya’sHIVincidenceisdrivenbyabroadsetofpopulations, includingsignificantcontributionsfromsero-discordantcouplesandadolescentgirlsandyoungwomen(AGYW):

NewadultHIVinfections,2013²

HIVincidenceovertime³(inmillions)

Sources:(1)KenyaAidsStrategicFramework2014/15-2018/19,MinistryofHealth,2014;(2)KenyaPreventionRevolutionRoadmap,MinistryofHealth,2014;(3)KenyaAIDSResponseProgressReport,NationalAidsControlCouncil, 2014

8APRIL2016

RemainingChallenges

• Despitegrowinginvestment,Kenyaisstrugglingwithfinancialsustainability forHIVtreatmentandprevention,andhasbeguntodevelopadditionaldomesticfundingsources

• Thecurrenthealthservicesystem faceschallengesinplanning, coordination, and inadequate infrastructureinvestment,leadingtocapacityconstraintsinHIV-AIDSclinicssuchasashortagesofstaffing,insufficientspace/facilityinfrastructure,andshortagesintestingkits

• PLHIV continue tofacehighlevelsofstigma throughout thecountry

• Currentmessaginganddistributionchannelsareinsufficientforreachingkeypopulations; theGoK willneedtocontinuetoadjustcurrentstrategiesinorder toserveat-riskpopulations,andinvestinyouth-friendlyservices/facilities

• Riskperception islowamongcertaintargetpopulations,whichmakespreventionuptakeaconstantchallenge

Context• Throughaheightened levelofinvestmentandafocusoncombinationprevention, thegovernmenthasmadesignificantprogressin

reducingthenumberofnewinfections:44%decreaseamonginfants;7%amongadultsbetween2008and2013¹

• Giventhesmallerreduction inadult infections,Kenya’smostcurrentstrategyhasshiftedtowardsfocusingonprioritygeographieswithhigh-incidence,andintegratingthosewhoaredisproportionately affectedbytheepidemic:girls,womenandkeypopulationssuchasFSW,MSM,peoplewhoinjectdrugs(PWID),andpeopleinprison²

Current Efforts

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

• HighreachofHIVtestingandcounsellingforhigh-riskpopulations, with lowerratesforgeneralpublic² through~5000testingsites:- FSW(68%)- MSM(74%)- PWID(60%)- Women- general(47.3%)- Men- general(35.8%)

• Varyingpercentofkeypopulations not receivingtargetedinterventions³:- FSW(30%)- MSM(45%)- PWID(76%)

HIVPrevention&TreatmentinKenya

Sources:(1)KenyaAidsStrategicFramework2014/15-2018/19,MinistryofHealth,2014;(2)KenyaPreventionRevolutionRoadmap,MinistryofHealth,2014;(3)KenyaAIDSResponseProgressReport,NationalAidsControlCouncil, 2014

9APRIL2016

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)includeprovisionofPrEPtokeypopulationsseverelyaffectedbyHIV

• ThePharmacyandPoisonsBoardapprovedPrEPinDecember2015,andnationaltreatmentandimplementationguidelinesexpected inJune2016

• AlthoughnationalplansandpoliciesincludeprovisionsforPrEP,questionsremainonconcreteplanstodeliverPrEPtotargetpopulations,planstoencourageandsupportuptake,andfundingforPrEP

• RemainingquestionsaboutthemosteffectivedeliverychannelsfordistributionofPrEP,aswellasthehealthcaresystemcapacitytoreachkeypopulationsandprovideadditionalPrEP-relatedservices

• FundingforPrEP isstillunclear,yetdonorssuchasGatesandPEPFARhaveshowninitialcommitmentstofundPrEPintroduction inKenya

• PlanningforPrEPwilllikelybeinitiallyfocusedonhigh-priority,high-burdengeographicregionswithinKenya

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

10APRIL2016

PlandevelopedtoimplementWHOPrEPguidelinesfortargeted

populations

PrEPproduced,purchased,anddistributedin

sufficientquantitytomeetprojecteddemand

PrEPservicesdeliveredbyappropriatechannelswithaccesstotarget

populations

TargetpopulationsseekandareabletoaccessPrEPandbeginuse

TargetpopulationadherestoPrEPatrecommendedfrequencyand forideal

timeperiod

PLANNINGANDBUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

What’sNeededtoIntroducePrEPOPTIONSaimstotakearobustandcomprehensive approachtoanalyzingthesituationaroundPrEP. ThegoalofthisexerciseistoidentifykeybottlenecksandopportunitiestointroduceandscalePrEPeffectively ineachOPTIONScountry.Thisinformationwilleventuallyfeedintotheinvestmentcasesandwillbeusedtoinformandcapturecountryprogress.Toidentifywhat’sneeded forPrEPintroduction, wehaveorganizedtherestofthesituationanalysisalongthePrEPvaluechain,introducedbelow.

ValueChainforPrEP

11APRIL2016

ValueChainAnalysesThefollowing slidesholdthreeanalysesalongthevaluechain

• Resourcesthatexistin-countrytosupport andacceleratePrEPintroduction

• GapsinresourcesthatcouldactasbarrierstoeffectivePrEPintroduction

• Keyconsiderations toinformcomprehensive in-countryplanning forPrEPintroduction

• Alistofspecificfactorsthatneedtobein-placetoeffectivelyintroducePrEPforeachcomponent ofthevaluechainalongwithprogressto-dateforeachfactor

• Detailsoncurrentsituation,keyactors,responsibilities,timelinesandprogresstowardseachactivityareincluded intheappendix

• Remainingquestions toinformin-countrydiscussionsandplanning

• Remainingquestions toinformongoingmodelling,researchandanalysisefforts

• OpportunitiesforotherpartnerstosupportaccelerationofPrEPintroduction

12APRIL2016

ResourcesandGapsforPrEPinKenya

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

ExpectedStrengths

EmergingKeyConsiderations

•PrEPcoulduseexistingsupply chainsystemsforARVs,butnewdeliverychannelswould requireadditional planning•County coordination andtargetingwillrequireconsideration

•Healthsystemwillneedadditional capacity(e.g.,staff,equipment) todeliverPrEP

•Channels forPrEP willneedtobeidentified fortargetpopulationsincluding AGYW

•Ongoingtesting forPrEPusersmayputadditionalstrainonhealthsystemcapacity• Strategiesareneededtoencourageeffective useforeachtargetpopulation

• StigmaisamajorconcernforuptakeinAGYWandsero-discordant couples

• Awareness/demand forPrEPisunknown;willrequire investmentindemandgeneration

• NeedcommunicationscampaignforPrEP

• Implications ofPrEPforAGYWremainuncertain;demonstration projectswillprovideadditionaldataandinsights

• Sourcesoffinancing forPrEPareuncertain

• National plans callforusingPrEPwithin currentcombination preventionforFSW,MSMandserodiscordant couplesinhigh-burden counties

•Truvadaisnowregisteredforprevention•PrEP national guidelinesexpected inJune2016•Procurement processeshaveeffectivelysuppliedARVswithout shortagesthrough astronge-system

•Current distributionchannelsforHIVtestingandcounsellingarewidespread anddiverse•Healthsystemhas highreachofsomeat-riskgroupssuchasFSWandMSM

•NationalHIVM&Eplantomeasureprogressisinplace.NASCOPandpartners plantodevelopanationalPrEPM&Eplan•Demoprojects aregeneratinginsightsoneffectiveuseconcerns

• HighreachandusageofHIVtesting/counsellingservicesforat-riskpopulations

• Demonstration projectswillprovideinsight onuserneedsandpreferencesforPrEP

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Impact, costandcost-effectiveness analysesforPrEP aspartofcomprehensive HIVprevention portfolio

Identification andquantification oftargetpopulations forPrEP

InclusionofPrEPandfemale-controlledmethodsincurrent orupcoming national HIVprevention plans

Timeline andplan forPrEPintroduction andscale-up

Abudget forPrEProll-out totargetpopulations

Sufficient funding toachievetargets

Regulatoryapprovalofform(s)oforalPrEPbyauthorities

Effectivedemandandsupply forecastingmechanismsforPrEP

Manufactureridentification andcontract negotiation topurchasePrEP

Product andpackagingdesigntomeettargetpopulation needsandpreferences

Developmentofdistribution plan forPrEPtoreachtargetpopulations

Effectivedistributionmechanisms toavoidPrEPstock-outsinpriority facilities

Issuanceofstandardclinical guidelines forprescription anduseofPrEP

Sufficientinfrastructure andhumanresourcestoconduct initial HIVtestsandprescribePrEPinprioritychannelsPlantoengagehealthcareworkers onPrEPanddeliverytotargetpopulations (includingmitigatingstigma)

Toolstohelppotentialclients andHCWunderstandwhoshould usePrEP havebeencreated

Sufficient resourcestoroll-out plansforhealthcare workerengagement

Clearandinformativecommunications onPrEPforgeneralpublicaudiences

Developmentofdemandgenerationstrategiestargetedtounique needsofdifferent populations

Linkages betweenHTC,PrEPprescription, andPrEPaccesstoenablePrEPuptake

Information forclientsonhowtoeffectivelyusePrEPforalltargetpopulations

Establishedplanstosupport effectiveuseandregularHIV,creatinine testing thatreflect theuniqueneedsoftargetpopulations

Capacity toprovideongoingHIV andcreatinine level testingforPrEPusersaccessibletotargetpopulations

Monitoring systemtosupport datacollectionforongoinglearning(e.g.,rateofpatientsreturning for2ndvisit,non-HIVSTIrates)

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

TowardsIntroductionofPrEPinKenya

Significantprogressand/ormomentum

Earlyprogress

Initialconversationsongoing

COLORKEY

14APRIL2016

KeyQuestionsforPrEPinKenya

• WhatistheincrementalcostandimpactofaddingPrEPtocombinationpreventionfortargetpopulationsintargetgeographies?

• Towhatextentaretargetpopulationswillingandabletopay forPrEP?

• HowwilltheintroductionofPrEPbefinanced?

• WhowillmanufacturePrEP?Howwillitbepriced/packaged?Whatalternativescouldbeused?

• HowwillPrEPprocurementanddistributionbemanagedbetweenthenationalandcountylevels,particularlyforpotentialchannelsthatarenotdeliveringARVs?

• Whatwillbeconsidered“effectiveuse”foreachpopulationandhowwillitbeencouraged?

• TowhatextentwillongoingtestingneedsforPrEPusersfurtherstrainhealthsystemscapacity?

• Howwillongoingmonitoringbemanaged?

• Whatarethemosteffective channelstoreachtargetpopulationswithPrEP(e.g., healthfacilities,communitychannels)?

• Howwillhealthcareworkers,includingcommunityhealthworkers,beengagedandsupportedtodeliverPrEP?

• WhatisthecurrentdemandgenerationstrategyforPrEP?

• HowwillstigmabeaddressedbothtoensuretargetpopulationscaneffectivelyaccessPrEPandtoensurethatusebysome(e.g.,FSW)doesnotstigmatize PrEPforothers(e.g.,AGYW)?

PLANNINGANDBUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

15APRIL2016

Natio

nalstakeho

lders

KenyaMinistryofHealth- createsnationalplans/priorities,andoverseesthefollowingHIV-specificdivisions

NACC- implementsstrategicplans,coordinatesstakeholders,leveragesresources,andprovidescareforPLHIV

NASCOP- oversees policyandguidelines,coordinatestechnicalHIVprogramming,managessupplychainsandcapacity-building,performsM&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-makedecisionsregardingplanning,funding,procurement/distribution,andhealthfacilitycapacity-buildingforPrEP

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

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

Dono

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

Otherpotentialdonors(HNWIs,local philanthropicorganizations,UKAID,UNITAID)

KeyStakeholdersforPrEP

Specificorganizationswillbedetermineduponnationallevel

implementationplans

Currently involved

Potential/futureinvolvement

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

16APRIL2016

County-levelHIVstructuresinKenyaCounty governmentsareresponsible fordevelopingHIVpreventionbudgetsandimplementationplans atthelocallevel,andthereforewillbecriticalpartnersinanyeffortstointroducePrEP inKenya.

County-level governancestructures forHIV

CountyExecutiveCommitteeoversees effective deliveryoftheHIVresponse atthecountylevel

CountyGovernment(Governor)implementsnationalpolicyandensuresresourceallocationfor

HIVprograms

CountyHIVCommitteeensures effective deliveryoftheHIVresponse atthecountylevel

CountyHIVCoordinationUnit(NACC)coordinates

implementationofthe KASF

CountyHIVInter-agencyCoordinatingCommittee

comprisedofstakeholderWorkingGroupsrepresentingthevariousconstituenciese.g.,CSO,FBOs,Youth,PWID,PLHIVcoordinatesandoversees implementationof

globalfundprojects

CountyKASFMonitoringCommittee

countymonitoringofKASFactivitiesacrossfive

StrategicDirectionareasofPrevention,Treatment,HumanRights,Systems

StrengtheningandResearch

Sub-County/ConstituencyHIVCommittees

membersoftheCountyHIVCommittee,responsiblefortheeffective deliveryoftheHIVresponse atthesub-

countylevel

CountyHealthManagementTeam

responsibleforensuringintegrationofHIVservices

atthecounty level

NationalGovernmentcoordinatesfunctionsof

ministriesandgovernmentdepartmentstoreinforceNACC’srole;coordinatesallocationof

fundingtodistricts

NACCSecretariatfacilitatesdeliveryof

KASF,includingaccountabilityofsectorsandpartnersinvolved

andsustainablefinancing

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

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APPENDIXA.ValueChainDetailB.TimelineforPrEPC.References

18APRIL2016

AppendixA:ValueChainDetail

Thefollowing slidesprovideadditionaldetailoneachsectionofthePrEP 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

• 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 (HealthPolicyProject,Avenir)

• Costingstudiesunderway (CHAI/LVCTHealth);expectedQ42016

Identification andquantification oftargetpopulations forPrEP

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

• PlansforAGYWremainuncertain

InclusionofPrEPandfemale-controlledmethodsincurrent orupcoming nationalHIVprevention plans

• PrEP ismentionedintheKASFandincludedinRevolutionRoadmap aspartofrecommendedpreventioninterventions

Timeline andplan forPrEPintroduction andscale-up

• Earlyconsiderations articulated• NASCOPhasaskedLVCTHealthtosupportdevelopmentofanimplementationplan

Abudget forPrEProll-out totargetpopulations

• Earlybudgetconsiderationsandthinking happeningaspartofbroaderPrEPplanning

Sufficient funding toachievetargets

• DREAMShasresourcesdedicatedtoPrEPforAGYW

• GatesFoundationhasexpressedinterestinPrEPscale-up.

20APRIL2016

PotentialTargetPopulationsforPrEPAdolescentgirlsandyoungwomen(AGYW)

Sero-discordantcouples FemaleSexWorkers(FSW)

PeopleWho InjectDrugs(PWID)

Menwhohavesexwithmen(MSM)

KeyIndica

tors

• ~4.1MtotalAGYW(ages 15-24)inKenya,basedon2009Census¹

• 21%ofnewadultinfectionsperyearareamongAGYW³

• 4.5%prevalence;byage24therateforAGYWisalmost4timeshigherthanforyoungboys²

• ~90%ofyoungwomentestforHIVatleastoncebythetimetheyareage 24²

• ~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%testedforHIVinthepastyear andknowtheirstatus⁶

• 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

Questio

ns

• WhatmessageswillbeappropriateforencouraginguseofPrEP withoutstigma?

• WhichchannelswillbeeffectiveforPrEP delivery?

• WhatadditionalcommunitysupportmechanismsneedtobeinplaceforPrEP’s effective use?

• 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

21APRIL2016

Budgeting

Current Funding• 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)

• Current fundinggoestoward³:

RemainingGapsandChallenges• ItislikelythatPrEP willnotbefunded

byGoK,spellingtheneedforadditionalfundingfromexternaldonors suchasPEPFAR

• TheoverallHIV/AIDS fundinggap (in$USDM)willcontinueuntil2019³:

PotentialNewFundingSources• FunderssuchastheGatesFoundation

haveshowninitialcommitmentstofurther fundPrEP throughcurrentrequestsforproposals

• TheNationalHospitalInsuranceFund(NHIF)willfinancetheKenyangovernment’suniversalhealthcare.Kenyaseekstoincreasethenumberofcontributors tothisfundtocovercostsofART,andpotentiallyfundadditionalHIVservices

• KenyaHIVTrust/InvestmentFundwillraisenational/countyresourcesthatwillsubsidizegovernmentHIVcosts

• DeterminingtheabilityandwillingnesstopayforPrEP inaprivatehealthcaresettingmightenablesomecost-recovery

Summary• Kenya’sHIV/AIDStotalexpenditureshaverisenovertime,accountingfor2%oftotal

countryGDP.Over68% offundingcomingfromexternalsources³• Thecountryhasprojected fundinggapstoimplementthenewstrategicplan(KASF)• Kenyawillstrivetoclosefundinggapsbymaximizingprogramefficiencytoreduce

costs,andincreasingdomesticfinancingby50%by2019

Nationalbudget

$956.2McostsforHIV$210.3Mofwhichisprevention$0M ofwhichiscommittedtoPrEP

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

22APRIL2016

Procurement&DistributionKeyStakeholders• Gileadlicenses Truvadamanufacturing globally.Itsregionalbusiness

partnerinKenya iscurrentlyPhillipsPharmaceuticalsLimited• Pharmacy andPoisons Board- approves allnewmedications• KenyaMedicalSuppliesAuthority- centralprocurement agency

undertheMoH; partnerswithdonors,countygovernments andcommunity-based organizations (CBOs) toestablish effective supplychains

• CBOs andcountylevelgovernments - willberesponsible forthe localsupplychainofPrEP

KeyStrengths andOpportunities

• Strong supply chainfor ARVs,withlimitedinstances ofshortages

• Strong E- MedicalRecordSystem (EMR) toensure ART coordinationandqualitymanagement system inplace

• Althoughthe detailsonwhowillprocurePrEPare stillunclear,theGoK has committedtosupporting procurementforPrEP tomake itavailablewherever needed (pharmacies, HIVclinics)

KeyEmerging Considerations• Need foradditionaldata ontargetpopulations demand estimates

anduser preferences toinformdemand forecasts

• Lackofclarityonwhowillmanufacture and distributePrEP– likelynotachallengewhen handledbycurrentARV channels butquestionsremain aboutadditionaldelivery channels notadministeringART

• HighpriceofTruvada – couldshiftwithemergence ofalternativesoralPrEPdrugs

ReadinessforPrEPIntroductionReadinessFactor ProgressRegulatoryapprovalofform(s)oforalPrEPbyauthorities

• Truvada approvedforpreventionbythePharmacyandPoisonsBoard

• OtherformsoforalPrEPinpipeline

EffectivedemandandsupplyforecastingmechanismsforPrEP

• StrongsupplychainmanagementinplaceforARVs,whichwilllikelytranslatetoPrEPreadiness

Manufactureridentification andcontract negotiationtopurchasePrEP

• Notoutsideofdemonstrationprojects

Product andpackagingdesigntomeettargetpopulation needsandpreferences

• Currently aplasticpillbottle,toberefilledmonthly;unknownifformatwillbeconsistentforotherformsoforalPrEP

Developmentofdistribution plan forPrEPtoreachtargetpopulations

• NACCandotherentitiesdeterminingmosteffectivechannelsandaccompanyingdistributionplans

• NASCOP’s RFPsforimplementationofPreventionRevolutionRoadmapwillprovideinsightondistribution

Effectivedistributionmechanisms toavoidPrEPstock-outsinpriority facilities

• KenyahashistoricallymaintainedastrongsupplychainforARVs,withlimitedinstancesofshortages.LikelytotranslatetoPrEP

23APRIL2016

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, andsupportmechanismsnecessaryforeffective distributionofPrEPtotargetpopulations

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

KeyEmergingConsiderations• HealthworkersinmanysettingsarenotequippedtodistributePrEPtotarget

populations,oraddressstigma• HIVtestingkitshortagescouldimpedePrEPprescription/access• NeedbetterunderstandingoffulllandscapeofpotentialPrEPdistribution

channels inordertomosteffectivelyreachtargetpopulations• Capacity-buildingwillbeneededinordertoequipnon-ARVdeliverychannelsas

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

• Noear-markedfundingforPrEPisavailableforcapacity-building

ReadinessforPrEPIntroductionReadinessFactor ProgressIssuanceofstandardclinicalguidelines forprescription anduseofPrEP

• CDCcurrentlydraftingstandardtreatmentguidelines;NASCOPexpected toissueguidelines inJune2016

Sufficientinfrastructure andhumanresourcestoconduct initial HIVtestsandprescribePrEPinprioritychannels

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

• Humanresourcesneedslikelytobedetermined tomeetPrEPguidelines

Plantoengagehealth careworkersonPrEPanddeliverytotargetpopulations(includingmitigatingstigma)

• No planinplace,butconsiderationsarebeginningtoemerge inrelationtotheneedsspecifictoPrEPdeliveryandthetargetpopulationslikelytoaccessPrEP.

Toolstohelppotential clientsandHCWunderstandwhoshould usePrEPhavebeencreated

• Somematerialsalreadyexistfromdemonstrationprojects

• LVCTHealthdevelopingariskassessment toolforPrEPuse

Sufficient resourcestoroll-out plansforhealthcare workerengagement

• Resources notyetsecured.

24APRIL2016

CurrentPrEPDeliveryChannelsDemonstrationProjectsandOpenLabelExtensions DREAMS

Background

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

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

KeyS

trengths

• DemoprojectsalreadyreachingtargetpopulationsathighriskofcontractingHIV• ExistingaccesstoPrEPandassociatedtesting,monitoring,andcounsellingservices• ExperiencedstaffhighlyknowledgeableaboutPrEP• Valuableinsightsfromrecruitmentandretentioneffortsthusfar• LowlevelsofstigmaamongstaffworkingwithPrEPusers

• Targetedprogramreachinghigh-risk(asidentifiedbycommunity-ledcriteria)adolescentgirlstostart2016/17• PrEPdeliverycoupledwithbehaviorchangeactivitiesandextensivecounseling• FundingforPrEPsecured(TruvadadonatedbyGilead,programcostsfromDREAMSfunding)• PotentialtoexpandPrEPthroughout thesedistrictsgivenother investmentstomakePrEPavailabletoDREAMSparticipants,includinglogistics,procurement,demandgeneration,andcommunitybuy-inefforts

Key

Challenges • PerceptionofPrEPaspartofan“experiment”deterspotential

usersfearingpoorsafetyandefficacyofdrug• Highercostsofdelivery indemonstrationprojectcontext

• DREAMS’PrEPcomponent toreachonlyadolescentgirlsincommunitieswheremanyotherpopulationscouldbenefitfromPrEP• ReachlimitedtoHoma Bay,Siaya,KisumuandNairobi

25APRIL2016

ComprehensiveCareCenters &otherARTsites SexualandReproductiveHealth(SRH)careproviders

Background

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

KeyS

trengths

• Mostvisibletogeneralpopulation

• Systemsguidedandlinkedwithcountyandnationalstandards/agendas

• Canprovidegreateraccesstokeypopulations(FSW,MSM,PWID)

• Effectivelyreachhigh-riskindividualswithlow/nostigmapresentincentersoramongstaff

• Frequentuseofpeer-educatorprograms,whichmightbecriticaltoeffectiveuseandincreaseddemandgeneration

• Opportunitiestodeliverthroughprivatechannelsaccessingkeypopulationssuchas FHI’sGoldStarNetworkclinicsinNairobi,thecoastalregion,andRiffValley

• DiscreteaccesstoPrEPwithoutstigmaforthosewhocanaffordit

• Notdependentonaid

• Providegreateraccesstosero-discordantwomenandAGYWinfemale-friendlyandtrustedsettings

• StaffhavelowerlevelsofstigmaagainstAGYWwhoseek familyplanningandHTCservices

• Post-abortioncareclinicshavethepotentialtoreachwomenatveryhighriskofHIVinfection

• LowcostofdemandgenerationsincewomenarealreadyvisitingSRHservices

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

Key

Challenges • HCWstigmaagainsttargetpopulationsdetersmanyfromaccessingcarethroughthesechannels

• Staffandresourcesperceivedtobestretchedthin,resultinginsuboptimalcare• Maynoteffectivelyreachtargetpopulationsathighestrisk

• PotentiallylimitedexperienceandtraininginHTClinkages

• Limited/nolaboratorycapacityfornecessary PrEPmonitoring

• AGYWmayhavetroubleaccessing

PotentialPrEPDeliveryChannelsThisisanareaoffocus

forOPTIONS.Additionaldetailsexpectedbythe

endof2016

26APRIL2016

IndividualUptakeKeyStakeholders• DREAMS-willpotentiallyhaveresearchandimplementationpracticefor

AGYWusingPrEPthatcanbeusedtoinformfurtherscale-up(managedbyGlobalCommunitiesinKenya)

• Community-basedandfaith-basedorganizations- willplayakeyroleinreachingtargetpopulationslocallyandinfluencingcommunitybuy-inforPrEP

• Localandnationalmedia- tohelpaccuratemessagingonPrEPasaneffective andsafe preventionoption

KeyStrengthsandOpportunities• SomeresearchexistsonuserpreferencesforPrEPinkeypopulations

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

• NASCOPhasplansforadditionalresearchspecificallyondeliverychannelsandaccesspointsforPrEP

• ImplementationstakeholdersacknowledgetheimportanceofaddressingstigmainordertoreachAGYWandsero-discordantcouples

KeyEmergingConsiderations• Stigmaisamajorconcernforuptake.Thisincludesboththestigma

associatedwithHIVandthosenormallythoughtofas“highrisk”populations,aswellasstigmaagainstyoungwomenwhomightbesexuallyactiveandseekingSRHcare.ThereisastrongneedtonormalizePrEPandcreateasupportivecommunicationstrategyforitsuse

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

ReadinessforPrEPIntroductionReadinessFactor Progress

Clearandinformativecommunications onPrEPforgeneralpublic audiences

• Nocommunication strategyyetexists.

Developmentofdemandgenerationstrategiestargetedtounique needsofdifferent populations

• Whileearlyconsiderationsfordemandgenerationare beingdiscussed,strategies arenotyetbeingcreated

Linkages betweenHTC,PrEPprescription, andPrEPaccesstoenablePrEPuptake

• Necessary linkageswillbeunknownuntilPrEPguidelines(outliningchannels,populations,andprescriptiondetails)arecompleted.IfPrEPisdeliveredthroughARVchannels,thelinkagesare likelytoenablePrEPuptake

Information forclients onhowtoeffectivelyusePrEPforalltargetpopulations

• Informationexistsforthoseparticipatingindemoprojects.Generalinformationforalltargetpopulationswillneedtobedeveloped.

27APRIL2016

KeyConsiderations

Stigma

• Earlystigmalingers:makingPrEPwidelyavailablebeyondkeypopulationswouldhelpmitigatepreconceptionsofPrEPasanoptiononlyforFSWandMSM.Thisisimportantbecausemostdemoprojectshavebeendonewithkeypopulations.AnyPrEPcommunicationscampaignwillneedtodirectlyaddressthestigmaassociatedwiththosepopulations.

• Amonghealthworkers:thechallengesaretwofold- healthcareworkershavetheirownbiasesaboutwhoshouldbeaccessingbirthcontroloptionsandHIVpreventionservices,andtheyoftenlacktheappropriateinformationandtrainingtoeffectivelyprovidearangeofoptionsforindividualstomakeinformeddecisions.

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

DrugPreconceptions

• There arefearsaboutdevelopingresistancetoARVswhileonPrEP,anddevelopingphysicalsideeffectsassociatedwithARVs.

• PeoplerecognizeTruvadaasanARVanddonotwanttobeseentakingitiftheyareHIVnegative.

Messengers• Messages aroundPrEPneedtobeproactive,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”

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

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

KeyEndUserThemesforPrEP

28APRIL2016

EffectiveUse&MonitoringKeyStakeholders• NACC- holdscountry-wideresponsibilitytotrackKASFprogressandHIV-related

programsuccess• CDC- workscloselywithGOKandimplementingpartnerstosupportlabsystems

andnetworksstrengthening• NationalHIVReferenceLaboratory(NHRL)- leadspolicyandguidelines

formulationonHIV-relatedlabservicestostrengthencountry’slaboratorycapacity

KeyEmergingConsiderations• MechanismsforgatheringlocaldataonPrEPimpactarenotestablished• Planstoincreaseeffectiveusedonotexist;noroleshavebeenassignedfor

generatingthesupportsystemsneeded tofostereffective useatlarge• Interventionsusedtoencourageeffective useamongdemoprojectparticipants

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

• Frequent,ongoingmonitoringneedsyettobedeterminedandlikelytobothdriveupcostsofdeliveryanddiscourageongoinguseofPrEP

ReadinessforPrEPIntroductionReadinessFactor Progress

Establishedplanstosupport effectiveuseandregularHIV,creatinine testing thatreflect theuniqueneedsoftargetpopulations

• Effectiveuseyettobedefined• Whileearlyconsiderationsforencouragingandsupportingeffective useandadherencetoregulartestingarebeingdiscussed,specificstrategies fortargetpopulationsarenotyetbeingcreated.

Capacity toprovideongoingHIV andcreatinine level testingforPrEPusersaccessibletotargetpopulations

• While thereisincreasingHTCcapacityforcurrentefforts,gapsremainparticularlyforreachingtargetpopulations.Additionally,exacttestingneedsforPrEPareyettobedetermined.

Monitoring systemtosupport datacollection forongoinglearning(e.g.,rateofpatientsreturning for2ndvisit,non-HIVSTIrates)

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

KeyStrengthsandOpportunities• Nationalmonitoringandevaluationframework includesprioritiestoincrease

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

• VarioussurveysexisttocollectnationaldataontheHIVepidemic,includingthesituationroomtoolwhichwillshowlive,localupdatesonHIVincidenceandmortality

• NASCOPleadingthedevelopmentPrEPM&Eplans• Lessonsoneffectiveusefromdemoprojectstolearnfromandbuildoninclude

consistentregimens,structuredfollow-up,andcounselling/communitysupport

29APRIL2016

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

EMOTIONandGEMSstudies

ConfidenceProjectstudy (LVCTHealthandLSHTM)onPrEPacceptabilityreports

DevelopmentofanationalresearchagendaforHIV

Planning/

Implem

entation

WHOPrEPImplementation Guidelinesexpected

KenyaPrEPtreatmentguidelinesandimplementationplanexpected

DREAMSprogrammingimplementedinHoma Bay,Siaya, Kisumu, andNairobi

Policy NextNationalAIDSStrategicFramework

(KASF)developed

Financing

NASCOP RFPsforPreventionRevolutionRoadmapimplementation,includingPrEP

KenyaGlobal

Exacttimelinestobeclarified

30APRIL2016

AppendixC:References• KenyaAidsStrategicFramework2014/15-2018/19,MinistryofHealth,2014• KenyaPreventionRevolutionRoadmap,MinistryofHealth,2014• KenyaAIDSResponseProgressReport,NationalAidsControlCouncil,2014• KenyaMonitoringandEvaluationFramework 2014/15-2018/19,MinistryofHealth,2014• NationalguidelinesonHIVtestingandcounselling,MinistryofHealth,2008• GuidelinesonUseofAntiretroviralDrugsforTreatingandPreventingHIVInfection:Arapidadvice,MinistryofHealth,2014• 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:Resultsofaconsultationwithcommunity stakeholders,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,2015