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 [email protected]
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
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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