OPTIONSCountrySituationAnalysisInterimFindings:Zimbabwe

FSGinpartnershipwithPangaeaGlobal

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OPTIONSIntroductionOneoffivecooperativeagreementsawardedbyUSAIDwithPEPFARfundingthroughRoundThreeoftheAnnualProgramStatement(APS)forMicrobicideResearch,Development,andIntroduction.

OPTIONSObjectiveDevelopastreamlined,adaptableproductdeliveryplatformforcurrentandfuturemicrobicideandARV-basedHIVpreventionoptions.

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

OPTIONShasfourmajorgoalsoverthenextfiveyears:

4APRIL2016

OPTIONSHowWeWork

• OPTIONSisnotaservicedelivery project;weapplysystemsthinkingtosupportandaccelerateproductintroduction

• Oursupportisflexibleandisdesignedtoberesponsivetonationalcountryprioritiesandplans

• InadditiontoPangaea,whohassignificantexperienceworkingonHIVpreventionandtreatmentinZimbabwe,ourconsortiumbringsmulti-disciplinaryexpertisetotheefforttointroducefemale-controlledHIVpreventionproductsinZimbabwe

• Wearetakingsignificantstepstoensurewedonotreplicateexistingorongoingwork– ourmissionistofillgapsandhelpanswerkeyquestionsasoutlinedbythenationalgovernment,theUSAIDcountrymission,andotherkeylocalstakeholders

5APRIL2016

AbouttheSituationAnalysis• This document includes a summary of preliminary findings from the

OPTIONS situation analysis for oral PrEP in Zimbabwe, completed by FSGwith significant input and consultation fromPangaea Global AIDS

• The situation analysis aims to take a comprehensive and robust approachto assessing the “state of the field” for oral PrEP in Zimbabwe, includingopportunities and resources aswell as gaps and expected challenges

• This document reflects findings from secondary research and in-countryconsultationswith key stakeholders

• This is designed as a “living document,” to be updated on an ongoing basiswith additional information and stakeholder feedback to inform ongoingplanningand decision-makingaroundoral PrEP

• Ifyouhaveanyupdates,additionalinformation,orfollow-upquestionsregardingthissituationanalysis,pleaseemailNeerajaBhavarajuatneeraja.bhavaraju@fsg.org

6APRIL2016

ExecutiveSummary• Zimbabweisearly-stage increatingtheconditions,policies,andpracticesneeded tosuccessfullyroll-outandscale-upPrEP.The

country’sHIVresponsehashistoricallybeenon theleadingedgeamongpeersandgenerallyresponsive toglobalguidelines.

• InMarch2016,theMinistryofHealthandChildCare(MOHCC)convenedanationalworkinggroup toadapttheWHO“testandstart”guidelinesissuedinNovember2015.Aspartofthateffort,asub-committeeonplanningfororalPrEPhasbeenestablished.Thissub-committeewillmeettodevelopnationalguidelinesonPrEPandplanforroll-outinthecomingmonths,withanexpectedtimelineofJune2016.

• ThekeychallengesforPrEPinZimbabweareensuringtimelyapprovalofTruvada forprevention, identifyingandagreeingontargetpopulations, deployinganeffectivecommunicationsstrategy,andnavigatingthehealthsystemcapacitylimitationsinherentinclosingZimbabwe’sexistingtreatmentgapwhileinvestingin“new”preventionmethods.

– ZimbabwewillsoonreleaseanupdatedHIVstrategicplanthatfocusesonkeypopulations andcombination preventionpackages,butomitsPrEP.Whilesomehaveasensethatnotenough isknownyettoinvestinPrEP, thismaybechanging.Inearly2015,MOHCC officialsexpressedinterestinintroducing PrEP forabroadrangeofhigh-riskpopulations,includingadolescentgirlsandyoungwomen(AGYW).

– Therearesignificantlegalandculturalbarriers toquantifyingandreachingthekeygroupsforwhomPrEPwouldbewell-suited,particularlyfemalesexworkers(FSW)andmenwhohavesexwithmen(MSM),whosepracticesareillegal,andAGYW,whofacestigmaandopposingculturalnormsrelatedtoHIVprevention.

– ZimbabwehasmadesolidprogressinexpandingcoverageofARTandHTCsites,buttreatmentgapsremain;inaddition,healthcareworkerknowledgeandattitudesandenduserawarenessanddemandhavecontinuedtobecriticalfactorsdeterminingthesuccessofHIVpreventionandtreatmentinterventions.

• Despitethesechallenges,PrEProlloutinZimbabwewillbefacilitatedbythecountry’smanystrengths,includingincreasinglyharmonizedprocurement,distribution, andM&Esystems,anactivecivilsociety,thepresenceoftheDREAMSinitiative,andanearlycompletePrEPdemonstrationproject (SAPPH-IRe).

• Inthenear-term,decisionsonPrEP inZimbabwerevolvearound thequestion:“HowmuchshouldbeinvestedinPrEP,forwhom,how,andinwhichareas?”

7APRIL2016

CurrentStateofHIVinZimbabweContext• ZimbabwehasoneofthelargestHIVburdens inSouthernAfrica,with1.2Mpeople livingwithHIV(PLHIV)• TheHIVepidemicexhibitsgrowingratesamongwomen – HIVprevalenceisnow1.5xhigheramongwomenthanmen• Keydriversoftheepidemicincludemultipleandconcurrentpartnerships,inter-generationalsex,discordantcouplesandlow(but

rising)circumcisionrates;severalkeygeographiesandpopulations listedbelowremaindisproportionatelyaffectedbytheepidemic• DespitehighabsoluteHIVburdenandeconomicchallenges,rateshavedeclinedsubstantiallyinrecentyears(prevalencereduced

from25%to15%,adultincidence reducedbyhalfto0.98%,and75%fewerchildrenborn fromHIV+mothersinthelastdecade)

Demographics• Sourceofnew infections(not

mutuallyexclusive):– 55%amongpeopleinstableunions– 36%amongyoungpeople– 12%amongsexworkersandclients– 4-7%amongMSMandpartners

• Prevalence(notmutuallyexclusive):– 17%amongwomeningeneral– 12%amongmeningeneral– 5-6%amongwomen15-24years– 50-70%amongFSW– 14%inprisons

• Incidence byageandgender (2013):

Geography• Geographichotspots:

– Threeprovinces:MatabelelandNorth,Bulawayo,MatabelelandSouth– 14additionaldistrictsrecentlynamedashotpots

• HIVprevalencebyprovince:%ofpeople15-49yearsold

Male Female

• HIVincidencebyprovince:Newinfections,people15-49years

20142015 2016

Trends• Prevalencehasbeendecreasingin

recentyears:

• Incidencehasbeendecreasinginrecentyears:

0k5k10k15k20k

0-14 15-24 25-49 50+

Male

Female

Sources:(1) ZimbabweNationalHIVandAIDSEstimates:2013.MinistryofHealthandChildCare.2013;(2)ZimbabweNationalHIVandAIDSStrategicPlan2011-2015(ZNASPII).MinistryofHealthandChildCareandNationalAIDSCouncil.March2015;(3)ZimbabweNationalHIVandAIDSStrategicPlan2015-2018(ZNASPIII)[Notofficiallylaunched].MinistryofHealthandChildCareandNationalAIDSCouncil.March2015.

8APRIL2016

HIVPreventionandTreatmentContext• Improvementsinprevalenceandincidence ratesprimarilyduetosuccessfulpreventioneffortsandreduction inpersonal risk-taking

behavior,while HIV-relateddeathshavebeenreducedbyover60%due toZimbabwe’streatmentandsupport program• Forprevention,thegovernmenthasprioritizedsocialandbehaviorchangeinterventions,condom promotionanddistribution

(coupledwithintensifiedawareness oncorrectandconsistentuseofcondoms),andvoluntarymedicalmalecircumcision• Fortreatment,HIVtestingandcounselling (HTC) hasbeenidentifiedasakeyentrypoint forART,andprovider-initiatedHTC(which

comprises80%ofallcurrenttestinginZimbabwe)isbeingscaledup• NationalHIVresponseissoonbeginningitsthirdandmostadvancedstage(ZNASPIII),focusedonkeypopulations andgeographies

Current Efforts• Sustainingcurrenttreatmentandcareinvestment• RapidlyscalingupVMMC to80%by2018usingWHO

guidelines/standards• Comprehensiveprevention programsforsexworkers,

adolescentandyoungpeople,discordantcouples• ScalingupinnovativecommunityHIVtestinginitiatives,

including self-testingkitsviaaPSIpilotfundedbyUNITAID• RollingoutPITC to94%ofhealthfacilities• Integratingsocialnormandbehaviorchangeinterventions

intodeliveryofsocialandHIV-relatedservices• Communitysystemstrengthening• Preventing secondary increasesin theepidemicduetolower

levelsoffunding• Zimbabwehasallowedtheexistenceofinformallobby

groups forFSW,prisoners,andMSM

RemainingNeeds• Coveragegaps:Zimbabweisbehindby55%inproviding

treatmentforHIV+children;mostcommitmentsforARTendin2016,whichwillcreateadditionalgapsforHTC

• Datagaps: datagapsexistgenerallyandparticularlyforkeypopulations

• Keypopulations: Current strategiesareinequitabletokeypopulations(e.g.,needformorefemale-controlledoptions,as27%ofZimbabwe’swomenhaveexperiencedsexualviolenceintheirlifetime;irregularcondomuseamongMSM)andlegalcodesandstigmaposechallengesforkeypopulations

• Healthsystem:Zimbabwe’shealthsystemhasbeenweakened byeconomiccrisisandisoftenseenasnot“friendly”towomenandadolescents;communityorganizationshaveoftenlackeddefinition,cohesion,prioritization,andfunding

Sources:(1) ZimbabweNationalHIVandAIDSEstimates:2013.MinistryofHealthandChildCare.2013;(2)ZimbabweNationalHIVandAIDSStrategicPlan2011-2015(ZNASPII).MinistryofHealthandChildCareandNationalAIDSCouncil.March2015;(3)ZimbabweNationalHIVandAIDSStrategicPlan2015-2018(ZNASPIII)[Notofficiallylaunched].MinistryofHealthandChildCareandNationalAIDSCouncil.March2015.

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KeyConsiderationsforPrEP• Achieving national targets: Zimbabwe has demonstrated strong political will

by adopting the global 90-90-90 goals and committing to reducing newinfections by 75%. However, this target may be difficult to meet withoutreducing infection among high-incidence populations (e.g., sero-discordantcouples, AGYW, FSW, and MSM) through prevention methods appropriate forthese populations. As one MOHCC representative noted, “There is no way tomove towards zero new infections unless we have PrEP as part of theinterventions package.”

• Protecting human rights and upholding zero discrimination: Several of thehigh-risk populations for whom PrEP is most appropriate are also thepopulations most discriminated against by Zimbabwean society and legalframeworks (e.g., FSW, MSM). Excluding PrEP from the prevention strategyruns contrary to Zimbabwe’s vision for “zerodiscrimination.”

• Promoting equity: Zimbabwe promises to “uphold equity-orientedinterventions that promote allocation of resources preferentially to the needyso as to address challenges related to unfair differences” in outcomes. PrEP isappropriate for those most left behind by the country’s HIV response.

• Enabling a gender-sensitive response: Zimbabwe’s strategic plan commits to"promoting and implementing a gender responsive national AIDs response inthe next five years,” but the dominant HIV prevention strategiesrecommended and prioritized aremale-controlled (e.g., condoms, VMMC)

• Ensuring truly “comprehensive” prevention: Zimbabwe’s plan calls for a“comprehensive prevention program for sex workers and adolescent girls.”The current package for FSW includes HIV testing and treatment, condompromotion, solidarity programs, violence and abuse support, and protectivepolicing, but excludes health education, skills training, PrEP, and others.

WhyPrEPisunderconsiderationinZimbabwe CurrentPrEPContext• Zimbabwehasconvenedanational

workinggroup toadapttheWHO“testandstart”guidelinesinMarch2016,includingasub-committeeonPrEP

• Truvada hasbeenregisteredforprevention,butiscurrentlyapprovedonlyfortreatment;nogenericsorotheralternativeformsoforalPrEPareapprovedforprevention

• PrEPdemonstration project ledbyCESSHARisendingin2016;DREAMSprogramfocusedonAGYWislaunchingin2016withaPrEPcomponent

• NewHIVstrategicplan beinglaunchedinearly2016includescomprehensivepreventionbutexcludesPrEP;potentialtopushforPrEPinclusionduringmid-termreviewinlate2016orearly2017

• WhileFSWandAGYWareprioritizedforHIVprevention,notallkeypopulationsaremeaningfullyincluded(e.g.,MSM)andnoneareprioritizedforPrEPspecifically

• Significantlegalandculturalfactorscontinue tomarginalizeMSMandFSWandobscureabilitytoquantifythesizeandHIVratesofthesepopulations.

Sources:(1) AchievinganAIDS-FreeGenerationforGayMenandOtherMSMinSouthernAfrica.amfAR,TheFoundationforAIDSResearchandJohnsHopkinsBloombergSchoolofPublicHealth.May2013;(2)FSGinterviewwithPangaeaGlobal.December16,2015;(3)ZimbabweNationalHIVandAIDSStrategicPlan2015-2018(ZNASPIII)[Notofficiallylaunched].MOHCCandNationalAIDSCouncil.March2015.

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PlandevelopedtoimplementWHOPrEPguidelinesfortargeted

populations

PrEPproduced,purchased,anddistributedin

sufficientquantitytomeetprojecteddemand

PrEPservicesdeliveredbyappropriatechannelswithaccesstotarget

populations

TargetpopulationsseekandareabletoaccessPrEPandbeginuse

TargetpopulationadherestoPrEPatrecommendedfrequencyand forideal

timeperiod

PLANNINGANDBUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

What’sNeededtoIntroducePrEPOPTIONSaimstotakearobustandcomprehensive approachtoanalyzingthesituationaroundPrEP. ThegoalofthisexerciseistoidentifykeybottlenecksandopportunitiestointroduceandscalePrEPeffectively,particularlyforwomenandgirls,ineachOPTIONScountry.Thisinformationwilleventually feedintotheinvestmentcasesandwillbeusedtoinformandcapturecountryprogress.Toidentifywhat’sneeded forPrEPintroduction, wehaveorganizedtherestofthesituationanalysisalongthePrEPvaluechain,introducedbelow.

ValueChainforPrEP

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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

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ResourcesandGapsforPrEPinZimbabwe

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

EmergingKeyConsiderations

• Notallkeypopulationsfully representedinnewplan

• PrEPnotincludedinrevisedplan

• Noclearfundingsources forPrEPbeyondDREAMS

• Truvada registeredastreatmentbutnotprevention

• Demandforecastactivitieswillinvolvepopulationsforwhichlittledataexists

• AccessofkeypopulationstoHTC

• Negative/stigmatizinghealthcareworkerattitudestowardstargetpopulations

• Capacitylimitations insomeHIVchannels

• Low(butrising)ratesofHTCusage

• Demandgenerationplans early-stage

• StigmaandlawsinhibitaccesstoHIVservices

• LittleisknownaboutPrEPadherenceingeneralandamongkeypopulations

• OngoingtestingofPrEPuserscouldplacestrainontheexistingHIVtestingcapacity

ExpectedStrengths• Newplan (ZNASP III)callsforHIVinvestmentinchildren,adolescents,youngpeople,women,girls,keypopulations

• Innovativedomesticfinancingmechanism

• Well-coordinatedprocurementanddistributionsystemthatserves publicandNGOchannels

• CoordinationchallengesinARVscale-upresolved

• VarietyofHIVservicechannelswithstrongcoverage(e.g.,ARTsites,CBHC,HTCcentres,civilsociety,mobileclinics)

• Widedisseminationoftreatmentguidelines

• GoodHTCcoverage• RecentpositivelegalchangerelevanttoFSWs

• PITCisbeingpushed• Civilsocietypresenceadvocatingforkeypops(e.g.,FSW,MSM)

• Singleharmonizedmonitoringandevaluationsystem

• Newplan(ZNASPIII)mentionsM&Eplantobedevelopedandupholdsimportanceofmonitoring

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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

TowardsIntroductionofPrEPinZimbabwe

Issuanceofstandardclinical guidelines forprescription anduseofPrEP

Sufficientinfrastructure andhumanresourcestoconduct initial HIVtestsandprescribePrEPinprioritychannels

Plantoengagehealthcareworkers onPrEPanddeliverytotargetpopulations (includingmitigatingstigma)

Toolstohelppotentialclients andHCWunderstandwhoshould usePrEP

Sufficient resourcestoroll-out plansforhealthcare workerengagement

Clearandinformativecommunications onPrEPforgeneralpublicaudiences

Developmentofdemandgenerationstrategiestargetedtounique needsofdifferent populations

Linkages betweenHTC,PrEPprescription, andPrEPaccesstoenablePrEPuptake

Information forclientsonhowtoeffectivelyusePrEPforalltargetpopulations

Sufficient resources toroll-out plansfordemandgeneration

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

Significantprogressand/ormomentum

Earlyprogress

Initialconversationsongoing

COLORKEY

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KeyQuestionsforPrEPinZimbabwe

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

• WhataretheincrementalbenefitsandcostsofPrEPfortargetpopulations?

• WillPrEPbeincludedintherevisednationalplan?

• Whatpopulationsandsub-segmentswillreceivePrEP?

• HowwillPrEPbefunded beyond demonstrationprojectsandDREAMS?

• WhenwillTruvada,oralternatives,beapproved forprevention?

• Whatisthetotalforecastedneed forPrEP,andhowwilleffectiveforecastsbedevelopedgivendatalimitations?

• Howwillthesupplychainbemanagedtoavoidstock-outsorperceivedcompetition withtreatment?

• Whichdeliverychannels willbeusedtodeliverPrEPtokeypopulations,inwhatsequence?

• Howcannon-publicfacilitiesbeleveragedforPrEP?

• HowandwhenwillhealthcareworkerengagementforPrEPbedelivered?Whatareexpectedopportunitiesorchallenges?

• Towhatextent,how,andwithwhatfundingwillthechallengesofstigma,access,anddemandgenerationbeaddressed?Who willaddressthesechallenges?

• WhowillcoordinateZimbabwe’snationalcommunicationscampaignforPrEPandwhenwillthatstart?

• Whatinvestmentand/orcapacity-buildingneedstobedone tomitigatestrainon thesystemfromongoingtesting(HIVandcreatininelevels)ofPrEPusers?

• Willusersadhere toeffectiveuseofPrEP?Howcanadherence/effectiveusebeencouragedandsupported?

15APRIL2016

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

KeyStakeholdersforPrEP

MOHCCdevelopsnationalstrategicplan,identifiesdrugneeds,doesforecasts,specifiesdeliverytimelines,createstreatmentguidelines

NACprovideslogisticalandtechnicalassistanceduringplanpreparation...

…andNACisresponsibleforoverseeingmonitoring&evaluation

Technicalworkinggroupsfocusedonkeythemesareinvolvedinplanning

Civilsocietygroups(e.g.,CeSSHAR,Katswe Sisterhood,GALZ,ZNNP+,ZAN,WAG,WASN)advocateforkeypopulationinclusioninplan,equitableaccess,anddemandgeneration

Natio

nalstakeho

lders

LocalImplem

enters

Dono

rs

Pangaeacanhelpensureinclusionofkeypopulationsinitssecretariatrole

Keypopulationsareincludedintechnicalworkinggroupsbutmoreeffortsareneededtoensuremeaningfulrepresentation

CCMoverseesGlobalFundproposalsandgrants

NatPharm quantifiesdrugneedsandoversees storage

MCAZperformsqualityassuranceandregistration

SPBregulatesandmanagespublicprocurement

LocalmanufacturershavehadsomeinvolvementinARVproductioninthepast

HealthcarefacilitiesalreadydeliveringARTlikelytobethefirsttodeliverPrEP

OtherpublicHIVservicechannels couldpotentiallydeliverPrEP(e.g.,CBHCs,HTCcenters,ART sites,mobileclinics)

Specificorganizationswillbedetermineduponnationallevel

implementationplans

GeneralHTCandHIVpreventionpartnersmayplayaroleinPrEPdeliverypendingnationalimplementationplans(e.g.,FHI,PSI,OPHID,ZAPSO,ZACH,ZNFPC,PSZclinics)

Otherstakeholders(e.g.,youthcenters,sexworkerclinics,andcivilsocietyorganizations)mayplayaroleinensuringPrEPaccessamongkeypopulations

CESHHARconductingonlyPrEPimpactstudyinZimbabwe(amongFSW)

Internationalbilateralfundersanddomesticpublicfundingsources(e.g.,PEPFAR,DFID,CIFF,CIDA,ZimbabweNationalAIDSTrustFund)

Multilateraldonors(e.g.,GlobalFund,WHO,UNITAID)

UNAIDSsupportscivilsocietycoordination

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APPENDIXA.ValueChainDetailB.TimelineofMajorResearchandActivitiesC.References

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AppendixA: ValueChainDetail

Thefollowing slidesprovideadditionaldetailoneachsectionofthePrEPvaluechaininZimbabwe

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PlanningforPrEPKeyStakeholders• MOHCC isresponsiblefordevelopingnationalstrategicplanaswellas

conveningatheguidelineadaptationTWGforWHOguidelinesonUTTandPrEP,andthePrEPsub-committee

• CountryCoordinatingMechanismoverseesGFproposalsandgrants• Technicalworkinggroupsfocusedonkeythemesareinvolvedinplanning• Keypopulationsareincludedinthesegroups,butmoreeffortsareneeded

toensuremeaningfulrepresentation• NAC provideslogisticalandtechnicalassistanceinthepreparationofplan• Advocacygroups forkeypopulations(e.g.,GALZ,ZNNP+,WASN,etc.)• PrEPimplementingpartners-DREAMS (CeSShAR,PSI)&HPTN(UZ-UCSF)

KeyStrengthsandOpportunities• ZNASPIIIidentifieskeypopulationsas,adolescents,AGYW,keyFSW,

MSM,andpeopleinstableunionsandsero-discordantcouples• ZNASPIIIcallsforprioritizationofspecificgeographichotspots• Technicalworkinggroupsincludesomekeypopulationsinplanning• NationalAIDSLevydraws3%ofprivateincome(totaling~$19M),ofwhich

10%goestoHIVprevention• HIVpolicyenvironmentappearstobewelldeveloped,supportedby

strongtechnicalexpertise,andresponsive toWHOguidelines

KeyEmergingConsiderations• Notallkeypopulationsmeaningfullyrepresentedinworkinggroupsor

nationalplan(e.g.,planstatesthatnotenoughdataexistsonMSM,butit’sunclearifMSMhaveinputoriftheyaredeemed “priority”)

• ConcernthatPrEPwillbefocusedprimarilyonFSW,whichcouldstigmatizetheuseofPrEP forotherpopulations(e.g.,AGYW)

• PrEPnotincluded inrevisednationalstrategicplan(ZNASPIII)• RecentsuccesseswithVMMChavemadeitakeypreventionstrategy,but

government’sinvestmentinscalingitupmaypreventadditionalfocusonPrEPscale-up

• Nationalleadersremainconcernedabout resistanceresultingfromPrEP

ReadinessforPrEPIntroductionReadinessFactor Progress

Impact, costandcost-effectiveness analysesforPrEP aspartofcomprehensive HIVprevention portfolio

• CESSHARdemoprojectunderway;potentialforadditionalstudies(e.g.,PSIstudyonwillingnesstopay,fundedbyUNITAID)

• BMGFcompilingcostdatafromPrEPdemoprojectstocreatestandardizedcostingmodel

Identification andquantification oftargetpopulations forPrEP

• PrioritiesincludecomprehensivepreventionprogramsforSW,adolescentandyoungpeople,peopleinstableunions,anddiscordantcouples,withafocusongeographichotspots.TargetpopulationsforPrEPspecificallyhavenotbeenidentified

InclusionofPrEPandfemale-controlledmethodsincurrent orupcoming nationalHIVprevention plans

• PrEPhas notyet beenincludedinNationalStrategicPlans,buttheprocesstodosoisbeginningandthereismovementtoincludeit.

Timeline andplan forPrEPintroduction andscale-up

• ATWGhasbeenconvenedtoadaptWHOTest andStartGuidelinesforZimbabweaswellasasub-committeeonPrEP.Thereisatimeline forcompletingguidelines,theseguidelineswillguideimplementation.

Abudget forPrEProll-out totargetpopulations

• VeryearlybudgetconsiderationsandthinkinghappeningaspartofbroaderPrEPplanning.

Sufficient funding toachievetargets

• Earlyconversationshavetakenplace,yetlittleclarityexists.SomesmallinitialfundingexpectedforPrEPfromDREAMSandlikelyfromUNITAID

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KeyPopulationsforPrEPAdolescentgirlsandyoungwomen(AGYW)

Sero-discordant couples Menwhohavesexwithmen(MSM)

Womenengagedinsexwork(FSW)

KeyIndica

tors

• ~1.7Mtotaladolescent girls(ages10-19),ofwhich61,000 livingwithHIVand~1.6Mwithout HIV

• 4-6%prevalence(ages15-19)• 4,700 newlyinfectedadolescent

girls(ages15-19)eachyear,compared to2,100 boys

• 18% ofadolescent girls(ages15-19)haveexperienced sexualviolence

• 45%havetestedforHIV

• Heterosexual peopleinstableunionsorpeople engaginginlowriskheterosexual sexaccount foraround54.8% ofallnewHIVinfections

• 11.3%ofmarried/cohabitingcouplesaresero-discordant

• In6.7%ofcouplesthemanistheHIVpositiveandin4.5%thewomanisHIV-positive

• Unknown numberoftotalMSM

• ~24%prevalenceamongMSM(basedonresearch includingZimbabweandothercountries)

• 4% oftotalnewinfections and7% including theirpartners areamongMSM

• 52,214 totalFSWinZimbabwe• 20% prevalenceoverallbasedon

CESSHARestimate, but50-70% insmallerstudies

• 12% ofZimbabwe’stotalincidenceisamongsexworkersandtheirclients

Prioritiza

tion

• Innewnationalplan,AGYWareincluded asapriority population forcomprehensive prevention butnotPrEP

• AGYWwillbethefocusoftheDREAMSinitiativeinsixdistrictsthroughout Zimbabwe

• Innewnationalplan,peopleinstableunionsandsero-discordant couples areacknowledgedtobeamongkeypopulations

• OneofthePriority AreasofFocusistoreduceacquisitionfromortolong-term sexualpartners

• MSMindirectlylistedaskeypopulation innational plan(e.g.,“moredataneeded”)

• MSMincludedinGlobalFund’sKP-REACHinitiative ($11MforHIVresponseacrossmultiplesub-SaharanAfricancountries)

• Strongcivilsocietyadvocates(e.g.,GALZ)

• Innewnationalplan,FSWincludedasapriority forcomprehensiveprevention butnotPrEP

• Zimbabwe’sonlyongoingPrEPimpactstudy(SAPPH-IRe)seekstodemonstrate acceptability andfeasibilityofPrEPandmaximizeadherence amongasubsetof28,000highway-basedFSW

Questio

ns • Whichchannelswould bemostappropriate fordelivering PrEPtoAGYW?

• WilltherebefundingspecificallyforPrEPforAGYW?

• Whichchannelswould bemostappropriate fordeliveringPrEPtopeople instableunionsandsero-discordant couples ?

• WhatisthesizeandHIVprevalenceofthepopulation?

• Whichchannelswould bemostappropriate fordelivering PrEPtoMSM?

• WhatwillbetheresultsofSAPPH-IRe study,andtheirimpactonPrEPpolicy?

Sources:AdolescentGirls– (1)HIVandAIDSinZimbabwe.AVERT.May1,2015;(2)RethinkingHIVPreventiontoPrepareforOralPrEPImplementationforYoungAfricanWomen.Celum,etal;JournaloftheInternationalAIDSSociety.2015;(3)SexualandReproductiveHealthNeedsOfAdolescentsinZimbabwe.Guttmacher Institute.2014;(4)ZimbabweNationalHIVandAIDSEstimates:2013.MinistryofHealthandChildCare.2013.ZimbabweNationalHIVandAIDSStrategicPlan2015-2018(ZNASPIII)[Notofficiallylaunched].MinistryofHealthandChildCareandNationalAIDSCouncil.March2015.MSM– (1)Fosteringevidence-basedHIVprogrammingformenwhohavesexwithmen(MSM)insub-SaharanAfrica.TheGlobalFund,WHO,andANOVAInstitute.April24,2013:(2)PSAf StudytoCharacterizeSexualMinoritiesinZambia[PartofresearchthatincludesZimbabwe]. TheCommunication InitiativeNetwork:(3)ZimbabweNationalHIVandAIDSStrategicPlan2015-2018(ZNASPIII)[Notofficiallylaunched].MinistryofHealthandChildCareandNationalAIDSCouncil.March2015.FSW– (1)EngagementwithHIVPreventionTreatmentandCareamongFemaleSexWorkersinZimbabwe:aRespondentDrivenSamplingSurvey.Cowan,etal;PLOSOne.October2013;(2)Truvada asPrEP:ANewHIVPreventionOptionontheTableforZimbabwe?ICASAYouthFront.October19,2015;(3)“Youarewastingourdrugs:”HealthServiceBarrierstoHIVTreatmentforSexWorkersinZimbabwe.Mtetwa,etal,ofBMCPublicHealth.2013.

20APRIL2016

BudgetingforPrEP

Current Funding forHIV• 85%isfrominternational sources• 15%isfromdomestic resources,

largelytheNationalAIDSTrustFundlevy(thuslinkedtoeconomicgrowth)

• Levyhasdrawn~$20-50M,ofwhich50%goestoARTprogram,23%toprogramlogistics,10%toprevention,6%toM&E,5%toenablingenvironment,and4%toassets

• Funding forHIVinZimbabwe (publicdomesticandinternational,‘09-’16):

RemainingGapsandChallenges• OffundingfromNationalAIDSLevy,

only10%isallocatedtoprevention• Onaper-PLHIVbasis,Zimbabwe

receivesoneofthelowestpercapitaallocationsgloballyfromcombinedfundingofGlobalFundandPEPFAR

• WorldBank2011expenditure reviewshowedpercapitadevelopmentassistanceforhealthinZimbabwetobewellbelowneighboring countries

• HIVcosts,commitments,andgap:

PotentialNewFunding• PEPFAR,GlobalFund,andZimbabwe

governmentrecentlyjointfundedthenew$3MZIMPHIAstudy

• GlobalFundgiving$11MtoKP-REACH(KeyPopulations:Representation,Evidence,andAttitudeChange)effort

• Zimbabwesubmitteda$40.2Mrequest forincentivefundingonMay18th,2015, fromtheGlobalFund (ontopofits~$145averageannualcommittedallocationthrough2016):

Summary:• Stronggrowth infunding overpast5yearsduetoPEPFARfundsdoubling to$95M

andnewfundingmodelincreasingaverageGFannualgrantsfrom$67Mto$145M• Zimbabwe’sHIVfundingneedsareprojectedtogrowto~$600Mby2018and

~$700Mby2023,butcurrentannualfundingcommitmentsare<$400M• HIVtreatmenttakinglargershareofresourcesasmorepeopleareputonART

$525MtotalHIVcosts$183Mofwhichisprevention$0 ofwhichiscommittedtoPrEP

Year TotalCost Available Gap2013 $330M $223M 32%2014 $401M $279M 30%2015 $466M $304M 35%2016 $525M $264M 50%2017 $567M $238M 58%2018 $591M $238M 60%

IncentiveFundingArea RequestedLaboratoryandPharmaceuticals $19.5MYouth andAdolescents $10.0MCommunity andKeyPopulations $2.9MMonitoring andEvaluation $4.2MGrantManagement $3.6MTOTAL $40.2M

Sources:(1)126MillionAdditionalFundingAnnounced toFightHIVinZimbabwe.UnitedNationsDevelopmentProgram.January20,2015;(2)GlobalAIDSResponseReport:ZimbabweCountryReport.UNAIDS.December2014:(3) GlobalFundapproves$17millionfornewHIVprogrammes inAfrica.InternationalHIV/AIDSAlliance.July6,2015;(4)GlobalFundCountryAllocations:2014-2016.TheGlobalFundtoFightAIDS,Tuberculosis, andMalaria.March12,2014;(5)NationalAIDSCouncil:Funding.NationalAIDSCouncilofZimbabwe.2011;(6)Zimbabwe:MinistryofHealthandChildCaretoLaunchNewHealthSurvey– ZimbabwePopulation-Based HIVImpactAssessment.AllAfrica.September17,2015.;(7)ZimbabweNationalHIVandAIDSStrategicPlan2011-2015(ZNASPII).MinistryofHealthandChildCareandNationalAIDSCouncil.March2015:(8)ZimbabweNationalHIVandAIDSStrategicPlan2015-2018(ZNASPIII)[Notofficiallylaunched].MOHCCandNationalAIDSCouncil.March2015;(9)ZimbabwePlannedFunding.PEPFAR.2014.

21APRIL2016

SupplyChainManagementKeyStakeholders• MOHCC identifiesdrugneeds,specifiesdeliverytimelines,oversees

developmentoftreatmentguidelines• Gileadfilesforprevention indicationofTruvadainZimbabwetoMCAZ• NatPharm conductsquantificationstoforecastdemandbasedon

programneeds,runscentralmedicalstore,publicwarehouses,andlocalbranches

• MCAZperformsqualityassuranceandproduct registrationforalldrugs• StateProcurement Boardregulatesandmanagesallpublicprocurement

KeyStrengthsandOpportunities• Zimbabwehaswell-coordinated procurementanddistributionsystemto

whichPrEPcanbeadded;coordinationsystemisflexibletodeliverPrEPtospecifiedgeographiesandchannels(NGOorpublic)

• ZimbabweisoneofAfrica’spioneerprocurement reformcountries,withWorldBanksupportingSPBtraining,assessment,andcapacity-building

• WidedisseminationoftreatmentguidelinesamongpublichealthfacilitiesbodeswellforpotentialPrEP-relatedguidance

• PotentialforPrEP tobedonated byGilead(althoughthiscouldbebothanopportunity andachallenge)

KeyEmergingConsiderations• Truvadaiscurrently registeredastreatmentbutnotprevention.

RegistrationbyMCAZseentobeoneofthemosturgentprioritiestomoveforwardinZimbabwe.

• ForARVscale-up,thereweresomecoordination challenges,asprocurementhappened individuallybydonor agenciesandwasn’talwaysharmonized,thoughsomeofthishasbeen resolved/streamlined

• QuantificationprocessinformingNatPharm procurement reliessolelyonprogramtargets.ProcessmaynotbeadequateforPrEPforecasting

ReadinessforPrEPIntroductionReadinessFactor Progress

Regulatoryapprovalofform(s)oforalPrEPbyauthorities

• PrEP(Truvada) isnotregisteredforprevention,onlytreatment. PlansaretosecureapprovalforTruvadatobeusedasPrEPbyJuly2016

Effectivedemandandsupply forecastingmechanismsforPrEP

• StrongsupplychaininplaceforARVs,whichwilllikelytranslatetoPrEPreadiness– butnoPrEPspecificplanningconductedto-date

Manufactureridentification andcontract negotiationtopurchasePrEP

• Veryearlystage.WHOmeetinginMarch2016todiscussalternativestoTruvadafororalPrEPmayinfluencewhatformsofPrEPZimbabwepurchases

Product andpackagingdesigntomeettargetpopulation needsandpreferences

• Unclear todateandlikelytodependonchosenPrEPmanufacturer

Developmentofdistribution plan forPrEPtoreachtargetpopulations

• Nodistributionplanisyetinplacebutwillbedevelopedin2016/2017

Effectivedistributionmechanisms toavoidPrEPstock-outsinpriority facilities

• Zimbabwehasa robustdrugprocurementanddistributionmechanismthat iscentrallycoordinatedforpublicandNGOsites; ARVstock-outs arerare.

• NatPharm doesnotanticipatemajorobstaclesinaddingPrEPtocurrentdistribution

22APRIL2016

PrEPDeliveryPlatformsKeyStakeholders• GeneralHIVservicechannels:community-and-home-basedcareproviders

(CHBC),HTCcenters,ARTsites(includingcentral,district,local,andmissionhospitals),mobileclinics

• GeneralHIVpreventionpartners:ZNFPC,PSI,PSZclinics• GeneralHTCimplementingpartners: PSI,OPHID,ZAPSO,ZACH,WHO• Youth/AGYW:youthcenters,healthfacilityyouth-friendlycorners;FSW:

networkofsexworkclinics;MSM:civilsocietyandadvocacyorganizations(e.g.,GALZ)

KeyStrengthsandOpportunities• DespitesomecapacityissuesduringARVscale-up,thereappearstobecapacity

forPrEPdeliveryaslongaspolicyclarifiestargetpopulations• CHBCshavesignificantreach(e.g.,theyreached700kpeoplein2011)• 1,460HTCcentersidentifiedaskeychannelforARVs andHIVprevention• ARTsitestripledfrom‘10to’14,and>85%livewithin3kminmostdistricts• StrongNGOprogramsandpoliticalwilltosupportFSW• GALZhasHCWcontactsacrossthecountry;couldprovidePrEPtoMSM• Earlysuccessesinaddressingnurses’negativeFSWattitudeswithtraining

KeyEmergingConsiderations• CHBCshavelimited skills andexperience,lower quality assurance,andweaker

referral systems• Community-basedHTCisnotrobust,andHTCisparticularlylaggingfortarget

populationsincludingAGYW• Civilsocietyorgsaccessibleinurbanareasbutnotperi-urbanorrural• OfficialclinicaltrainingonPrEPneededfromMOHCC.Trainingsoftenreach

staffatprovincialhospitals,butnotlocallevelfacilitieswherepopulationswithhighHIVriskarelikelytogo

• Trainingneededfromgroupswhounderstandandrepresentkeypopulations(GALZ,CESHAAR,AFRICAID)onhowtodeliverPrEPtokeypopulations(GALZtrained500HCWsin2015inMSMsensitization)

ReadinessforPrEPIntroductionReadinessFactor ProgressIssuanceofstandardclinical guidelines forprescription anduseofPrEP

• Treatmentguidelinesarenotyetunderdevelopment.

Sufficientinfrastructure andhumanresourcestoconduct initial HIVtestsandprescribePrEPinprioritychannels

• Network of1,460HTCcentersidentifiedaskeychannelforARVsandHIVprevention.ThesearelikelytoserveaskeyinfrastructureforPrEProll-out,but outreachwillbeneeded.Humanresources needtobedeterminedbyroll-outplan.

Plantoengagehealthcareworkers onPrEPanddeliverytotargetpopulations (includingmitigatingstigma)

• No planinplace,butconsiderationsarebeginningtoemerge

• GALZconductinghealthcareworkertrainingproject–demonstratingresultsofreducedstigma

Toolstohelppotentialclients andHCWunderstandwhoshould usePrEP havebeencreated

• NoscreeningtoolforPrEPhasbeendeveloped/agreed upon,butHPTN082willbetestingatoolthatcouldpotentiallybeusedforscaleup.

Sufficient resourcestoroll-out plansforhealthcare workerengagement

• Resources notyetsecured.Needed resources willbedeterminedalongwithhealthcareworkerengagement plansandidentificationofPrEPdeliverychannels.

23APRIL2016

CurrentPrEPDeliveryChannelsDemoprojectsandOpenLabelExtensions DREAMS

Background

• TheSAPPH-IreDemonstrationProjectinZimbabwehasbeenimplementedat14outreachsitesthatofferHIVservicestofemalesexworkers.ThestudybeganinJuly2014withenrollmentof2,800women.• HPTNtoinitiatethreestudiesin2016,includingHPTN082andIMPACT.

• TheDREAMS initiative(Determined, Resilient, Empowered,AIDS-free,Mentored,and Safewomen)willprovidePrEPtoyoungwomeninsixdistricts(Bulawayo,Gweru,Mazowe,Makoni,Mutare,Chipinge)beginningin2016/2017,butiscurrentlywaitingforMCAZregistrationofTruvadaforprevention. ItislikelythatoralPrEPintheformofTruvadawillbedonatedbyGileadforusebyDREAMS.

KeyS

trengths

• DemoprojectreachingtargetpopulationsathighriskofHIVtransmission• ExistingaccesstoPrEPandassociatedtesting,monitoring,andcounsellingservices• ExperiencedstaffhighlyknowledgeableaboutPrEP• APrEPdemoproject/researchtaskforcewillbeconvened tosharevaluableinsightsfromrecruitmentandretentioneffortsthusfar,includingdemandcreationandmessaging,andmodelsofservicedelivery• LowlevelsofstigmaamongstaffworkingwithPrEPusers

• Targetedprogramreachinghigh-risk(asidentifiedbycommunity-ledcriteria)adolescentgirlstostart2016/17• PrEPdeliverycoupledwithHTC,behaviorchangeactivities,extensivecounseling,communitymobilization,andinitiativestostrengthenfamilies• PotentialtoexpandPrEPdistrict-widegivenotherinvestmentstomakePrEPavailabletoDREAMSparticipants,includinglogistics,procurement,demandgeneration,andcommunitybuy-inefforts

Key

Challenges

• PerceptionofPrEPaspartofan“experiment”deterspotentialusersfearingpoorsafetyandefficacyofdrug• Highercostsofdelivery indemonstrationprojectcontext

• DREAMSPrEPtoreachadolescentgirlsonlyincommunitieswheremanyotherpopulationscouldbenefitfromPrEP• Reachlimitedto1451youngwomeninDREAMSdistricts(53,654youngwomenwillbetargetedwithHTC)

24APRIL2016

ComprehensiveCareCenters &otherARTsites SexualandReproductiveHealth(SRH)careproviders

Background

Public (Gov’t) NGO Private

• Publichospitals,clinics,andotherhealthcarecenters(e.g.,VMMCclinics)

• NGO-runclinics,carecenters,otherHIV serviceprogramssuchasPSINewStartCenters,FHI’snewprograms,andkeypopulationclinics(SistersClinic)

• Private fee-for-serviceproviders

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

KeyS

trengths

• Mostvisibletogeneralpopulations

• Systemsguidedandlinkedwithcountyandnationalstandards/agendas

• Canprovidegreateraccesstokeypopulations(FSW,MSM,PWID)

• Effectivelyreachhigh-riskindividualswithlow/nostigmapresentincentersoramongstaff

• Frequentuseofpeer-educatorprograms,whichmightbecriticaltoeffectiveuseandincreaseddemandgeneration

• Opportunitiestodeliverthroughprivatechannelsaccessingkeypopulationssuch

• DiscreteaccesstoPrEPwithoutstigmaforthosewhocanaffordit

• Notdependentonaid

• Providegreateraccesstosero-discordantwomenandAGYWinfemale-friendlyandtrustedsettings

• StaffhavelowerlevelsofstigmaagainstAGYWwhoseek familyplanningandHTCservices

• Post-abortioncareclinicshavethepotentialtoreachwomenwithveryhighriskofHIVinfection

• LowcostofdemandgenerationsincewomenarealreadyvisitingSRHservices• ~1500ARTsitesthroughoutZimbabwe

• Well-integratedprocurementanddeliverysystems• LaboratorycapacityfornecessaryPrEPmonitoringinplace• HTC-trainedstaff

Key

Challenges • HCWstigmaagainsttargetpopulations,ifpresent,candetermanyfromaccessingcarethroughthesesites

• Staffandresourcesperceivedtobestretchedthin,resultinginsuboptimalcare• Nosingleoutleteffectivelyreachesalltargetpopulations

• PotentiallylimitedexperienceandtraininginHTClinkages

• Limited/nolaboratorycapacityfornecessary PrEPmonitoring

• AGYWmayhavetroubleaccessing

PotentialPrEPDeliveryChannelsThisisacontinued areaoffocus.Additional detailsexpectedbytheendof

2016.

25APRIL2016

IndividualUptakeKeyStakeholders:• NGOgroups,includingCHAI,areinearlystages ofdemandgeneration

researchandpromotion• Networks (ZNPP+,ZAN)mayhelpwithdemandgenerationactivities• FHI360 iscominginasanewpartnerunderPEPFARonHTCandmay

introducenewplansformobilizingtestingandcarelinkagesthatcouldbeleveraged forPrEPdelivery

• PEPFARandGlobalFundmaybekeyfundersofdemandgeneration• PSI deploying354Kself-testingkits,whichmightbecriticalinprovidingHTC

tohighriskpopulationsnotalreadyaccessingtestingservices

KeyStrengthsandOpportunities:• GoodHTCcoverage,butactualHTCusageislessfavorable:91%ofwomen

and88%ofmenknowwheretoaccessHTC,but57%ofwomen(45%ofyoungwomen)and36%ofmen(24%ofyoungmen)haveeverbeentestedandreceivedresults

• PITCisbeingpushedbyMOHCCandscaledupto94%ofhealthfacilities• TrackrecordofsuccesswithVMMC,aswellasrecognitionthatgapsin

consistentcondomusepersist,particularlyamongkeypopulations• GALZ,CESHAAR, SAFAIDS,andothersareworkingtoadvocateforlegal

reformforFSWandMSM• Recentpositivelegalchangearound“loiteringlaws”showthatthingsmaybe

movingpositivelyforFSW

KeyEmergingConsiderations• FSW:sexworkillegal,highratesofabuse/violence,highopportunityand

transportationcostskeepFSWfromchoosingtoaccessHIVservices• MSM:practicesareillegal(unlikelytochange),facilitiesrefusetreatment• AGYW:uptakechallengeswithotherproducts(e.g.,forculturalreasons,only

1/4ofadolescentgirlsusethepill,whichaccountsformajorityoftheirmoderncontraceptiveuse),lowHTCuptake

• General:directadvertisingofRxmedicinestothepublicisprohibited,concernsaboutPrEP’s unintendedconsequences(e.g.,resistance,undetectedHIVinfections,riskierbehavior,increasedabuse/violence)

ReadinessforPrEPIntroductionReadinessFactor ProgressClearandinformativecommunicationsonPrEPforgeneralpublicaudiences

• Nocommunicationsstrategy orplanningforonehasbeeninitiateddodate.

Developmentofdemandgenerationstrategiestargetedtouniqueneedsofdifferentpopulations

• Demandgenerationactivitiesarenotinplacebeyondthoseattachedtospecificdemoprojects,butthesehaven’tbeenresearchedorvetted.

Linkages betweenHTC,PrEPprescription,andPrEPaccesstoenablePrEPuptake

• Necessary linkageswillbeunknownuntilPrEPguidelinesoutliningchannels,populations,andprescriptiondetailsarecompleted.IfPrEPisdeliveredthroughARVchannels,thelinkagesare likelytoenablePrEPuptakeatleastinthosepopulationsalreadyaccessingsuchchannels.

Information forclientsonhowtoeffectivelyusePrEPforalltargetpopulations

• Informationexistsforthoseparticipatingindemoprojects.GeneralinformationforalltargetpopulationsincludingAGYWwillneedtobedeveloped.

Sufficientresourcestoroll-outplansfordemandgeneration

• Resources notyetsecured.Needed resources willbedeterminedandultimatelysecuredonceZimbabwedeterminesdemandgenerationneedsandplans.

26APRIL2016

KeyConsiderations

Stigma

• Earlystigmalingers:makingPrEPwidelyavailablebeyondkeypopulationswouldhelpmitigatepreconceptionsofPrEPasanoptiononlyforFSWandMSM.ThisisimportantbecauseonlydemoprojecttodateinZimbabweisworkingwithFSW.AnyPrEPcommunicationscampaignwillneedtodirectlyaddressthestigmaassociatedwiththispopulation

• Amonghealthworkers:thechallengesaretwofold- healthcareworkershavetheirownbiasesaboutwhoshouldbeaccessingbirthcontroloptionsandHIVpreventionservices,andtheyoftenlacktheappropriateinformationandtrainingtoeffectivelyprovidearangeofoptionsforindividualstomakeinformeddecisions

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

DrugPreconceptions

• There arefearsaboutdevelopingresistancetoARVswhileonPrEP,anddevelopingphysicalsideeffectsassociatedwithARVs

• PeoplerecognizeTruvadaasanARVanddonotwanttobeseen takingitiftheyareHIVnegative

Messengers• Messages aroundPrEPneedtobeproactive,consistent,andcomefrommultipledirections.Importantmessengers include:nationalandcountygovernments,ministries,CBOs,celebrities,religiousleaders,healthcareworkers,peersandvariousformsofmedia(e.g.print,radio,online)

Messages

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

• Risk inrelationships:potential toappealtolikely PrEPusersbyhighlightingtheriskassociatedbytheirownconduct andalsothatoftheirpartnerswhomayhavemultiplesexualpartners

• Riskperception:youngwomeninKenyagenerallydonotseethemselvesathighriskforHIVtransmission.Theyaremorefocusedoneconomicopportunityandeducation

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

KeyEnd-userThemesforPrEP

27APRIL2016

EffectiveUse&MonitoringKeyStakeholders:• NACisresponsibleforoverseeingthenationalM&Eplan• NGOs havebeenparticularlyimportantinprovidingpost-testsupport

servicesforHIV-negativeandHIV-positivepeoplethataddressriskreduction,disclosure,andtreatmentadherence

KeyEmergingConsiderations• Whileadatasystem(DHIS2)exists,onlysomeoffacility/patientdata

ispulled intoDHIS.Additionally, facilityregistersand reportingtoolsdonot (yet)reflectneedstotracktheroll-outofPrEP.Therefore,M&EtoolswillneedtoberevisedtobeabletoreportonPrEProllout

• Littleisknownabout PrEPadherence ingeneral,andevenlessonhowitmaydifferamongtargetpopulations inZimbabwe

• WhileitseemslikethereissufficientcapacityforHIVtesting,ongoingtestingofPrEPuserscouldplacestrainon theexistingsystem

ReadinessforPrEPIntroductionReadinessFactor Progress

EstablishedplanstosupporteffectiveuseandregularHIV,creatininetestingthatreflecttheuniqueneedsoftargetpopulations

• Whileearlyconsiderationsforencouragingandsupportingeffective useandadherencetoregulartestingarebeingdiscussed,specificstrategies fortargetpopulationsarenotyetbeingcreated.

CapacitytoprovideongoingHIV andcreatinineleveltestingforPrEPusersaccessibletotargetpopulations

• While thereisincreasinglysufficientHTCcapacityforcurrentefforts,gapsremainandresourcesmaycontinuetobeachallenge.Additionally,exacttestingneedsforPrEPareyettobedetermined.Countrytreatmentguidelinesshouldoutlinethesespecificneeds.

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

• M&EforPrEPlikelytobeintegratedwithexistingARVM&Esystem.PrEPguidelineswillneedtodictatemonitoringand trainingneeds.

KeyStrengthsandOpportunities:• Zimbabwehasasinglemonitoring andevaluationsystem.This

systemislinkedtoindividualproject/programM&EsystemsbeingusedbyHIV/AIDSserviceorganizations;thissystemappearstobeintheprocessofbecomingmoreintegratedandharmonized

• M&EforPrEPlikelytobeintegratedwithexistingARVM&Esystem• ZNASPIIIstatesthat“acontextualNationalM&EPlanwillbe

developed toguidetheimplementationofthestrategicplananditspartnersystems”

28APRIL2016

AppendixB:ExpectedPrEPActivitiesQ1|16 Q2|16 Q3|16 Q4|16 Q1|17 Q2|17 Q3|17 Q4|17 2018 2019 2020

Research

SAPPHIRE results expectedforPrEPamongFSWinZimbabwe

ZIMPHIA survey datacollectionamong15kZimbabwehouseholds

POWER datacollection rolloutandcohort protocol (Q1);preliminary datatoshare(Q2)

HTPN082andIMPACTdemoprojectsbegin by

Planning/Im

plem

entation

Guideline Adaptation Committeemeets,incl.PrEPworkinggroup

Newnational strategicplan for2016-2018(ZNASPIII)ineffect

DREAMS activitiestotakeplaceinZimbabweinidentified hotspotdistricts

ZNASP IIImid-termreview;opportunity topushforPrEPinclusion inplan

CHAIdemandgenerationresearchinitial resultsexpected

GatesresearchoncostofPrEPdeliveryacrossdemoprojectsinitial resultsexpected

Policy

Zimbabwe likelytoformallyadoptWHOguidelines

Gilead licensure processapprovalexpected Q2(Pulseasdistributor)

ZimbabweGlobal

29APRIL2016

AppendixC:References• 126MillionAdditional FundingAnnouncedtoFightHIVinZimbabwe.United NationsDevelopment Program.January20,2015.• AchievinganAIDS-FreeGenerationforGayMenandOtherMSMinSouthernAfrica.amfAR,TheFoundation forAIDSResearchandJohnsHopkinsBloomberg

SchoolofPublicHealth.May2013.• Country Updates:Zimbabwe.PrEPWatch.2015.• Engagementwith HIVPreventionTreatmentandCareamongFemaleSexWorkersinZimbabwe:aRespondent DrivenSamplingSurvey.Cowan,etal;PLOSOne.

October 2013.• EvaluationsandRegistration andHowWeRegulate.MedicinesControl Authority ofZimbabwe.2012.• GlobalAIDSResponseReport:ZimbabweCountry Report.UNAIDS.December2014.• GlobalFundCountry Allocations:2014-2016.TheGlobalFundtoFightAIDS,Tuberculosis, andMalaria.March12,2014.• HIVandAIDSinZimbabwe.AVERT.May1,2015.• ManagementofHIV&AIDSCommodities inZimbabwe:ACapacityAssessmentofNatPharm andMinistryofHealthandChildWelfare .DELIVER,forUSAID.

July2006.• National AIDSCouncil:Funding.National AIDSCouncilofZimbabwe.2011.• Procurement andSupplyChainManagementinZimbabwe.UNDP andGlobal Fund.March4,2015.• Procurement ChallengesintheZimbabweanPublic Sector:APreliminary Study.Journal ofTransport andSupplyChainManagement.2015.• Rethinking HIVPreventiontoPrepareforOralPrEPImplementation forYoungAfricanWomen.Celum, etal;Journal oftheInternational AIDSSociety.2015.• SexualandReproductive HealthNeedsOfAdolescentsinZimbabwe.Guttmacher Institute.2014.• Successwith PrEP:Next StepstoSupport PolicyDecisionsinSouthernandEastAfrica.AVAC,UNAIDS,andWHO.October26,2014.• TruvadaasPrEP:ANewHIVPrevention OptionontheTableforZimbabwe? ICASAYouthFront.October 19, 2015.• “Youarewastingourdrugs:”HealthServiceBarriers toHIVTreatmentforSexWorkersinZimbabwe.Mtetwa,etal,ofBMCPublic Health.2013.• ZimbabweBeginsPublic Procurement Modernization.TheWorldBank.May13,2015.• ZimbabweFailstoCapitalize on$4bnARVsMarket.RobinMuchetu ofTheSundayNews.April12,2015.• Zimbabwe:MinistryofHealth andChild CaretoLaunch NewHealthSurvey– ZimbabwePopulation-Based HIVImpactAssessment.AllAfrica.September17,

2015.• ZimbabweNationalHIVandAIDSEstimates:2013.MinistryofHealthandChild Care.2013.• ZimbabweNationalHIVandAIDSStrategicPlan2011-2015 (ZNASPII).MinistryofHealthandChild CareandNational AIDSCouncil.March2015.• ZimbabweNationalHIVandAIDSStrategicPlan2015-2018 (ZNASPIII)[Notofficially launched].MinistryofHealthandChild CareandNational AIDSCouncil.

March2015.• ZimbabwePharmaceutical CountryProfile.MinistryofHealthandChildWelfare,Directorate ofPharmacyServices,incollaboration withtheWorldHealth

Organization.June2011.• ZimbabwePlannedFunding.PEPFAR.2014.