OPTIONSCountrySituationAnalysisInterimFindings:Zimbabwe

FSGinpartnershipwithPangaeaGlobal

DECEMBER2016

2DECEMBER2016

OPTIONSIntroductionOneoffivecooperativeagreementsawardedbyUSAIDwithPEPFARfundingthroughRoundThreeoftheAnnualProgramStatement(APS)forMicrobicideResearch,Development,andIntroduction.

OPTIONSObjectiveDevelopastreamlined,adaptableproductdeliveryplatformforcurrentandfuturemicrobicideandARV-basedHIVpreventionoptions.

OPTIONSConsortiumMembers

KENYA

SOUTHAFRICA

ZIMBABWE

3DECEMBER2016

OPTIONS ConsortiumAims

Developevidence-basedbusinesscasesandacoordinatedinvestmentstrategy forARV-basedpreventionproductintroductiontoensuretimelyglobal,nationalandprivatesectoractiononpriorityareas

AIM1 AIM2 AIM3 AIM4

Providetechnicalassistanceandsupportforhealthsystemsstrengthening(HSS) withrapiduseofdatatoidentifyandaddressimplementationbottlenecksthroughoutthevaluechain

Supportcountrylevel regulatoryapproval,policydevelopment,programplanning,marketingandimplementationstrategiesforARV-basedpreventionproductintroduction

Facilitateandconductimplementationscience(IS)toadvancetheintroductionofandaccesstomicrobicidesandARV-basedpreventiontechnologies

OPTIONShasfourmajorgoalsoverthenextfiveyears:

4DECEMBER2016

OPTIONSHowWeWork

• OPTIONSisnotaservicedelivery project;weapplysystemsthinkingtosupportandaccelerateproductintroduction

• Oursupportisflexibleandisdesignedtoberesponsivetonationalcountryprioritiesandplans

• InadditiontoPangaea,whohassignificantexperienceworkingonHIVpreventionandtreatmentinZimbabwe,ourconsortiumbringsmulti-disciplinaryexpertisetotheefforttointroducefemale-controlledHIVpreventionproductsinZimbabwe

• Wearetakingsignificantstepstoensurewedonotreplicateexistingorongoingwork– ourmissionistofillgapsandhelpanswerkeyquestionsasoutlinedbythenationalgovernment,theUSAIDcountrymission,andotherkeylocalstakeholders

5DECEMBER2016

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 from Pangaea 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 as well as gaps and expected challenges

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

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

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

6

ExecutiveSummary• Zimbabwehasbeencreatingtheconditions,policies,andpracticesneededtosuccessfullyroll-outandscale-upPrEP.The

country’sHIVresponsehashistoricallybeenontheleadingedgeamongpeersandgenerallyresponsivetoglobalguidelines.

• InMarch2016,theMinistryofHealthandChildCare(MOHCC)convenedanationalworkinggrouptoadapttheWHO“testandstart”guidelinesissuedinNovember2015.Aspartofthateffort,asub-committeeonPrEPhasbeenestablished.Thissub-committeehasbeenmeetingtodevelopnationalguidelinesonPrEPandaplanforrollout.

• PrEPguidelineshavebeenreleasedaspartofcountry’sARTguidelines,andimplementationplanningisexpectedtobegininearly2017.Therolloutisexpectedtobephased,beginningwithtargetpopulations.

• ThekeychallengesforPrEPinZimbabwearesecuringfundingforPrEP,identifyingandagreeingonexacttargetgeographiesandpopulations,deployinganeffectivecommunicationsstrategy,andnavigatingthehealthsystemcapacitylimitationsinherentinclosingZimbabwe’sexistingtreatmentgapwhileinvestingin“new”preventionmethods.

– Zimbabwe’sHIVstrategicplanfocusesonkeypopulationsandcombinationprevention,andnowincludesPrEP.MOHCCofficialshaveexpressedinterestinintroducingPrEPforabroaderrangeofpopulationsbeyondkeypopulations(MSM,femalesexworkers),includingadolescentgirlsandyoungwomen(AGYW)andthoseinsero-discordantrelationships.

– TherearesignificantlegalandculturalbarrierstoquantifyingandreachingthekeygroupsforwhomPrEPwouldbewell-suited,particularlySWandMSM,whosepracticesareillegal,andAGYW,whofacestigmaandopposingculturalnormsrelatedtoHIVprevention.

– ZimbabwehasmadesolidprogressinexpandingcoverageofARTandHTCsites,buttreatmentgapsremain;inaddition,healthcareworkerknowledgeandattitudesandenduserawarenessanddemandhavecontinuedtobecriticalfactorsdeterminingthesuccessofHIVpreventionandtreatmentinterventions.

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

• Inthenear-term,decisionsonPrEPinZimbabwerevolvearoundthequestion:“HowmuchshouldbeinvestedinPrEP,forwhom,how,andinwhichareas?”

7DECEMBER2016

CurrentStateofHIVinZimbabweContext• ZimbabwehasoneofthelargestHIVburdensinSouthernAfrica,with1.4MpeoplelivingwithHIV(PLHIV)andaprevalencerate

~14.7%.Therewereanestimate~64,000newinfectionsin2015• TheHIVepidemicexhibitsgrowingratesamongwomen – HIVprevalenceisnow1.5xhigheramongwomenthanmen• Keydriversoftheepidemicincludemultipleandconcurrentpartnerships,inter-generationalsex,discordantcouplesandlow(but

rising)VMMCrates;severalkeygeographiesandpopulationslistedbelowremaindisproportionatelyaffectedbytheepidemic

Demographics• Sourceofnewinfections(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

• Incidencebyageandgender(2013):

Geography• Geographichotspots:

– Threeprovinces:MatabelelandNorth,Bulawayo,MatabelelandSouth– 14additionaldistrictsrecentlynamedashotpots

• HIVprevalencebyprovince:%ofpeople15-49yearsold

Male Female

• HIVincidencebyprovince:Newinfections,people15-49years

201420152016

Characteristics• TheHIVepidemicinZimbabweis

generalized,feminizedandgenerallyhomogenous,thoughnotablehotspotsofhighHIVtransmissionhavebeenidentifiedthroughoutthecountryincities,bordertowns,andminingandfishingareas

• TheHIVprevalenceratehasdecreasedto~14.7%in2015from~20%in2005

• From2011-2015:• NationalHIVincidencehas

decreasedfrom1.29to0.74• AIDSdeathshavedecreased

from115,117to31,217• ARTcoverageforadultsand

childrenhasincreasedfrom31.3%to72%

0k5k

10k15k20k

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),MinistryofHealthandChildCareandNationalAIDSCouncil.March2015;(4)ZimbabweProgressReport,GlobalAIDSResponse,NationalAIDSCouncil,2016;(5)2015Spectrumdataestimates

8DECEMBER2016

HIVPreventionandTreatmentContext• Improvementsinprevalenceandincidenceratesprimarilyduetosuccessfulpreventioneffortsandreductioninpersonalrisk-taking

behavior,while HIV-relateddeathshavebeenreducedbyover60%duetoZimbabwe’streatmentandsupportprogram• Forprevention,thegovernmenthasprioritizedsocialandbehaviorchangeinterventions,condom promotionanddistribution

(coupledwithintensifiedawareness oncorrectandconsistentuseofcondoms),andvoluntarymedicalmalecircumcision• ARTscaleupiskeytoZimbabwe’sHIVstrategy.HIVtestingandcounselling(HTC) hasbeenidentifiedasakeyentrypointforART,

andprovider-initiatedHTC(whichcomprises80%ofallcurrenttestinginZimbabwe)isbeingscaledup• 80%ofallhealthfacilitiesofferART.Therewere879,271peopleonARTby2015,with73%reachingdurableviralsuppression• NationalHIVresponseisguidedbythethirdandmostadvancedstage(ZNASPIII),focusedonkeypopulationsandgeographies

CurrentEfforts• Sustainingcurrenttreatmentandcareinvestment,including

throughthecountry’sin1460HTCcenters• RapidlyscalingupVMMC to80%by2018usingWHO

guidelines/standards• Comprehensivepreventionprogramsforsexworkers,

adolescentandyoungpeople,sero-discordantcouples• ScalingupinnovativecommunityHIVtestinginitiatives,

includingself-testingkitsviaaPSIinMberengwa andBuhera• RollingoutPITC to94%ofhealthfacilities• Integratingsocialnormandbehaviorchangeinterventions

intodeliveryofsocialandHIV-relatedservices• Communitysystemstrengthening• Preventing secondaryincreasesintheepidemicduetolower

levelsoffunding• Zimbabwehasallowedtheexistenceofinformallobby

groupsforFSW,prisoners,andMSM

RemainingNeeds• Coveragegaps:Zimbabweisbehindby55%inproviding

treatmentforHIV+children;mostcommitmentsforARTendin2016,whichwillcreateadditionalgapsforHTC

• Datagaps: datagapsexistgenerallyandparticularlyforkeypopulations

• Keypopulations:Currentstrategiesareinequitabletokeypopulations(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.

9DECEMBER2016

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 “zero discrimination.”

• 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 are male-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• Zimbabweconvenedanationalworking

grouptoadapttheWHO“testandstart”guidelinesinMarch2016,includingasub-committeeonPrEP. Thecountry’sARTguidelinesnowincludeachapteronPrEP

• Truvada hasbeenregisteredforprevention,butiscurrentlyapprovedonlyfortreatment;nogenericsorotheralternativeformsoforalPrEPareapprovedforprevention.Itappearsthatanpreventionindicationmaynotbeneeded

• PrEPdemonstrationprojectledbyCeSHHAR concludedin2016;DREAMSprogramfocusedonAGYWlaunchedin2016withaPrEPcomponent.OthersincludeHPTN082andIMPACT

• NewHIVstrategicplan launchedin2016includescomprehensivepreventionincludingoralPrEP

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

• SignificantlegalandculturalfactorscontinuetomarginalizeMSMandFSWandobscureabilitytoquantifythesizeandHIVratesofthesepopulations

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

10DECEMBER2016

PlandevelopedtoimplementWHOPrEPguidelinesfortargeted

populations

PrEPproduced,purchased,anddistributedin

sufficientquantitytomeetprojecteddemand

PrEPservicesdeliveredbyappropriatechannelswithaccesstotarget

populations

TargetpopulationsseekandareabletoaccessPrEPandbeginuse

TargetpopulationadherestoPrEPatrecommendedfrequencyand forideal

timeperiod

PLANNINGANDBUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

What’sNeededtoIntroducePrEPOPTIONSaimstotakearobustandcomprehensiveapproachtoanalyzingthesituationaroundPrEP. ThegoalofthisexerciseistoidentifykeybottlenecksandopportunitiestointroduceandscalePrEPeffectively,particularlyforwomenandgirls,ineachOPTIONScountry.Thisinformationwilleventuallyfeedintotheinvestmentcasesandwillbeusedtoinformandcapturecountryprogress.

Toidentifywhat’sneededforPrEPintroduction,wehaveorganizedtherestofthesituationanalysisalongthePrEPvaluechain,introducedbelow.

ValueChainforPrEP

11DECEMBER2016

ValueChainAnalysesThefollowingslidesholdthreeanalysesalongthevaluechain

• Resourcesthatexistin-countrytosupportandacceleratePrEPintroduction

• GapsinresourcesthatcouldactasbarrierstoeffectivePrEPintroduction

• Keyconsiderations toinformcomprehensivein-countryplanningforPrEPintroduction

• Alistofspecificfactorsthatneedtobein-placetoeffectivelyintroducePrEPforeachcomponentofthevaluechainalongwithprogressto-dateforeachfactor

• Detailsoncurrentsituation,keyactors,responsibilities,timelinesandprogresstowardseachactivityareincludedintheappendix

• Remainingquestionstoinformin-countrydiscussionsandplanning

• Remainingquestionstoinformongoingmodelling,researchandanalysisefforts

• OpportunitiesforotherpartnerstosupportaccelerationofPrEPintroduction

12DECEMBER2016

ResourcesandGapsforPrEPinZimbabwe

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

EmergingKeyConsiderations

• Notallkeypopulationsfully representedinnewplan

• Noclearfundingsources forPrEPbeyondDREAMS

• Truvada registeredastreatmentbutnotprevention

• Demandforecastactivitieswillinvolvepopulationsforwhichlittledataexists

• Access ofkeypopulationstoHTC

• Negative/stigmatizinghealthcareworkerattitudestowardstargetpopulations

• Capacitylimitations insomeHIVchannels

• Low(butrising)ratesofHTCusage

• Demandgenerationplans stillearly-stage

• StigmaandlawsinhibitaccesstoHIVservicestohigh-riskpopulations

• LittleisknownaboutPrEPadherenceingeneralandamongkeypopulations

• OngoingtestingofPrEPuserscouldplacestrainontheexistingHIVtestingcapacity

ExpectedStrengths

• Newplan callsforHIVinvestmentinchildren,adolescents,youngpeople,women,girls,keypopulations

• Innovativedomesticfinancingmechanism

• Well-coordinatedprocurementanddistributionsystemthatservespublicandNGOchannels

• CoordinationchallengesinARVscale-upresolved

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

• Widedisseminationoftreatmentguidelines

• GoodHTCcoverage• RecentpositivelegalchangerelevanttoFSWs

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

• Singleharmonizedmonitoringandevaluationsystem

• Newplan(ZNASPIII)mentionsM&Eplantobedevelopedandupholdsimportanceofmonitoring

13DECEMBER2016

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

TowardsIntroductionofPrEPinZimbabwe

Issuanceofstandardclinicalguidelinesforprescription anduseofPrEP

Sufficientinfrastructure andhumanresourcestoconductinitialHIVtestsandprescribePrEPinprioritychannels

Plantoengagehealthcareworkers onPrEPanddeliverytotargetpopulations(includingmitigatingstigma)

ToolstohelppotentialclientsandHCWunderstandwhoshouldusePrEP

Sufficientresourcestoroll-outplansforhealthcareworkerengagement

ClearandinformativecommunicationsonPrEPforgeneralpublicaudiences

Developmentofdemandgenerationstrategiestargetedtouniqueneedsofdifferentpopulations

Linkages betweenHTC,PrEPprescription,andPrEPaccesstoenablePrEPuptake

Information forclientsonhowtoeffectivelyusePrEPforalltargetpopulations

Sufficientresources toroll-outplansfordemandgeneration

EstablishedplanstosupporteffectiveuseandregularHIV,creatininetestingthatreflecttheuniqueneedsoftargetpopulations

CapacitytoprovideongoingHIV andcreatinineleveltestingforPrEPusersaccessibletotargetpopulations

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

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

Significantprogressand/ormomentum

Earlyprogress

Initialconversationsongoing

COLORKEY

14DECEMBER2016

KeyQuestionsforPrEPinZimbabwe

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

• WhataretheincrementalbenefitsandcostsofPrEPfortargetpopulations?

• WhenwillPrEPbemeaningfullyincludedinnationalplan?

• Whatpopulationsandsub-segments,andwhere,willreceivePrEPbeyonddemoprojectsandDREAMS?

• HowwillPrEPbefundedbeyondcurrentlevels?

• WhenwillTruvada,oralternatives,beapproved forprevention?

• WhatisthetotalforecastedneedforPrEP,andhowwilleffectiveforecastsbedevelopedgivendatalimitations?

• Howwillthesupplychainbemanagedtoavoidstock-outsorperceivedcompetitionwithtreatment?

• Whichdeliverychannels willbeusedtodeliverPrEPtokeypopulations,inwhatsequence?

• Howcannon-publicfacilities(e.g.NGO,private)beleveragedforPrEP?

• HowandwhenwillhealthcareworkerengagementforPrEPbedelivered?Whatareexpectedopportunitiesorchallenges?

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

• Whowillcoordinatethe communicationscampaignforPrEPandwhen?Whatarethemosteffectivemessagestoreachpopulationsatrisk,includingthoseincities,commercialfarming,mining,borders,etc.?

• Whatinvestmentand/orcapacity-buildingneedstobedonetomitigatestrainonthesystemfromongoingtesting(HIVandcreatininelevels)ofPrEPusers?

• WillusersadheretoeffectiveuseofPrEP?Howcanadherence/effectiveusebeencouragedandsupported?

• Howwillservicesbelinkedacrossfacilitieswhennotavailableon-site?

15DECEMBER2016

PLANNING&BUDGETING

SUPPLYCHAINMANAGEMENT

PREPDELIVERYPLATFORMS

INDIVIDUALUPTAKE

EFFECTIVEUSE&MONITORING

KeyStakeholdersforPrEP

MOHCCdevelopsnationalstrategicplan,identifiesdrugneeds,doesforecasts,specifiesdeliverytimelines,createstreatmentguidelines,M&Eplans

NACprovideslogisticalandtechnicalassistanceduringplanpreparation...

NACisresponsibleforoverseeingmonitoring&evaluation

Technicalworkinggroupsfocusedonkeythemesareinvolvedinplanning

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

Nationa

lstakeho

lders

LocalImplem

enters

Dono

rs

Pangaeacanhelpensureinclusionofkeypopulationsinitssecretariatrole

Keypopulationsareincludedintechnicalworkinggroupsbutmoreeffortsareneededtoensuremeaningfulrepresentation

CCMoverseesGlobalFundproposalsandgrants

NatPharm quantifiesdrugneedsandoverseesstorage

MCAZperformsqualityassuranceandregistration

SPBregulatesandmanagespublicprocurement

LocalmanufacturershavehadsomeinvolvementinARVproductioninthepast

HealthcarefacilitiesalreadydeliveringARTlikelytobethefirsttodeliverPrEP

OtherpublicHIVservicechannels couldpotentiallydeliverPrEP(e.g.,CBHCs,HTCcenters,ARTsites,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

16DECEMBER2016

APPENDIXA.ValueChainDetailB.TimelineofMajorResearchandActivitiesC.References

17DECEMBER2016

AppendixA: ValueChainDetail

ThefollowingslidesprovideadditionaldetailoneachsectionofthePrEPvaluechaininZimbabwe

18DECEMBER2016

PlanningforPrEPKeyStakeholders• MOHCC isresponsiblefordevelopingnationalstrategicplanaswellas

conveningatheguidelineadaptationTWGforWHOguidelinesonUTTandPrEP,andthePrEPsub-committee

• CountryCoordinatingMechanismoverseesGFproposalsandgrants• Technicalworkinggroupsfocusedonkeythemesareinvolvedinplanning• Keypopulationsareincludedinthesegroups,butmoreeffortsareneeded

toensuremeaningfulrepresentation• NAC provideslogisticalandtechnicalassistanceinthepreparationofplan• Advocacygroups forkeypopulations(e.g.,GALZ,ZNNP+,WASN,etc.)• PrEPimplementingpartners- DREAMS (CeSHHAR,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)

• PrEPnotmeaningfullyincluded inZNASPIII• RecentsuccesseswithVMMChavemadeitakeypreventionstrategy,but

government’sinvestmentinscalingitupmaypreventadditionalfocusonPrEPscale-up

• Nationalleadersremainconcernedabout ARVresistanceresultingfromPrEP

ReadinessforPrEPIntroductionReadinessFactor Progress

Impact, costandcost-effectivenessanalysesforPrEP aspartofcomprehensiveHIVpreventionportfolio

• CESSHAR, IMPACCT,HTPN082demoprojects underway;potentialforadditionalstudies

• BMGFcompilingcostdatafromPrEPdemoprojectstocreatestandardizedcostingmodel

IdentificationandquantificationoftargetpopulationsforPrEP

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

InclusionofPrEPandfemale-controlledmethodsincurrentorupcomingnationalHIVpreventionplans

• PrEP hasbeenincorporatedintotheZimbabweNationalStrategicPlan

Timelineandplan forPrEPintroductionandscale-up

• ATWGon WHOTestandStartGuidelines,aswellasasub-committeeonPrEP, developedoralPrEPguidelines. Implementationplanningissettobeginin2017

• ZIMPHIAstudyresultssharedinDecember2016.InsightsfromdatasettoinformPrEProllout

Abudget forPrEProll-outtotargetpopulations

• A costed implementationplan,tobedevelopedin2017,willbeusedasaresourcemobilizationtool.Nobudgethasbeencreatedasofyet

Sufficientfunding toachievetargets

• Available fundinglimitedtoDREAMSandCeSHHAR

19DECEMBER2016

KeyPopulationsforPrEPAdolescentgirlsandyoungwomen(AGYW)

Sero-discordant couples Menwhohavesexwithmen(MSM)

FemaleSexWorkers(FSW)

KeyIndicators

• ~1.7Mtotaladolescentgirls(ages10-19),ofwhich61,000livingwithHIVand~1.6MwithoutHIV

• 4-6%prevalence(ages15-19)• 14,000 newlyinfectedadolescent

girls(ages15-24)in2015=66%ofnewinfectionsinthatagerange

• 18% ofadolescentgirls(ages15-19)haveexperiencedsexualviolence

• 45%havetestedforHIV

• Heterosexualpeopleinstableunionsorpeopleengaginginlowriskheterosexualsexaccountforaround54.8% ofallnewHIVinfections

• 11.3%ofmarried/cohabitingcouplesaresero-discordant

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

• Unknown numberoftotalMSM

• ~24%prevalenceamongMSM(basedonresearchincludingZimbabweandothercountries)

• 4% oftotalnewinfectionsand7% includingtheirpartnersareamongMSM

• 40,000-80,000totalFSWinZimbabwe

• 20% prevalenceoverallbasedonCESSHARestimate,but50-70%insmallerstudies

• 12% ofZimbabwe’stotalincidenceisamongsexworkersandtheirclients

• ~30%of HIV+FSWareonART

Prioritiza

tion • Innewnationalplan,AGYWare

includedasaprioritypopulationforcomprehensivepreventionbutnotPrEP

• AGYWwillbethefocusoftheDREAMSinitiativeinsixdistrictsthroughoutZimbabwe

• Innewnationalplan,peopleinstableunionsandsero-discordantcouplesareacknowledgedtobeamongkeypopulations

• OneofthePriorityAreasofFocusistoreduceacquisitionfromortolong-termsexualpartners

• MSMindirectlylistedaskeypopulationinnationalplan(e.g.,“moredataneeded”)

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

• Strongcivilsocietyadvocates(e.g.,GALZ)

• Innewnationalplan,FSWincludedasapriorityforcomprehensivepreventionandpossiblyPrEP

• Zimbabwe’sonlyongoingPrEPimpactstudy(SAPPH-IRe)seekstodemonstrateacceptabilityandfeasibilityofPrEPandmaximizeadherenceamongasubsetof28,000highway-basedFSW

Questions • Whichchannelswouldbemost

appropriatefordeliveringPrEPtoAGYW?

• WilltherebefundingspecificallyforPrEPforAGYW?

• WhichchannelswouldbemostappropriatefordeliveringPrEPtopeopleinstableunionsandsero-discordantcouples?

• WhatisthesizeandHIVprevalenceofthepopulation?

• WhichchannelswouldbemostappropriatefordeliveringPrEPtoMSM?

• 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]. TheCommunicationInitiativeNetwork:(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.;Cowan FM,Mtetwa S,Davey C,Fearon E,Dirawo J,etal.(2013) EngagementwithHIVPreventionTreatmentandCareamongFemaleSexWorkersinZimbabwe:aRespondentDrivenSamplingSurvey.PLOSONE8(10):e77080.doi:10.1371/journal.pone.0077080

20DECEMBER2016

BudgetingforPrEP

CurrentFundingforHIV• 85%isfrominternational sources• 15%isfromdomestic resources,

largelytheNationalAIDSTrustFundlevy(thuslinkedtoeconomicgrowth)

• Levyhasdrawn~$20-50M.TheLevywasextendedtotheminingsectorwhichwilladdsignificantadditionalresourcestotheFund

• FundingforHIVinZimbabwe (publicdomesticandinternational,‘09-’16):

RemainingGapsandChallenges• OffundingfromNationalAIDSLevy,

only10%isallocatedtoprevention• Onaper-PLHIVbasis,Zimbabwe

receivesoneofthelowestpercapitaallocationsgloballyfromcombinedfundingofGlobalFundandPEPFAR

• WorldBank2011expenditurereviewshowedpercapitadevelopmentassistanceforhealthinZimbabwetobewellbelowneighboringcountries

• HIVcosts,commitments,andgap:

PotentialNewFunding• PEPFAR,GlobalFund,andZimbabwe

governmentrecentlyjointfundedthenew$3MZIMPHIAstudy

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

• Zimbabwesubmitteda$40.2MrequestforincentivefundingonMay18th,2015,fromtheGlobalFund (ontopofits~$145averageannualcommittedallocationthrough2016):

Summary:• Stronggrowthinfundingoverpast5yearsduetoPEPFARfundsdoublingto$95M

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

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

$525MtotalHIVcosts$183Mofwhichisprevention$41M* committedtoPrEP*AmountonlyavailableforDREAMS

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 $19.5MYouthandAdolescents $10.0MCommunityandKeyPopulations $2.9MMonitoringandEvaluation $4.2MGrantManagement $3.6MTOTAL $40.2M

Sources:(1)126MillionAdditionalFundingAnnouncedtoFightHIVinZimbabwe.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-BasedHIVImpactAssessment.AllAfrica.September17,2015.;(7)ZimbabweNationalHIVandAIDSStrategicPlan2011-2015(ZNASPII).MinistryofHealthandChildCareandNationalAIDSCouncil.March2015:(8)ZimbabweNationalHIVandAIDSStrategicPlan2015-2018(ZNASPIII)[Notofficiallylaunched].MOHCCandNationalAIDSCouncil.March2015;(9)ZimbabwePlannedFunding.PEPFAR.2014.

21DECEMBER2016

SupplyChainManagementKeyStakeholders• MOHCC identifiesdrugneeds,specifiesdeliverytimelines,oversees

developmentoftreatmentguidelines• GileadfilesforpreventionindicationofTruvadainZimbabwetoMCAZ• NatPharm conductsquantificationstoforecastdemandbasedon

programneeds,runscentralmedicalstore,publicwarehouses,andlocalbranches

• MCAZperformsqualityassuranceandproductregistrationforalldrugs• StateProcurementBoardregulatesandmanagesallpublicprocurement

KeyStrengthsandOpportunities• Zimbabwehaswell-coordinated procurementanddistributionsystemto

whichPrEPcanbeadded;coordinationsystemisflexibletodeliverPrEPtospecifiedgeographiesandchannels(NGOorpublic)

• ZimbabweisoneofAfrica’spioneerprocurementreformcountries,withWorldBanksupportingSPBtraining,assessment,andcapacity-building

• WidedisseminationoftreatmentguidelinesamongpublichealthfacilitiesbodeswellforpotentialPrEP-relatedguidance

• PotentialforPrEPtobedonatedbyGilead(althoughthiscouldbebothanopportunityandachallenge)

• Truvada iscurrentlyapprovedfortreatmentbutnotprevention,yetMCAZhassignaledthatthisindicationissufficient touseTruvada forprevention

KeyEmergingConsiderations• ForARVscale-up,thereweresomecoordinationchallenges,as

procurementhappenedindividuallybydonoragenciesandwasn’talwaysharmonized,thoughsomeofthishasbeenresolved/streamlined

• QuantificationprocessinformingNatPharm procurementreliessolelyonprogramtargets.Processmaynotbeadequate forPrEPforecasting

ReadinessforPrEPIntroductionReadinessFactor Progress

Regulatoryapprovalofform(s)oforalPrEPbyauthorities

• PrEP(Truvada)isnotregisteredfor treatment, whichMCAZhasindicatedissufficientforuseofthemedicationforpreventionpurposes

EffectivedemandandsupplyforecastingmechanismsforPrEP

• StrongsupplychaininplaceforARVs,whichwilllikelytranslatetoPrEPreadiness– butnoPrEPspecificplanningconductedto-date

ManufactureridentificationandcontractnegotiationtopurchasePrEP

• PulsepharmaceuticalshasbeenidentifiedasthedistributorofPrEP

Productandpackagingdesigntomeettargetpopulation needsandpreferences

• Unclear todateandlikelytodependonchosenPrEPmanufacturer

DevelopmentofdistributionplanforPrEPtoreachtargetpopulations

• Nodistributionplanisyetinplace butwillbedevelopedin2016/2017

Effectivedistributionmechanisms toavoidPrEPstock-outsinpriorityfacilities

• Zimbabwe hasa robustdrugprocurementanddistributionmechanismthat iscentrallycoordinatedforpublicandNGOsites; ARVstock-outs arerare.

• NatPharm doesnotanticipatemajorobstaclesinaddingPrEPtocurrentdistribution

22DECEMBER2016

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)• 1,460HTCcentersidentifiedaskeychannelforARVsandHIVprevention• 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 ProgressIssuanceofstandardclinicalguidelinesforprescription anduseofPrEP

• ConsolidatedPrEPguidelineswerereleasedinNovember2016

Sufficientinfrastructure andhumanresourcestoconductinitialHIVtestsandprescribePrEPinprioritychannels

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

• Humanresources needtobedeterminedbyroll-outplan

Plantoengagehealthcareworkers onPrEPanddeliverytotargetpopulations(includingmitigatingstigma)

• GALZconductinghealthcareworkertrainingproject–demonstratingresultsofreducedstigma

• OralPrEPisexpectedtobeincludedinhealthcareworkerstrainingmanuals

ToolstohelppotentialclientsandHCWunderstandwhoshouldusePrEP havebeencreated

• OralPrEPhasbeenincludedontheOperationalServiceDeliveryManual

• PrEPfactsheetisbeingfinalized• HPTN082willbetestingascreeningtool thatcouldpotentiallybeusedforscaleup

Sufficientresourcestoroll-outplansforhealthcareworkerengagement

• Neededresources willbedeterminedalongwithhealthcareworkerengagementplansandidentificationofPrEPdeliverychannels.

23DECEMBER2016

CurrentPrEPDeliveryChannelsDemoprojectsandOpenLabel Extensions DREAMS

Backgrou

nd

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

• TheDREAMS initiative(Determined, Resilient, Empowered,AIDS-free, Mentored,and Safewomen)hasbegunprovidingPrEPtoyoungwomen(18-24)inthree(Chipinge,Mutare,andBulawayo) ofthesixDREAMSdistricts(Bulawayo,Gweru,Mazowe,Makoni,Mutare,Chipinge)beginningin2016.PrEPisbeingrolledoutusingthePSINewStartCentres• PrEPintheformofTruvada isdonatedbyGileadforusebyDREAMS

KeyStreng

ths

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

• Targetedprogramreachinghigh-risk(asidentifiedbycommunity-ledcriteria)adolescentgirls• Districtlevelmicroplanning andhotspotanalysisisunderwaytoeffectivelytargetprogramactivities• ZimbabweisbenefitingfromsupplementaryTest&StartandVMMCfundingtorapidlyexpandaccessofmalesexualpartnersofAGYWtohighimpactHIVservicesintheDREAMSdistricts• PrEPdeliverycoupledwithHTC,behaviorchangeactivities,extensivecounseling,communitymobilization,andinitiativestostrengthenfamilies• PotentialtoexpandPrEPdistrict-widegivenotherinvestmentstomakePrEPavailabletoDREAMSparticipants,includinglogistics,procurement,demandgeneration,andcommunitybuy-inefforts

Key

Challeng

es • PerceptionofPrEPaspartofan“experiment”deterspotentialusersfearingpoorsafetyandefficacyofdrug• Highercostsofdeliveryindemonstrationprojectcontext

• DREAMSPrEPtoreachadolescentgirlsonlyincommunitieswheremanyotherpopulationscouldbenefitfromPrEP• Reachlimitedto1,451youngwomeninDREAMSdistricts(53,654youngwomenwillbetargetedwithHTC)

24DECEMBER2016

ComprehensiveCareCenters &otherARTsites SexualandReproductiveHealth(SRH)careproviders

Backgrou

nd

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

KeyStreng

ths

• Mostvisibletogeneralpopulations

• Systemsguidedandlinkedwithcountyandnationalstandards/agendas

• Canprovidegreateraccesstokeypopulations(FSW,MSM,PWID)

• Effectivelyreachhigh-riskindividualswithlow/nostigmapresentincentersoramongstaff

• Frequentuseofpeer-educatorprograms,whichmightbecriticaltoeffectiveuseandincreaseddemandgeneration

• Opportunitiestodeliverthroughprivatechannelsaccessingkeypopulationssuch

• DiscreteaccesstoPrEPwithoutstigmaforthosewhocanaffordit

• Notdependentonaid

• Providegreateraccesstosero-discordantwomenandAGYWinfemale-friendlyandtrustedsettings

• StaffhavelowerlevelsofstigmaagainstAGYWwhoseekfamilyplanningandHTCservices

• Post-abortioncareclinicshavethepotentialtoreachwomenwithveryhighriskofHIVinfection

• PotentiallyprovidelowcostofdemandgenerationsincewomenarealreadyvisitingSRHservices

• ~1500ARTsitesthroughoutZimbabwe• Well-integratedprocurementanddeliverysystems• LaboratorycapacityfornecessaryPrEPmonitoringinplaceatmanyofthesesites• HTC-trainedstaff

Key

Challeng

es • HCWstigmaagainsttargetpopulations,ifpresent,candetermanyfromaccessingcarethroughthesesites

• Staffandresourcesperceivedtobestretchedthin,resultinginsuboptimalcare• Nosingleoutleteffectivelyreachesalltargetpopulations

• PotentiallylimitedexperienceandtraininginHTClinkages

• Limited/nolaboratorycapacityfornecessaryPrEPmonitoring

• AGYWmayhavetroubleaccessing

PotentialPrEPDeliveryChannelsThisisacontinuedareaoffocus.Additionaldetails

expectedtoemerge

25DECEMBER2016

IndividualUptakeKeyStakeholders:• NGOgroups,includingCHAI,areinearlystagesofdemandgeneration

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

introducenewplansformobilizingtestingandcarelinkagesthatcouldbeleveragedforPrEPdelivery

• PEPFARandGlobalFundmaybekeyfundersofdemandgeneration• PSI deploying354,000HIVself-testingkits,whichmightbecriticalin

providingHTCtohighriskpopulationsnotalreadyaccessingtestingservices

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

• Demandgenerationactivitiesarenotinplace beyondthoseattachedtospecificdemoprojects,butthesehaven’tbeenresearchedorvetted

Linkages betweenHTC,PrEPprescription,andPrEPaccesstoenablePrEPuptake

• Necessary linkageswillbeunknownuntilPrEPguidelinesoutliningchannels,populations,andprescriptiondetailsarecompleted.IfPrEPisdeliveredthroughARVchannels,thelinkagesarelikelytoenablePrEPuptakeatleastinthosepopulationsalreadyaccessingsuchchannels

Information forclientsonhowtoeffectivelyusePrEPforalltargetpopulations

• Informationexistsforthoseparticipatingindemoprojects.

• APrEPfactsheetisunderdevelopment

Sufficientresourcestoroll-outplansfordemandgeneration

• Resources notyetsecured.Neededresources willbedeterminedandultimatelysecuredonceZimbabwedeterminesdemandgenerationneedsandplans

26DECEMBER2016

KeyConsiderations

Stigma

• Earlystigmalingers:makingPrEPwidelyavailablebeyondkeypopulationswouldhelpmitigatepreconceptionsofPrEPasanoptiononlyforFSWandMSM.ThisisimportantbecauseonlydemoprojecttodateinZimbabweisworkingwithFSW.AnyPrEPcommunicationscampaignwillneedtodirectlyaddressthestigmaassociatedwiththispopulation

• 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

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

• Risk inrelationships:potential toappealtolikely PrEPusersbyhighlightingtheriskassociatedbytheirownconduct andalsothatoftheirpartners whomayhavemultiplesexualpartners

• Riskperception:youngwomeninKenyagenerallydonotseethemselvesathighriskforHIVtransmission.Theyaremorefocusedoneconomicopportunityandeducation

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

KeyEnd-userThemesforPrEP

27DECEMBER2016

EffectiveUse&MonitoringKeyStakeholders:• MOHCCisresponsibleforvettingtheM&Eindicatorsandoverseeing

theworkofthePrEPandM&ETWGs,whichwillworktodevelopandapproveoralPrEPM&Erecommendations

• NACisresponsibleforoverseeingthegeneralnationalM&Eplan• USAIDanditsSIteamisinvolvedintherefinementofM&Eindicators

andreviewinganddevelopingtoolstosupporttheprocess• NGOs havebeenparticularlyimportantinprovidingpost-testsupport

servicesforHIV-negativeandHIV-positivepeoplethataddressriskreduction,disclosure,andtreatmentadherence

KeyEmergingConsiderations• Whileadatasystem(DHIS2)exists,onlysomeoffacility/patientdata

ispulledintoDHIS.Additionally,facilityregistersandreportingtoolsdonot(yet)reflectneedstotracktheroll-outofPrEP.Therefore,M&EtoolswillneedtoberevisedtobeabletoreportonPrEProllout

• LittleisknownaboutPrEPadherenceingeneral,andevenlessonhowitmaydifferamongtargetpopulationsinZimbabwe

• WhileitseemslikethereissufficientcapacityforHIVtesting,ongoingtestingofPrEPuserscouldplacestrainontheexistingsystem

ReadinessforPrEPIntroductionReadinessFactor Progress

EstablishedplanstosupporteffectiveuseandregularHIV,creatininetestingthatreflecttheuniqueneedsoftargetpopulations

• Earlyconsiderationsforencouragingandsupportingeffectiveuseandadherencetoregulartestingarebeingdiscussed

• However,specificstrategies fortargetpopulationsarenotyetbeingcreated

CapacitytoprovideongoingHIV andcreatinineleveltestingforPrEPusersaccessibletotargetpopulations

• While thereisincreasinglysufficientHTCcapacityforcurrentefforts,gapsremainandresourcesmaycontinuetobeachallenge.Additionally,exacttestingneedsforPrEPareyettobedetermined.Countrytreatmentguidelinesshouldoutlinethesespecificneeds

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

• Toolsandindicatorsformonitoringarecurrentlybeingreviewed

• M&EforPrEPlikelytobeintegratedwithexistingARVM&Esystem.PrEPguidelineswillneedtodictatemonitoringand trainingneeds

KeyStrengthsandOpportunities:• Zimbabwehasasinglemonitoringandevaluationsystem.This

systemislinkedtoindividualproject/programM&EsystemsbeingusedbyHIV/AIDSserviceorganizations;thissystemappearstobeintheprocessofbecomingmoreintegratedandharmonized

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

developedtoguidetheimplementationofthestrategicplananditspartnersystems”

28

NationalM&EStructure/Process:

Steps Who

DeveloprecommendedoralPrEPM&Eindicators OralPrEPTWGVetrecommendedindicatorsandmakerefinements asneeded MOHCCandUSAID

Approverefinedindicators M&ETWGNecessarydatacollectiontoolsreviewedanddeveloped OPTIONS andUSAID

Integrate indicatorsintoDHIS_2andelectronicpatientmedicalrecordsystem MOHCC

Possibly:monitor earlyrollouttopilotpopulations,includingtrackingclientscyclingonandofforalPrEP

TBD,withtechnicalsupportfromCHAI/PMM

29DECEMBER2016

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 Results

HTPN082andIMPACTdemoprojectsbegin

Plan

ning/Im

plem

entatio

n

GuidelineAdaptationCommitteemeets,incl.PrEP workinggroup

New nationalstrategicplan for2016-2018(ZNASPIII)ineffect

MOHCC-directedPrEPimplementationplanningperiod

DREAMS activitiestotakeplaceinZimbabweinidentifiedhotspotdistricts

ZNASP IIImid-termreview;opportunitytopushforPrEPinclusioninplan

CHAIdemandgenerationresearchinitialresultsexpected

GatesresearchoncostofPrEPdeliveryacrossdemoprojectsinitialresultsexpected

Policy

Zimbabwe releasesPrEPguidelines

Gilead licensureprocessapprovalexpected(Pulseasdistributor)

TBD

30DECEMBER2016

AppendixC:References• 126MillionAdditionalFundingAnnouncedtoFightHIVinZimbabwe.UnitedNationsDevelopmentProgram.January20,2015.• AchievinganAIDS-FreeGenerationforGayMenandOtherMSMinSouthernAfrica.amfAR,TheFoundationforAIDSResearchandJohnsHopkinsBloomberg

SchoolofPublicHealth.May2013.• CountryUpdates:Zimbabwe.PrEPWatch.2015.• EngagementwithHIVPreventionTreatmentandCareamongFemaleSexWorkersinZimbabwe:aRespondentDrivenSamplingSurvey.Cowan,etal;PLOSOne.

October2013.• EvaluationsandRegistration andHowWeRegulate.MedicinesControlAuthorityofZimbabwe.2012.• GlobalAIDSResponseReport:ZimbabweCountryReport.UNAIDS.December2014.• GlobalFundCountryAllocations:2014-2016.TheGlobalFundtoFightAIDS,Tuberculosis,andMalaria.March12,2014.• HIVandAIDSinZimbabwe.AVERT.May1,2015.• ManagementofHIV&AIDSCommoditiesinZimbabwe:ACapacityAssessmentofNatPharm andMinistryofHealthandChildWelfare .DELIVER,forUSAID.

July2006.• NationalAIDSCouncil:Funding.NationalAIDSCouncilofZimbabwe.2011.• ProcurementandSupplyChainManagementinZimbabwe.UNDPandGlobalFund.March4,2015.• ProcurementChallengesintheZimbabweanPublicSector:APreliminaryStudy.JournalofTransportandSupplyChainManagement.2015.• RethinkingHIVPreventiontoPrepareforOralPrEPImplementationforYoungAfricanWomen.Celum,etal;JournaloftheInternationalAIDSSociety.2015.• SexualandReproductiveHealthNeedsOfAdolescentsinZimbabwe.Guttmacher Institute.2014.• SuccesswithPrEP:NextStepstoSupportPolicyDecisionsinSouthernandEastAfrica.AVAC,UNAIDS,andWHO.October26,2014.• TruvadaasPrEP:ANewHIVPreventionOptionontheTableforZimbabwe? ICASAYouthFront.October19, 2015.• “Youarewastingourdrugs:”HealthServiceBarrierstoHIVTreatmentforSexWorkersinZimbabwe.Mtetwa,etal,ofBMCPublicHealth.2013.• ZimbabweBeginsPublicProcurementModernization.TheWorldBank.May13,2015.• ZimbabweFailstoCapitalizeon$4bnARVsMarket.RobinMuchetu ofTheSundayNews.April12,2015.• Zimbabwe:MinistryofHealthandChildCaretoLaunchNewHealthSurvey– ZimbabwePopulation-BasedHIVImpactAssessment.AllAfrica.September17,

2015.• ZimbabweNationalHIVandAIDSEstimates:2013.MinistryofHealthandChildCare.2013.• ZimbabweNationalHIVandAIDSStrategicPlan2011-2015(ZNASPII).MinistryofHealthandChildCareandNationalAIDSCouncil.March2015.• ZimbabweNationalHIVandAIDSStrategicPlan2015-2018(ZNASPIII)[Notofficiallylaunched].MinistryofHealthandChildCareandNationalAIDSCouncil.

March2015.• ZimbabweProgressReport, GlobalAIDSResponse,NationalAIDSCouncil,2016.• ZimbabwePharmaceuticalCountryProfile.MinistryofHealthandChildWelfare,DirectorateofPharmacyServices,incollaborationwiththeWorldHealth

Organization.June2011.• ZimbabwePlannedFunding.PEPFAR.2014.