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SITUATIONANALYSISTOOLKITSTEP1:DATACOLLECTION

1OPTIONSSITUATIONANALYSISTOOLKIT|STEP1DATACOLLECTION

PleaseacknowledgeUSAID/OPTIONSwithuseofthistoolkit.

PURPOSEANDUSE

This toolkit is designed to help implementers plan for introduction and roll out of oral PrEP. The toolkitenables implementers to1)catalogue thecurrentsituationat thecountry-level for the introductionofOralPrEP,2) identifyexistingassetsandstrengthsthatcouldbeleveragedforPrEPintroduction,and3)highlightgaps in understanding, processes, or resources that will need to be addressed to support successful PrEPintroduction.Byworkingthroughthesethreesteps,implementerswillcompleteaSituationAnalysisthatcanbeusedtoguideplanningandpreparationforthelaunchandscale-upoforalPrEP.SituationAnalysisToolkit:3Steps

ThistoolkitwasdevelopedandusedbytheOPTIONSConsortiumtoconductaSituationAnalysistohelpplanfororalPrEProlloutinKenya,ZimbabweandSouthAfricain2015/16.Workingconcurrentlyinthreecountriesandallowingtimefordocumentcollection,compilation,reviewandrevisionOPTIONSwasabletocompletethethreestepprocessinthree-fourmonths.OPTIONS and its partners at USAID and PEPFAR are eager to share these tools to help others supportingsimilarmarketplanningefforts inothercountriesorforotherproducts. Ifyouhaveanythoughts,feedback,questions or requests for additional information, please contact Neeraja Bhavaraju at FSG (an OPTIONSconsortiummember)[email protected].



STEP1:DATACOLLECTION

Thisdocument is a tool fordata collection.Questionsguide in-countrydataand information-gathering inastructuredandefficientwayusingsecondaryresearch, interviews,meetings,andothercommunication.Theresulting findings from this research can be packaged in several ways (e.g., through the Situation AnalysisSummaryand/ortheImplementationPlanningFrameworkthatarealsoprovidedastemplates).

The questions included here are organized along a simplified “value chain” that chartswhat is needed forcountry introduction of Oral PrEP through fivemajor stages: (1) Planning and Budgeting, (2) Supply ChainManagement,(3)PrEPDeliveryPlatforms,(4)IndividualUptake,and(5)EffectiveUseandMonitoring.

Contents

Thequestionsincludedhereareinthreesections:

• SectionOne:ContextThesequestionsprovideanoverviewofthekeystakeholdersforPrEP,thekeyquestions/considerationsaboutPrEP,andtheongoingresearchandactivitiesrelatedtoPrEP.Thissectionmaybecompletedlast,pullingupfromdetailsinothersectionsofthisdocument.

• SectionTwo:ValueChainResearchThesequestionsidentifykeyactors,challengesandopportunitiesateachpointalongthevaluechain.Thesequestionshelpcountriesmaptherecent,ongoing,upcoming,andneededresourcesandactivitiesrelatedtotheintroductionofPrEP.

• SectionThree:TargetPopulationDataThesequestionsgatherinformationonpotentialtargetpopulationsforPrEPuseandfurtherdetailsontheongoingresearchandmodellingtakingplacein-country.

Process

Gathering this information requiresa combinationof secondaryandprimary research. Documents suchasnational strategic plans for HIV/AIDS, national HIV behavioural and other health surveys, PEPFAR countrydocuments, AIDSInfoOnline.org, and PrEPWatch.org have been immensely helpful in conducting situationanalyses. Interviews with relevant experts and stakeholders are needed to augment this research and tounderstandthemostcurrentcontextandinformationonPrEP.



SECTIONONE:CONTEXT

Name(s)(ofthosecompletingthisportionofthesituationanalysis)

Organization(s)coordinatingsituationanalysis

Country

Datacollectionapproach

Whoarethekeyregionalornationalstakeholdersrelevantforeffectivescale-upofPrEPinyourcountry?

Whoarethekeyglobalstakeholdersrelevantforeffectivescale-upofPrEPinyourcountry?

Whatarethebiggestquestionsorconcernsonthemindsofthesestakeholders?

Whatefforts(e.g.,PrEPdemonstrationprojects,otherresearch,modelling,workinggroups)areunderwaytoanswerthesequestions?



SECTIONTWO:VALUECHAIN

Thenextsectionprovidesatemplateforcollectionofqualitativedataalongthevaluechain.Theaimofthisdatacollectionistoidentifykeyassetsandbottlenecksforintroductionandscale-upofPrEP.

In order to make this analysis as robust and comprehensive as possible it is structured along thecomponentsofthevaluechainforPrEP(seegraphicbelow).

ValueChainOutline

Thesectionbelowincludesatableforeachcomponentofthevaluechaininthegraphicabove.Eachtableincludesseveralquestionseachwithseveralcolumns:

• Onespacetocollectinformation(“response”)• Onespacetonoteyourlevelofcertaintyinthatresponse(high-moderate-low).Thiswillenableyou

tocaptureyourorothers’hypothesesandrefineonanongoingbasis,asopposedtowaitinguntilyouhaveabsolutecertainty.

• Onespacetocapturethesourceofyourinformation(e.g.,individualsorsecondarysources)



PLANNINGANDBUDGETING

Cost-effectivenessandimpactanalyses

Questions Response Certainty Source

Whatisthecurrentthinkingonthecost-effectivenessandimpactofPrEPaspartofacomprehensivecombinationapproachtoHIVprevention?

Levelofcertainty

Whatareotherconsiderations? Leaveblankifnone Whatanalyseshavealreadybeenconductedorwillbeconducted?

SeeSection3,Table2

Targetpopulationsquantificationandprofiling


Towhatextenthavedecisionsabouttargetpopulationsbeenmade?

Levelofcertainty

WhatistheexpectedoutcomeforPrEP(ifongoingprocess)? Levelof

certainty

Whatstakeholdersareinvolvedcurrentlyorwillneedtobeinvolvedinplanning?

Levelofcertainty

Whatistheexpectedtimeline?Whatarerelevantkeymilestones?

Levelofcertainty

Whatareotherconsiderations? Leaveblankifnone

Whatdataalreadyexists? SeeSection3,Table1

InclusionofPrEPandfemale-controlledmethodsinnationalHIVplans


TowhatextentisPrEPalreadyincludedinnationalHIVplans?

WhatisexpectedforPrEP(ifongoingprocess)?

IsplanningforPrEPexpectedtofallwithinHIVpreventionorHIVtreatment?

Levelofcertainty




Levelofcertainty

Whatistheexpectedtimelinetodevelopaplan?Whatarerelevantkeymilestones?

Levelofcertainty


TimelineandPlanforPrEPIntroduction


TowhatextenthasatimelineandplanforPrEPintroductionalreadybeendeveloped?


Levelofcertainty

Whatistheexpectedtimelinetodevelopaplanandtimelineforintroduction?Whatarerelevantkeymilestones?

Levelofcertainty


NationalgovernmentbudgetingforHIVpreventionandtreatment


TowhatextentisPrEPalreadyincludedingovernmentbudgets?

IsbudgetingforPrEPexpectedtofallwithinHIVpreventionorHIVtreatment?

Levelofcertainty

Whatstakeholdersarecurrentlyorshouldbeinvolvedinthebudgetingprocess(ifdifferentfromplanning)?

Levelofcertainty

WhatistheexpectedtimelinetodevelopabudgetforPrEPscale-up?Whatarerelevantkeymilestones?

Levelofcertainty


GlobalstakeholderbudgetingforHIVpreventionandtreatment




Whatglobalfundershave/areexpectedtocommit(ted)fundingforPrEPscale-up?

Whatistheexpectedtimelinefordecisions?Whatarerelevantkeymilestones?

Levelofcertainty


SUPPLYCHAINMANAGEMENT

ProductRegistrationwithNationalAuthorities


Whatisthecurrentsituation?


certainty

Whoisinvolved/willbeinvolvedintheregistrationprocess?

Levelofcertainty


Levelofcertainty

Towhatextentwillregistrationbeabarriertoeffectivescale-upofPrEPprovision?

Chooseanitem Levelofcertainty

Why?Whatspecificchallengesdoyouanticipate? Leaveblankifanswertopreviousquestionis1or2 Levelofcertainty

Whatopportunitiesdoyouseethatcouldovercomethesebarriers,orfacilitateprogress?

Leaveblankifanswertopreviousquestionis1or2 Levelofcertainty


Demandandsupplyforecasting


Towhatextentwillsupply/demandforecastingbedifferentforPrEPthanforARVs?Howwillitdiffer?

Levelofcertainty

WhoisexpectedtomanageforecastingforPrEP? Levelof

certainty Whatistheexpectedtimeline/frequencyforPrEPforecasting?

Levelofcertainty



Towhatextentwillthisactivitybeabarriertoeffectivescale-upofPrEPprovision?





Whatareotherconsiderations? Leaveblankifnone Whatanalyseshavealreadyorwillbeconducted? SeeSection3,Table2

Supplieridentification,pricenegotiation,andpurchasecontractestablishment


TowhatextentwilltheprocurementprocessforPrEPdifferfromtheexistingprocessforARVs?Howwillitdiffer?

Levelofcertainty

WhoisexpectedtomanagethisprocessforPrEP? Levelof

certainty Whatistheexpectedtimeline?Whatarerelevantkeymilestones?

Levelofcertainty







FinancingmechanismsforpurchaseofPrEP


HowdoyouexpectthepurchaseofPrEPwillbefinanced?

Levelofcertainty

TowhatextentwilltherebesufficientfinancingforpurchaseofPrEP?

Chooseanitem. Levelofcertainty







DistributionplantoreachtargetpopulationswithPrEP


WhatistheexpectedplanningprocessfordistributionofPrEP?

Levelofcertainty

Whois/willbeinvolvedindevelopingdistributionplans? Levelof

certainty Whatistheexpectedtimeline?Whatarerelevantkeymilestones?

Levelofcertainty



SafeandtimelydistributiontokeyPrEPdeliverypoints


TowhatextentwillPrEPbedistributedthroughexistingmechanismsusedtodistributeARVs?Whatmightbedifferent?

Levelofcertainty

Towhatextentwillsafedistributionbeabarriertoeffectivescale-upofPrEP?






Qualityassuranceguidelinesandregulations


PleasenoteanyadditionalconsiderationsonguidelinesfordistributionofPrEPthatyoufeelarerelevant.



PREPDELIVERYPLATFORMS

IssuanceofStandardTreatmentGuidelinesforPrEP


Whatisthecurrentsituation?


certainty

Whowillissuetreatmentguidelines?Whoinfluencesthesedecisions?

Levelofcertainty


Levelofcertainty







OrganizationalabilitytodeliverPrEPservices


TowhatextentdothehealthcarefacilitiesthatreachtargetpopulationshavecapacitytodeliverPrEP?

SeeSection3,Table1 Levelofcertainty

Howisthisexpectedtochangeinthenext1-3years? Levelof

certainty

Whatstakeholdersare/willbuildhealthsystemcapacitytodeliverPrEP?

Levelofcertainty

Whatarekeymilestonestoconsider? Levelof

certainty Towhatextentwillhealthcarecapacitybeabarriertoeffectivescale-upofPrEP?








Plantoreachandsupporthealthcareworkers


WhattypesofHCWswillbeabletoprescribe/dispensePrEP?

Levelofcertainty

TowhatextentisthereaplanforhowHCWswillbetrainedtodeliverPrEP?

IsitexpectedthatHCWswhodonotcurrentlyprescribeARVswillbeprescribingPrEP?Ifso,whatadditionalsupportisplannedforthem?

Levelofcertainty

WhatstakeholdersareinvolvedcurrentlyorwillneedtobeinvolvedinplanningforHCWtraining?

Levelofcertainty

WhatarekeymilestonestoconsidertoreachHCWs? Levelof

certainty Whatareotherconsiderations? Leaveblankifnone Whatanalyseshavealreadybeenconducted? SeeSection3,Table2

HCWawareness,abilityandwillingnesstoprescribePrEPtotargetpopulations


TowhatextentareHCWsaware,ableandwillingtoprescribePrEPwhenitbecomesavailable?

Levelofcertainty

TowhatextenthavetoolstohelppotentialclientsandHCWunderstandwhoshouldusePrEPbeencreated?

Levelofcertainty

Whatstakeholdersarecurrentlyorwillneedtobeinvolvedintraining/preparingHCWstodeliverPrEP?

Levelofcertainty

Whatistheexpectedtimeline?WhatarerelevantkeymilestonestoreachHCWs?

Levelofcertainty

TowhatextentwillHCWcapacitybeabarriertoeffectivescale-upofPrEP?








FundingforcapacitytoprescribeanddispensePrEP


Towhatextentwilltherebesufficientfundingtobuildneededhealthcarecapacity?






INDIVIDUALUPTAKE

PrEPcommunications


TowhatextenthasaclearandinformativecommunicationsplanforPrEPeducationandawarenessbeendeveloped?

Isthereanintegratedplanningprocessforcommunications?Whoisinvolved/willbeinvolved?

Levelofcertainty

Arethererelevantkeymilestones? Levelof

certainty Whatareotherconsiderations? Leaveblankifnone Levelof

certainty Whatanalyseshavealreadybeenconducted? SeeSection3,Table2

Demandgenerationplanning


TowhatextenthavedemandgenerationplansbeendevelopedforHCT(orPrEPspecifically)?

Isthereanintegratedplanningprocessfordemandgeneration?Whoisinvolved/willbeinvolved?

Levelofcertainty



Ifthereareintegratedormajorprocesses,arethererelevantkeymilestones?

Levelofcertainty

Whatareotherconsiderations? Leaveblankifnone Levelof

certainty Whatanalyseshavealreadybeenconducted? SeeSection3,Table2

Demandgenerationfortargetpopulations


TowhatextentdotargetpopulationscurrentlyunderstandanddemandPrEP?

SeeSection3,Table1

WhatorganizationsareexpectedtoimplementdemandgenerationactivitiesforPrEP?

Levelofcertainty

TowhatextentwilllackofdemandforPrEPbeabarriertoeffectivescale-upofPrEP?


Why?Whatspecificchallengesdoyouanticipate?

Leaveblankifanswertopreviousquestionis1or2

Levelofcertainty



Levelofcertainty


LinkagestoenablePrEPuptake


Towhatextentdo/willlinkagesbetweenHTC,PrEPprescription,andPrEPaccessenablePrEPuptake?

WhatorganizationsareexpectedtoestablishandensureeffectivelinkagestoenablePrEPuptake?

Levelofcertainty

Towhatextentwilllackofeffectivelinkagesbeabarriertoeffectivescale-upofPrEP?




Levelofcertainty



Levelofcertainty




Fundingfordemandgeneration


WhatisthefundingplanforPrEPdemandgeneration/whatisitlikelytobe?

Levelofcertainty

TowhatextentwilltherebesufficientfundingforPrEPdemandgeneration?




Levelofcertainty



Levelofcertainty


Regulationsrelatedtodemandgeneration


Pleasenoteanyexpectedguidelinesorregulationrelevantfordemandgenerationimplementationthatyoufeelwillberelevant.

Leaveblankifnone Levelofcertainty

EFFECTIVEUSEANDMONITORING

EffectiveUsePlan


Towhatextentdoyouexpecteffectiveusetobeabarrierforscale-upofPrEP?

Chooseanitem

Whatstakeholderswillberesponsiblefordevelopingaplanand/orexecutingprogrammingaroundeffectiveuse?

Levelofcertainty


OngoingHIVandothertestingforPrEPusers




TowhatextentwillinsufficientHIVandother(e.g.,creatinine)testingcapacitybeabarriertoscale-upofPrEP?




Levelofcertainty



Levelofcertainty


COMPLETEVALUECHAIN

Questions Response

WhatotheractivitieswillbeimportantforPrEPscale-upinyourcountrythatarenotincludedhere?

Leaveblankifnone

Whatotherstakeholdersorinfluencerswillbeimportantthathavenotbeennotedalready?

Leaveblankifnone

Pleasenoteanythingelsethatyoufeelisrelevant,butnototherwisecapturedhere.

Leaveblankifnone

SECTIONTHREE:ADDITIONALINFORMATION

Table1:Targetpopulationdemographicsanddistributionchannels[Thesetargetpopulationsmayvaryacrosscountries]

Femalesexworkers

Menhavingsexwithmen

Youngwomen

Discordantcouples

Other(e.g.,IDU)

Totalpopulation(#)

HIVprevalence(%)

HIVincidence(%per100person-years)

Levelofgeographicconcentration

Chooseanitem.

Chooseanitem.

Chooseanitem.

Chooseanitem.

Chooseanitem.

CurrentARVcoverageforHIV-positivepopulations(%)

CurrentadherenceratesforARVtreatment(%)



CurrentcoverageforHIVcounseling,testing(%)

CurrentcoverageforHIVprevention(%)

Currentcoverageforcontraception(%)

Currentlevelofawareness/demand

Chooseanitem.

Chooseanitem.

Chooseanitem.

Chooseanitem.

Chooseanitem.

Expectedbarrierstouptake

ExistingservicedeliverychannelsforHIVpreventionservices

Strengthandreachofexistingchannels

Chooseanitem.

Chooseanitem.

Chooseanitem.

Chooseanitem.

Chooseanitem.

Othernon-HIVrelatedservicedeliverychannelsthatcouldincorporatePrEP(e.g.,reproductivehealthclinics)

Expectedreachofnon-HIVdeliverychannels

Chooseanitem.

Chooseanitem.

Chooseanitem.

Chooseanitem.

Chooseanitem.

Whatisneededfornon-HIVdeliverychannelstodeliverPrEP

Sourcesfordata

Yearofdata

Additionalnotes

Table2:Existingresearchandanalysis

Whatexistinganalyseshavebeenconducted(orareunderway)?

Whatorganizationswereinvolved?

Howmuchconfidencedoyouhaveinthefindings?

Whataretheremaininggaps?

Targetpopulationquantificationandprofiling

Deliverychannelidentification

BudgetestimatesforPrEPdelivery,bytargetpopulationanddeliverychannel



Cost-effectiveness/impactestimatesofPrEPfortargetpopulations

Demand/supplyforecasting

Plantoengagehealthcareworkersand/orbuildhealthsystemcapacity

Demandgenerationplan

Monitoringandevaluationplan