Research Priori,es for Differen,ated Care

ICAPGrandRounds,23May2017CharlesB.Holmes,MD,MPHJohnsHopkinsUniversity

Outline

• WhyweneednewapproachestoHIVservicedelivery?• DifferenLatedcare-whatisit?whatisitnot?• Whatdoweknow,andwhatdoweneedtolearnwhenitcomestodifferenLaLngcare?

• PrioriLesfordifferenLatedcareresearch• Conclusions

Why do we need new approaches?

•  Scale• Quality•  Timingforimpact•  Equity/rights• Humanresource,costandinfrastructureconstraints

Why do we need new approaches?

•  Scale• Quality•  Timingforimpact•  Equity/rights• Humanresource,costandinfrastructureconstraints

2030

18.2milliononART

2016

37milliononART

Why do we need new approaches?

•  Scale• Quality•  Timingforimpact•  Equity/rights• Humanresource,costandinfrastructureconstraints

Why do we need new approaches?

•  Scale• Quality•  Timingforimpact•  Equity/rights• Humanresource,costandinfrastructureconstraints

90-90-90by2020ifwewanttoachieve2030UNgoalsforreducingnewinfecLonsanddeaths

Why do we need new approaches?

•  Scale• Quality•  Timingforimpact•  Equity/rights• Humanresource,costandinfrastructureconstraints

Cookeetal,BMCPublicHealth2010UNAIDS,2016

Why do we need new approaches?

•  Scale• Quality•  Timingforimpact•  Equity/rights• Humanresource,costandinfrastructureconstraints

Health systems delivery innovators to the rescue? The example of community adherence groups (CAGS)..

•  Scale• Quality•  Timingforimpact•  Equity/rights• Humanresource,infrastructureandcostconstraints

“belonging to a group strengthens people, they become very strong in groups “

Decrooetal,TMIH2014Rasschaertetal,PLOSOne2014Jobartehetal,PLOSOne2016

Decreasedvisitfrequency

What is differen,ated care?

•  “DifferenLatedcareisaclient-centeredapproachthatsimplifiesandadaptsHIVservicesacrossthecascade,inwaysthatbothservetheneedsofPLHIVbe`erandreduceunnecessaryburdensonthehealthsystem.”

-Grimsrudetal,JIAS2016

σιµπλιφιχατιον τασκ σηιφτινγ δεχεντραλιζατιον, χομμυνιτψ-βασεδ χαρε οπτιµιζεδ χαρε

πατιεντ-χεντερεδ χαρε νεεδσ-βασεδ χαρε !

Differen,ated care- puJng the pa,ent at the center of care

Duncombe,JTropMed2013Grimsrud,JIAS,2016

What is differen,ated care NOT?

• DifferenLatedcareisnotasilverbulletthatisguaranteedtoimproveoutcomesandreducecosts

•  ItisnotenLrelynew,anditisnotcomprisedofasinglemodel•  Itisnottheend-ratheritisonemeanstothe“ends”thatwecareabout:coverage,qualityandimpact

Opinion:Ifcarefully,yetboldlyimplemented,monitoredandstudied,theprinciplesofdifferenLatedcarecouldhelptotransformcaresystemsforthebenefitofindividualsandpublichealth

What progress is being made in moving towards more differen,ated care? • RapidspreadofprogrammaLcinterestandgeneraLonofpilotdata•  EmergingdataoneffecLvenessandcost-effecLvenessfromrandomizedevaluaLonsofdifferenLatedcaremodels

•  EmergingdatafromM&Eofongoingandexpandingpilotprograms• NewguidancefromWHO,naLonalgovernmentsandfunders

•  CommunityofpracLceemerging-CQUIN

• ComparaLvelyli`leimplementaLonscience

High-level ques,ons

•  HowcanweusedifferenLatedcareasatooltohelpusimprovequality(retenLon/VLsuppression),coverageandimpact?

•  Howcanwestriketherightbalancebetweensimplicityofdeliverywhileallowingforflexibility/innovaLon?

•  HowcanwecreatealessmedicalizedsystemforhealthypaLents,whilemaintaininglevelsofsafetyandnotdoingharm?

•  Howcanwebe`erleveragecommunityspirittocreatestrongerandmoresustainablesupportstructuresforlong-termadherenceandsLgmareducLon?

•  Canweusethesegainstospareunnecessaryuseofresourcesandallowforgreaterscale?

“Implementa,on research plays an important role in iden,fying barriers to, and enablers of, effec,ve global health programming and policymaking, and leveraging that knowledge to develop evidence-based innova,ons in effec,ve delivery approaches”

- Fogarty Interna,onal Center “Implementa,on research does not isolate the effects from the context – rather it focuses precisely on the interac,on between the interven,on and the context”

- Allotey TDR 2011

What are some priori,es for differen,ated care implementa,on research? • Visitspacing• ModelselecLon/deployment–“guidedchoice”• PaLentexperiencetodrivedemandfordifferenLated/be`ercare•  SpecialpaLentpopulaLons•  ThescienceofdifferenLatedcarescale-up

Visit spacing anyone?

•  Thestandardofcareinmostsejngs:frequentvisitstoclinic/pharmacy

•  Isthestandardofcaremakingpeoplenon-adherenttovisits?

•  SpacingofvisitsisarguablythesimplestformofdifferenLatedcare

•  Yet,itisunder-implementedinmostsejngs..

Modyetal,CROI2017

Conceptual framework- visit spacing

DecreasedfrequencyofvisitsforstablepaLents/Increasedvolumesofdrugsdispensed

DecreasedpaLentcosts/Lmeburden

Increasedvisitadherence/retenLon

Decreaseddailyclinicvisitvolume Increasedservice

deliverycapacitypersite

IncreasedproviderLmeforsickpaLents

Increasedpublichealthimpact

IncreasedpaLentsaLsfacLon

Spacing visits and refills

•  MSFevaluatedastrategyofsix-monthlyappointments(SMA)forstableARTpaLentsinChiradzuluDistrict,Malawi

•  StablepaLents(aged≥15,onfirst-lineART≥12months,CD4count≥300,NoOI,notpregnant/breasoeeding

• Clinicalassessments1-2monthsà6months.ARVrefills3months•  MedianLmefromSMAeligibilitytoenrolmentwas6months(interquarLlerange0-17months).ThecumulaLveprobabilityofdeathorlosstofollow-upfiveyearsaperfirstSMAeligibilitywas56.3%(95%CI:52.4-60.2%)amongthoseneverSMAenrolled;13.9%(95%CI:12.5-15.6%)amongearlySMAenroleesand8.1%(95%CI7.2-9.0%)amonglateSMAenrolees.

•  OnethirdofpaLentsreturningtorouLnecareatsomepoint•  UnabletocontrolforselecLonbiasanddifferencesamongthosewhodidanddidnotenrollintheprogram

Cawleyetal,AIDSDurban2016

Cluster RCT of Visit Spacing- Zambia MOH/CHAI •  16faciliLes-controlvsintervenLon•  IntervenLon:Pharmacistjobaide,QIofficer,checklists,troubleshooLng,forecasLngtool(controltoo)

• Primaryoutcome:meanchangeintheproporLonofpaLentsreceivingthree-monthrefillsbetweenbaselineandend-lineforeachfacility

•  3-monthfollow-up

McCarthy,etal,2017PLOSOne

McCarthy,etal,2017PLOSOne

ProporLonofpaLentsreceiving3-monthrefills Averagechangeinvisitsperday/site

Retrospec,ve analysis of visit-spacing- Zambia

Modyetal,CROI2017

• Stable HIV-infected pa,ents on ART (OnART>180days,CD4>200cells/μLfor6months,NoTBdiagnosisinpast6months)•  Presented for rou,ne follow-up between January 1, 2013 – July 31, 2015 at one of 63 CIDRZ-supported clinics in Zambia

Spacing visits Pa,ents whose earliest scheduled return to clinic was at 6 months were less likely to: • miss their next visit (aOR 0.23) •  have a gap in medica,on (aOR

0.50) •  become LTFU by their next

visit (aOR 0.48) compared to those scheduled to return at 1 month.

Modyetal,CROI2017

Visit spacing •  ThesethreestudiessuggestthefeasibilityandlikelyeffecLvenessof3-6monthappointments

•  FurthersupportedindirectlythroughCAGs,whichfacilitateindividualsbeingseenclinicallyonlyevery6months

•  Alsosuggestthatvisit-spacingmayrequireaddiLonalstrategiesinordertopromoteitsuptakeamongproviders

•  Althoughgapsinourknowledgebase-seemstobeli`lejusLficaLonfornotsimplyaligningrefillswithappointmentsat6monthsforstablepaLentsandthisisbroadlyendorsedbyWHO

• Wheredowegofromhere?

Visit spacing research agenda

• WhatarethemosteffecLvequality-improvementapproachestodriveandsustaintheshipto6-monthvisits/refills?

•  Strategystudiesnestedinbroaderscale-up?Whatelementsaremostimportantandlinkedtothebestoutcomes?

• Howcanlabperformance(e.g.,VL)bestreamlined/alignedwithvisitsinawaythatdoesnotdefeatgainsmadethroughvisitspacing?

•  SystemsintervenLonsthatusetechnologymoreeffecLvelytoensureadequatestocks?

•  e.g.,real-Lmemonitoringofpharmacyrefillscheduling-trendtowardsshorterrefillperiodsislikelyagoodfuncLonalindicaLonofdruginsecurity..

Visit spacing research agenda, cont’d

• AnyqualitaLveevidenceofdisconnecLontohealthfacility/adherencesupport?

•  Howcantechnologybeemployedtoaddressthis?2-waySMS?

• HowcanexcesscapacitybemosteffecLvelyre-deployed?Shipresourcestocommunitysupport/SMS,etc?

• Whatistheappropriatevisitfrequencyforkidsatvariousstagesoftheirtreatment?

•  1-yearvisit-spacingforthehealthiest15million?Isitsafe?Whatisneededtoaccompanyit?RCT’srequired..

Effec,ve selec,on/deployment of differen,ated care models •  WehavemulLplemodelsthathaveproveneffecLveinadd’ntovisitspacing

•  CAGS:91.8%retenLonat4years

•  ARTadherencegroups:94%retenLonat1year(Forthosewhohave

optedin)•  FurtheremergingmodeleffecLvenessdatafromMSF,CIDRZ,etc

•  Whataboutthosethatdon’topt-inforwhateverreason?

Luque-Fernandez,PLOSOne2013

CAGS

ARTClubs

Howcanweintroducegreaterflexibilityintohealthsystemsinordertoaddresstheheterogeneousneedsandpreferencesofindividualsinneedoflife-longcare?

• HowwellareweadapLng/differenLaLngcarebasedonempiricevidenceofthemostinfluenLalbarriers?

• WhatifweexplicitlytookintoaccountempiricdataonpaLentbarrierswhendecidingwhatmodelswouldbemosteffecLveattheindividualorsitelevel?

CIDRZBe`erInfoStudyNaLonalDisseminaLonMtg,2016

Understanding the nature of individual barriers to care

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

BeierInfo Study- Pa,ent reported reasons for stopping care by clinic among the lost (and traced)

Psychosocial Clinic StructuralCIDRZBe`erInfoStudyNaLonalDisseminaLonMtg,2016

Research agenda around “guided choice” for op,mal care differen,a,on •  CanchoiceofmodelsbeguidedbyperceivedandobservedpaLentneedsandhealthsystemscapacity?

•  Dodifferentmodelsworkbe`erforvarioustypesofpaLentneeds/barriers?

•  DoindividualsreporLngsolelystructuralorclinic-basedbarrierstocaredobestwhenguidedtovisit-spacing,whereasthosereporLngpsychosocialbarriersmaydobestinamodelincorporaLngpeer-communitysupport?

•  ConsideraLonshouldalsobegiventohowtomonitorandscreenformodelappropriatenessascareproceeds..

•  StepwiseincreasesinintensityoverLmedependingonoutcomes?

•  E.g.,Visit-spacingàCAGsàmoreintensivemodels?

The pa,ent experience: a key driver of demand genera,on for differen,ated care?

•  IfwebelievethatpaLentsshouldbeatthecenterofcare,howwellarewelisteningtotheirvoices?

• HowcandataonthepaLentexperienceofcarebesystemaLcallyincorporatedintothehealthcaredeliverysystemtodrivegreater:

•  Flexibility•  Accountability•  ResponsivenesstopaLentneeds•  UptakeofdifferenLatedmodelsofcare

Whatadreadfulwaytospendmyday.Iwishthey

wouldjustgivemealongerrefillof

mymedicine.Iamhealthy!

Research agenda on the pa,ent experience •  FirstneedtosystemaLcallymeasurethepaLentexperience

•  PaLentreportedexperiencemeasures(PREMs),PaLentreportedoutcomes(PROs)•  AdapLngforlowerresourcesejngs-valueofrouLneSMS/exitinterviews

•  Then,useit!PaLentexperience

Capturedbyexitinterview/SMS(e.g.,desirefornewcaremodels,

concernsaboutwaitLmes,stockoutsandstaffajtudes)

Aggregatedandsummarized/hotspotsidenLfied

FedbacktoHCW,sitesandhigherleveldecision-makerstoenabletargetedtrainingonpaLent-

centeredness,otherintervenLons

IncreaseddifferenLatedcaremodeluptake,improvedstaffresponsiveness,

improvedqualityofcare

Special pa,ent popula,ons.. •  KeypopulaLonfriendlymodels

•  WhatmodelsaremosteffecLveatreducingsLgmaandenhancingretenLonandoutcomes?

•  Adolescents•  Canwkd/off-hours“club”-typeapproaches

effecLvelyreachandretainadolescentsinHIVandRHandothercare,andhowcanthisbeadaptedbyMOHgivenopenrestricLveHRpolicies?

•  Pregnantandbreasoeedingwomen•  WhatisthemosteffecLveapproachto

maintainingconLnuityofcareandsocialsupportwhenwomeninvariousmodelsofcarebecomepregnant?

•  E.g.,ARTclubs,CAGs,visitspacing..

•  “UnstablepaLents”•  Whatmodelofadvancedadherencecounselingis

mosteffecLve?•  Whatisthemostefficientvisitscheduleandcare

teamtomanagepaLentsrequiringaswitchtosecondorthirdlinetherapy?

•  Studiesoffeasibility,acceptabilityandeffecLvenessareneeded

Differen,ated care scale-up fidelity - CHAI study in Malawi

CHAIProjectreport,2017

CHAI assessment of mul,-month prescribing penetra,on in Malawi

CHAIProjectreport,2017

CHAIProjectreport,2017

Research agenda around the scale-up of differen,ated care •  IntheabsenceofrobustnaLonaldatasystems,howopenshouldwebeconducLngspecialstudies(CHAIexamplefromMalawi)toassessscale-upfidelity/effecLveness/safety?

• WhataretheinformaLonsystemfeaturesandprogramindicatorsthatbestenabletrackingofpaLentoutcomesunderdifferentmodelcondiLons?

• WhatalternaLvestrategiescanbeembeddedandtestedduringscale-up?•  Arehigh-burdencommuniLeswithhighpenetraLonofdifferenLatedcaremodelsexperiencingimprovedoutcomesandreducedsLgma?

•  Arecost-effecLvenessprojecLonsbeingmetasscaleisachieved?HowcanprogrammaLcexpenditureanalysisbeusedtoensuretheefficiencyofdifferenLatedcarescale-up?

Conclusions •  Convergenceofdemandsonthehealthsystemrequirenewapproaches,includingtheuseofdifferenLatedcareprinciples

•  ThereisanemergingdifferenLatedcareresearchagendathatincludeshowtomakethebestofexisLngmodels(especiallyvisitspacing)thatmaketheleastdemandsonpaLents/system

•  EmergingdataonpaLentbarriers/preferencesmaybeusefultohelpguideraLonalsiteandindividual-leveldeployment/choicesofvariousdifferenLatedcaremodels–opportuniLestotesttheconceptof“guidedchoice”

•  ThepaLentexperienceisanoverlookedsourceofinformaLonandshouldbemeasuredandused/testedasastrategytodrivetheuptakeofpaLent-friendlydifferenLatedmodelsandgreaterresponsivenessofthehealthsystemtopaLentneedsandpreferences

•  TherearesubstanLalopportuniLestotailordifferentatedcareforspecialpopulaLonsthatcouldbenefitfromgreatera`enLontoacceleraLngevaluaLonsoffeasibility,acceptabilityandeffecLveness

•  Weneedtheabilitytomeasurethepaceandqualityofscale-upthroughincorporaLonofdifferenLatedcaredataintoexisLnginformaLonsystems,yetalsoneedspecialstudieswherethisisnotyetpossible

•  StudiesareneededtoassesswhetherthebroaderhopesfordifferenLatedcare(reducedpaLentcosts,simplicity,sLgma,systemscosts,etc)arerealizedwhentakentoscale

Acknowledgements •  ThankstotheCIDRZstaff,

managementandBoardofDirectors

•  ThankstotheGovernmentoftheRepublicofZambia

•  ThankstoourresearchandprogramgroupsthathavecreatedanelectricintellectualenvironmentthatcloselylinkedtoadvancingtheneedsofthoseservedbyindividualslivingwithHIV

•  ElvinGeng•  IzukanjiSikazwe•  CarolynBolton-Moore•  KombatendeSikombe•  MpandeMukumbwa-

Mwenechanya•  NancyCzaicki•  JakePry•  CrispinMoyo

•  PaulSomwe•  AriannaZanolini•  AalokeMody•  MwanzawaMwanza•  LauraBeres•  StephTopp

•  ChandaMwamba•  CardinalHantuba•  AnjaliSharma•  TheaSavory•  MonikaRoy•  NancyPadian•  TaniaTembo•  HojoonSohn•  DavidDowdy•  Andmanyothers..•  Thankstoothercolleagues

whohavebeenleadersinthisfieldwhosethinkinghasinfluencedthiswork:

•  MSF,MargaretPrustandElizabethMcCarthy/CHAI,NathanFord/WHO,PeterEhrenkranzandGeoffGarne`/BMGF,MiriamRabkin/ICAP

•  Thankyoutoourfunders/partners

•  CDC•  PEPFAR•  BillandMelindaGates

FoundaLon•  NaLonalInsLtutesof

Health