TechniquesandInterventionstoImproveAdherencetoHIVCare

AadiaRana,MDAssociateProfessorofMedicine

UABSchoolofMedicineAdvancedManagementIssuesinHIVCareConference

Cleveland,OhioSeptember13,2018

Acknowledgements

•  Conflictsofinterests:Nofinancialconflictsofinterest•  Acknowledgements:Dr.MichaelMugavero,Dr.JulieDombrowski

LearningObjectives

•  DefinetheNationalHIV/AIDSStrategyGoalsforlinkagetoandretentioninHIVmedicalcare

•  ReviewtheimportanceofretentioninHIVcare•  PresenttheepidemiologyoftheHIVCarecontinuum•  Reviewevidence-basedinterventionstoimprovelinkageto&retentionincare•  DescribewaysthatHIVclinicscanimproveretentioninHIVcare

TermsforthisPresentation

•  Engagementincare-anumbrellatermfortheongoingrelationshipbetweenapatientandacareprovider

•  Linkagetocare-completionofaninitialvisitwithanHIVmedicalproviderafterdiagnosis(aone-timeevent)

•  Retention-keepingpatientsincare

•  Relinkage-bringingpatientswhohavefallenoutofcarebacktoHIVmedicalcare

•  PLWH–peoplelivingwithHIV

AudiencePoll1

Towhatextentareyoucurrentlyworkingoninterventionstoimprovelinkagetoandretentionincareatyourclinic?•  Ourclinicdoesnothavelinkageandretentionactivities•  Iamawareoftheseactivitiesoccurringbutdonotworkonthem•  Iproduceorreviewdatawithateam•  Ihelpdetermineinterventions•  Iparticipateintheinterventions

NationalHIV/AIDSStrategyTargets

•  IncreasethepercentageofnewlydiagnosedpersonslinkedtoHIVmedicalcarewithinonemonthoftheirHIVdiagnosisto85%

•  IncreasethepercentageofpersonswithdiagnosedHIVwhoareretainedinmedicalcaretoatleast90%

•  IncreasethepercentageofpersonswithdiagnosedHIVinfectionwhoarevirallysuppressedtoatleast80%

Source:CDC.HIVSurveillanceReport.SupplementalReport.2017;22(2)

EngagementinCareisDynamic

Powersetal,LongitudinalHIVCareTrajectoriesinNorthCarolinaJAIDS2017;74(S2)

“Consistently High” (26%)

“Steadily Declining” (16%)

“Consistently Low” (26%)

“Early Increasing” (17%)

“Late Increasing” (15%)

WhyisRetentioninCareimportant?

SuccessofHIVTreatment

57% Reduced Risk of Death or Serious Events with Immediate Therapy

INSIGHTSTARTStudyGroup,InitiationofAntiretroviralTherapyinEarlyAsymptomaticHIVInfection.NEJM2015RodgerAetal,SexualActivityWithoutCondomsandRiskofHIVTransmissioninSerodifferentCouplesWhentheHIV-PositivePartnerIsUsingSuppressiveAntiretroviralTherapy2016;316(2):171-181.

ImplicationsofMissedHIVMedicalCareVisits

PLWH initiating outpatient HIV medical care at UAB Clinic, 2000 – 2005 (N=543)

Characteristic HR (95%CI)a “No show” visit in 1st year 2.90 (1.28- 6.56) Age (HR per 10 years) 1.58 (1.12-2.22) CD4 count <200 cells/mL 2.70 (1.00-7.30) Log10 plasma HIV RNA 1.02 (0.75-1.39) ART started in 1st year 0.64 (0.25-1.62)

a Cox proportional hazards (PH) analysis also adjusts for sex, race/ethnicity, insurance, affective mental health disorder, alcohol abuse, and substance abuse.

Missed HIV medical care visits associated with: •  Delayed ART initiation

•  Poor retention in care

•  Longer time to VS

•  Greater cumulative VL burden (viremia copy-years)

•  Racial disparities in VS

•  Declines in CD4 count •  Inpatient hospitalization

•  Mortality

MugaveroM,etalCID2014;Horberg2013;Colubi,2012 Mugaveroetal.ClinInfectDis2009;48

ImportanceofNo-ShowVisits

No-showvisitsareanindependentpredictorofmortality

MugaveroM,etalCID2014

RetainedincarebyDHHScoreindicator(N=2166)

NotretainedincarebyDHHScoreindicator(N=1506)

Skarbinskietal.JAMAInternMed2015;175

WhoisatriskforpoorRetentioninCare?

AssessingBarrierstoCareandTreatment

AdherenceDemographics

SubstanceUse

MentalHealth

Poverty

Stigma

Forgetting!

MedicationSideEffects

Predictorsforlowerretention

Bulsara,etal;AIDSBehav2016 345studiesreviewed,30included

PersonsLivingwithDiagnosedorUndiagnosedHIVInfection,HIVCareContinuumOutcomes,

2014

Source:CDC.HIVSurveillanceReport.SupplementalReport.2017;22(2)

AudiencePoll2• 22year-oldmantestsHIV+atahealthfairboothhostedbyalocalAIDSServiceorganization

• Hehasnoinsuranceorprimarycaredoctor

• Assuminghelinkstomedicalcarethroughstandardproceduresinyourarea,howmanypeoplewillhebeaskedtotalkwithbeforehemeetshisHIVmedicalprovider?

1.  One

2.  Two

3.  Threeormore

4.  Dependsonwhereheisdiagnosed

5.  Idon’tknow

ModelsofLinkagetoCare48hoursto≥6weeks

+HIVTest

+HIVTest

+HIVTest

PartnerServicesInterview

LinkageAssistance& PartnerServices

Interview

MedicalVisit EligibilityAssessment

LinkageAssistance

MedicalVisit

CaseManagementIntake

CENTRALELIGIBILITY

LinkageAssistance

PartnerServicesInterview

MedicalVisit EligibilityAssessment

+/-Casemanagement

intake

Wecannotconcludethatpatients“aren’tready”toengageinHIVcareiftheprocesstogetcareistoocomplicated

SlidecourtesyJulieDombrowskiMD

AudiencePoll3

▪  Whatisthewaittimeforanewpatientappointmentinyourclinic?

• (or,ifyoudonotworkinaclinic,fortheaverageclinicinyourarea)

1.  <1week2.  1-2weeks3.  2-4weeks4.  >4weeks

TheValueofNewPatientOrientation:ProjectCONNECT

•  Within5daysofcallingtoschedulefirstappointment

•  Questionnaire•  Baselinelabtesting•  Socialworker•  Prophylacticmeds

•  Mentalhealthandsubstanceabusereferrals

•  Clinicnoshowrate31%→16%

Sources:MugaveroMJ,etal.TopHIVMed.2008;16:156-61; UABwebsite:http://www.uab.edu/medicine/1917clinic/becoming-a-new-patient

SanFranciscoRAPID:SameDayARTInitiation

PilcherC,etal;JAIDS,2017;74,2RosenS,etal.PLoSMed2016;13(5),3KoenigS,etal.PLoSMed2017;14(7)

TimefromHIVDxto:

SOC(n=47)

RAPID(n=39)

ART 22(14-48) 1(0-7) Clinicreferral 11(3-4) 6(2-11) VL<200c/mL 170(79-363) 65(52-119)

Prospectivecohort(consecutiveptswithnewHIVdiagnosis,2013-2014). Same-dayARTinitiationcohort:ptswithacuteorrecentinfection(<6months)orCD4<200cells/mm3. GlobalrapidARTstarttrials: RapITRCT(n=377,SouthAfrica):RR1.36(95%CI:1.24,1.49)forART,1.26(1.05,1.50)forVSw/rapidARTinitiation2 GHESKIOCentersRCT(n=703,Haiti):improved12-moincarew/VS(53%vs44%,p=0.008)andmortality(3%vs6%,p=0.03)insamedayARTgroup3

AtlantaRapidEntryandARTClinicforHIV(REACH)pilotprogram

DaysfromHIVDxto:

Pre-Reach(n=117)

Post-Reach(n=90)

p

ART 22(13,38) 4(1,6) <0.0001 Clinicreferral 12(6,23) 2(1,4) <0.0001

VL<200c/mL 67(34,126) 41(21,72) <0.0001

Adjustedforage,race,gender,andARTnaive

Colasantietal.CROIMarch2018.Poster#1109

SuggestionstoImproveLinkagetoCare

1.  Eligibilitydeterminationshouldbeintegratedintoclinicswhereverpossible

2.  Allowpatientstoaccesscasemanagersbeforemedicalproviderstoaddressbarrierstoattendingclinic

3.  Implementanorientationvisitifmedicalprovidernotavailableinshorttime(5-7days)

4.  ConsiderationforaSameDay/RapidStartARTprogram

5.  Set-upaformalsystemtoaddressnewpatientno-shows-Differentthanroutinereschedulingoradministrativecall-Seekoutandengagethepatient

AudiencePoll4•  Your22yolinkedtolocalRWclinicandobtainedaprescriptionforARTthroughADAP

• Hehasbeendepressedsincehisdiagnosisandhasnotdisclosedtoanyone,norisheouttohisfamily

• Heoccasionallyusescrystalmethbut‘onlywhenhewantstohaveagoodtime’ontheweekends

• HedoesnotanticipateanybarrierstotakinghisART.Hehasnevertakenmedicationsregularlypriortothis.

Whatservicescouldhebelinkedtoinyourareathatcouldsupporthisadherencetocareandtreatment? 1.  Casemanagement 2.  Mentalhealthcounseling 3.  Patientnavigators

4.  Substanceuseprograms

5.  LGBTQfriendlyclinic

6.  Someoftheabove

7.  Alloftheabove

8.  Idon’tknow

9.  Hedoesn’tneedanyservices

Addressingbarrierstoretention

•  Substanceuse:AA/NA,MAT,casemanagement

•  Demographics:youth,LGBTQ,andPOC-friendlyaccess

•  Physicalhealth:treatHCV,pain,comorbidities

•  MentalHealth:integratebehavioralhealth

•  Support:navigateinsurance,transport,childcare

•  Healthbeliefs:addressstigmaandbias,cultivateempathy,trauma-informedandstrengths-basedcare,ARTAS,MotivationalInterviewing

Low-Effort,Clinic-WideInterventiontoImproveAttendancewithHIVPrimaryCare

•  SixHIV-specialtyclinicsparticipatedinacross-sectionallysampledpretest-posttestevaluationofbrochures,posters,andmessagesthatconveyedtheimportanceofregularclinicattendance

•  Clinicattendanceforprimarycarewassignificantlyhigherintheinterventionversuspreintervention

Gardneretal.CID2012

We have good evidence that people with HIV who come to their appointments do better than those who don’t. When you miss your appointments, we can’t work together to keep you healthy. Thank you for doing such a good job of keeping your appointments. It makes it easier for all of us to work together to keep you healthy.

Sample Messages:SampleMessages:

“WehavegoodevidencethatpeoplewithHIVwhocometotheirappointmentsdobetterthanthosewhodon’t.When youmissyourappointments,wecan’tworktogethertokeepyouhealthy.”

“Thankyoufordoingsuchagoodjobofkeepingyourappointments.Itmakesiteasierforallofustoworktogethertokeepyouhealthy.”

CDC/HRSAREPCEfficaciousforHIVCareEngagement

GardnerLIetal.ClinInfectDis2014;59;ShresthaRKetal.JAIDS2015;68 SlidecourtesyMichaelMugavero

•  RCTat6HIVclinics

•  N=1838

•  3studyarms(1:1:1) *EnhancedContact(EC) *EC+skills(EC+) *SOC

•  Outcomes@12-months: *Visitadherence

*4-monthvisitconstancy

•  EC&EC+superiortoSOC

•  Efficacyinsubgroups

•  Notefficaciouswithyouth,substanceuse,unmetneeds

ProjectHOPETrial–RCTin11Hospitals

Metschetal,JAMA2016

HIV+adultsadmittedtothehospital •  VL>200&CD4<500

•  Substanceuse

Navigationintervention

Navigationintervention+

Financialincentives

Treatmentasusual

EffectofPatientNavigation+/-FinancialIncentivesonViralSuppressionamongHospitalizedPatientswithHIV&SubstanceUse

ProjectHopeRCT

p=0.30

p=0.03

p=0.81

p=0.70

MetschLR,etal,JAMA2016

%ofp

articipantswith

VL<200

OpenArmsCenterinJackson,MS

Source:CourtneySims(UMMC)

SuggestionstoImproveRetentiontoCare•  Ongoingassessmentsofbarrierstocare

•  Systematicidentificationofthoseathighestriskofdisengagement–missedvisits

•  Integrationofmentalhealth,substanceuse,navigationandsupportservicesintoclinicalcare

TheProvider’sRoleinRetentioninCare

•  Ongoingassessmentofpotentialbarrierstocare

•  “Whatcanwedotomakethiseasierorbetterforyou?”

•  Connectiontoservicesforcurrentoranticipatedbarriers.

•  PositiveMessagingforstayingconnected

•  InquireaboutbarriersMakeaconcreteplantoaddressthebarriers

RelinkagetoCare:BeyondtheClinic

AudiencePoll5

• Yourpatientattended2visitsintheyearafterhisdiagnosisbuthasnowmissedallofhisscheduledandrescheduledvisitsforthepast12months

• Hisphonenumberisdisconnectedandnoalternativecontactsarelisted

• Whatdoyoudonow?

1.  Keepcalling,maybehejustranoutofminutes

2.  Mailacertifiedletter

3.  Seeifyoucanstalkhimonsocialmedia

4.  Somepeoplejustaren’treadyforcare

5.  OutreachfromCommunityBasedOrganizations

6.  HealthDepartmentprograms?

7.  Someoftheabove

8.  Alloftheabove

DatatoCare

•  LaboratoriesreportCD4&VLresultstothehealthdepartmentinmostU.S.states

•  HealthdepartmentscanuseHIVsurveillancedatatomonitorthecontinuum&todirectinterventionstoimprovethecontinuum

•  CDCnowencouragesallhealthdepartmentstoimplementa“DatatoCare”strategy

•  Usessurveillancedatatoidentify&re-engageout-of-carePLWH

•  Mayormaynotinvolvecoordinationwithmedicalproviders

Effectiveinterventions.org

ExamplesofDatatoCarePrograms

HealthDepartment

HIVClinic Patient

HealthDepartment HIVClinic

Check-in

Datain

Databack

Patient

HealthDepartment Patient

1.

2.

3.

Withmostcurrentrelinkagetocareefforts,weareworkingtoreturnpatientsbacktothesamesystemthatfailedtoengagetheminthefirstplace.

Forthehardest-to-reachpatients,canwechangethestructureofcareweoffer?

TheMaxClinic:MedicalCareDesignedtoEngagetheHardest-to-ReachPersonsLiving

withHIVinSeattleandKingCounty,Washington

Dombrowskietal.AIDSPatientCareandSTDs.2018Apr;32(4):149-156.

Identification of Potential MAX Patients

Case Coordinators [Disease Intervention Specialists (DIS)] •  Intensive support & outreach •  Single point of contact for patients & providers •  Calls, text messages •  Meet patients in hospital, clinic, home, or jail

•  Walk-in medical care, 5 afternoons per week (in STD Clinic) •  Snacks and meal vouchers (each visit, up to once weekly) •  Cell phones and bus passes (contingent renewal) •  Cash incentives (q2 months)

•  $25 for visit + lab draw •  $100 for suppressed VL & 1x bonus for 3 in a row ($100)

Enrollment of Patients in MAX Clinic

Dombrowskietal.AIDSPatientCareandSTDs.2018Apr;32(4):149-156.

SuggestionstoImproveRe-linkagetoCare•  Designateastaffpersontore-engagepatientsincare

•  Systematicallyidentifypoorlyengagedpatients•  Calltocheckin,scheduleappointment,coordinatewithCM

•  Takereferralsfromproviders&CMforoutreach

•  Ifyourclinichascapacity,considersettingupspecialproceduresforthehardest-to-reachpatients

• Walk-incare•  Intensivecasemanagementandoutreachsupport•  ConsideropportunitiestoworkwithHD

TheProvider’sRoleinRelinkagetoCare

•  Assessthepatient’sperceptionofthetime“outofcare”

•  Inquireaboutbarriers(withattentiontohealthcaresystembarriers)

•  “Whatcanwedotomakethiseasierorbetterforyou?”

•  Makeaconcreteplantoaddressthebarriers

•  ConsiderationforrestartingARTiskey

•  Don’tcreatetoohighathreshold

UnansweredQuestions&AreasforFutureWork•  Roleoflong-actinginjectableantiretrovirals

•  Effectivenessoftargetedincentives

•  Roleofcommunityhealthworkers

•  Novelservicedeliverymodels

CouldLAARThavearoleinaddressingsomeofthesebarriers?

• Directly-ObservedTherapy• Intolerantoforalmedications• CompetingResponsibilities• Stigma

•  AtthebeginningIthought…OhmyGod…IhopeIgetoverthisdepression.But,myGod…IhopeIwon’tbetakingthesepillsallmylife.ThenIwentontotheinjectablephase…anditwaslikeIsawthelight.AndIsaid,God…howeasyandconvenientthisis.Itwaslikeseeingthelight.-Spain,Maletrialparticipant

•  IloveitbecauseIdon'thavetotakeadailymedication,sothat'sjustonelessthingonmyplatethatIhavetoworryabout…Idefinitelyfeelthere'slesspressure.Iliketheinjectionbecauseit'snotadaily,inmyface,Ihavetodothis.–U.S.,Femaletrialparticipant-

•  Inreality,takingthepilleverydaykeepsit[HIV]present…andtheshotisjustonceamonth…yourememberitwhenyoucomeinandtherestofthetimeyoucanbasicallyforgetit.–Spain,Maletrialparticipant

KerriganDetal.ExperienceswithLAART:AqualitativestudyamongPLHIVparticipatinginLatte-2intheUSandSpain.PLOSOne.2018.

ACTG5359APhaseIIIRandomized-ControlTrialtoEvaluate

Long-ActingAntiretroviralTherapyinNon-adherentHIV-InfectedIndividuals

Co-Chairs:AadiaRana,JoseCastillo-MancillaCo-ViceChairs:RaphaelJ.Landovitz,KarenTashima Investigators: OmarGalárraga(BehavioralEconomist),MichaelStirratt(NIMH),SteveShoptaw(NIDA),DavidWohl

•  ART-experienced,HIV-infectedmalesandnon-pregnantfemales≥18yearsofagewith:•  HIV-1RNA>200copies/mL •  Evidenceofnon-adherenceaccordingtoatleastoneofthefollowingcriteria:

•  Poorvirologicresponsewithin18monthspriortostudyentry(definedas<1log10decreaseinHIV-1RNAorHIV-1RNA>200copies/mLattwotimepointsatleast4weeksapart)inindividualswhohavebeenprescribedARTforatleast6consecutivemonths.

•  Losstoclinicalfollow-upwithin18monthspriortostudyentrywithARTnon-adherencefor≥6consecutivemonths.Losttoclinicalfollow-upisdefinedaseithernocontactwithproviderormissed2ormoreappointmentsina6-monthperiod.ARTnon-adherenceisdefinedasalapseinART≥7days(consecutiveornon-consecutive),inthe6-monthperiodwheretheywerelosttoclinicalfollow-upperparticipantreport.

•  NoevidenceofanyclinicallyrelevantRPVorINSTIresistance-associatedmutations(historicallyoruponscreening).

•  Abilityofsiteclinician,inconjunctionwithparticipant,toconstructa≥3-drugARTregimenwith≥2drugspredictedtobefullyactive,includingaboostedPI/cobiand/oranINSTI.

DataforCareAlabama(D4CAL)7RyanWhiteClinicsinAlabama

|7daysprior|1-3daysprior|Atmedicalvisit|MedicalvisitMISSED|

StayConnected

EPC:LRC*

1-2MissedVisits(MediumRisk)

EPC:FrontDeskorLRC*forinitialvisits

EPCwithin2daysbyLRC*+Healthcareteam

|7daysprior|1-3daysprior|Atmedicalvisit|MedicalvisitMISSED|

EPC:FrontDeskorLRC*forinitialvisits

≥3MissedVisits(HighRisk)

EPC:LRC*;SocialWorkerforpatientsonICM**

StayConnected

EPCwithin2daysbyLRC*+Healthcareteam

*LRC=Linkage&RetentionCoordinator **IntensiveCaseManagement

KeyTakeaways

•  NHASgoalby2020=85%linkedtocarewithin1month

•  RyanWhiteeligibilitydeterminationshouldbeintegratedintoclinicswhereverpossible

•  Orientationvisitswithlabscanhelpfacilitatelinkagetocare•  ConsiderationforRapidStart/SameDayStartprogram

•  Assessingandaddressingrisksforpoorretentionincareshouldbeongoingandintegratedintoclinicalcare.

•  Collaborationbetweenclinicsandhealthdepartmentscanwork

•  Implementsystematicretentionandre-engagementprocedures

•  Considernovelservicedeliveryforthehardest-to-reachpatients

Resources▪  Bulsara,etal;AIDSBehav2016▪  CDC.Compendiumofevidence-basedinterventionsandbestpracticesforHIVprevention.Centersfor

DiseaseControlandPrevention.http://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html.

▪  CDC.HIVSurveillanceReport.SupplementalReport.2017;22(2)▪  Colasantietal.CROIMarch2018.Poster#1109▪  Dombrowskietal.AIDSPatientCareandSTDs.2018Apr;32(4):149-156.▪  Effectiveinterventions.org▪  Gardneretal.CID2012▪  GardnerLIetal.ClinInfectDis2014;59;ShresthaRKetal.JAIDS2015;68▪  INSIGHTSTARTStudyGroup,InitiationofAntiretroviralTherapyinEarlyAsymptomaticHIVInfection.

NEJM2015373(9):795-807▪  KoenigS,etal.PLoSMed2017;14(7)▪  Metschetal,JAMA2016▪  Mugaveroetal.ClinInfectDis2009;48▪  MugaveroM,etalCID2014;Horberg2013;Colubi,2012▪  MugaveroMJ,etal.TopHIVMed.2008;16:156-61;▪  PilcherC,etal;JAIDS,2017;74▪  Powersetal,LongitudinalHIVCareTrajectoriesinNorthCarolinaJAIDS2017;74(S2)▪  RodgerAetal,SexualActivityWithoutCondomsandRiskofHIVTransmissioninSerodifferentCouples

WhentheHIV-PositivePartnerIsUsingSuppressiveAntiretroviralTherapy2016;316(2):171-181.▪  RosenS,etal.PLoSMed2016;13(5)▪  Skarbinskietal.JAMAInternMed2015;175