Guidelines for Improving Entry Into and Retention Guidelines for Improving Entry Into and Retention in Care and ARV Adherence for Persons with in Care and ARV Adherence for Persons with HIV:  Evidence, Implications for Practice and HIV:  Evidence, Implications for Practice and

Resources for ImplementationResources for Implementation

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Webinar Agenda

Introduction to the Guidelines Melanie A Thompson, MD, AIDS Research Consortium of

Atlanta, Atlanta, Georgia

Monitoring Entry, Retention, and ART Adherence Robert Gross, MD MSCE, Associate Professor of Medicine (ID)

and Epidemiology, University of Pennsylvania Perelman School of Medicine

Interventions to Improve Engagement in HIV Care Michael J. Mugavero, MD, MHS, Associate Professor of

Medicine, University of Alabama at Birmingham

AETC National Resource Center, www.aidsetc.org

June 5, 2012 www.annals.org

Quality of Body of Evidence

Interpretation

Excellent (I) RCT evidence without important limitationsOverwhelming evidence from observational studies

High (II) RCT evidence with important limitationsStrong evidence from observational studies

Medium (III) RCT evidence with critical limitationsObservational study evidence without important limitations

Low (IV) Observational study evidence with important or critical limitations

Strength of Recommendation

Strong (A) Almost all patients should receive the recommended course of action.

Moderate (B) Most patients should receive the recommended course of action. However, other choices may be appropriate for some patients.

Optional (C) There may be consideration for this recommendation on the basis of individual patient circumstances. Not recommended routinely.

Monitoring Entry, Retention, Monitoring Entry, Retention,

and ART Adherenceand ART Adherence

Robert Gross, MD MSCERobert Gross, MD MSCEAssociate Professor of Associate Professor of

Medicine (ID) and EpidemiologyMedicine (ID) and Epidemiology

University of Pennsylvania University of Pennsylvania Perelman School of MedicinePerelman School of Medicine

PennPennInfectious DiseasesInfectious Diseases

CCEBCCEB

Monitoring OverviewMonitoring Overview

• Most research on adherenceMost research on adherence

• Entry and retention have Entry and retention have emerged as highly importantemerged as highly important–Less data available on “how to”Less data available on “how to”

–More local logistics come into playMore local logistics come into play

• Overarching messageOverarching message–““Monitoring provides key data on Monitoring provides key data on

which patients need interventions”which patients need interventions”

Entry MonitoringEntry Monitoring

• Systematic monitoring of entry Systematic monitoring of entry into care for all HIV+ (IIA)into care for all HIV+ (IIA)–associated with survivalassociated with survival

• Monitoring challengeMonitoring challenge–Multiple sources of data (e.g., Multiple sources of data (e.g.,

dedicated testing sites, clinics)dedicated testing sites, clinics)

–Responsible parties need to be Responsible parties need to be identified and logistics arranged identified and logistics arranged

Retention MonitoringRetention Monitoring

• Systematic monitoring of retention of all Systematic monitoring of retention of all HIV+ in care (IIA)HIV+ in care (IIA)– Decreased morbidity/mortalityDecreased morbidity/mortality– Decreased community viral loadDecreased community viral load

• Various metrics usedVarious metrics used– Visit adherence, gaps in care, visits per Visit adherence, gaps in care, visits per

time frametime frame

• Logistics easier than for entryLogistics easier than for entry– Use medical records and admin dataUse medical records and admin data– May require integration of sources May require integration of sources

Adherence VignetteAdherence Vignette

• 45 y.o. HIV infected man45 y.o. HIV infected man–Philadelphia VAMCPhiladelphia VAMC

–Serial monoRx in 90s, then HAARTSerial monoRx in 90s, then HAART

–Excellent adherence, but multiple Excellent adherence, but multiple resistance mutations acquiredresistance mutations acquired

–CD4=0 (0%) x 3 yearsCD4=0 (0%) x 3 years

• New regimenNew regimen–DRV/r in combination therapyDRV/r in combination therapy

–VL <50 copies/ml, CD4~300cells/mmVL <50 copies/ml, CD4~300cells/mm33

Why Monitor?Why Monitor?

• Follow-up visitFollow-up visit–UDVL UDVL

–Queried re: adherence Queried re: adherence as alwaysas always

–Had stopped meds entirely for 3 wks!Had stopped meds entirely for 3 wks!

–New onset depressionNew onset depression

–Depression/non-adherence overcomeDepression/non-adherence overcome

–Resumed adherence and no Resumed adherence and no subsequent virologic failuresubsequent virologic failure

Need for Continued MonitoringNeed for Continued Monitoring

• Can detect impending failureCan detect impending failure– Irrespective of viral load monitoring Irrespective of viral load monitoring

(Bisson G, Gross R, et al. PLoS Med 2008)(Bisson G, Gross R, et al. PLoS Med 2008)

• Ability to intervene before failureAbility to intervene before failure

• Same principles likely apply to Same principles likely apply to entry and retention in careentry and retention in care

MonMonitoriitoring ng

RecRecomom

menmendatidationsons

• Assess adherence each visitAssess adherence each visit–Self-report (IIA)Self-report (IIA)

–Pharmacy refill data (IIB)Pharmacy refill data (IIB)

–Cannot recommend microelectronic Cannot recommend microelectronic monitors at this time (IC)monitors at this time (IC)

–Do not recommend drug Do not recommend drug concentrations at this time (IIIC)concentrations at this time (IIIC)

–Do not recommend routine pill counts Do not recommend routine pill counts (IIIC)(IIIC)

Self-ReportsSelf-Reports

• Must use non-judgmental toneMust use non-judgmental tone–Preamble admitting perfect Preamble admitting perfect

adherence unrealtistic, but desiredadherence unrealtistic, but desired

–Allow for honestyAllow for honesty

• Specify time period of recallSpecify time period of recall

• Multiple potential toolsMultiple potential tools–Choice of tool site specificChoice of tool site specific

Self-Report ExamplesSelf-Report Examples

• ACTG questionnaireACTG questionnaire–How many doses missed yesterday, 1, 2, How many doses missed yesterday, 1, 2,

and 3 days beforeand 3 days before

–How many doses missed over w/e?How many doses missed over w/e?

–When last dose missed?When last dose missed?

• Visual Analog ScaleVisual Analog Scale–Ask ~how many doses taken over past Ask ~how many doses taken over past

monthmonth

–Place X on graduated linePlace X on graduated line

Use of Pharmacy Refill DataUse of Pharmacy Refill Data

• Specify period of interestSpecify period of interest–Past 1, 2, 3 months for examplePast 1, 2, 3 months for example

–Cannot be shorter than length of days Cannot be shorter than length of days supplysupply

–Too long may be irrelevant dataToo long may be irrelevant data

• Ensure full data captureEnsure full data capture– If centralized pharmacy: simpleIf centralized pharmacy: simple

– If multiple commercial pharmacies: If multiple commercial pharmacies: logistically challenging, but doablelogistically challenging, but doable

Medication Possession RatioMedication Possession Ratio

Fourth Fourth fillfill} } }

First fillFirst fill Second Second fillfill

Third fillThird fill

First intervalFirst interval Second Second intervalinterval

Third intervalThird interval

Adherence metric: Adherence metric:

((ΣΣ interval days supply) interval days supply)//(4(4thth fill date-1 fill date-1stst fill fill date)date)

Time Time

Microelectronic monitorsMicroelectronic monitors

• Strongly associated with VLStrongly associated with VL–Can provide objective feedbackCan provide objective feedback

–Useful in interventionUseful in intervention

–Granular view of dose timing and daily Granular view of dose timing and daily takingtaking

• Logistical limitationsLogistical limitations–CumbersomeCumbersome

– Inconvenient (cannot pocket doses)Inconvenient (cannot pocket doses)

–CostCost

DruDrug g

ConConcentcentratirationsons

• Variable association with VLVariable association with VL–Some drugs strongly associatedSome drugs strongly associated

–Different pts on different drugsDifferent pts on different drugs

–Variability across drugs limits programmatic Variability across drugs limits programmatic utilityutility

• Logistical limitationsLogistical limitations–Need for specimens (blood, hair)Need for specimens (blood, hair)

–Need for sophisticated labNeed for sophisticated lab

–Turnaround timeTurnaround time

–CostCost

Pill CountsPill Counts

• Infrequent association with VLInfrequent association with VL–Yet commonly usedYet commonly used

–Demanding of staff timeDemanding of staff time

• Other valueOther value–Limits dispensing expensive drug if Limits dispensing expensive drug if

supply not usedsupply not used

–Can add information to pharmacy Can add information to pharmacy refill datarefill data

Michael J. Mugavero, MD, MHScAssociate Professor of Medicine

University of Alabama at BirminghamJanuary 16, 2013

Interventions to Interventions to Improve Engagement Improve Engagement

in HIV Carein HIV Care

Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618

HIV Treatment CascadeHIV Treatment Cascade

49%

21% Undiagnosed

Ulett et al. AIDS Pt Care STDS 2009;23:41-49, Mugavero et al. Clin Infect Dis 2011;52(S2).

12

3

Engagement in Care: 3 Engagement in Care: 3 ComponentsComponents

Factors associated w/ poor Factors associated w/ poor engagementengagement Younger age Female sex Racial / ethnic minority Lack of health insurance Mental illness Substance abuse Unmet needs for supportive services Passive referral to medical care HIV testing in non-medical setting

Keruly et al. AJPH 2002;92, Robbins et. al. JAIDS 2007;44, Giordano et al. Clin Infect Dis 2007;44, Mugavero et al. JAIDS 2009;50, Metsch et al. Clin Infect Dis 2008;47, Hall et al. JAIDS 2012;60, Hightow-Weidman et al. AIDS Pt Care and STDs 2011;S1:S31, Torian et al. Arch Intern Med 2008;168:1181

Implications of poor engagementImplications of poor engagement

Individual Level Delayed ART receipt & ART non-adherence Inferior CD4 count & viral load outcomes Emergence of HIV resistance mutations Increased risk for clinical events & mortality

Population Level Mediator of health care disparities Role in transmission

•Change in risk transmission behaviors

• Impact of ART in reducing transmission

Keruly et al. AJPH 2002;92, Robbins et. al. JAIDS 2007;44, Park et al. J Intern Med 2007;261, Giordano et al. Clin Infect Dis 2007;44, Mugavero et al. JAIDS 2009;50, Marks et al. AIDS 2006;20, Metsch et al. Clin Infect Dis 2008;47, Cohen et al. N Engl J Med 2011;365

Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618

COMMUNITYCOMMUNITY CLINICCLINIC

Thompson MA et al. Ann Intern Med 2012;156

37 Evidence-based recommendations 5 Recommendations for entry into & retention in

care Emphasis on special populations Recommendations for future research

Evidence-Based Recommendations:Evidence-Based Recommendations:Entry into and Retention in CareEntry into and Retention in Care

Systematic monitoring of entry into HIV care (IIA)

Systematic monitoring of retention in HIV care (IIA)

Brief, strengths-based case management for individuals with a new HIV diagnosis (IIB)

Intensive outreach for individuals not engaged within 6 months of a new HIV diagnosis (IIIC)

Use of peer or paraprofessional patient navigators (IIIC)

Thompson MA et al. Ann Intern Med 2012;156

Brief, strengths-based case management for Brief, strengths-based case management for individuals with a new HIV diagnosis (IIB)individuals with a new HIV diagnosis (IIB)

Gardner LI et al. AIDS 2005;19

CDC ARTAS: Multi-site RCT to test linkage case management (CM) vs. SOC to improve care entryEmpowerment & self efficacy Asks clients to identify internal strengths &

assetsUp to 5 CM contacts allowed in 90 days

78% linkage to care w/in 6 months in CM group vs. 60% in SOC group (P<0.01)

High (II): RCT evidence w/ limitations Strong evidence observational studies

Moderate (B):Most patients should receive Other choices may be appropriate for some

Intensive outreach for individuals not Intensive outreach for individuals not engaged in medical care w/in 6 mos of a engaged in medical care w/in 6 mos of a new diagnosis (IIIC)new diagnosis (IIIC) Recommendation based upon HRSA SPNS

initiative A series of observational studies with

comparators that measured behavioral and biological outcomes

Outreach recommendation based on 1 study (n=104)

Intensive outreach improved retention in care & HIV-1 RNA suppression in pts underserved by health system Youth, women, mental health, substance

abuse

Medium (III): RCT evidence w/ critical limitationsObservational evidence w/o limitations

Optional (C):Consideration on individual circumstances Not recommended routinely

Naar-King S et al. AIDS Patient Care STD. 2007;21 Suppl 1

Bradford JB et al. AIDS Patient Care STDS. 2007;21 Suppl 1

Recommendation based upon HRSA SPNS initiative A series of observational studies with

comparators that measured behavioral and biological outcomes

PN recommendation based on 4 studies (n>1100 pts)

PN increased retention in care from 64% to 79% and 50% increase in HIV-1 RNA suppression at 12 months

Use of peer or paraprofessional patient Use of peer or paraprofessional patient navigators (PN) may be considered (IIIC)navigators (PN) may be considered (IIIC)

Medium (III): RCT evidence w/ critical limitationsObservational evidence w/o limitations

Optional (C):Consideration on individual circumstances Not recommended routinely

National HIV/AIDS StrategyNational HIV/AIDS Strategy

Increase linkage to care w/in 3 months of Dx from 65% to

85%

Increase HIV serostatus

awareness from 79% to 90%

Increase RW clients

in continuous care from

73% to 80%

Increase proportion of HIV Dx’d persons

with undetectable VL by 20%

http://www.iom.edu/Reports/2012/Monitoring-HIV-Care-in-the-United-States.aspx

http://www.incarecampaign.org/

Coming soon…proposed areas of focus:

1. Compilation of a resource repository on entry into care, retention in care, and re-engagement in care

2. Development of a trainer toolkit to increase uptake of the evidence based interventions among Ryan White providers

3. Development of training tools that address engagement in care for special populations and psychosocial aspects of retaining patients

4. Development of tools to identify funding support for implementation of engagement in care activities that may include Ryan White, the Affordable Care Act, and Medicare/Medicaid

AETC Engagement in Care AETC Engagement in Care WorkgroupWorkgroup

February 2013 – January 2014February 2013 – January 2014

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