Guidelines for Improving Entry Into and Retention in Care and ARV Adherence for Persons with HIV: Evidence, Implications for Practice and Resources for Implementation Welcome! The webinar will begin at 3:00 p.m. ET/2 p.m. CT/1 p.m. MT/12 p.m. PT To join by phone: Enter participant Code: #

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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,

June 5,

Quality of Body of Evidence Interpretation Excellent (I) RCT evidence without important limitations Overwhelming evidence from observational studies High (II) RCT evidence with important limitations Strong evidence from observational studies Medium (III) RCT evidence with critical limitations Observational 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, and ART Adherence Robert Gross, MD MSCE Associate Professor of Medicine (ID) and Epidemiology University of Pennsylvania Perelman School of Medicine Penn Infectious Diseases CCEB

Monitoring Overview Most research on adherenceMost research on adherence Entry and retention have emerged as highly importantEntry and retention have emerged as highly important –Less data available on “how to” –More local logistics come into play Overarching messageOverarching message –“Monitoring provides key data on which patients need interventions”

Entry Monitoring Systematic monitoring of entry into care for all HIV+ (IIA)Systematic monitoring of entry into care for all HIV+ (IIA) –associated with survival Monitoring challengeMonitoring challenge –Multiple sources of data (e.g., dedicated testing sites, clinics) –Responsible parties need to be identified and logistics arranged

Retention Monitoring Systematic monitoring of retention of all HIV+ in care (IIA)Systematic monitoring of retention of all HIV+ in care (IIA) –Decreased morbidity/mortality –Decreased community viral load Various metrics usedVarious metrics used –Visit adherence, gaps in care, visits per time frame Logistics easier than for entryLogistics easier than for entry –Use medical records and admin data –May require integration of sources

Adherence Vignette 45 y.o. HIV infected man45 y.o. HIV infected man –Philadelphia VAMC –Serial monoRx in 90s, then HAART –Excellent adherence, but multiple resistance mutations acquired –CD4=0 (0%) x 3 years New regimenNew regimen –DRV/r in combination therapy –VL <50 copies/ml, CD4~300cells/mm 3

Why Monitor? Follow-up visitFollow-up visit –UDVL –Queried re: adherence as always –Had stopped meds entirely for 3 wks! –New onset depression –Depression/non-adherence overcome –Resumed adherence and no subsequent virologic failure

Need for Continued Monitoring Can detect impending failureCan detect impending failure –Irrespective of viral load monitoring (Bisson G, Gross R, et al. PLoS Med 2008) Ability to intervene before failureAbility to intervene before failure Same principles likely apply to entry and retention in careSame principles likely apply to entry and retention in care

Monitoring Recommendations Assess adherence each visitAssess adherence each visit –Self-report (IIA) –Pharmacy refill data (IIB) –Cannot recommend microelectronic monitors at this time (IC) –Do not recommend drug concentrations at this time (IIIC) –Do not recommend routine pill counts (IIIC)

Self-Reports Must use non-judgmental toneMust use non-judgmental tone –Preamble admitting perfect adherence unrealtistic, but desired –Allow for honesty Specify time period of recallSpecify time period of recall Multiple potential toolsMultiple potential tools –Choice of tool site specific

Self-Report Examples ACTG questionnaireACTG questionnaire –How many doses missed yesterday, 1, 2, and 3 days before –How many doses missed over w/e? –When last dose missed? Visual Analog ScaleVisual Analog Scale –Ask ~how many doses taken over past month –Place X on graduated line

Use of Pharmacy Refill Data Specify period of interestSpecify period of interest –Past 1, 2, 3 months for example –Cannot be shorter than length of days supply –Too long may be irrelevant data Ensure full data captureEnsure full data capture –If centralized pharmacy: simple –If multiple commercial pharmacies: logistically challenging, but doable

Medication Possession Ratio Fourth fill }}} First fill Second fill Third fill First interval Second interval Third interval Adherence metric: ( Σ interval days supply) / (4 th fill date-1 st fill date) Time

Microelectronic monitors Strongly associated with VLStrongly associated with VL –Can provide objective feedback –Useful in intervention –Granular view of dose timing and daily taking Logistical limitationsLogistical limitations –Cumbersome –Inconvenient (cannot pocket doses) –Cost

Drug Concentrations Variable association with VLVariable association with VL –Some drugs strongly associated –Different pts on different drugs –Variability across drugs limits programmatic utility Logistical limitationsLogistical limitations –Need for specimens (blood, hair) –Need for sophisticated lab –Turnaround time –Cost

Pill Counts Infrequent association with VLInfrequent association with VL –Yet commonly used –Demanding of staff time Other valueOther value –Limits dispensing expensive drug if supply not used –Can add information to pharmacy refill data

Michael J. Mugavero, MD, MHSc Associate Professor of Medicine University of Alabama at Birmingham January 16, 2013 Interventions to Improve Engagement in HIV Care

Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618 HIV 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) Engagement in Care: 3 Components

Factors associated w/ poor engagement 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 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 COMMUNITY CLINIC

Thompson MA et al. Ann Intern Med 2012; Evidence-based recommendations  5 Recommendations for entry into & retention in care  Emphasis on special populations  Recommendations for future research

Evidence-Based Recommendations: Entry 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 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 entry  Empowerment & self efficacy  Asks clients to identify internal strengths & assets  Up 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 engaged in medical care w/in 6 mos of a 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 limitations Observational 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 navigators (PN) may be considered (IIIC) Medium (III): RCT evidence w/ critical limitations Observational evidence w/o limitations Optional (C): Consideration on individual circumstances Not recommended routinely

National 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%

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 Workgroup February 2013 – January 2014

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