Guidelines for Improving Entry Into and Retention
in Care and ARV Adherence for Persons with
HIV: Evidence, Implications for Practice and
Resources 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 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.
Penn
Infectious Diseases
Monitoring Entry, Retention,
and ART Adherence
Robert Gross, MD MSCE
Associate Professor of
Medicine (ID) and Epidemiology
University of Pennsylvania
Perelman School of Medicine
CCEB
Monitoring Overview
• Most research on adherence
• Entry and retention have
emerged as highly important
–Less data available on “how to”
–More local logistics come into play
• Overarching message
–“Monitoring provides key data on
which patients need interventions”
Entry Monitoring
• Systematic monitoring of entry
into care for all HIV+ (IIA)
–associated with survival
• Monitoring 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)
–Decreased morbidity/mortality
–Decreased community viral load
• Various metrics used
–Visit adherence, gaps in care, visits
per time frame
• Logistics easier than for entry
–Use medical records and admin data
–May require integration of sources
Adherence Vignette
• 45 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 regimen
–DRV/r in combination therapy
–VL <50 copies/ml, CD4~300cells/mm3
Why Monitor?
• Follow-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 failure
–Irrespective of viral load monitoring
(Bisson G, Gross R, et al. PLoS Med 2008)
• Ability to intervene before failure
• Same principles likely apply to
entry and retention in care
Monitoring Recommendations
• Assess 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 tone
–Preamble admitting perfect
adherence unrealtistic, but desired
–Allow for honesty
• Specify time period of recall
• Multiple potential tools
–Choice of tool site specific
Self-Report Examples
• ACTG 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 Scale
–Ask ~how many doses taken over
past month
–Place X on graduated line
Use of Pharmacy Refill Data
• Specify 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 capture
–If centralized pharmacy: simple
–If multiple commercial pharmacies:
logistically challenging, but doable
Medication Possession Ratio
Time
First fill
Second fill
Third fill
Fourth fill
}
}
}
First interval
Second interval
Third interval
Adherence metric:
(Σ interval days supply)/(4th fill date-1st fill date)
Microelectronic monitors
• Strongly associated with VL
–Can provide objective feedback
–Useful in intervention
–Granular view of dose timing and
daily taking
• Logistical limitations
–Cumbersome
–Inconvenient (cannot pocket doses)
–Cost
Drug Concentrations
• Variable association with VL
–Some drugs strongly associated
–Different pts on different drugs
–Variability across drugs limits
programmatic utility
• Logistical limitations
–Need for specimens (blood, hair)
–Need for sophisticated lab
–Turnaround time
–Cost
Pill Counts
• Infrequent association with VL
–Yet commonly used
–Demanding of staff time
• Other value
–Limits dispensing expensive drug if
supply not used
–Can add information to pharmacy
refill data
Interventions to Improve
Engagement in HIV Care
Michael J. Mugavero, MD, MHSc
Associate Professor of Medicine
University of Alabama at Birmingham
January 16, 2013
HIV Treatment Cascade
21% Undiagnosed
49%
Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618
Engagement in Care: 3 Components
3
1
2
Ulett et al. AIDS Pt Care STDS 2009;23:41-49, Mugavero et al. Clin Infect Dis 2011;52(S2).
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
COMMUNITY
CLINIC
Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618
 37 Evidence-based recommendations
 5 Recommendations for entry into & retention in care
 Emphasis on special populations
 Recommendations for future research
Thompson MA et al. Ann Intern Med 2012;156
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)
 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
Gardner LI et al. AIDS 2005;19
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):
Optional (C):
RCT evidence w/ critical limitations
Consideration on individual circumstances
Observational evidence w/o limitations Not recommended routinely
Naar-King S et al. AIDS Patient Care STD. 2007;21 Suppl 1
Use of peer or paraprofessional patient navigators
(PN) may be considered (IIIC)
 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
Medium (III):
Optional (C):
RCT evidence w/ critical limitations
Consideration on individual circumstances
Observational evidence w/o limitations Not recommended routinely
Bradford JB et al. AIDS Patient Care STDS. 2007;21 Suppl 1
National HIV/AIDS Strategy
Increase HIV
serostatus
awareness from
79% to 90%
Increase linkage to
care w/in 3 months of
Dx from 65% to 85%
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/
AETC Engagement in Care Workgroup
February 2013 – January 2014
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
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