Transcript Slide 1

in+care Campaign
Meet the Author
September 19, 2012
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Agenda
• Welcome & Introductions, 5min
• IAPAC Guidelines, 30min
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Introduction to the Guidelines - Melanie Thompson, MD
Monitoring - Robert Gross, MD
Interventions for Entry/Retention - Michael Mugavero, MD
Recommendations for Special Populations - Victoria Cargill, MD
• Q & A Session, 20min
• Updates & Reminders, 5min
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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
• Entry into care shortly after dx
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
• Retention has multiple benefits
–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
Need for Continued Monitoring
• Can detect impending failure
–Irrespective of viral load monitoring
(e.g., Bisson G, Gross R et al. PLoS
Med 2008)
• Intervention before failure
• Same principles likely for
entry and retention in care
Monitoring Recommendations
• Assess adherence each visit
–Self-report (II A)
–Pharmacy refill data (MPR) (II B)
–Do not recommend microelectronic
monitors at this time (I C)
–Do not recommend drug
concentrations at this time (III C)
–Do not recommend routine pill
counts (III C)
RECOMMENDATIONS:
ENTRY INTO AND RETENTION IN CARE
Michael J. Mugavero, MD, MHSc
University of Alabama at Birmingham
www.iapac.org
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
RECOMMENDATIONS:
ENTRY INTO/RETENTION IN CARE
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Systematic monitoring of successful entry into HIV care is
recommended for all individuals diagnosed with HIV (IIA)
Systematic monitoring of retention in HIV care is
recommended for all patients (IIA)
Brief, strengths-based case management for individuals with
a new HIV diagnosis is recommended (IIB)
Intensive outreach for individuals not engaged in medical
care within 6 months of a new HIV diagnosis may be
considered (IIIC)
Use of peer or paraprofessional patient navigators may be
considered (IIIC)
www.iapac.org
Brief, strengths-based case management for individuals
with a new HIV diagnosis is recommended (IIB)
 CDC ARTAS1: Multi-site RCT to test a case management (CM)
intervention vs. SOC to improve linkage to care
 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):
Moderate (B):
RCT evidence w/ limitations
Most patients should receive
Strong evidence from observational studies Other choices may be appropriate for some
1Gardner
LI et al. AIDS 2005;19
www.iapac.org
Brief, strengths-based case management for individuals
with a new HIV diagnosis is recommended (IIB)
 CDC ARTAS II1: 79% effect size for LTC w/in 6 months
 Health departments and CBOs
 Structural factors & best practices for implementation2
 LTC implementation w/ HIV testing in non-clinical settings3
 Key characteristics, Core components, Operational factors
 Barriers: System/Community, Organizational,
Clinician/Staff, Individual/Client
1Craw
JA et al. J Acquir Immune Defic Syndr. 2008;47, 2Craw JA et al. BMC Health Serv Res. 2010;10 , 3 Gilman B et al. AIDS
Patient Care STDS. 2012;26
www.iapac.org
Intensive outreach for individuals not engaged in medical
care within 6 months of a new diagnosis may be considered (IIIC)
 Recommendations based upon HRSA SPNS outreach initiative1
 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 and HIV-1 RNA
suppression in patients underserved by health care system
 Youth, women, mental health, substance abuse disorders
Medium (III):
RCT evidence w/ critical limitations
Observational evidence w/o limitations
1Naar-King S
Optional (C):
Consideration based on individual circumstances
Not recommended routinely
et al. AIDS Patient Care STDS. 2007;21 Suppl 1
www.iapac.org
Use of peer or paraprofessional patient navigators may
be considered (IIIC)
 Recommendations based upon HRSA SPNS outreach initiative1
 A series of observational studies with comparators that
measured behavioral and biological outcomes
 PN recommendation based upon 4 studies (n>1100 pts)
 PN associated w/ increased retention in care from 64% to 79%
and 50% increase in HIV-1 RNA suppression @ 12 months
Medium (III):
RCT evidence w/ critical limitations
Observational evidence w/o limitations
1Bradford JB
Optional (C):
Consideration based on individual circumstances
Not recommended routinely
et al. AIDS Patient Care STDS. 2007;21 Suppl 1
www.iapac.org
Use of peer or paraprofessional patient navigators may
be considered (IIIC)
 Patient navigation shares features w/ advocacy, health
education & case management1
 Distinctive features of patient navigation:
 Concerned with individuals vs. system as a whole
 Less pro-active in addressing knowledge gaps
 Use principles of CM but don’t have a “home agency”
 Usually do not have nursing or SW degrees, although apply
strengths-based principles
 PN often peers or near-peers w/ shared cultural background
1Bradford JB
et al. AIDS Patient Care STDS. 2007;21 Suppl 1
www.iapac.org
FUTURE RESEARCH RECOMMENDATIONS :
ENTRY INTO/RETENTION IN CARE
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Comparative evaluation of monitoring strategies in
conjunction with intervention studies
Comparison of retention measures with one another
Operational research to optimize / standardize measurement
Comparative evaluation of CM in community settings
Comparative evaluation and cost effectiveness for best
practices for implementation of CM interventions
Comparative evaluation of other intervention approaches:
peer support, patient navigation, health literacy, life skills
Prospective evaluation of pay for performance interventions
www.iapac.org
Improving Retention and Treatment
Adherence in Vulnerable Populations
Victoria A Cargill, MD, MSCE
Director of Minority
Research and Clinical Studies
Office of AIDS Research
Focus on Special Populations
• Who: Homeless, incarcerated, mentally ill,
substance using, pregnant women, adolescents
and children
• Why: Disparities in care retention, medication
adherence and poor outcomes have been well
documented
• All share unique challenges superimposed upon
their HIV infection
• Given the challenges, effective evidence based
interventions are needed
Substance Use Disorders
• Individuals with substance use and/or alcohol disorders
are at higher risk for poor retention, adherence and
virologic failure with worse outcomes
• Offer buprenorphine or methadone to opioid dependent
patients. (Level II A)
• Directly administered ART is recommended for
individuals with substance use disorders. (Level I B)
• Integration of directly administered ART into
methadone maintenance programs (Level II B)
Related Vulnerabilities
Mental Health Disorders
• Mental health disorders are
common among individuals
living with HIV – with a
strong relationship between
depression and nonadherence
• Screening, management and
treatment for depression and
other mental illness in
combination with adherence
counseling. (II A)
Homeless and Marginally
housed
• Homelessness disrupts daily
routines including
medication taking and make
medication storage
challenging.
• Case management to address
the many adherence barriers
in the homeless. (III B)
• Pill box organizers (II A)
Incarcerated Populations
• Globally HIV prevalence is higher among incarcerated
populations. Incarceration provides an opportunity to
provide ART yet stigma and other barriers confound
this opportunity.
• DAART is recommended during incarceration. (III B)
• It may also be considered upon release to the
community. (II C)
Note: DAART in prison is associated with higher rates of
viral suppression. DAART through community workers
was superior in achieving viral suppression.
Both Ends of the Spectrum
Pregnant Women
Children and Adolescents
• Globally optimum ART
adherence during pregnancy
remains a challenge, further
confounded by limited data on
effective adherence
interventions.
• Targeted PMTCT treatment
improves adherence to ART
for PMTCT. (III B)
• Labor ward based MPTCT
adherence services for women
who are not receiving ART
before labor. (II B)
• HIV infected children and
adolescents have a wide
range of needs depending
upon their developmental
stage, and care giving
situations.
• Intensive youth focused case
management for adolescents
and young adults to improve
entry into care and retention.
(IV B)
Pediatric and Adolescent Populations
Additional recommendations:
• Pediatric and adolescent focused therapeutic support
interventions using problem solving approaches. (IIIB)
• Pediatric and adolescent focused support using problem
solving to address psychosocial context and issues. (IIIB)
• Pill swallowing training my be helpful for younger
patients. (IV B)
• DAART for pediatric and adolescent patients based upon
short term treatment outcomes data. (IV C)
Lessons Learned
• Paucity of data to guide
evidence based
recommendations for many of
these vulnerable populations.
• Even when evidence exists it
may be skewed
• The diversity of the population
of interest – e.g. children and
adolescents – may further
limit the data, as the
developmental stages make
comparison across age groups
difficult.
• Long term studies of the
success of adherence
interventions that can be
linked to HIV biomarkers are
sorely needed.
• Limited data on the impact of
important transitions on ART
adherence for many of these
populations.
• Rigorous implementation and
effectiveness studies on ART
adherence interventions in
pregnancy are virtually
nonexistent.
Future Directions
• For special populations, the groups with the greatest number of gaps
included: children and adolescents, the incarcerated, substance
using individuals and those with mental illness.
• Specific and targeted gaps were identified for pregnant women and
homeless/marginally housed individuals
▫ Investigation of specific ART adherence barriers related to
pregnancy.
▫ Controlled studies to understand adherence barriers in the
antenatal and post partum period.
▫ Identifying better strategies to assess adherence and detect
lapses in homeless and marginally housed individuals.
▫ More studies on DAART effectiveness, useful adherence tools,
and effective case management for homeless/marginally housed
individuals.
Time for Questions
and Answers
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Upcoming Events and Deadlines
•
Campaign Office Hours:
Mondays & Wednesdays 4-5pm ET
•
Data Collection Submission Deadline:
October 1, 2012
•
Improvement Update Submission Deadline:
October 15, 2012
•
Next Campaign Webinar:
Identifying Patients at Risk of Falling Out of Care
Tuesday, September 25, 2012 3pm ET
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Campaign Headquarters:
National Quality Center (NQC)
90 Church Street, 13th floor
New York, NY 10007
Phone 212-417-4730
[email protected]
incareCampaign.org
youtube.com/incareCampaign
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