Transcript Developing Guidelines for Treatment Adherence, Entry Into

Melanie Thompson, MD
AIDS Research Consortium of Atlanta
Simoni, et.al. Topics in HIV Medicine, 2003
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Drug levels were a strong correlate of
protection (OR 12.9, p<0.001)
◦ 92% reduction in risk with adequate drug levels
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To improve treatment outcomes
through evidence-based
recommendations for
◦ Maximizing treatment adherence
◦ Optimizing entry into and retention in care
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How much is enough?
◦ Early studies found 90-95% adherence needed to
maintain viral suppression1
◦ Different regimens may require different thresholds of
adherence for success2
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How is adherence measured and monitored?
◦ Multiple modalities for measurement
◦ No “gold standard” for measurement or monitoring
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How can adherence be improved?
◦ Multiple levels for intervention: structural, behavioral,
ART regimen, challenges on of special situations (e.g.
homelessness, co-morbidities)
1Patterson,
AIDS, 2000; 2Maggiolo, CID, 2005
19% VL<50 c/mL
Gardner et al. Clin Infect Dis 2011;52.
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NO BRAINER #1: If you can’t access care, you
cannot access ART – so adherence is
irrelevant
Timely entry into care is hampered by late
diagnosis…in the USA
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Not being diagnosed
Stigma, fear of discrimination
Cost: time off work, visit and med costs
Distrust in health care system
Multiple “hurdles” to enter a clinic or practice
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Other competing “life events”: no time for HIV
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◦ Residency requirements
◦ Adequate documentation of residence or
citizenship
◦ Distance from home or job
◦ Ability to take off time from work
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NO BRAINER #2: Continuous access to care is
necessary for access to ART
Structural barriers to continuous care
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Clinic location, hours, rules
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Patient’s job, childcare requirements
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Cost for visit and medication (including “co-pay”)
Individual barriers
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Competing life factors: housing, food, childcare
Co-morbidities: substance abuse, depression,
concurrent diseases requiring subspecialist care
Poverty and chaos
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“The empiric data necessary to make strong
recommendations regarding the most
efficacious way to improve ART adherence are
currently lacking.”
“In response to this dearth…a common
response from experts has been to
recommend strategies based on
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methodologically limited data
research from adherence in other fields
empirically demonstrated correlates of adherence
clinical experience
Simoni et al. Topics in HIV Medicine 2003:11(6)
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Treatment adherence guidelines have never
before been created; research is of varied quality
The science of treatment adherence is crosscutting, including virology, pharmacology,
behavioral science, sociology, technology, and
health care implementation and delivery
Entry into and retention in care are an essential
component of antiretroviral treatment success,
but are complex and have not been well studied
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Treatment adherence strategies are
contextual and may have different
outcomes depending on populations
and health care settings
Attempt to make global
recommendations requires recognition
of structural and cultural challenges
as well as resource limitations
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Funding by IAPAC and the US NIH Office of
AIDS Research
Invitation of international leaders in
antiretroviral therapy and treatment
adherence to convene an expert panel
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Creation of draft outline
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Appointment of section and topic leaders
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Decisions about appropriate methodology
Decisions regarding recommendations
(consensus)
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Drafting of document
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Publication of guidelines document
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Publication of implementation materials as
“tool kit”
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Systematic literature review
◦ Collaboration with CDC’s Prevention Research
Synthesis including 45,000 citations between 1996
and 5/2011
◦ Development of literature review strategy
 Scope of review: 1996 was beginning of access to
HAART
 Sources of literature
 Inclusion criteria and key words
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Evidence grading process
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Hybrid system using selected elements of GRADE
Literature quality scoring by 2 independent
consultants
Panel ultimately responsible for assigning grade
Generation of recommendations by
consensus
◦ Strength of recommendation assigned by panel
◦ Justification of recommendations based upon
evidence
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Background & Rationale: Jean Nachega &
Melanie Thompson
Methodology: Larry Chang
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Monitoring and Measurement of Adherence:
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Interventions to Promote Adherence:
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Robert Gross
Michael Mugavero
Special Topics: Victoria Cargill
Issues Specific To Resource-limited Settings:
Catherine Orrell
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Interventions to Promote Adherence
◦ Entry into and retention in care: John Bartlett
◦ Antiretroviral treatment strategies:
Michael Mugavero
◦ Behavioral interventions: K. Rivet Amico
◦ Structural interventions: Chris Gordon
◦ Adherence tools: Jim Scott
Special Topics Affecting Adherence
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Substance use: Rick Altice
Concurrent medical conditions: Princy Kumar
Homelessness: David Bangsberg
Mental health: Michael Stirrett
Incarceration: Curt Beckwith
Children and adolescents: Adele Webb
Pregnancy: Jean Nachega
Frederick Altice, MD
Bernard Hirschel, MD
Catherine Orrell, MD
K. Rivet Amico, PhD
Charles Holmes, MD
Celso Ramos-Filho MD
David Bangsberg, MD
Tim Horn
Robert Remien, PhD
Magda Barini-Garcia, MD
Shoshana Kahana, PhD
James Scott, Pharm D
John Bartlett, MD
Peter Kilmarx, MD
Jane Simoni, MD
Curt Beckwith, MD
Princy Kumar, MD
Kimberly Smith, MD
Victoria Cargill, MD
Cindy Lyles, PhD
Michael Stirratt, PhD
Larry Chang, MD
Rafael Mazin, MD
Melanie Thompson, MD
Vanessa Elharrar, MD
Henry Masur, MD
Evelyn Tomaszewski,
MSW
Tia Frazier, RN
Michael Mugavero, MD
Marco Vitoria, MD
Christopher Gordon, PhD
Peter Mugyenyi, MD
Adele Webb, MD
Robert Gross, MD
Jean Nachega, MD
Dec 2010: Formative Meeting
Jan 2011: First Panel Meeting: draft
outline, writing teams
Feb-Apr 2011: Define Methodology
Apr-July 2011: Literature Review and
Evidence Grading
July-Sept 2011: Drafting of
Manuscript
Publication!
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IAPAC: Jose Zuniga PhD, Angela Knudson
CDC Prevention Research Synthesis Project:
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Literature Review and Evidence Grading:
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Cindy Lyles PhD
Jennifer Johnsen MD MPH, Laura Bernard
MPH, Kathryn Muessig MPH
Funding: US National Institutes of Health,
Office of AIDS Research