Developing Guidelines for Treatment Adherence, Entry Into and Retention in Care Melanie Thompson, MD AIDS Research Consortium of Atlanta
Developing Guidelines for Treatment Adherence,
Entry Into and Retention in Care
Melanie Thompson, MDAIDS Research Consortium of
Atlanta
“Adherence is the Achilles Heel of
Antiretroviral Therapy”
Simoni, et.al. Topics in HIV Medicine, 2003
As in Treatment, So in Prevention Drug levels were a strong correlate of
protection (OR 12.9, p<0.001)◦ 92% reduction in risk with adequate drug levels
To improve treatment outcomes through evidence-based recommendations for ◦Maximizing treatment adherence ◦Optimizing entry into and retention in
care
The Goal of Adherence Guidelines
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
How is adherence measured and monitored?
◦ Multiple modalities for measurement
◦ No “gold standard” for measurement or monitoring
How can adherence be improved?
◦ Multiple levels for intervention: structural, behavioral, ART regimen, challenges on of special situations (e.g. homelessness, co-morbidities)
Challenges in Understanding Adherence
1Patterson, AIDS, 2000; 2Maggiolo, CID, 2005
Treatment “Adherence” Cascade
Gardner et al. Clin Infect Dis 2011;52.
19% VL<50 c/mL
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
Entry Into Care
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
◦ Residency requirements◦ Adequate documentation of residence or citizenship◦ Distance from home or job◦ Ability to take off time from work
Other competing “life events”: no time for HIV
Entry Into Care
NO BRAINER #2: Continuous access to care is necessary for access to ART
Structural barriers to continuous care◦ Clinic location, hours, rules
◦ Patient’s job, childcare requirements
◦ Cost for visit and medication (including “co-pay”)
Individual barriers
◦ Competing life factors: housing, food, childcare
◦ Co-morbidities: substance abuse, depression, concurrent diseases requiring subspecialist care
◦ Poverty and chaos
Retention in Care
“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
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)
Review of ART Adherence Interventions, 2003
Treatment adherence guidelines have never before been created; research is of varied quality
The science of treatment adherence is cross-cutting, 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
Why Is This Challenging?
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
Why Is This Challenging?
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
Creation of draft outline
Appointment of section and topic leaders
Guidelines Process
Decisions about appropriate methodology
Decisions regarding recommendations (consensus)
Drafting of document
Publication of guidelines document
Publication of implementation materials as “tool kit”
Guidelines Process
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
Methodology
Evidence grading processo Hybrid system using selected elements of GRADEo Literature quality scoring by 2 independent
consultantso Panel ultimately responsible for assigning grade
Generation of recommendations by consensus
◦ Strength of recommendation assigned by panel
◦ Justification of recommendations based upon evidence
Methodology
Background & Rationale: Jean Nachega & Melanie Thompson
Methodology: Larry Chang Monitoring and Measurement of Adherence:
Robert Gross Interventions to Promote Adherence:
Michael Mugavero Special Topics: Victoria Cargill Issues Specific To Resource-limited
Settings: Catherine Orrell
Guidelines Content
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
Guidelines Content, cont’d
Special Topics Affecting Adherence◦ 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
Guidelines Content
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
The Panel
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
Timeline
Publication!
IAPAC: Jose Zuniga PhD, Angela Knudson CDC Prevention Research Synthesis Project:
Cindy Lyles PhD Literature Review and Evidence Grading:
Jennifer Johnsen MD MPH, Laura Bernard MPH, Kathryn Muessig MPH
Funding: US National Institutes of Health, Office of AIDS Research
Acknowledgements