Guidelines for Improving HIV Care and Adherence: Evidence, Practice Implications, and Implementation Resources

1. 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: 1-888-205-5513 Enter participant Code: 987837#

2. Webinar Information • Participant phone lines are muted. Please type your questions and comments in the CHAT BOX at any time. Presenters will address questions during the Q&A sessions. • Registered participants will receive the webinar slides and a link to the webinar recording via e-mail today. The slides and recording will also be available on the AETC NRC website: https://www.aids-etc.org

3. 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

4. June 5, 2012www.annals.org

5. Rationale • Viral suppression improves individual health and decreases transmission • NoCARE= no ART • Successful ART requires RETENTION in care • High ADHERENCE is required for maximal and durable individual and public health benefit

6. Methods • Systematic review of the international literature since 1996 • Keyword searches of CDC’s Prevention Research Synthesis database of over 46,000 citations; ad hoc and hand searches of key literature; and conference abstracts from last 2 years produced over 300 studies • Qualifying studies had to have a comparator arm • Interventions had to have been studied in context of HIV • Evidence reviewed by 2 independent reviewers using modified Newcastle-Ottawa and Cochrane criteria • Writing Team graded quality of body of evidence and strength of recommendations

7. Methods: Monitoring • Keyword searches specific to adherence measurement or monitoring • Qualifying studies had to include at least one adherence measurement method and have a biologic or clinical outcome • Two independent reviewers abstracted data using Quality Assessment for Diagnostic Accuracy Studies (QUADAS) tool

8. Quality of the Body of Evidence and Strength of Recommendations

9. Guideline Structure • Monitoring • Interventions • Entry Into and Retention in Care • ART Strategies • Adherence Tools • Education and Counseling • Health Systems and Service Delivery • Special Populations • Emerging Issues • Recommendations for Future Research

10. Penn Infectious Diseases CCEB Monitoring Entry, Retention, and ART Adherence Robert Gross, MD MSCE Associate Professor of Medicine (ID) and Epidemiology University of Pennsylvania Perelman School of Medicine

11. 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”

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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)

18. 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

19. 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

20. 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

21. 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)

22. 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

23. 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

24. 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

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

26. HIV Treatment Cascade 21% Undiagnosed 49% Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618

28. Engagement in Care: 3 Components 3 2 1 Ulett et al. AIDS Pt Care STDS 2009;23:41-49, Mugavero et al. Clin Infect Dis 2011;52(S2).

29. 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

30. 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

31. COMMUNITY CLINIC Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618

32. 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 Med2012;156

33. 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

34. 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) Gardner LI et al. AIDS 2005;19

35. 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 Naar-King S et al. AIDS Patient Care STD. 2007;21 Suppl 1

36. 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 Bradford JB et al. AIDS Patient Care STDS. 2007;21 Suppl 1

37. National HIV/AIDS Strategy Increase HIV serostatus awareness from 79% to 90% Increase RW clients in continuous care from 73% to 80% Increase linkage to care w/in 3 months of Dx from 65% to 85% Increase proportion of HIV Dx’d persons with undetectable VL by 20%

38. http://www.iom.edu/Reports/2012/Monitoring-HIV-Care-in-the-United-States.aspxhttp://www.iom.edu/Reports/2012/Monitoring-HIV-Care-in-the-United-States.aspx

39. http://www.incarecampaign.org/

40. Coming soon…proposed areas of focus: Compilation of a resource repository on entry into care, retention in care, and re-engagement in care Development of a trainer toolkit to increase uptake of the evidence based interventions among Ryan White providers Development of training tools that address engagement in care for special populations and psychosocial aspects of retaining patients 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 WorkgroupFebruary 2013 – January 2014

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