Elements of the Care Continuum Michael J. Mugavero, MD, MHSc Associate Professor of Medicine University of Alabama at Birmingham Birmingham, Alabama FORMATTED: 12/09/15 Slide 3 of 38 Learning Objectives After attending this presentation, participants will be able to: Describe conceptual frameworks for the continuum of HIV care ( treatment cascade ) Describe the individual & population health implications of HIV care engagement across the continuum Describe approaches to measuring engagement in care and adherence in clinical settings Describe evidence based approaches proven to improve engagement in care & ART adherence in clinical settings Case presentation Slide 4 of 38 21 y/o diagnosed with HIV 06/2009 Established care and started ART 08/2009 Excellent initial response to treatment 08/2009 09/2009 11/2009 02/2010 HIV VL c/ml 115,000 384 <48 <48 CD4 count 78 251 376 455 1
Case presentation Slide 5 of 38 Sporadic visits and then lost to care Re-engaged after lengthy gap Cough, weight loss, night sweats, KS lesions 02/2010 11/2010 11/2012 04/2013 HIV VL c/ml <48 22,700 80,300 200,000 CD4 count 455 248 108 64 Slide 6 of 38 HIV Treatment Cascade Slide 7 of 38 20% Undiagnosed 50% Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618 2
Slide 8 of 38 HRSA Continuum of Care Not in Care Fully engaged Unaware of HIV status Aware of HIV status May be receiving other medical care but not HIV care Entered HIV medical care but dropped out In and out of HIV care or infrequent user Fully engaged in HIV medical care Cheever. Clin Infect Dis 2007;44:1500-1502 Slide 9 of 38 http://www.whitehouse.gov/the-press-office/2013/07/15/executive-order-hiv-care-continuum-initiative National HIV/AIDS Strategy: 2020 Goals Increase HIV serostatus awareness to at least 90% Slide 10 of 38 Increase retention among persons diagnosed to at least 90% Increase linkage to care w/in 1 month of Dx to at least 85% Increase proportion of persons diagnosed with viral suppression to at least 80% Ulett et al. AIDS Pt Care STDs 2009;23:41-49, Mugavero et al. Clin Infect Dis 2011;52(S2). 3
Slide 11 of 38 Adapted from: Mugavero et al. Clin Infect Dis 2011;52(S2) 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 Slide 12 of 38 Slide 13 of 38 ~90% of HIV Transmissions in 2009 in the US Skarbinski et al. JAMA Intern Med 2015;175 4
Temporal Trends in Late Presentation Slide 15 of 38 500 CD4 = 307.0 + 1.5(year) 450 CD4 cells/mm3 400 350 300 250 200 150 1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011 Year of Presentation Lesko et al. Clin Infect Dis 2013;57 UAB 1917 Clinic: Linkage to care Slide 16 of 38 Problem identified: Scheduled new patient visits often no show Study of patients calling to establish HIV care at UAB 1917 Clinic, 2004-2006 31% of patients (160 of 522) failed to attend a clinic visit within 6 mos. of initial call Average time 28 days from call to scheduled visit Mugavero et al. Clin Infect Dis 2007;45 Project CONNECT Client- Oriented New Patient Navigation to Encourage Connection to Treatment Slide 17 of 38 5
Slide 18 of 38 Project CONNECT: Program evaluation Time Period No Show Unadjusted OR (95%CI) Pre-CONNECT (n=522) 30.7% 1.0 Post-CONNECT (n=361) 17.7% 0.48 (0.35-0.68) a Multivariable model controls for age, race, sex, insurance, location of residence and time from call to scheduled visit. Adjusted OR (95%CI) a 1.0 0.54 (0.38-0.76) Early missed visits and mortality Slide 20 of 38 Study of UAB 1917 Clinic patients initiating outpatient HIV care, 2000 2005 (N=543) Characteristic HR (95%CI) a No show visit in 1 st year 2.90 (1.28-6.56) Age (HR per 10 years) 1.58 (1.12-2.22) CD4 count <200 cells/ L 2.70 (1.00-7.30) Log 10 plasma HIV RNA 1.02 (0.75-1.39) ART started in 1 st year 0.64 (0.25-1.62) a Cox proportional hazards (PH) analysis also adjusts for sex, race/ethnicity, insurance, affective mental health disorder, alcohol abuse, and substance abuse. Mugavero et al. Clin Infect Dis 2009;48 Slide 21 of 38 Measure Missed visit data? Ease of calculating Follow-up time Missed visit Yes Easy ~1 day Appointment Yes Moderate ~1 yr adherence No-show rate Yes Moderate ~1 yr Constancy: Visit per 3, 4 or 6 mo intervals No Moderate ~1 yr Gaps No Easy ~1 yr HRSA/HAB No Moderate-to-difficult 1 yr DHHS No Moderate-to-difficult 2 yrs Adapted from: Giordano TP (2012) Measuring retention in HIV care. www.medscape.com. 6
Slide 22 of 38 Missed visits and disparities in viral suppression Zinski A et al. Am J Public Health 2015;105 Guidelines: Linkage and Retention Interventions Recommendation Monitor entry into HIV care Monitor retention in HIV care Brief, strength-based CM for linkage (ARTAS model) Intensive outreach for retention Strength/Quality IIA IIA IIB IIIC Slide 23 of 38 Peer of paraprofessional patient navigation for retention IIIC Thompson MA et al. Ann Intern Med 2012;156 CDC/HRSA RIC Intervention Phase I. Clinic-wide intervention Posters & brochures: Waiting rooms & exam rooms Brief messages: From all clinic staff Pre-intervention vs. post-intervention evaluation Slide 24 of 38 Phase II. Pt-centered behavioral intervention Enhanced contact: Personal reminder calls 7- and 2- days before visits, w/in 24-48 hrs of missed visits Skill building modules: problem solving, provider communication and organizational skills Randomized-controlled trial 7
Slide 25 of 38 RIC Phase I: Improved visit adherence Slide 26 of 38 10% 8% 7.6% 6% 5.5% 5.1% 4% 3.0% 2% 0% Overall New or Reengaging Gardner LI et al. Clin Infect Dis 2012;55 Detectable viral load CD4<350 RIC Phase II: Improved visit adherence Slide 27 of 38 80% 70% 67% 72% 70% 70% 66% 65% 65% 74% SOC Intervention 71% 66% 60% 50% Gardner LI et al. Clin Infect Dis 2014;59 Overall Black/AA Female Medicare Medicaid 8
Slide 28 of 38 http://www.cdc.gov/hiv/prevention/research/compendium/lrc/index.html Slide 29 of 38 http://aidsetc.org/engagement-toolkit Guidelines: Monitoring ART Adherence Recommendation Self-reported adherence Pharmacy refill data (MPR) NOT drug concentrations NOT pill counts NOT electronic devices (MEMS) Strength/Quality IIA IIB IIIC IIIC Plasma HIV RNA (viral load) is the biological correlate of the adherence behavior, NOT a screening tool for adherence! IC Slide 30 of 38 Thompson MA et al. Ann Intern Med 2012;156 9
Self-reported ART NON-adherence Slide 32 of 38 Although it commonly overestimates ART adherence, self-reported NON-adherence has high predictive value Guidelines: ART Adherence Strategies Recommendation Reminder devices & interactive communication technologies Education & counselling using adherencerelated tools Various individual, group & peer education & counselling CM services (eg, food / housing) Integration of med management into pharmacy systems Thompson MA et al. Ann Intern Med 2012;156 Strength/Quality IB IA IIA-IIIC IIIB IIIC Slide 33 of 38 Back to our case Slide 34 of 38 Resumed ART & chemo with good response VL rebound & no show visit personal call Improved retention, sustained VL suppression, triathlon Summer 2014 remains in care with sustained VS! 04/2013 07/2013 12/2013 03/2014 HIV VL c/ml 200,000 79 525 <20 CD4 count 64 253 226 365 10
Slide 35 of 38 COMMUNITY CLINIC State of Alabama HIV Surveillance 2012 Annual Report; http://www.adph.org/aids/assets/finalized_2012hivsurveillance.pdf Slide 36 of 38 FAMILY CLINIC Slide 37 of 38 11
Take Home Points Slide 38 of 38 Engagement across the continuum of HIV care is dynamic and impacts individual & population health Systematic monitoring of engagement in care and ART adherence is foundational Prognostic value of missed visits Predictive value of self-reported NON-adherence Evidence-based interventions for engagement in care and ART adherence amenable to clinical settings Partnerships with public health and community agencies essential to improve continuum outcomes 12