Michael J. Mugavero, MD, MHSc
Associate Professor of Medicine
University of Alabama at Birmingham
May 20, 2015

 To describe conceptual frameworks for the continuum of HIV care (“treatment cascade”)
 To describe the individual & population health implications of HIV care engagement
 To describe approaches to measuring engagement and ART adherence
 To describe evidence based approaches proven to improve engagement in care & ART adherence

HPTN 052 Press release, May 12, 2011

50%
MMWR; 63(47);1113-1117, Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6347a5.htm

 21 y/o AAM diagnosed with HIV 06/2009
 Established care and started ART 08/2009
 Excellent initial response to treatment
HIV VL c/mL
CD4 count
08/2009
115,000
78
09/2009
384
251
11/2009
<48
376
02/2010
<48
455

 Sporadic visits and then lost to care
 Re-engaged after lengthy gap…
 Cough, weight loss, night sweats, KS lesions
HIV VL c/mL
CD4 count
02/2010
<48
455
11/2010
22,700
248
11/2012
80,300
108
04/2013
200,000
64

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

http://www.whitehouse.gov/the-press-office/2013/07/15/executive-order-hiv-care-continuum-initiative

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%
Ulett et al. AIDS Pt Care STDS 2009;23:41-49, Mugavero et al. Clin Infect Dis 2011;52(S2).

Adapted from: Mugavero et al. Clin Infect Dis 2011;52(S2)

 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
 Community Level
• Contributor to health care disparities
• Role in HIV 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

Hall HI et al. JAMA Intern Med . 2013;173(14):1337-1344

MMWR; 63(47);1113-1117, Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6347a5.htm

 Undiagnosed HIV infection: Hidden threat
• Transmission rates 3-7x higher in undiagnosed
• 20% undiagnosed  49% of new infections
 HIV testing influence on linkage to care
• Rapport, information quality & counseling provided
• Active vs. passive referral for services
• Delayed linkage w/ testing in community settings
Hall HI et al. AIDS 2012;6:26 Garland et al. AIDS Education and Prevention 2011;23:117, Hightow-Weidman et al. AIDS Pt Care and STDs
2011;S1:S31, Torian et al. Arch Intern Med 2008;168:1181

500
CD4 = 307.0 + 1.5(year)
450
400
350
300
250
200
150
Year of Presentation
Lesko et al. Clin Infect Dis 2013;57

MMWR; 63(47);1113-1117, Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6347a5.htm

MMWR; 63(47);1113-1117, Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6347a5.htm

http://www.effectiveinterventions.org/en/highimpactprevention/publichealthstrategies/DatatoCare.aspx

Figure. Kaplan-Meier survival curve for time from HIV diagnosis to viral suppression, by entry to care within 3 months of HIV diagnosis.
Hall HI, et al. (2013); PLoS ONE 8(12): e84318. doi:10.1371/journal.pone.0084318 http://www.plosone.org/article/info:doi/10.1371/journal.pone.0084318

Patient A
Patient B
Patient C
Patient D
Missed
Visits
Yes; 1
Yes; 4
No; 0
Yes; 1
Appt.
Adherence
80%
33%
100%
67%
Mugavero, Davila, Nevin & Giordano. AIDS Pt Care STDs 2010;24
Visit
Constancy
100%
50%
75%
25%
Gap in
Care
No
Yes
No
Yes
HRSA HAB
Measure
Yes
Yes
Yes
No

Measure
Missed visit
Appointment adherence
No-show rate
Constancy:
Visit per 3, 4 or 6 mo intervals
Gaps
HRSA/HAB
DHHS
Yes
No
No
No
No
Missed visit data?
Ease of calculating
Yes
Yes
Easy
Moderate
Moderate
Moderate
Easy
Followup time
~1 day
~1 yr
~1 yr
~1 yr
~1 yr
Moderate-to-difficult 1 yr
Moderate-to-difficult 2 yrs
Adapted from: Giordano TP (2012) Measuring retention in HIV care. www.medscape.com.

Study of UAB 1917 Clinic patients initiating outpatient HIV care, 2000 – 2005 (N=543)
Characteristic
“No show” visit in 1 st year
HR (95%CI) a
2.90 (1.28- 6.56)
Age (HR per 10 years)
CD4 count <200 cells/mL
Log
10 plasma HIV RNA
ART started in 1 st year
1.58 (1.12-2.22)
2.70 (1.00-7.30)
1.02 (0.75-1.39)
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

Missed “No Show” Visits
Retained
(Zero “no show” )
1725 (41%)
Not Retained
(>1 “no show”)
1753 (42%) HRSA HAB
Quality
Indicator
Retained
Not Retained 251 (6%) 433 (10%)

HRSA HAB
Quality
Indicator
Retained
Missed “No Show” Visits
(Zero “no show” )
Retained 1725 (41%)
Referent
Not Retained 251 (6%)
HR=1.01;0.54-1.87
Not Retained
(>1 “no show”)
1753 (42%)
433 (10%)

HRSA HAB
Quality
Indicator
Missed “No Show” Visits
Retained
(Zero “no show” )
Retained 1725 (41%)
Referent
Not Retained 251 (6%)
HR=1.01;0.54-1.87
Not Retained
(>1 “no show”)
1753 (42%)
HR=1.72;1.33-2.21
433 (10%)
HR=1.48;1.33-1.65

Zinski A et al, AJPH (in press)

Zinski A et al, AJPH (in press)

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
Peer of paraprofessional patient navigation for retention
IIIC
Thompson MA et al. Ann Intern Med 2012;156

http://www.cdc.gov/hiv/prevention/research/compendium/lrc/index.html

http://aidsetc.org/engagement-toolkit

MMWR; 63(47);1113-1117, Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6347a5.htm

Recommendation
Self-reported adherence
Pharmacy refill data (MPR)
NOT drug concentrations
NOT pill counts
NOT electronic devices (MEMs)
Strength/Quality
IIA
IIB
IIIC
IIIC
IC
Plasma HIV RNA is the biological correlate of the adherence behavior, NOT a screening tool
Thompson MA et al. Ann Intern Med 2012;156

Recommendation
Reminder devices & interactive communication technologies
Education & counselling using adherence-related 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

Michael J. Mugavero, 1 K. Rivet Amico, 2 Andrew O. Westfall, 1
Heidi M. Crane, 3 Anne Zinski, 1 James H. Willig, 1 Julie
Dombrowski, 3 Wynne E. Norton, 4 James L. Raper, 1 Mari M.
Kitahata, 3 Michael S. Saag 1
1 Department of Medicine, University of Alabama at Birmingham (UAB),
2 University of Connecticut, 3 Department of Medicine, University of
Washington, 4 Department of Health Behavior, UAB
Supported by grants 1R21AI087360-01, 3K23MH082641-02S1 and 1R24AI067039-04

 Area under the curve estimate of cumulative viral load burden over time
 Example: 10,000 copy-years
• 1,000 c/mL per day for 10 years
• 10,000 c/mL per day for 1 year
 VCY approximated as time-weighted sum using
 i trapezoidal rule:
   
J i t i
   j 1

  i
   i
  
/ 2
Cole et al. Am J Epidemiology 2010;171

Relationship between 2 year visit adherence and cumulative VL burden measured by viremia copy-years (VCY) among 258 patients initiating HIV care;
UAB 1917 Clinic & UW Madison Clinics
Visit adherence 0-79% (n=83): mean VCY=143,038; 80-99% visit adherence (n=95): mean VCY=56,894; 100% visit adherence (n=80): mean VCY=35,754 copy x years/mL, respectively.

Characteristic
Viremia copy-years
24-week viral load
Most recent viral load
Age (per 10 years)
Most recent CD4 count
HR (95%CI) a
1.44 (1.07-1.94)
1.07 (0.87-1.32)
1.15 (0.94-1.41)
1.51 (1.18-1.94)
0.72 (0.61-0.86)
“VCY predicted mortality independent of most recent CD4 count, suggesting cumulative HIV replication causes harm independent of its effect on the degree of immunodeficiency.”
Mugavero et al. Clin Infect Dis 2011;53

 Resumed ART & chemo with good response
 VL rebound & no show visit  personal call
 Improved retention, sustained VL suppression, triathlon summer 2014!
HIV VL c/mL
CD4 count
04/2013
200,000
64
07/2013
79
253
12/2013
525
226
03/2014
<20
365

COMMUNITY CLINIC
State of Alabama HIV Surveillance 2012 Annual Report; http://www.adph.org/aids/assets/Finalized_2012HIVSurveillance.pdf

FAMILY CLINIC

 Webinars are available on our website for on-demand viewing.
 You will find slides from today’s presentation posted to the front page of our website: www.nationalhivcenter.org
.
 Please complete the evaluation at the end of the webinar. Your feedback will inform our programming.
 If you are interested in individualized technical assistance, please visit our website and complete a TA Request Form.
 Learn more about the National LGBT Health Education Center at their website: www.lgbthealtheducation.org
 Join us for our next webinar:
Implementing PrEP for HIV Prevention: State-wide Initiatives and
Provider Experiences
Thursday, June 4, 2015 @ 1:00 PM ET
(Find a link to register on our website: www.nationalhivcenter.org
)