Nicole Johns (OHP)'s presentation to the RWPC's Comprehensive Planning Committee on the implications of the Gardner Cascade for the Philadelphia EMA.

1. TEST AND TREAT
Gardner Cascade in context

2. Intro to „Test and Treat‟
 Most people in HIV treatment (ART) reach
undetectable VL
 People with undetectable viral load are significantly
less likely to transmit virus
 Collectively, individuals with lower VL lead to
communities with lower community VL = less
transmissions
 Failures in the system of care pose barriers to full
success of T&T:
 Late diagnosis
 Non-linkage or flawed linkage to care
 Insufficient use of ART
 Non-adherence to ART

3. Test and Treat Components
(HRSA)
 Testing and identification of PLWHA as soon as
possible
 Linkage of people testing positive for HIV to HIV
care
 Patient education to encourage self management
and facilitate retention in care, adherence to
treatment, and prevention of STIs
 Supportive services for promotion of sexual health
maintenance
 Monitoring and evaluation of test and treat
strategy

4. Intro to Gardner‟s Research
 Test and treat strategy supported by
mathematical models and epidemiological
data
 Areas with high coverage of ART have
decreased incidence of HIV
 HOWEVER barriers to implementation of Test
and Treat strategies have not been adequately
evaluated.

5. Objectives of Gardner‟s Review
 To describe and quantify the spectrum of
engagement in HIV care
 To understand how gaps in the continuum of
care affect virological outcomes in the US
 To understand how to address these gaps for
Test and Treat to be successful strategy
 To explore effects of interventions to improve
components of engagement in care

6. Gardner‟s Review Search
Strategy
 PubMed search - cross-match of HIV or AIDS
with
 Prevalence United States
 Incidence United States
 Late diagnosis
 Linkage to care
 Retention in care
 Engagement in care
 Adherence
 Persistence
 Resistance
 Bibliographies of pertinent articles were
reviewed
 Emphasis was based on population based

7. HIV Care Continuum
Not in HIV Care Engaged in HIV Care
Unaware of Aware of Receiving some Entered HIV Cyclical or Fully engaged
HIV infection HIV infection medical care but care but lost to intermittent user in HIV care
(not in care) not HIV care follow-up of HIV care
Adapted from
Eldred et al AIDS Patient Care STDs 2007;21(Suppl1):S1-S2
Cheever LW Clin Infect Dis 2007;44:1500-2

8. Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States

9. Undiagnosed HIV Infection
 1.1 million in the US with HIV/AIDS
 21% of those not aware HIV+ (US)
 35%-45% of newly diagnosed individuals have
AIDS within 1 year (US)

10. Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States

11. Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States

12. Linkage in Care
 Longer delays in linkage with medical care are
associated with greater likelihood of
progression to AIDS by CD4 criteria
 HIV+ people not linked to care pose a greater
risk of transmission
 Gardner concludes that ~75% of newly
diagnosed HIV+ people successfully like to
HIV care within 6-12 months, 80-90% link
within 3-5 years

13. Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States

14. Retention in Care
 3 population based studies in US found 45-
55% of known HIV+ individuals fail to receive
HIV care during any year
 In some communities, one-third of HIV+
people fail to access care for 3 consecutive
years
 ~50% of HIV+ (aware) people are not engaged
in regular HIV care.
 Poor engagement in care is associated with
poor health outcomes, including increased
mortality and increased risk of HIV
transmission

15. Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States

16. Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States

17. Antiretroviral Therapy
 Gardner estimates that 80% of in-care HIV+
individuals should be receiving ART, but 25%
of those are not.
 4-6% of in-care HIV+ people discontinue ART
each year
 70-80% adherence leads to durable viral
suppression in most people
 78-87% of individuals on ART had an
undetectable viral load.

18. Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States
19%

19. Test and Treat Implications
 Epidemiological data suggests that ART
reduces risk of HIV transmission in
serodiscordant heterosexual couples by 92-
98%
 Ecological data show that incidence of HIV
transmission may be occurring in communities
with high treatment coverage (San Francisco)

20. Simulations of the Engagement in HIV Care Spectrum to
Account for Inaccuracy in our Engagement Estimates
1200000
Number of Individuals
Un-Diagnosed HIV
1000000
Not Linked to Care
800000
Not Retained in Care
600000 ART Not Required
400000 ART Not Utililzed
66%
Viremic on ART
200000 34% 28%
19% 22% 21% Undetectable Viral Load
0
Current Dx 90% Engage 90% Treat 90% VL<50 in 90% Dx, Engage,
Tx, and
VL<50 in 90%
(a) (b) (c) (d) (e) (f)

21. Newer Data for Discussion
 Marks et al. estimated that 29 – 34% of HIV-
infected individuals in the U.S. have an
undetectable viral load (Clin Infect Dis 2011;53:1168–9)
 Dombrowski et al. estimate that 42 – 45% in
Seattle King County are undetectable (AIDS
2011;epub ahead of print)
 In a cohort of newly diagnosed individuals in
Denver, 28% are undetectable 12 – 18 months
after diagnosis.

22. Limitations
 Unable to assess the impact of financial
barriers to HIV care in the U.S.
 Overlap in the stages of engagement in HIV
care
 Cross-sectional depiction of a longitudinal
process
 The review applies to the U.S. and not to
resource-poor settings

23. Conclusions
 Engagement in care is critical to the successful
management of HIV infection
 For the individual
 For the population
 Deficiencies in the spectrum of engagement in
care present formidable barriers to „test and
treat‟ for HIV prevention:
 Failure to diagnose
 Failure to link to care
 Failure to be retained in care
 Failure to receive and adhere to antiretroviral therapy
 Research is needed on ways to improve
transitions across all steps in the engagement
in care cascade

24. Local Context of Cascade

25. Undiagnosed HIV/AIDS - EMA
 In EMA estimated 6,800 people are unaware
of their status
 In Philadelphia- 25% concurrent HIV/AIDS in
2009 (a.k.a. “late testers”) – consumer survey
data supports this number
 Most likely to be
 African American/Hispanic
 Male
 Over 40
 Heterosexual or unidentified risk

26. HIV/AIDS- Incidence
AIDS (1/1/2008 – 12/31/2010) HIV (1/1/2008 – 12/31/2010)
 Total: 1540  Total: 1835
 72% Male  73% Male
 53% 20-44  68% 20-44
 44% 45+  25% 45+
 59% African  59% African
American/Black American/Black
 21% White  22% White
 14% Hispanic  16% Hispanic
 44% Heterosexual  38% Heterosexual
 30% MSM  40% MSM
 16% IDU  11% IDU

27. HIV/AIDS Diagnosed -
Prevalence
AIDS – 15,163 HIV – 10,486
 73% Male  68% Male
 61% 45+  54.4 % 20-44
 32% MSM  42.9% 45+
 30% IDU  37% Heterosexual
 29% Heterosexual
 33% MSM
 21% IDU
 59% African
American/Black  56% African
American/Black
 24% White
 25% White
 13% Hispanic
 14% Hispanic

28. Linkage to Care
 Surveillance data show that 73% of PLWHA in
Philadelphia are linked to care – 11,500
 2010 Unmet EMA need estimate – 6,044
 Philadelphia Unmet Need – 4,388
 73% of PLWHA with unmet need are male
 65% are African American/Black
 Of those with unmet need - Medicaid (29%) and
unknown insurance status (25%)

29. Client Services Unit
 10 weeks after initial intake – 78% in MCM
 Linkage to Medical care within 10 weeks –
97% (includes people already in care at
intake)
 26% had no insurance at intake
 44% had Medicaid

30. Linkage to Care - Survey
 74% of respondents got into care right away
 85% within a year of diagnosis
 Late testers slightly more likely to get into care
right away
 4% got into care after they were sick

31. Retention
 7719 Philadelphia PWHA retained in care
(HRSA definition)
 93% of consumer survey respondents had a
regular place for HIV care
 77% of respondents had 3 or more HIV care
visits in 12 months
 95% of respondents had any # of visits in 12
months

32. ART and Adherence
 38% of survey respondents had CD4 over 500.
33% between 200-500
11% under 200
13% did not know
 90% of survey respondents on ART
 97% of late testers
 89% of HIV+

33. Viral Load
 6,793 PLWHA on ART in Philadelphia
 5,366 have suppressed viral load (79% of ART)
 67% of survey respondents report
undetectable viral load
 27% of undetectables were late testers
 14% did not know viral load

34. Philadelphia Estimate for Stage of
Engagement in Care
25,000
19,691
20,000
15,753
15,000
11,500
10,000
7,719
6,793
5,366
5,000
-
HIV-infected HIV-diagnosed Linked to HIV Retained in On ART Supressed viral
(as of care HIV care load (<=200
12/31/09) copies/mL)
Source: AACO, Dr. Kathleen Brady

35. Context and Controversy
Other viewpoints

36. HRSA‟s Pros and Cons of Test and
Treat
Pro Con
 Widespread effective ART may lower
 Widespread testing and treatment has
large financial cost implications
community viral load
 Many barriers to HIV testing remain
 More people will benefit from treatment
 Modeling studies are flawed
 Evidence shows Test and Treat works
 We may not be able to treat our way
 The strategy would help mitigate health out of the epidemic
disparities
 Demand for treatment exceeds supply
 Risk reduction counseling can be included in  Behavioral disinhibition/risk
HIV testing compensation would compromise any
 Test and treat would help link and retain decrease in incidence
people in care  Current testing system makes
 Test and treat would present opportunities capturing acute infections difficult
for prevention with patients‟ partners  Viral suppression may not be possible
for everyone
 People would receive referrals to supportive
services earlier in disease course  Widespread treatment is unsustainable
 People could begin treatment earlier in  Treatment initiation may take time.
disease course
Unknown long term toxicities
 Stigma and discrimination continue to
 STI screening, treatment, and sexual health exist
education would be facilitated
HRSA CARE ACTION, January 2012

37. Supporting Research
 A meta analysis examined 11 cohorts of
serodiscordant heterosexual couples with the
HIV+ partner on ART and a VL<400 showed
NO transmissions (Attia, Egger, Muller, et
al., 2009)
 HPTN 052 – HIV+ men and women who were
on ART had a 96% reduced risk of transmitting
the virus to sexual partners

38. Effectiveness of Test and Treat
 Dodd, Garnett & Hallet, 2010
 Impact of Test and Treat depends crucially on the
epidemiological context
 In some situations less aggressive interventions
achieve the same results
 Testing every year and following up with
immediate treatment is not necessarily the most
cost-efficient strategy
 Test and Treat intervention that does not reach full
implementation or coverage could increase long-
term ART costs.

39. Early retention in care and VL
 Mugavero, Amico, Westfall et al., 2012
 Higher rates of early retention in HIV care are
associated with achieving viral load suppression
and lower cumulative viral load burden
 63% of overall sample achieved viral load
suppression in less than a year after entry into
care
 Insured people reached suppression faster
 The more visits (less no shows) the more likely
the person was to have viral load suppression
 Each clinic “no show” conveyed a 17% increased risk
of delayed viral load suppression

40. VL and Risk Behaviors
 Kalichman, Cherry, Amaral, et al., 2010 (MSM)
 Nonadherence to ART was associated with greater
number of sex partners and engaging in unprotected
and protected anal intercourse (not moderated by
substance use)
 Belief that having an undetectable viral load leads to
lower infectiousness was associated with greater
numbers of partners, including nonpositive
partners, and less condom use
 Men who had undetectable viral load and believed
having an undetectable viral load made them less
infectious were significantly more likely to have had
an STI recently.
 Beliefs regarding viral load rather than viral load itself
influence behavior