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TEST AND TREAT
Gardner Cascade in context
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
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
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.
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
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
HIV Care Continuum
Adapted from
Eldred et al AIDS Patient Care STDs 2007;21(Suppl1):S1-S2
Cheever LW Clin Infect Dis 2007;44:1500-2
Not in HIV Care Engaged in HIV Care
Unaware of
HIV infection
Aware of
HIV infection
(not in care)
Receiving some
medical care but
not HIV care
Entered HIV
care but lost to
follow-up
Cyclical or
intermittent user
of HIV care
Fully engaged
in HIV care
Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States
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)
Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States
Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States
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
Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States
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
Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States
Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States
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.
Model Demonstrating the Spectrum of
Engagement in HIV Care in the United States
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)
Simulations of the Engagement in HIV Care Spectrum to
Account for Inaccuracy in our Engagement Estimates
66%
21%28%34%
22%19%
0
200000
400000
600000
800000
1000000
1200000
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)
NumberofIndividuals
Un-Diagnosed HIV
Not Linked to Care
Not Retained in Care
ART Not Required
ART Not Utililzed
Viremic on ART
Undetectable Viral Load
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.
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
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
Local Context of Cascade
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
HIV/AIDS- Incidence
 Total: 1540
 72% Male
 53% 20-44
 44% 45+
 59% African
American/Black
 21% White
 14% Hispanic
 44% Heterosexual
 30% MSM
 16% IDU
 Total: 1835
 73% Male
 68% 20-44
 25% 45+
 59% African
American/Black
 22% White
 16% Hispanic
 38% Heterosexual
 40% MSM
 11% IDU
AIDS (1/1/2008 – 12/31/2010) HIV (1/1/2008 – 12/31/2010)
HIV/AIDS Diagnosed -
Prevalence
 73% Male
 61% 45+
 32% MSM
 30% IDU
 29% Heterosexual
 59% African
American/Black
 24% White
 13% Hispanic
 68% Male
 54.4 % 20-44
 42.9% 45+
 37% Heterosexual
 33% MSM
 21% IDU
 56% African
American/Black
 25% White
 14% Hispanic
AIDS – 15,163 HIV – 10,486
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%)
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
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
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
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+
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
19,691
15,753
11,500
7,719
6,793
5,366
-
5,000
10,000
15,000
20,000
25,000
HIV-infected HIV-diagnosed
(as of
12/31/09)
Linked to HIV
care
Retained in
HIV care
On ART Supressed viral
load (<=200
copies/mL)
Philadelphia Estimate for Stage of
Engagement in Care
Source: AACO, Dr. Kathleen Brady
Other viewpoints
Context and Controversy
HRSA’s Pros and Cons of Test and
Treat
 Widespread effective ART may lower
community viral load
 More people will benefit from treatment
 Evidence shows Test and Treat works
 The strategy would help mitigate health
disparities
 Risk reduction counseling can be included in
HIV testing
 Test and treat would help link and retain
people in care
 Test and treat would present opportunities
for prevention with patients’ partners
 People would receive referrals to supportive
services earlier in disease course
 People could begin treatment earlier in
disease course
 STI screening, treatment, and sexual health
education would be facilitated
 Widespread testing and treatment has
large financial cost implications
 Many barriers to HIV testing remain
 Modeling studies are flawed
 We may not be able to treat our way
out of the epidemic
 Demand for treatment exceeds supply
 Behavioral disinhibition/risk
compensation would compromise any
decrease in incidence
 Current testing system makes
capturing acute infections difficult
 Viral suppression may not be possible
for everyone
 Widespread treatment is unsustainable
 Treatment initiation may take time.
Unknown long term toxicities
 Stigma and discrimination continue to
exist
Pro Con
HRSA CARE ACTION, January 2012
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
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.
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
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

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Test and Treat: The Gardner Cascade in Context

  • 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 Adapted from Eldred et al AIDS Patient Care STDs 2007;21(Suppl1):S1-S2 Cheever LW Clin Infect Dis 2007;44:1500-2 Not in HIV Care Engaged in HIV Care Unaware of HIV infection Aware of HIV infection (not in care) Receiving some medical care but not HIV care Entered HIV care but lost to follow-up Cyclical or intermittent user of HIV care Fully engaged in HIV care
  • 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 66% 21%28%34% 22%19% 0 200000 400000 600000 800000 1000000 1200000 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) NumberofIndividuals Un-Diagnosed HIV Not Linked to Care Not Retained in Care ART Not Required ART Not Utililzed Viremic on ART Undetectable Viral Load
  • 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  Total: 1540  72% Male  53% 20-44  44% 45+  59% African American/Black  21% White  14% Hispanic  44% Heterosexual  30% MSM  16% IDU  Total: 1835  73% Male  68% 20-44  25% 45+  59% African American/Black  22% White  16% Hispanic  38% Heterosexual  40% MSM  11% IDU AIDS (1/1/2008 – 12/31/2010) HIV (1/1/2008 – 12/31/2010)
  • 27. HIV/AIDS Diagnosed - Prevalence  73% Male  61% 45+  32% MSM  30% IDU  29% Heterosexual  59% African American/Black  24% White  13% Hispanic  68% Male  54.4 % 20-44  42.9% 45+  37% Heterosexual  33% MSM  21% IDU  56% African American/Black  25% White  14% Hispanic AIDS – 15,163 HIV – 10,486
  • 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. 19,691 15,753 11,500 7,719 6,793 5,366 - 5,000 10,000 15,000 20,000 25,000 HIV-infected HIV-diagnosed (as of 12/31/09) Linked to HIV care Retained in HIV care On ART Supressed viral load (<=200 copies/mL) Philadelphia Estimate for Stage of Engagement in Care Source: AACO, Dr. Kathleen Brady
  • 36. HRSA’s Pros and Cons of Test and Treat  Widespread effective ART may lower community viral load  More people will benefit from treatment  Evidence shows Test and Treat works  The strategy would help mitigate health disparities  Risk reduction counseling can be included in HIV testing  Test and treat would help link and retain people in care  Test and treat would present opportunities for prevention with patients’ partners  People would receive referrals to supportive services earlier in disease course  People could begin treatment earlier in disease course  STI screening, treatment, and sexual health education would be facilitated  Widespread testing and treatment has large financial cost implications  Many barriers to HIV testing remain  Modeling studies are flawed  We may not be able to treat our way out of the epidemic  Demand for treatment exceeds supply  Behavioral disinhibition/risk compensation would compromise any decrease in incidence  Current testing system makes capturing acute infections difficult  Viral suppression may not be possible for everyone  Widespread treatment is unsustainable  Treatment initiation may take time. Unknown long term toxicities  Stigma and discrimination continue to exist Pro Con 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

Editor's Notes

  1. Synthesized all these data to develop cascade model; 79% of HIV+ people are aware 50% are not adequately engaged in care 60% of HIV+ individuals are not receiving regular HIV care because of deficits in diagnosis, linkage to care, or retention in care Of the remaining 40%, ~80% require ART, 75% of whom receive it ~80% of treated individuals have an undetectable viral load That’s just 19% of the HIV+ population in the US Not surprising that with >80% of the HIV+ population with detectable viral loads we have not seen a decrease in incidence
  2. Current estimates 90% diagnosed, other % remain the same 90% of HIV+ diagnosed are engaged in care 90% in care receive ART 90% of people on ART achieve viral suppression Assumes 90% known HIV diagnosis, 90% engagement in care, 90% receipt of ART, 90% achievement of undetectable viral load This demonstrates that improvement in any one component does not have a significant effect on the number of people achieving viral load suppression. Success of Test and Treat relies on the success of each component, by overcoming multiple sequential barriers. If an individual cannot overcome a specific barrier, they cannot move on the continuum and reach undetectable status. Improvement in the entire continuum of care is required for Test and Treat to substantially increase the proportion of HIV+ people with undetectable viral loads. Even if we reach 90% for all measures, ~34% of HIV+ individuals will still have a detectable viral load.
  3. HIV-infected number is estimate based on CDC estimate that 21% of HIV infected people do not know status. Number calculated by adding 21% to 15,753 of known HIV+. HIV-diagnosed, #linked and retained in care are from AACO surveillance data On ART and suppressed viral load #’s are estimated from Medical Monitoring Project data