Creating a Continuum of Care: The HIV Treatment Cascade in the

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Challenges of the

US Cascade of Care

Melanie Thompson, MD

AIDS Research Consortium of Atlanta

Georgia Department of Public Health

CHALLENGE #1: FINDING DATA TO

BUILD A CASCADE

The “Gardner Cascade”

Gardner E, et al. CID 2011:52 (Mar 15)

CDC Treatment Cascade (July, 2012)

HIV Care Cascade in Georgia, 2010

100

90

80

70

60

50

40

30

20

10

0

80

51

OOPS!

Diagnosed Linked to care Retained in care

Prescribed ART Viral

Suppression

Diagnosed 1,970 with HIV disease

Estimated 2,375 individuals with HIV disease (1,970 + 20%)

Linked 1,026 (51%) to care within 3 months of HIV diagnosis

Courtesy J. Kelly, GA Department of Public Health

The “Gardner Cascade”

79%

75%

50%

80%

75%

80%

Gardner E, et al. CID 2011:52 (Mar 15)

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Sources of Data:

HIV - Total and Diagnosed

• Total number of persons living with HIV in the US:

CDC

– Hall HI, Song R, Rhodes P, et al. Estimation of HIV incidence in the United

States. JAMA 2008; 300:520–9.

• Number of persons diagnosed with HIV in the US:

CDC

– Campsmith ML, Rhodes PH, Hall HI, Green TA. Undiagnosed HIV prevalence among adults and adolescents in the United States at the end of 2006. J

Acquir Immune Defic Syndr 2010; 53:619–24.

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Sources of Data: Linkage

• St. Louis, Missouri (1997–2002): 73% in HIV care within 1 year after HIV diagnosis

(Perkins)

• New York City: 64% in care within 3 months of new HIV diagnosis

(Torian)

• ARTAS: 60% receiving only passive referrals to care linked to HIV care within 6 months.

(Gardner)

• “In summary, we conclude that 75% of individuals with newly diagnosed HIV infection successfully link to HIV care within 6–12 months after diagnosis”

Perkins D, et al. AIDS Care 2008; 20:318–26.

Torian LV, et al. Arch Intern Med 2008; 168:1181–7.

Gardner LI, et al. AIDS 2005; 19:423–31

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Sources of Data: Retention

• Three population-based studies from the US:

45%–55% fail to receive HIV care during any year

(Perkins, Ikard, Olatosi)

• Multiple cohort studies: 25%–44% of HIV-infected individuals are lost to follow-up

(Hill, Arici, Coleman, Mocroft)

• “In summary, ~ 50% of known HIV-infected individuals are not engaged in regular HIV care.”

Perkins D, et al. AIDS Care 2008; 20:318–26.

Ikard K, et al. AIDS Educ Prev 2005; 17:26–38.

Olatosi BA, et al. AIDS 2009; 23:725–30.

Hill T, et al. J Clin Epidemiol 2010; 11:432–8.

Arici C, et al..HIV Clin Trials 2002; 3:52–7.

Coleman S, et al.. AIDS Patient Care STDS 2007;21:691–701.

Mocroft A, et al. HIV Med 2008; 9:261–9

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Source of Data: Need for ART

• In 2012, both DHHS and IAS-USA recommended that all persons with HIV be offered ART regardless of CD4 cell count

– Panel on Antiretroviral Guidelines for Adults, and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services, March 27, 2012: Available at: http:www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.

– Thompson MA, et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society-USA panel. JAMA

2012;308:387-402. doi:10.1001/jama.2012.7961.

• Therefore the number of persons “in need” of ART is the same as the number of persons living with HIV, whether diagnosed or undiagnosed

o

Source of Data: ART

• US (2003): 67% of HIV-infected persons in care were eligible for ART (CD4 cell count <350 cells/µL);, 21% of these were not receiving therapy

(Teshale)

• British Columbia: 89% of individuals in care required ART; 27% declined or failed to initiate therapy.

(Lima)

• “We estimate that 80% of in-care HIV-infected individuals in the United States should be receiving ART but that 25% of these individuals are not receiving therapy.”

Teshale E, et al. abstract 12th CROI. Boston, MA, USA: 2005.

Lima VD, et al. PLoS One 2010; 5:e10991.

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Source of Data: Viral Suppression

• 2 studies: 78%–87% of individuals receiving

ART, including those receiving initial and subsequent regimens, had an undetectable viral load

– Gill VS, Lima VD, Zhang W, et al. Improved virological outcomes in British Columbia concomitant with decreasing incidence of HIV type 1 drug resistance detection. Clin Infect Dis

2010; 50:98–105.

– Das M, Chu PL, Santos GM, et al. Decreases in community viral load are accompanied by reductions in new HIV infections in San Francisco.PLoS One 2010; 5:e11068.

• “ ~ 80% of treated individuals have an undetectable viral load (defined as < 50 copies/mL).”

0

CDC Cascade, 2011

MMWR, December 2, 2011;60(47);1618-23.

CDC Cascade Data Sources

• Linkage to care

– Marks G, et al. Entry and retention in medical care among HIV diagnosed persons: a meta-analysis. AIDS 2010:24:2665-78

– Torian, et al. (see previous)

• Retention in care

– Hall IH, et al. Retention in care of HIV-infected adults in 13 US areas. National HIV Prevention

Conference. Atlanta. August 14-17, 2011.

– Tripathi A, et al. The impact of retention in early HIV medical care on viro-immunological parameters and survival: a statewide study. AIDS Res Hum Retroviruses 2011;27;751-8.

• Antiretroviral prescription: Medical Monitoring

Project

• Viral suppression: Medical Monitoring Project

June 5, 2 012 www.annals.org

RECOMMENDATIONS:

ENTRY INTO/RETENTION IN CARE

 Systematic monitoring of successful entry into HIV care is recommended for all individuals diagnosed with HIV (IIA)

 Systematic monitoring of retention in HIV care is recommended for all patients (IIA)

 Brief, strengths-based case management for individuals with a new HIV diagnosis is recommended (IIB)

 Intensive outreach for individuals not engaged in medical care within 6 months of a new HIV diagnosis may be considered (IIIC)

 Use of peer or paraprofessional patient navigators may be considered (IIIC) www.iapac.org

CHALLENGE #2: STANDARDIZE THE

METRICS

IOM Metrics

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

Measure Numerator

HIV Positivity # HIV positive tests in 12-month period

Late HIV Diagnosis # persons with a dx of Stage 3 HIV (AIDS) within 3 mo of dx of HIV infection in 12-mos

Linkage to HIV

Medical Care

# who attended a routine HIV medical care visit within 3 months of HIV dx

Retention in HIV

Medical Care

Antiretroviral

Therapy (ART)

Viral Load

Suppression

Housing Status

7 Core HHS Indicator Measures

# with an HIV dx and at least 1 HIV medical care visit in each 6 mo period of the 24 mo measurement period, with a minimum of 60 days between the 1 st medical visit in the prior

6 mo period and the last medical visit in the subsequent 6 mo period

# with an HIV dx who are prescribed ART in 12 months

# with HIV diagnosis with a viral load <200 copies/mL at last test in the 12–month period

# with HIV diagnosis who were homeless or unstably housed in the 12-month period

Denominator

# HIV tests conducted in 12-mo

# persons with an HIV diagnosis in the 12-mos

# who attended a routine HIV medical care visit within 3 mo of

HIV dx

# with an HIV diagnosis with at least 1 HIV medical care visit in the first 6 mo of the 24‐mo measurement period

# with an HIV diagnosis with ≥ 1

HIV medical care visit in 12 mo

# with HIV diagnosis who had at least one HIV medical care visit in the 12-months

# with HIV diagnosis receiving

HIV services in the last 12 months

CHALLENGE #3: CASCADES DIFFER

BY CONTEXT

CDC Treatment Cascade (July, 2012)

CDC Treatment Cascade: Race

CDC Treatment Cascade: Age

CDC Treatment Cascade: Risk

CHALLENGE #4: IMPLEMENTATION

BARRIERS

Impact of Social Determinants of

Health on the Care Cascade

• Every step is affected by

– Stigma and discrimination

– Racism, homophobia

– Poverty

– Risk of criminalization

– High incarceration rates and difficulty with transition

– Housing instability

– Employment instability

– Co-existing conditions: substance use, mental health disorders

Increasing Diagnosis: Challenges

• Testing must be free and accessible

• Stigma deters testing

– Fear of loss of job, loss of insurance or increased premiums,

– Pre-existing conditions – ACA will address

– Rejection by family and friends, effect on children

– Domestic violence

• Mixed messages: high impact (targeted) testing vs “know your status”; funding streams dictate testing availability

• Home HIV testing: not inexpensive; how to track numbers and linkage?

• Fourth generation Ag-Ab testing will bring about increased need for surveillance and services for acute infection

Linkage and Retention: Challenges

• Barriers include Ryan White eligibility requirements for indigent populations

– Identity, income, residency, HIV status

• Transportation, child care

• Clinics only open when patients are at work; taking off work costs money, risks job

• Co-morbidities require seeing different doctors

• Frequent doctor visits = disclosure

• Co-pays

• Other life priorities, lack of education about why care is important

• Depression, substance use disorders

ART and Viral Suppression: Challenges

• Fear of toxicity

• Cost: high co-pays, high deductables,

Medicare donut hole

• Meds = disclosure

• Drugs for co-morbidities

• Potential drug interactions

• Lack of education about benefits

CHALLENGE #5: HOW WILL THE ACA

AFFECT THE CARE CASCADE?

What is Affordable Care?

• “Affordable” premiums are not the whole story

• High deductable plans are unaffordable for many

• High co-pays are often unaffordable and may lead to inconsistent drug access

• SU/MH benefits often minimal, if present

• Transportation not covered

• Case management not covered

When Insurance Isn’t Enough

• It is October

• Denise is a 38 yo black woman with a new HIV diagnosis with CD4 count of 675 cells/µL

• She works in a restaurant and has insurance

– Her insurance has a $2000 deductable

• She began EFV/TDF/FTC because of ease of use but could not tolerate EFV

• She changed to ATV/RTV + TDF/FTC but could not tolerate ritonavir

• She then started RAL + TDF/FTC

Lessons Learned: PCIP

• Most existing Ryan White clinics not prepared or structured to file for and receive insurance payments: patients on PCIP must seek other care providers

• Copays and deductables now paid by state RW funds may not be covered for ACA plans

• Traditional health insurance often does not provide wrap-around services: what will RW cover? Patients dependent upon these services

a few thoughts…

Recommendations

• Base cascades on real data: build systems to collect

• Need to coordinate with databases outside of public health: Medicare/Medicaid, Vital Statistics, pharmacy databases

• Need standard definition of each indicator (harmonize

IOM, HHS, HRSA, CDC)

• Need resources and guidance to assist local jurisdictions in creating their own care cascades

– Use cascade to monitor specific targeted populations over time: race/ethnicity, age, risk, gender

– Use local outcomes to build cascades of geographic areas: states, local jurisdictions, clinics, zip codes, census tracts

– Use cascade to educate and advocate

FUTURE RESEARCH RECOMMENDATIONS :

ENTRY INTO/RETENTION IN CARE

 Operational research to optimize / standardize measurement

 Comparative evaluation of monitoring strategies in conjunction with intervention studies

 Comparison of retention measures with one another

 Comparative evaluation of case management in community settings

 Comparative evaluation and cost effectiveness for best practices for implementation of case management interventions

 Comparative evaluation of other intervention approaches: peer support, patient navigation, health literacy, life skills

 Prospective evaluation of pay for performance interventions www.iapac.org

Recommendations

• We must fund wrap-around services, transportation, case management, patient navigation: RW safety net for insured patients

• We must have an ARV safety net

– Coverage for deductables and ARV co-pays for persons with private insurance who meet criteria

• We must have a safety net for undocumented persons who will not be accepted in Medicaid expansion programs

Back Up Slides

IOM Standards

• Proportion of people newly diagnosed with HIV with a CD4+ cell count

>200 cells/mm3 and without a clinical diagnosis of AIDS

• Proportion of people newly diagnosed with HIV who are linked to clinical care for HIV within 3 months of diagnosis

• Proportion of people with diagnosed HIV infection who are in continuous care (two or more visits for routine HIV medical care in the preceding 12 months at least 3 months apart)

• Proportion of people with diagnosed HIV infection who received two or more CD4 tests in the preceding 12 months

• Proportion of people with diagnosed HIV infection who received two or more viral load tests in the preceding 12 months

• Proportion of people with diagnosed HIV infection in continuous care for 12 or more months and with a CD4+ cell count ≥350 cells/mm3

• Proportion of people with diagnosed HIV infection and a measured

CD4+ cell count <500 cells/mm3 who are not on ART

• Proportion of people with diagnosed HIV infection who have been on

ART for 12 or more months and have a viral load below the level of detection

• All-cause mortality rate among people diagnosed with HIV infection

Supportive services

• Proportion of people with diagnosed HIV infection and mental health disorder who are referred for mental health services and receive these services within 60 days

• Proportion of people with diagnosed HIV infection and substance use disorder who are referred for substance abuse services and receive these services within 60 days

• Proportion of people with diagnosed HIV infection who were homeless or temporarily or unstably housed at least once in the preceding 12 months

• Proportion of people with diagnosed HIV infection who experienced food or nutrition insecurity at least once in the preceding 12 months

• Proportion of people with diagnosed HIV infection who had an unmet need for transportation services to facilitate access to medical care and related services at least once in the preceding 12 months

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