Challenges of the US Cascade of Care

1. Challenges of the US Cascade of Care Melanie Thompson, MD AIDS Research Consortium of Atlanta Georgia Department of Public Health

2. Challenge #1: finding DATA to build a cascade

3. The “Gardner Cascade” Gardner E, et al. CID 2011:52 (Mar 15)

4. CDC Treatment Cascade (July, 2012)

5. HIV Care Cascade in Georgia, 2010 OOPS! 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

6. The “Gardner Cascade” 79% 75% 50% 80% 75% 80% o Gardner E, et al. CID 2011:52 (Mar 15)

7. 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. o

8. 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 o

9. 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 o

10. 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

11. 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. o

12. 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

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

14. 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

15. June 5, 2012www.annals.org

16. 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)

17. Challenge #2: standardize the METRICS

18. IOM Metrics

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

20. 7 Core HHS Indicator Measures

21. Challenge #3: Cascades differ by context

22. CDC Treatment Cascade (July, 2012)

23. CDC Treatment Cascade: Race

24. CDC Treatment Cascade: Age

25. CDC Treatment Cascade: Risk

26. Challenge #4: Implementation barriers

27. 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

28. 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

29. 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

30. 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

31. Challenge #5: How Will the ACA Affect the Care Cascade?

32. 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

33. 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

34. 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

35. a few thoughts…

36. 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

37. 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

38. 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

40. Back Up Slides

41. 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

42. 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

43. 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