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					                                  Slide #1




Routine HIV Testing: Rationale,
Opportunities, and Challenges
     Kenneth H. Mayer, MD
      Professor of Medicine and
         Community Health
          Brown University
                                                      Slide #2

Who are you routinely testing for HIV in your practice?
1. Sexual partners of your HIV- infected patients
2. HIV-uninfected patients in your practice who
present with a new std
3. HIV- uninfected patients in your practice who
present with tuberculosis
4. HIV-uninfected patients in your practice with a fever
of unknown origin
5. All patients in your practice aged 13-64 years old
who have never been tested for HIV?

                                  Only 1
                                  1 and 2
                             All of the above
                        Not doing routine testing.
Slide #3
                                                             Slide #4
   September 22, 2006 CDC Recommendations:
           Routine Testing for HIV-1

                                  • Routine voluntary testing for
                                    patients ages 13-64 in
                                    healthcare settings – not
                                    based on patient risk

                                  • Opt-out testing

                                  • No separate consent for HIV

                                  • Pretest counseling not
                                    required

                                  • Repeat HIV testing left to
                                    discretion of provider, based
                                    on patient risk

MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17
Slide #5
Slide #6
                             Slide #7




Antiretroviral treatment decreases
         HIV transmission
                                                                             Slide #8
             Over 25% of HIV-Infected
             Americans Are Unaware

                          U.S. Population (13-64 yrs)
                                 200 million

                                HIV+ Population
                                   1.2 million




                                                              250,000- 312,000
                                                               HIV+ Unaware
                                                         (>0.1% of U.S. Population)
Glynn MK and Rhodes P, “Estimated HIV Prevalence in the United States at the end of
2003.” Presentation at the 2005 National HIV Prevention Conference, June 14, 2005.
                                                                             Slide #9

 Late HIV Testing Is Too Common
• Among 4,127 persons with AIDS1, 45% were first
  diagnosed HIV + within 12 months of AIDS diagnosis
• Late testers, compared to those tested early
  (> 5 yrs before AIDS dx.) were:
       – Younger, heterosexual, less educated, of color
• Late testers have increased mortality
       – In NYC, 25% pts diagnosed with AIDS with first HIV test
           • Median survival post-AIDS is 4 months2
• Mean survival 24.2 years when therapy initiated
  before CD4 < 200 cells/mm3
1.16states, CDC. MMWR. 2003;52:581-586; 2.Hanna, et. al., poster 925, CROI 2006;
3.Schackman B et al. Med Care 2006. 44:990-997.
                                                    Slide #10
          Missed Opportunities for HIV
              Diagnosis and Care
  41% of 4,315 South Carolina AIDS cases
    diagnosed within 12 months of 1st HIV test
          • 73% of late testers had at least one health care
            visit prior to 1st HIV test
          • 79% of visit diagnoses would not have
            prompted an HIV test
      – Median of 4 visits prior to 1st HIV test
      – Visit locations 79% ER, 12% inpatient, 7%
        outpatient, 1% free clinic
      – 36% heterosexual, 26% MSM, 7.8% IDU
* Dufus, MMWR, December 1, 2006
                                                                         Slide #11
                           HIV Incidence in U.S.
                           Over 25 Years of AIDS
                 180,000

                 160,000   Pre-ARV     ARVs, pre-HAART   Decade of HAART
                 140,000
HIV Incidence




                 120,000

                 100,000

                 80,000

                 60,000

                 40,000

                 20,000

                    000



                                              Year
                 40,000 infections annually despite improvements in therapy!
                                                                                  Slide #12
     Awareness of Serostatus Among People
     with HIV and Estimates of Transmission
                 100%                       Account for:
                              ~25%
                  90%       Unaware
                                of
                  80%       Infection                              ~54%
                                                                  of New
                  70%                                           Infections

                  60%
                  50%
                               ~75%
                  40%        Aware of
                             Infection                             ~46%
                  30%                                             of New
                                                                Infections
                  20%
                  10%
                   0%
                            People Living                       New Sexual
                            with HIV/AIDS                  Infections Each Year
Marks G, et al AIDS, 2006
      Normalizing Routine HIV                Slide #13


       Testing: Key Strategies

• Increase opportunities for testing
  Make HIV testing routine part of medical care
• Utilize accurate, rapid tests
  Provide new opportunities for early diagnosis
• Normalize HIV testing
  Help identify infections and triage into care
• Promote awareness of serostatus
  Help prevent new infections
  Prevention for positives
           Challenges for Routine
                                                 Slide #14



            Opt-out HIV Testing
• Stigma and discrimination
    Normalizing testing could decrease
• Patient awareness
    Provider responsibility to inform, educate
•   Lose possible benefit of counseling
•   Perceived coercion, privacy, civil liberties
•   Legal issues
•   Resources to pay for more testing and care
•   Insurers’ disincentive to know
     HIV Infection: Economic
                                            Slide #15



    and Demographic Realities

• PLHIV compared to general US population
  – Unemployed                  62% vs 5%
  – Income < $10,000/yr         45% vs 8%
• Source of insurance for PLHIV
  – Medicaid or Medicare        50%
  – Uninsured                   20%
• Ryan White Care Act
• Demographics of new infections
  – African Americans, MSM, young people
Slide #16
                                                                 Slide #17

HIV Testing: Legal Considerations

•   Issues concerning HIV testing policies vary by state,
    insurer, and sometimes employer
       eg, Medicare, military
       Confidentiality and access to care are governed by a
        wide range of federal and state laws
•   Title VII of the Civil Rights Act prohibits discrimination
       Concern that greatly expanded testing will test more
        people of color without an increase in linkage to care
•   Ethical considerations
       Public health ethics dictate that the primary beneficiary
        has to be those who are screened
       Programs must include sufficient $ and case
        management to ensure access to care
                                                  Slide #18

HIV Testing: Legal Considerations

• Testing HIV + has implications that can
  affect people’s livelihood and legal status
   Federal agencies may exclude or restrict
    employment/licensing of people with HIV
   Restrictions on the practice of HIV+ HCW
   Criminalized sexual activity of people with PLHIV
• Current HIV testing laws protect providers
  from liability as well as patients
• New guidelines may require amending some
  state laws
                                        Slide #19

  Opt-Out and Informed Consent

• Written informed consent is a legal
  process
• Patient education is an ethical and clinical
  responsibility
• Locally specific training needed for HCW to
  adapt new testing and consent
  requirements
• Informed consent can be secured in a
  number of ways, with modest time
  investment
• Chart documentation can be helpful
                                                                     Slide #20

 Where is HIV Testing Currently Performed?

                                               HIV tests*   HIV+ tests**


   Private doctor/HMO                            44%           17%
   Hospital, ED, Outpatient                      22%           27%
   Community clinic (public)                      9%           21%
   HIV counseling/testing                         5%            9%
   Correctional facility                         0.6%           5%
   STD clinic                                    0.1%           6%
   Drug treatment clinic                         0.7%           2%

*National Health Interview Survey, 2002
**Suppl. to HIV/AIDS surveillance, 2000-2003
                                                  Slide #21

 Routine HIV Testing in Hospitals

• Inpatient HIV testing is cost effective
 - Without routine screening, 53% of HIV diagnoses are
    because of opportunistic infections
 - This can be reduced to 38% with routine screening
• Testing costs don’t matter
 Cost-effectiveness of HIV screening is linked to the
 costs of providing care, not the test cost
• Importance of linkage to care
 Testing programs that have higher rates of linking
 patients to care are more economically efficient than
 those that only test.*
*Walensky. Med Decis Making. 2005;25:321
                                       Slide #22
   Opt-Out HIV Testing: Operational
Challenges in the Emergency Department

• EDs serve as a safety net with a large
  volume of patientsoften minority,
  uninsured, substance users
• Relatively high prevalence of HIV
  infection among patients in EDs
  (roughly 10% at Johns Hopkins ED)
• Pts may wait for long periods:
  opportunity for education about testing
• New educational approaches are being
  studied, e.g. videos
                                       Slide #23
The Community Health Center (CHC)
 Perspective: Issues and Challenges
• Health centers provide ¼ of all
  ambulatory care for uninsured patients
• CHCs have higher HIV prevalence
  2.4% vs 1.2% at all testing sites
• Highest rate of follow-up with 95% of
  clients receiving test results
• Challenges: access to primary care
  providers, HIV specialists, HIV
  medications, and funding
• Routine HIV testing will further stress
  CHC system
                                             Slide #24
      Routine Testing and an
 Already Stressed HIV Care System
• University of Alabama, Birmingham
  Current cost/year/patient = $18,000
      Drugs: $10,000
      Provider + clinic: $359/yr


• HIV Medicine Association: 2006 survey of 800
  clinics with 500-1500 patients
   – 40% report difficulty recruiting physicians
   – 85% had < 25% capacity to increase

  (Saag et al, 2007)
         Ryan White Care Act:                   Slide #25


      Ensuring Access to HIV Care
• $ distributed by local AIDS/HIV prevalence
  –   Discretionary program to fill gaps
  –   72% racial minorities, 33% women
  –   79% uninsured/underinsured, and/or public aid
  –   40% for drugs; 25% for medical care

• Challenges
  –   Increasing demand with growing HIV prevalence
  –   Prioritizing primary care services
  –   “Robbing Peter to pay Paul”
  –   Expanding access to life-saving medications
     Medicare and Medicaid:
                                               Slide #26



 Reimbursement for HIV Testing
Medicaid
   Largest source of federal $ for HIV care
   Covers 50% PLHIV
   Routine testing is optional under federal law
   Testing policies are state-dependent
Medicare
   Adding new testing requires Congress
   Routine HIV screening would apply only to
    6.8 million receiving disability beneficiaries
                                      Slide #27
 What Happened and What Would Have Happened
      Without Prevention Services in Place?




D. Holtgrave, 2006
                                               Slide #28

   Optimizing HIV Prevention Interventions

• Individual, small group, and community
  based interventions decrease HIV risk
  behavior1
• HIV risk behavior and infection occurs in a
  context of other psychosocial problems2
• To be maximally effective, interventions
  should address substance use, depression,
  past abuse, and violence
1http://www.cdc.gov/hiv/projects/rep

 2Stall,   R. et al (2003) AJPH, 93, 939-942
                                              Slide #29

   ELEMENTS OF SUCCESSFUL PREVENTION
               INTERVENTIONS
1. Information/education (not sufficient itself)
2. Motivation enhancement
3. Skills training
4. Social cognitive theory: increase self-efficacy
5. Theory of reasoned action: change norms and
   attitudes
6. Health belief model (benefits and barriers to
   health behaviors, perceived susceptibility)
7. Transtheoretical model (stages of change)
                                               Slide #30
    Routine Opt-Out Testing for HIV:
     Questions for the Road Ahead
• Are sufficient systems in place to ensure non-
  coercion, non-discrimination?
• Can barriers to routine testing be removed?
• Will the influx of newly diagnosed patients have
  access to care and treatment?
• Will the dramatic increases in funding required
  to increase clinical capacity be provided?
• Can care and prevention be optimized if
  comprehensive HIV primary care is not funded?
• Will we have sufficient numbers of skilled
  professionals to do the work?
                                                Slide #31

Routine HIV Testing: Conclusions

• Benefit of HIV treatment is evidence-based
    Reduces morbidity and mortality
      Early treatment better than late treatment
   Is cost-effective
• HIV diagnosis is too often late
•   HIV+ aware people may be less likely to transmit
•   HIV tests are improved (near perfect) and rapid
•   Routine HIV testing is cost-effective
•   Routine testing = fewer missed opportunities
•   But, even among those who know HIV status
    and are in care, 50% of those who need HAART are
    on treatment
                          Slide #32

 THE NEW PARADIGM




INEXTRICABLY INTERWOVEN