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Title: CDC's Revised Recommendations for HIV Testing in HealthCare Settings and Implications for California


1
CDC's Revised Recommendations for HIV Testing in
Health-Care Settings and Implications for
California
  • Christopher Hall, MD, MS
  • California STD/HIV Prevention Training Center
  • Chief, Clinical Affairs
  • STD Control Branch
  • CA Department of Health Services

2
Estimated Number of U.S. AIDS Cases, Deaths, and
Persons Living with AIDS,1985-2004
450
90
AIDS
1993 definition
implementation
400
Deaths
80
Prevalence
350
70
60
300
No. of cases and deaths (in thousands)
250
50
Prevalence (in thousands)
200
40
150
30
20
100
10
50
0
0
Year of diagnosis or death
Note. Data adjusted for reporting delays.
Courtesy of Branson - CDC
3
HIV Incidence and CDCsHIV Prevention
Budget(1983 Dollars), US, 1978-2006
HIV incidence
CDC HIV prevention budget
180,000
500,000,000
450,000,000
160,000
400,000,000
140,000
350,000,000
120,000
300,000,000
100,000
250,000,000
80,000
200,000,000
60,000
150,000,000
40,000
100,000,000
20,000
50,000,000
000
-
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
Year
Courtesy of Holtgrave JHU 2/07
4
Awareness of HIV Status among Persons with HIV,
United States
Number HIV infected 1,039,000
1,185,000 in California
150,000 Number unaware of their HIV
infection 252,000 - 312,000 (24-27)
in California
37,500 Estimated new infections
40,000 annually in California
6,000
Glynn M, Rhodes P. 2005 HIV Prevention Conference
5
Awareness of Serostatus Among People with HIV
and Estimates of Transmission
Accounting for
25 Unaware of Infection
54 of New Infections
Marks, et al AIDS 2006 20 1447-50
75 Aware of Infection
46 of New Infections
People Living with HIV/AIDS 1,039,000-1,185,000
New Sexual Infections Each Year 32,000
6
Rapid HIV Testing Oral fluid samples
Collecting oral fluid specimen for rapid HIV
testing. (FDA cleared. CLIA waived.)
7
Many Undergoing ConventionalHIV Testing Do Not
Return for Test Results
  • Researchers from the California Office of AIDS
    reviewed more than 101,000 records from the
    statewide HIV CT program in 2005
  • More than a quarter of 68,000 clients who were
    given a conventional HIV test did not return for
    test results
  • Of the 33,000 clients who received the rapid
    test, only 2.3 percent failed to get their test
    results
  • Of the 1,045 clients testing positive for HIV,
    623 took the conventional test 136 (22 percent)
    did not return for their test results
  • 422 took the rapid test only six (1.4 percent)
    left the office before receiving test results

UCSF-OA, Intl AIDS Conf 2006
8
Expansion of HIV Testingin the Health-care
Setting
Revised Recommendations for HIV Testing of
Adults, Adolescents, and Pregnant Women in
Health-Care Settings MMWR Sept 200655 (RR14)
1-17
9
Rationale forRevising Recommendations
  • Many HIV-infected persons access health care but
    are not tested for HIV until symptomatic
  • Effective treatment available
  • Awareness of HIV infection leads to substantial
    reductions in high-risk sexual behavior
  • Inconclusive evidence about prevention benefits
    from typical counseling for persons who test
    negative
  • Great deal of experience with HIV testing,
    including rapid tests

Courtesy of Branson - CDC
10
Terminology
  • Screening performing an HIV test for all persons
    in a defined population
  • Diagnostic testing performing an HIV test based
    on clinical signs or symptoms
  • Targeted testing performing an HIV test on
    subpopulations of persons at higher risk based on
    behavioral, clinical or demographic
    characteristics
  • Opt-out screening performing an HIV test after
    notifying the patient that the test will be done
    consent is inferred unless the patient declines

11
Terminology, cont
  • Informed consent process of communication
    between patient and provider through which the
    patient can participate in choosing whether or
    not to undergo HIV testing
  • HIV prevention counseling interactive process to
    assess risk, recognize risky behaviors, and
    develop a plan to take steps that will reduce
    risks

12
Objectives of Recommendations
  • Increase HIV screening in health-care settings
  • Foster earlier detection of HIV infection
  • Identify and counsel persons with unrecognized
    HIV infection
  • Link HIV-infected persons to clinical and
    prevention services
  • Further reduce perinatal HIV transmission

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
13
HIV Testing Recommendations for Adults and
Adolescents
  • Routine HIV screening for all patients aged13-64
    years, in all health-care settings
  • Unless prevalence of undiagnosed HIV infection in
    that setting is documented to be lt0.1
  • Health-care settings include
  • Emergency departments
  • Urgent care clinics
  • Primary care settings
  • Inpatient services
  • Corrections health-care facilities
  • TB clinics
  • STD clinics
  • Substance use clinics
  • Public health clinics
  • Community clinics

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
14
Repeat Screening
  • At least annually for all persons at high risk of
    HIV infection
  • Injection-drug users (IDUs)
  • Sex partners of IDUs
  • Persons who exchange sex for money or drugs
  • Sex partners of HIV infected
  • Men who have sex with men (MSM)
  • Heterosexuals who themselves or their sex
    partners have had gt1 sex partner since last HIV
    test
  • Before new sexual relationship

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
15
Consent and Pretest Information
  • Screening should be voluntary and free of
    coercion, undertaken only with patients
    knowledge and understanding

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
16
Consent and Pretest Information
  • Opt-out screening HIV testing will be performed
    unless patient declines
  • Patient should be notified (orally or in writing)
    about HIV testing information should include
    explanation of HIV infection, meaning of and
    results
  • Patient should be offered the opportunity to ask
    questions
  • Patient permitted to decline testing
  • Consent should be incorporated into patients
    general informed consent for medical care, as for
    other screening or diagnostic tests
  • Separate consent for HIV testing not recommended

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
17
Consent and Pretest Information
  • Informational materials should be easy to
    understand and available in languages of the
    populations served
  • Competent interpreters and bilingual staff should
    be available
  • If a patient declines an HIV test, this decision
    should be documented in the medical record

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
18
Communicating HIV Test Results
  • Negative HIV test results can be conveyed without
    direct personal contact
  • Persons at high risk for HIV infection should be
    advised to be retested periodically and should be
    offered prevention counseling
  • Positive HIV test results should be communicated
    confidentially, through personal contact
  • Friends or family members should not be used as
    interpreters
  • Patients should be linked to clinical care,
    counseling, support, prevention services

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
19
Documenting HIV Test Results
  • Positive or negative HIV test results should be
    documented in the patients confidential medical
    record and should be available to all of her
    health-care providers
  • The HIV test result of a pregnant woman also
    should be documented in her infants medical
    record

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
20
Partner Counseling and Referral
  • Providers should strongly encourage HIV-infected
    patients to disclose their HIV status to current
    and previous sex partners and recommend they be
    tested for HIV infection
  • Health departments can assist by notifying,
    counseling, and providing HIV testing for
    partners without disclosing the patients
    identity
  • Health departments may contact patients who
    receive a new diagnosis of HIV infection to
    discuss partner notification

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
21
Prevention Services forHIV-Negative Persons
  • HIV screening should not be based solely on
    assessment of patients HIV risks
  • But, risk assessment and prevention information
    should be incorporated into routing primary care
    of all sexually active persons
  • Prevention counseling should not be required as
    part of HIV screening programs in health-care
    settings
  • However, HIV testing presents excellent
    opportunity for prevention counseling
  • Persons with HIV risk behaviors should be
    provided with or referred to HIV risk-reduction
    services
  • In settings that serve patients at high risk for
    HIV, prevention counseling should be available
    (there or through referral)

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
22
Role for Rapid HIV Tests
  • Increase receipt of test results
  • Increase identification of HIV-infected pregnant
    women so they can receive effective prophylaxis
  • Increase feasibility of testing in acute-care
    settings with same-day results
  • Increase number of venues where testing can be
    offered to high-risk persons

Courtesy of Branson - CDC
23
Multispot HIV-1/HIV-2
Uni-Gold Recombigen
Reveal G2
OraQuick Advance
Courtesy of Branson - CDC
24
Performance of Rapid HIV Tests
Specificity (95 C.I.)
Sensitivity (95 C.I.)
100 (99.7-100) 99.8 (99.6 99.9) 99.9
(99.6 99.9)
99.6 (98.5 - 99.9) 99.3 (98.4 - 99.7) 99.6 (98.5
- 99.9)
OraQuick Advance - whole blood - oral
fluid - plasma
99.7 (99.0 100) 99.8 (99.3 100)
100 (99.5 100) 100 (99.5 100)
Uni-Gold Recombigen - whole blood -
serum/plasma
Courtesy of Branson - CDC
25
Regulatory and Legal Considerations
  • These CDC recommendations do not supersede state
    and local laws that govern HIV testing
  • Legal requirements related to informed consent
    and pretest counseling differ among states
  • Certain states, jurisdictions, or agencies (such
    as CA) do not now allow opt-out screening or may
    impose specific requirements for counseling,
    consent, confirmatory testing, or communicating
    HIV test results
  • Local jurisdictions should consider strategies to
    implement these recommendations within local
    parameters and to resolve conflicts with these
    recommendations

MMWR Sept 2006 55 (RR14) 1-17 - AETC NRC 1/07
26
Consent and California Law
  • Specific written consent for HIV testing is
    required
  • EXCEPT physicians and surgeons may obtain
    verbal consent
  • Opt-out not permitted in CA under existing law
  • Prevention counseling not required except in
    prenatal settings and state-funded counseling and
    testing sites

CA Health and Safety Code Sec. 120990 Clanon
PAETC 2/07
27
TB Treatment GuidelinesControlling TB ATS,
CDC, IDSA
  • Treatment of Tuberculosis Disease
  • Roles and Responsibilities of Jurisdictional
    Public Health Agencies
  • Counseling and voluntary testing for HIV
    infection should be offered to all persons with
    suspected and proven TB and to certain persons
    with LTBI, with referral for HIV treatment
    services when necessary.
  • Voluntary counseling and testing for HIV is
    recommended for all patients with TB.

MMWR. November 4, 2005 / Vol. 54 / No. RR-12
28
TB Treatment GuidelinesCA TB Controllers Assn
Joint Guidelines 4/03
  • Treatment of Tuberculosis Disease1
  • II. Diagnosis
  • D. An HIV test should be performed, with
    informed consent, at the time of diagnosis for
    all patients suspected of having TB, as both
    treatment and prognosis may be significantly
    impacted by HIV infection.
  • Management of Contacts2
  • HIV testing should be offered to all contacts
    who do not know their HIV status.

1. CA TB Controllers Assn Joint Guidelines
4/03 2. MMWR. December 16, 2005, Vol. 54/No. RR-15
29
HIV Testing in TB ClinicsCalifornia
  • In 2003, HIV testing was performed for lt50 of
    patients reported with TB in the United States,
    and only 63 of persons in the age group at
    greatest risk (persons aged 25-44 years) were
    tested.1
  • In California in 2002, 4 TB programs evaluated to
    assess determination of patients HIV status
    (n252)2
  • 29 (11.5) known to be HIV on intake
  • 193 (86.5) had HIV counseling documented
  • 128 (57.4) were tested
  • 14 (9.7) refused testing
  • 2 (of 4) sites had written policy for HIV
    counseling and testing
  • CDC. Reported tuberculosis in the United States,
    2003. 2004
  • 2. Lawton/Miller CDHS, 2006

30
Practical Issues for TB ProgramsPre- and
Post-test Counseling
  • Counseling is not required for HIV testing in
    medical settings, outside of state-funded
    counseling and testing programs and in pre-natal
    settings
  • Patients should receive culturally and
    linguistically appropriate information about HIV
  • Patients at higher risk should be counseled, if
    possible, or referred to appropriate counseling
    services

HIV Testing for TB Cases, Suspects, and Contacts
in CA. CDHS-TBC 2007
31
Practical Issues for TB ProgramsCommunication of
Positive Results
  • The clinician should provide the positive test
    result in person
  • Prevention counseling should be provided or,
    alternatively, active referral to local HIV/AIDS
    program provided
  • Linkage to care is essential
  • TB case manager responsible for ensuring
    effective referrals
  • The CA Office of AIDS can provide lists of local
    prevention and care providers

HIV Testing for TB Cases, Suspects, and Contacts
in CA. CDHS-TBC 2007
32
Practical Issues for TB ProgramsRelationship to
State-funded HIV Test Sites
  • The local TB control program may either include
    an HIV test as part of routine medical evaluation
    or utilize state-funded HIV counseling and
    testing sites
  • Existence of sites should not hinder TB control
    program efforts to ensure determination of HIV
    status of its patients
  • Counseling requirements of state-funded HIV
    counseling and testing sites do not apply to HIV
    testing conducted in medical settings
  • Revised recommendations do not modify existing
    reimbursement procedures at state-funded sites

HIV Testing for TB Cases, Suspects, and Contacts
in CA. CDHS-TBC 2007
33
Selected Best Practices for TB Programs
  • Provide TB cases, suspects, and contacts with
    information on importance of knowing HIV status
  • Adopt a policy for offering HIV testing routinely
    to clinic patients with unknown HIV status
  • Develop a written HIV testing and referral
    protocol
  • Ensure TB control program staff implement
    protocol by instituting a quality improvement
    program
  • Ensure newly HIV-diagnosed patients actively
    referred to care, PCRS, and other services

HIV Testing for TB Cases, Suspects, and Contacts
in CA. CDHS-TBC 2007
34
Controversial Issues related toCDC Revised
Recommendations
  • Cost effectiveness of routine testing
  • Who will pay for testing?
  • Will de-linking of counseling lead to increases
    in unsafe behaviors
  • Some prevention strategies do not rely primarily
    on individuals knowledge of HIV status
  • Greater burden on existing HIV care delivery
    systems
  • Will the effect of the revised recommendations be
    evaluated?

35
Summary
  • Recommendations Revised September 2006
  • Increase the number of persons aware of their
    HIV-infection status
  • Including those with TB and their contacts
  • Expand routine, voluntary, HIV screening in
    health care settings
  • Streamline consent procedures as allowed by law
    and regulation
  • Testing in health-care settings de-linked from
    counseling, but
  • Brief counseling linkage to care and
    disclosure services are key public health
    interventions

36
Resources on HIV Testing Recommendations
  • www.cdc.gov/hiv/topics/testing
  • www.aidsetc.org
  • www.aidsinfo.nih.gov
  • www.stdhivtraining.org
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