To Test or Not To Test
August 25, 2011
Paul McGaha, D.O., M.P.H.
Regional Medical Director
Texas Department of State Health Services
Tyler, TX
DISCLOSURE STATEMENT
Conflict of Interest
I have no real or perceived vested interests
that relate to this presentation nor do I
have any relationships with
pharmaceutical companies, biomedical
device manufacturers, and/or other
corporations whose products or services
are related to pertinent therapeutic areas
DISCLOSURE STATEMENT
Commercial support
There is no commercial company support for this CNE
activity
Non-Endorsement of Products
The Center for Health Training approval status refers
only to continuing nursing education activities and does
not imply that there is a real or implied endorsement of
any product, service, or company referred to in this
activity nor of any company subsidizing costs related to
the activity
Off-Label Product Use
This CNE activity does not include any unannounced
information about off-label use of a product for a purpose
other than that for which it was approved by the Food
and Drug Administration (FDA)
LEARNING OBJECTIVES
At the conclusion of this training, participants
will be able to…
• Describe the impact of HIV in East Texas
• Discuss the 2006 CDC Revised
Recommendations for HIV Testing
• Recognize the benefits of implementing
routine opt-out testing
• Explain the ethical issues related to routine
HIV testing in medical settings
Make HIV Testing Routine
in Your Practice
HIV/AIDS in the USA
• An estimated 1,039,000 to 1,185,000
persons are living with HIV/AIDS
• 56,300 new HIV infections annually
73% among males
45% among African Americans
34% among individuals ages 13-29
Since the first cases
were diagnosed 30 years ago •Over 576,000 Americans have lost their
lives to AIDS
•More than 56,000 people in the US become
infected with HIV each year
•There are more than 1.1 million Americans
living with HIV – 1 in 5 (21%) are unaware
of their infection
•Almost half of all Americans know someone
living with HIV
Only compose 12% of US population
Texas’ Major Infectious Disease
Challenges: HIV/AIDS
• Between 2002 - 2008, the number of living HIV/AIDS
cases in Texas rose ~6% a year
• During the same period, new HIV diagnoses stayed
stable at ~4,500 per year, and deaths at ~1,200 year
• In 2008, the rate among blacks was 4 - 5 times
higher than the rates in whites and Hispanics
– Blacks also had the highest number and rate of newly
diagnosed infections
9
Newly Diagnosed HIV Cases, Deaths, &
Persons Living with HIV (Texas, 1980-2008)
70000
New HIV Cases / Deaths
7000
Living with HIV
6000
5000
60000
50000
New HIV Cases
40000
4000
30000
3000
20000
2000
10000
1000
Deaths among HIV Cases
0
0
80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08
Year
10
Persons Living with HIV
8000
Newly-diagnosed HIV Case Rates by
Race/Ethnicity: Texas, 1999-2009
100
Hispanic
Cases per 100,000
90
Black
White
80
70
60
50
40
30
20
10
0
99
00
01
02
03
04
05
Year of Diagnosis
06
07
08
09
Newly-diagnosed HIV Cases*:
Texas, 1999-2008
7000
AIDS
HIV
6000
Cases
5000
4000
3000
2000
1000
0
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
Year
* AIDS cases were diagnosed with AIDS within 1 month of HIV diagnosis
13
Percent of Total HIV Diagnoses that were Late
Diagnoses* by Race/Ethnicity and Sex, Texas 2009
40%
Male
29%
Percent (%)
30%
23%
18%
20%
Female
20%
22%
16%
10%
0%
Black
White
*AIDS diagnosis occurred within 1
Hispanic
month of HIV diagnosis
Newly-diagnosed HIV Cases by
Race/Ethnicity: Texas, 2008
Texas Population
n=24,383,647
New HIV Cases
n=4,293
White
29%
48%
43%
11%
36%
Black
Hispanic
26%
5%
Other/Unknown
2%
15
Smith County HIV/AIDS Trends – 2010
▪ 309 persons living with
HIV/AIDS in Smith County
through 12-31-10
▪
▪
20 New cases of HIV
were reported in Smith
County in 2010
7,
35%
13,
65%
male
female
4 New cases of AIDS
were reported in Smith
County in 2010
Gender
Males (13)
Females (7)
Race
African American (14)
White (4)
Hispanic (1)
Unknown (1)
4,
20%
African
American
White
1,
1, 5%
5%
Hispanic
14,
70%
Unknown
Gregg County HIV/AIDS Trends – 2010
▪ 330 persons living with
HIV/AIDS in Gregg County
through 12-31-10
▪ 25 New cases of HIV
were reported in Gregg
County in 2010
11,
44%
14,
56%
male
female
▪ 6 New cases of AIDS
were reported in Gregg
County in 2010
Gender
Males (14)
Females (11)
Race
African American (17)
White (5)
Hispanic (2)
Unknown (1)
African
American
White
1,
2, 4%
8%
5,
20%
74,
68%
Hispanic
Unknown
Smith County – New HIV Cases by Race & Sex
2010 (n = 20)
Gregg County – New HIV Cases by Race & Sex
2010 (n = 25)
Smith County – Newly Reportable HIV Cases
2003 - 2010
30
28
27
25
23
20
21
20
20
2009
2010
20
14
15
10
5
0
2003
2004
2005
2006
2007
2008
Gregg County – Newly Reportable HIV Cases
2003 - 2010
40
34
35
31
31
30
25
25
21
20
18
18
16
15
10
5
0
2003
2004
2005
2006
2007
2008
2009
2010
“Late” HIV Testing is Common
• Among 4,127 persons with AIDS*, 45% were
first diagnosed HIV-positive within 12 months of
AIDS diagnosis (“late testers”)
• Late testers, compared to those tested early (>5
yrs before AIDS diagnosis) were more likely to
be:
Younger (18 -29 yrs)
Heterosexual
Less educated
African American or Hispanic *16 states
The Problem
• Every 9 ½ minutes someone in the U.S. is
infected with HIV
• More than 20% of those living with HIV do
not know it
• Late diagnosis contributes to:
– Poor outcomes, decreased productivity, and
early death
– Increased health care costs
– More transmission of HIV
Late HIV diagnosis contributes to:
• Poor outcomes, decreased productivity,
and early death;
• Increased health care costs; and
• More transmission of HIV
http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5506a1.htm?s_cid=ss5506a1_e
The Facts
• Persons who do not know they are
infected with HIV may be responsible for
more than half of new transmissions
• Most of those unaware of their infection
visit a health care facility but are not tested
for HIV
Effect of Awareness on Transmission
~25%
Accounts for
Unaware of
Infection
~75%
Aware of
Infection
~54%
of New
Infections
Marks, et al
AIDS 2006;20:1447-50
~46% of
New
Infections
People with HIV/AIDS:
1,039,000-1,185,000
New Sexual Infections
Each Year: ~32,000
The Facts
• 1 out of 3 HIV infected Texans are
diagnosed with AIDS within one year of
their HIV diagnosis.
The Facts
• Hospitals, community clinics, and doctor’s
offices account for more than half of all
HIV diagnoses in Texans.
The Facts
• Routine HIV testing in multiple major
emergency departments has identified
new HIV infections that would have
normally been missed.
The Solution
• Implement routine HIV testing in all health
care settings per the 2006 CDC
Recommendations MMWR 2006; 55 (RR14); 1-17
• Establishing early care for HIV positive
patients results in better survival gains
than chemotherapy (non-small cell lung
cancer), adjuvant chemotherapy (breast
cancer), acute myocardial infarction, and
bone marrow transplant. Walensky et al. JID, 2006
Objectives of the 2006 Revised
Recommendations
• Increase HIV screening in health-care /
medical settings.
• Foster earlier detection of HIV infection
• Identify and counsel persons with
unrecognized HIV infection and link them
to services
• Further reduce perinatal HIV transmission
CDC Revised Recommendations
for Adults and Adolescents
• Routine, voluntary HIV screening for all persons 13 - 64
in health care settings, not based on risk.
• Repeat HIV screening of persons with known risk at least
annually.
• Opt-out HIV screening with the opportunity to ask
questions and the option to decline.
• Include HIV consent with general consent for care;
separate signed informed consent not recommended.
• Prevention counseling in conjunction with HIV screening
in health care settings is not required.
CDC Revised Recommendations
for Adults and Adolescents
Intended for all health care settings:
•
•
•
•
•
•
•
•
•
•
Inpatient services
Emergency Departments
Urgent care clinics
STD clinics
TB clinics
Public health clinics
Community clinics
Substance abuse treatment centers
Correctional health facilities
Primary care settings
Definitions
• Informed Consent – A process of communication
between a patient and a provider through which the
informed patient can either choose or decline to test.
• Opt-in – Patients are provided pre-HIV test education
then must specifically consent, either orally or in writing,
to an HIV test.
• Opt-out – Performing an HIV test after notifying a patient
that the test is done routinely unless the patient
declines. Assent is inferred unless the patient declines.
Revised Recommendations
Adults and Adolescents
• Include HIV consent with general consent for
care with “opt out” option - A separate signed
informed consent should not be required
• Prevention counseling in conjunction with HIV
screening in health care settings should not be
required
• Arrange access to care, prevention, and
support services for patients with positive HIV
test results
Results in the US
• The $111 million effort provided funding for health
departments in 25 of the nation’s hardest-hit areas
– CDC-supported health departments were able to offer 2.8 million
HIV tests in just three years
• As a result of the Expanded Testing Initiative, more than
18,000 Americans living with HIV learned their HIV
status for the first time
– Approximately three-quarters of the individuals who were newly
diagnosed were successfully linked to HIV care, of those for
whom follow up data were available
• Each HIV infection averted saves an estimated
$367,000 in lifetime medical costs (2009 dollars)
http://www.whitehouse.gov/blog/2011/06/27/national-hiv-testing-day-2011-0
Results in Texas
• Opt-out HIV testing in STD clinics 1999
• Opt-out HIV testing pregnant women 1997
No. of Perinatally Infected
70
60
50
40
30
20
10
0
90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09
Year of Birth
Criteria that Justify Routine Screening
1. Serious health disorder that can be
detected before symptoms develop
2. Treatment is more beneficial when begun
before symptoms develop
3. Reliable, inexpensive, acceptable screening
test
4. Costs of screening are reasonable in
relation to anticipated benefits
5. Treatment must be accessible
Principles and Practice of Screening for Disease -WHO Public Health Paper, 1968
Benefits of Routine Testing
• Identify new HIV cases earlier
• Early diagnosis and treatment leads to:
–
–
–
–
better prognosis,
greater response to therapy,
reduced viral load,
lower transmission of HIV by reducing the number of
persons unaware of their HIV status and unknowingly
transmitting the virus to partners,
– slower clinical progression, and
– reduced mortality
What’s the Point?
• Reduce the number of new HIV infections
• Reduce health disparities
• Increase access to and use of HIV care
and treatment
Strategies to Overcome Barriers:
To facilitate routine HIV testing
• Conduct patient flow analysis to identify
best process for your setting.
• Institute routine testing in Standing
Delegation Orders.
• Integrate a reminder notification in EMR
system.
• Post reminder messages at points of care
directed at providers and staff.
Strategies to Overcome Barriers
CONSENT
• Texas law does not require separate
consent form for routine HIV testing.*
• General consent for care includes HIV
testing.
• Documented verbal consent is sufficient.
• Pretest counseling is NOT required.
* Texas Health and Safety Code, Chapter 81 – Communicable
Diseaseswww.statutes.legis.state.tx.us/Docs/HS/htm/HS.81.htm
Strategies to Overcome Barriers
DELIVERING RESULTS
• Providing HIV/AIDS diagnosis is no
different than delivering a diagnosis of
cancer or any other chronic disease. Back
et al. Arch Intern Med. 2007.
• Public health disease intervention
specialists (DIS) are available to provide
results, linkage to care and other services
for all newly reported HIV+ cases.
Strategies to Overcome Barriers
FOLLOW-UP CARE
• Local and regional health authorities follow
up on all newly reported HIV+ cases to
ensure linkage to treatment, prevention
counseling, and partner services.
• Treatment funding is available for eligible
persons who test positive.**
** Texas HIV Medication Programwww.dshs.state.tx.us/hivstd/meds
The Test Texas HIV Coalition is dedicated
to encouraging the implementation of
routine opt-out HIV testing in medical
settings.
http://testtexashiv.org/
Hospital Community Benefit Report
• If HIV screening is conducted as part of
community outreach, it may be eligible to
be included in a hospital's community
benefit report to the Internal Revenue
Service. For more information, consult
with the person in your hospital who is
responsible for community benefit
reporting
The ethical dilemma –
To test or not to test?
• What determines the ethical standards we
follow?
• What do we base our ethical standards on?
• How do these standards get applied to
specific situations, specifically to routine
HIV testing?
Three common principles
in bioethics
• Respect for persons (autonomy) entails respecting
the decisions of autonomous persons and protecting persons
who lack decision-making capacity and therefore are not
autonomous
– also imposes an obligation to treat persons with respect by
maintaining confidences and keeping promises
• Beneficence imposes a positive obligation to act in the
best interests of patients
– often is understood to require that the risks of research/treatment be
minimized and that the risks be acceptable in light of the potential
benefits
• Justice requires that people be treated fairly
– often understood to require that benefits and burdens be distributed
fairly within society
http://hivinsite.ucsf.edu/InSite?page=kb-08-01-05#S2X
Other approaches of ethical standards
• Utilitarian: Provides the most good or does the least
harm, produces the greatest balance of good over
harm for all
• Common good: Life in community is a good in itself
and our actions should contribute to that life
– Interlocking relationships of society are the basis of
ethical reason and that respect and compassion for all
others-especially the vulnerable-are requirements for
such reasoning
• Virtue: Dispositions that enable us to act according
to the highest potential of our character and on
behalf of values like honesty, courage, compassion,
generosity, tolerance, etc
Not everyone agrees on…
•
•
•
•
•
A standard behavior
The same set of human and civil rights
What is a ‘good’ and what is a ‘harm’
How to answer “What is ethical?”
Population health vs individual health
• Mandatory testing?
• Costs of testing
• Mandatory treatment?
American Medical Association
Opinion 2.23 – HIV Testing
• Physicians’ duties to promote patients’
welfare and to improve the public’s health
are fostered by routinely testing their adult
patients for HIV
• Physicians must balance these obligations
with their concurrent duties to their
individual patients’ best interest by the
guidelines that follow:
AMA Guidelines
Support routine universal routine universal opt-out HIV
screening

to protect patients, avoid injury to third parties, and promote public
health (beneficience)
Recommend/encourage patients to be screened


the ethical tenets of respect for autonomy and informed consent
require that physicians continue to seek patients’ informed consent
It is justifiable to test patients without prior consent only in limited
cases where the harms to individual autonomy are offset by
significant benefits to known third parties. Such exceptions including
testing for the protection of occupationally exposed health care
professionals or patients.
Ensure HIV positive patients receive appropriate follow-up
care and counseling (justice)
Comply with applicable disease reporting laws
Summary
• There is an urgent need to increase the proportion of
persons who are aware of their HIV-infection status.
• Many patients with HIV visit health care providers but
their infection goes undetected.
• People tend to decrease their risk behaviors when they
find out they are infected with HIV.
• HIV meets the criteria for screening, is cost effective,
and successful treatment is available.
“Learning one's positive serostatus is the
first step for newly diagnosed HIV patients
to get linked to care and treated early in
the disease process with the potential to
have a nearly normal lifespan.”
— C. Everett Koop, Former Surgeon General of the United States