To Test or Not To Test

August 25, 2011

Paul McGaha, D.O., M.P.H.Regional Medical Director

Texas Department of State Health ServicesTyler, TX

DISCLOSURE STATEMENTConflict 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 STATEMENTCommercial 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 UseThis 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 OBJECTIVESAt 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

9

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

10

Newly Diagnosed HIV Cases, Deaths, & Persons Living with HIV (Texas,

1980-2008)

0

1000

2000

3000

4000

5000

6000

7000

8000

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

New

HIV

Cas

es /

Dea

ths

0

10000

20000

30000

40000

50000

60000

70000

Per

son

s L

ivin

g w

ith

HIV

New HIV Cases

Deaths among HIV Cases

Living with HIV

Newly-diagnosed HIV Case Rates by Race/Ethnicity: Texas, 1999-2009

0

10

20

30

40

50

60

70

80

90

100

99 00 01 02 03 04 05 06 07 08 09Year of Diagnosis

Cas

es p

er 1

00,0

00

Hispanic Black White

13

Newly-diagnosed HIV Cases*:

Texas, 1999-2008

0

1000

2000

3000

4000

5000

6000

7000

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Year

Cas

es

AIDSHIV

* AIDS cases were diagnosed with AIDS within 1 month of HIV diagnosis

Percent of Total HIV Diagnoses that were Late Diagnoses* by Race/Ethnicity and Sex, Texas

2009

23%

29%

20%22%

18%16%

0%

10%

20%

30%

40%

Black White Hispanic

Per

cent

(%

)

Male Female

*AIDS diagnosis occurred within 1 month of HIV diagnosis

48%

11%

36%

5%

Newly-diagnosed HIV Cases by Race/Ethnicity: Texas,

2008

43%

29%

26% 2%

White

Hispanic

Other/Unknown

Black

Texas Populationn=24,383,647

New HIV Casesn=4,293

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

▪ 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)

13,65%

7,35% male

female

1,5%

1,5%

14,70%

4,20%

AfricanAmericanWhite

Hispanic

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

▪ 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)

14,56%

11,44% male

female

2,8%

1,4%

74,68%

5,20%

AfricanAmericanWhite

Hispanic

Unknown

Smith County – New HIV Cases by Race & Sex 2010 (n = 20)

0123456789

10

Male

Female

Gregg County – New HIV Cases by Race & Sex 2010 (n = 25)

02468

1012

Male

Female

Smith County – Newly Reportable HIV Cases 2003 - 2010

23

28

14

2021

20 20

27

0

5

10

15

20

25

30

2003 2004 2005 2006 2007 2008 2009 2010

Gregg County – Newly Reportable HIV Cases 2003 - 2010

34

18 18

31

16

31

25

21

0

5

10

15

20

25

30

35

40

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% Unaware of

Infection

~75% Aware of Infection

People with HIV/AIDS: 1,039,000-1,185,000

New Sexual Infections Each Year: ~32,000

Accounts for~54%

of New Infections

~46% of New

Infections

Marks, et alAIDS 2006;20:1447-50

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 AdolescentsIntended 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 RecommendationsAdults 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

0

10

20

30

40

50

60

70

90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09

Year of Birth

No.

of P

erin

atal

ly In

fect

ed

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 GuidelinesSupport 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