Why testing for
hiv should become
routine in your
practice setting
Her death at age 57 didn’t
have to happen
Anne didn’t appear to be at risk for HIV*
Married for 29 years with 3 children, Anne
was a fifth-grade public school teacher.
She and her husband were active in their
local church. She was a nonsmoker with
no known history of IV drug use.
One Friday afternoon, Anne felt sick,
with a severe, persistent cough and
difficulty breathing. With her physician’s
office closed, Anne went to the
emergency department (ED) of her local
hospital, where she was given antibiotics
and kept overnight for observation.
On Saturday morning, her condition
was still declining. A bronchoscopy
and histologic examination showed
Pneumocystis jiroveci. Now very
concerned, her physician tested her
for HIV. The rapid HIV test results
were positive.
Despite the rapid initiation of appropriate
treatments, Anne’s condition continued
to decline, and she died Tuesday
morning. Postmortem lab results showed
21 CD4 cells/mm3 and a viral load of
240,000 copies/mL.
Anne’s early death didn’t have to
happen. Routine HIV testing could have
identified her HIV status much earlier
and increased her chances of long-term
management of the disease.
*Hypothetical patient profile.
3
At least 18 times over many years, Anne
could have been tested but wasn’t
Anne’s medical and social history, 1998-2010
POSSIBLE
RANGE
OF HIV
EXPOSURE
1998
PCP
1999
OB/
GYN
2000
DENTAL VISIT:
ROOT CANAL
PCP
PCP
2001
2002
OB/
GYN
2003
DENTAL
VISIT
OB/
GYN
PCP
2004
DENTAL
VISIT
PCP
2005
PCP
OB/
GYN
2006
PCP
2007
ED VISIT FOLLOWING
A CAR ACCIDENT
PCP
ED VISIT
WITH
PERSISTENT
COUGH
OB/
GYN
2008
DENTAL
VISIT
2009
2010
AIDS
DIAGNOSIS
AND
DEATH
ATTENDED CHURCH REGULARLY ON SUNDAYS AND VOLUNTEERED AT LOCAL COMMUNITY FAIRS
For Anne, and for everyone potentially affected by HIV, it’s time to change
the way we approach HIV screening.
“We can’t just wait for people to present to us;
we have to make a move.”
erek Spencer, MS,
D
CRNP
E xecutive Director,
JACQUES Initiative,
Institute of Human
Virology
niversity of Maryland
U
School of Medicine
Baltimore, MD
The demographics of HIV
are evolving1
· Today, 18% of people who are newly diagnosed with HIV in New York
State are aged 50 years and older
· 40% of those living with HIV/AIDS are aged 50 years and older
· 32% of people newly identified as HIV-positive already have AIDS or
received an AIDS diagnosis within 12 months
Donna Futterman, MD
Director of the
Adolescent AIDS Program
The Children’s Hospital
at Montefiore
Bronx, NY
“One of the most effective strategies for reducing the number of new infections is
to identify persons currently unaware of their infections and provide them with
appropriate care, partner services, and support. Offering HIV testing only to
patients who present with risk factors will allow too many cases to go unidentified.”
5
Infection occurs across a broad
spectrum of the New York state
population
Estimated percentage of new HIV infections by transmission
category in New York State1,a
42%
MSM
31%
HIGH-RISK HETEROSEXUAL CONTACT
21%
OTHERb
5%
IDU
1%
MSM + IDU
N = 4152
Abbreviations: IDU, injection drug use; MSM, men who have sex with men.
a
Newly diagnosed HIV cases from January to December 2009 in the 62 counties in New York State.
b
Includes hemophilia, blood transfusion, perinatal exposure, and risk factors not reported or not identified.
1 in 5 HIV-positive people is unaware
of his or her status2
1,106,400
hiv estimated prevalence2
232,700
Estimated undiagnosed2
56,300
Estimated new annual infections3
Based on national HIV surveillance data from 2006.2,3
And unaware people drive most new infections4
100
90
80
~25%
Percentage
70
~54%
60
50
40
30
~75%
20
~46%
10
0
People living with hiv
New sexual infections per year
7
Unsafe sexual behavior is reduced
substantially after people become
aware they are HIV-positive5
Overall reduction in unsafe sex
Reduction in unsafe sex among
serodiscordant partners
53%
reduction in unsafe sex
in HIV persons aware of
their status relative to
persons unaware
68%
reduction in unsafe sex in HIV
persons aware of their status
(adjusted dataa) relative to
persons unaware when
sexual partners were
HIV-negative
Adjustment factor focused the analysis on behavior with partners at risk for HIV infection.
a
“HIV testing is a service that is so important now,
it’s almost negligent not to provide it.”
Jeremy Brown, MD
Department of
Emergency Medicine
George Washington
University Medical
Faculty Associates
Washington, DC
New York state’s amended HIV testing
law is an important step in making
HIV testing routine
Healthcare providers are mandated to offer HIV testing at least once to
everyone aged 13 to 64 years6
Consent for HIV testing has been simplified:
· Verbal consent can be given for rapid HIV tests
· Consent can be obtained as part of a general consent for medical care
· Consent can be for a particular period of time or open-ended; the patient may
revoke such durable consent at any time
· Certification is no longer required on lab requisitions
· Required pre-test information has been streamlined and can be given face-to-face
and/or in writing
9
Reducing new HIV infections must become
a national priority
Key goals of the 2010 National HIV/AIDS Strategy for
reducing new HIV infections by 20157
Lower the annual number of new infections by 25%
(from 56,300 to 42,225)
Reduce the hiv transmission rate by 30%
increase the percentage of people living with hiv
who know their serostatus from 79% to 90%
Download a pdf of the full plan at
http://aids.gov/federal-resources/policies/national-hiv-aids-strategy/nhas.pdf
“Our country is at a crossroads. Right now, we are experiencing a domestic
epidemic that demands a renewed commitment, increased public
attention, and leadership.”
President
Barack Obama
ational HIV/AIDS
N
Strategy for the
United States
July 2010
Progress has been made in
new york state
Expedited testing programs
· 95% of pregnant women in 2009 knew their HIV status before delivery (compared to
64% in 1997)
· Only 3 new infant HIV infections occurred in 2010 (down from 97 in 1997)
8
Testing, education, and syringe access programs
· Proportion of newly diagnosed IDU cases of HIV infection has been reduced
from 16% in 2002 to 5% in 20091,9
To learn more, please visit
www.health.ny.gov/diseases/aids/testing
11
But more progress must be made
New York State’s amended testing law and regulations require that
HIV testing be offered to patients aged 13 to 64 years by the following
providers regardless of clinical setting6:
Primary Care Providers
· Physicians
· Nurse Practitioners
· Physicians’ Assistants
· Midwives
Primary Care Fields of Medicine
· Family Medicine
· Internal Medicine
· General Practice
· OB/GYN
· Pediatrics
Hospitals
· Inpatient Care
· Emergency Department
· Outpatient Primary Care
Diagnostic & Treatment Centers
· Outpatient Primary Care
Private physician offices and wherever else
primary care is offered by a covered professional
· School-based Health Centers
· Employee Health Services
· Urgent Care Settings
· Retail Clinics
“Many different types of HIV tests are available and can be matched to a health
care setting’s processes and patient population. Some settings can incorporate
point of care rapid tests. Others find that conventional blood draws work best.
Hospital and large outpatient clinics may use multi-platform analyzers with
rapid results processed in the lab. There are many options. The important thing
is to find the test that works best for you and your patients.”
Humberto Cruz
Director
New York State
Department of Health
AIDS Institute
Could earlier treatment help?
It has long been thought that earlier initiation of antiretroviral therapy
could reduce the risk of HIV transmission. The HPTN 052 trial sought to
test this hypothesis.10,11 The trial was stopped 4 years early because of the
positive results.12
· A 96% reduction in HIV transmission risk in serodiscordant couples was seen when
the HIV-positive partner was put on treatment immediately vs delayed until the
infection progressed10
· A 41% reduction in clinical events was seen when treatment started early*
*Clinical events included death, World Health Organization stage 4 events, severe bacterial infections, and pulmonary tuberculosis
for index partners.
“The results are the first from a major randomized clinical trial to indicate that
treating an HIV-infected individual can reduce the risk of sexual transmission
of HIV to an uninfected partner.”
— National Institute of Allergy and Infectious Diseases; May 12, 201112
“The early initiation of antiretroviral therapy reduced rates of sexual transmission
of HIV-1 and clinical events, indicating both personal and public health benefits
from such therapy.”
— Myron S. Cohen, MD, The New England Journal of Medicine; July 18, 201110
13
Where else could progress be made?
Expansion of current testing programs
·
· Pharmacy-based testing initiatives
Routine testing in dental offices and specialty care practices
Reduce stigma
· If every person is offered an HIV test at some point in his or her
healthcare, then controversy and judgment should become obsolete
To learn more, please visit
www.health.ny.gov/diseases/aids/testing
HIV testing may be easier
than you think
Routine HIV testing is reimbursable through most private and public
insurance programs
Effective January 1, 2008, providers can bill for performing an HIV test with a rapid test
kit. More information is available at the American Academy of HIV Medicine website,
www.aahivm.org.
Rapid HIV tests are simple to use and require little or no specialized
equipment
Six rapid tests have been approved by the FDA for the initial screening of HIV
infection.13 Rapid tests come in kits containing all the reagents and equipment
necessary to perform an initial screen for HIV. Results from these tests are available
within 20 minutes, so they can be performed while patients wait.14
For some rapid HIV tests, federal requirements for laboratory personnel, quality
assessment, and proficiency testing can be waived.14 This waiver allows tests to be
administered in nontraditional laboratory settings such as doctors’ offices, mobile
vans, health fairs, and HIV counseling and testing sites.
15
Bodily fluids used in rapid HIV tests are easily obtained
Rapid HIV tests can be quickly performed using a variety of samples that require little
or no processing.14 Suitable samples include:
· Whole blood (obtained from finger stick or venipuncture), oral fluid, plasma,
or serum
Rapid testing works by detecting antibodies to HIV15
Rapid test kits contain HIV-specific antigens attached to a membrane. When blood or
oral fluid from a patient is added, any HIV-specific antibodies present in the sample
will bind to the HIV antigen on the membrane. Depending on the test used, bound
antibodies will be visible as a solid line or dot denoting a positive result.
Follow up with confirmatory testing15
Positive (reactive) results of a rapid HIV test must be verified with a confirmatory test
before a final diagnosis of HIV can be made.
Rapid HIV testing can be cost-effective16
Cost-effectiveness models show that screening is worthwhile, even in healthcare
settings where HIV prevalence is low. For example, in populations where prevalence
of undiagnosed HIV infection is ≥0.1%, HIV screening is as cost-effective as routine
screening for diseases such as colon cancer, breast cancer, and type 2 diabetes.
HIV screening in patients with potential
AIDS-defining events or sexually
transmitted diseases
Although routine HIV testing could lead to increased diagnosis of HIV before it progresses to
an AIDS-related illness, the data suggest that HIV screening rates are currently low even after
individuals present with such illnesses
Receipt of HIV screening by AIDS-defining event, compiled from administrative claims data from 8 US health plans
(N = 7451)17,a
Potential aids-defining event
n
HIV Screening rate (%)
Burkitt’s or immunoblastic lymphoma or primary lymphoma of brain
2980
3.0
Encephalopathy
2066
5.0
Invasive cervical cancer
958
4.4
Candidiasis of bronchi, trachea, lung, or esophagus
542
7.0
Histoplasmosis, disseminated or extrapulmonary
370
2.2
Wasting/cachexia
350
4.3
Disseminated herpes or herpes meningitis
94
13.8
M avium or M kansasii, disseminated or extrapulmonary
67
13.4
Pneumocystis carinii pneumonia
48
10.4
Kaposi’s sarcoma
35
8.6
Progressive multifocal leukoencephalopathy
20
0.0
CMV pneumonia or retinitis
16
25.0
Coccidioidomycosis, disseminated or extrapulmonary
13
7.7
Cryptococcosis, extrapulmonary
11
9.1
Miscellaneous (toxoplasmosis of brain, chronic isosporiasis, salmonella septicemia,
chronic cryptosporidiosis)
5
20.0
17
HIV screening in patients with sexually transmitted diseases or blood-borne pathogens
Receipt of HIV screening by risk, compiled from administrative claims data from health plans across 6 states
(N = 270,423)18,a
RISK
SAMPLE SIZE
HIV SCREENING RATE (%)
Total
270,423
32.7
Hepatitis
126,490
46.9
Hepatitis B
111,031
48.4
Diagnosis
2289
11.4
108,742
49.2
Hepatitis Cb
89,814
41.3
Diagnosis
4952
10.0
84,862
43.1
143,933
20.3
99,160
65.3
263
26.2
98,897
65.4
Chlamydial or
gonorrhea
infectionb
98,422
46.9
Diagnosis
15,469
33.6
Screening tests
82,953
49.4
b
Screening tests
Screening tests
STD
Syphilisb
Diagnosis
Screening tests
RISK
SAMPLE SIZE
HIV SCREENING RATE (%)
STD counseling,
screening
66,774
43.8
Human
papillomavirus
23,343
11.0
Trichomoniasisb
17,018
22.8
Diagnosis
3714
21.1
13,304
23.3
10,365
21.4
Epididymitis
8653
3.1
Condyloma
6392
13.3
Pelvic inflammatory
disease
1389
10.8
Other nongonococcal urethritis
501
22.2
Chancroid,
granuloma
inguinale, and
lymphogranuloma
venereum
213
19.7
Screening tests
Genital herpes
A national sample of commercially insured patients who were screened or
diagnosed with an STD or hepatitis B or C was used for this study.
b
Stratified HIV screening rate for a risk category by the method the category was
captured (ie, diagnosis codes vs screening laboratory tests).
a
The time is now to offer routine
HIV testing to all
The best possible patient care includes HIV testing
· Awareness of HIV status results in changes in risk behavior
· Earlier detection and patient support can result in better outcomes
· Public health benefit of reduced HIV transmission
· Routine HIV testing may reduce stigma and increases acceptance
5
19
19
by patients and physicians
Will you help to change the course
of the HIV epidemic?
To learn more, please visit
www.health.ny.gov/diseases/aids/testing
Samuel DeLeon, MD
Chief Medical Officer,
Urban Health Plan
South Bronx &
Corona, NY
“Routine screening for eligible patients is one of the best ways to find the undiagnosed
and get them into care. We know that early treatment improves health outcomes for
patients who test positive for HIV. Unless we test – and test routinely – we run the risk
of continuing to stigmatize the disease and leaving people untreated.”
19
Join the effort to start making HIV testing
routine in your setting today
Resources (including linkage to care)
New York State Department of Health
www.health.ny.gov/diseases/aids
New York State HIV/AIDS Hotlines
English: 1-800-541-AIDS
Spanish: 1-800-233-SIDA
TDD: 1-800-369-2437
Voice callers can use the New York Relay System 711
or 1-800-421-1220 and ask the operator to dial
1-800-541-2437
Centers for Disease Control and Prevention
STD Hotlines
English/Spanish: 1-800-232-4636
TTY: 1-888-232-6348
New York State HIV/AIDS Counseling Hotline
1-800-872-2777
New York State Partner Services
1-800-541-AIDS
New York State Department of Health
Confidentiality Hotline
1-800-962-5065
Legal Action Center: 1-800-223-4044 or 1-212-243-1313
Expanded Syringe Access Program (ESAP)
English: 1-800-541-AIDS
Spanish: 1-800-233-SIDA
Human Rights/Discrimination
New York State Division of Human Rights
1-718-741-8400
www.dhr.ny.gov/
Centers for Disease Control and Prevention
National Prevention Information Network
www.cdcnpin.org
Revised recommendations on routine testing for HIV
www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm
Guidelines for incorporating HIV testing into standard care
http://www.cdc.gov/actagainstaids/hssc/
References
1Bureau of HIV/AIDS Epidemiology. New York State HIV/AIDS Surveillance Annual Report – For Cases Diagnosed Through December 2009. Albany, NY: AIDS Institute, New
York State Department of Health; 2011. http://www.health.ny.gov/diseases/aids/statistics/annual/2009/2009-12_annual_surveillance_report.pdf. Published August
2011. Accessed August 7, 2012.
2Centers for Disease Control and Prevention. HIV prevalence estimates – United States, 2006. MMWR Morb Mortal Wkly Rep. 2008;57(39):1073-1076.
http://www.cdc.gov/mmwr/PDF/wk/mm5739.pdf. Accessed August 6, 2012.
3Hall HI, Song R, Rhodes P, et al; for the HIV Incidence Surveillance Group. Estimation of HIV incidence in the United States. JAMA. 2008;300(5):520-529.
4Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS.
2006;20(10):1447-1450.
5Marks G, Crepaz N, Senterfitt JW, Janssen RS. Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States:
implications for HIV prevention programs. J Acquir Immune Defic Syndr. 2005;39(4):446-453.
6New York State Department of Health. Amendment of Part 63 of Title 10 (HIV/AIDS Testing, Reporting and Confidentiality of HIV Related Information).
http://www.health.ny.gov/diseases/aids/testing/. Accessed April 10, 2013.
7White House Office of National AIDS Policy. National HIV/AIDS Strategy for the United States. http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf.
Accessed May 18, 2011.
8Prevention of perinatal transmission. About the AIDS Institute website. New York State Department of Health. http://www.health.ny.gov/diseases/aids/about/perinatal.htm.
Updated July 2012. Accessed August 6, 2012.
9Bureau of HIV/AIDS Epidemiology. New York State HIV/AIDS Surveillance Semiannual Report – For Cases Diagnosed Through December 2002. Albany, NY: AIDS Institute, New York State Department of Health; 2005. http://www.health.ny.gov/diseases/aids/statistics/semiannual/2002/surveillance_semiannual_report_2002.pdf. Revised March 2005. Accessed August 7, 2012
10Cohen MS, Chen YQ, McCauley M, et al; for the HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. New Engl J Med.
2011;365(6):493-505.
11McNeil DG Jr. Early H.I.V. therapy sharply curbs transmission. New York Times. May 12, 2011. http://www.nytimes.com/2011/05/13/health/research/13hiv.html.
Accessed June 7, 2011.
12Treating HIV-infected people with antiretrovirals protects partners from infection – findings result from NIH-funded international study [press release]. Bethesda,
MD: National Institute of Allergy and Infectious Diseases; May 12, 2011.
13 Center for Disease Control and Prevention. FDA-approved rapid HIV antibody screening tests. http://www.cdc.gov/hiv/topics/testing/rapid/rt-comparison.htm. Accessed July 19, 2011.
14 Center for Disease Control and Prevention. General and laboratory considerations: Rapid HIV tests currently available in the United States.
http://www.cdc.gov/hiv/topics/testing/resources/factsheets/rt-lab.htm. Accessed July 19, 2011.
15 Greenwald JL, Burstein GR, Pincus J, Branson B. A rapid review of rapid HIV antibody tests. Curr Infect Dis Rep. 2006;8(2):125-131.
16 Walensky RP, Freedberg KA, Weinstein MC, Paltiel AD. Cost-effectiveness of HIV testing and treatment in the United States. Clin Infect Dis. 2007;45(suppl 4):S248-S254.
17 Chen JY, Ma Q, Everhard F, Yermilov I, Tian H, Mayer KH. HIV screening in commercially insured patients screened or diagnosed with sexually transmitted diseases or blood-borne pathogens. Sex Transm Dis. 2011;38(6):522-527.
18 Chen JY, Tian H, Dahlin-Lee E, Everhard F, Mayer K. HIV testing and monitoring in privately insured members recently diagnosed with potential AIDS defining events. http://img.thebody.com/confs/croi2009/posters/1044_chen_poster.pdf. Accessed August 6, 2012.
19Das M, Chu PL, Santos G-M, et al. Success of test and treat in San Francisco? Reduced time to virologic suppression, decreased community viral load, and fewer new
HIV infections, 2004 to 2009. http://www.retroconference.org/2011/PDFs/1022.pdf. Accessed August 6, 2012.
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