HIV Screening In the ED: Is it right for

calgary?

HIV Screening In the ED: Is it right for

calgary? Chris McCrossin

PGY2 Emergency Medicine

Special Thanks to: Dr John Gill & Dr Bruce Macleod,

Chris McCrossin PGY2 Emergency Medicine

Special Thanks to: Dr John Gill & Dr Bruce Macleod,

Case

• P.G. 67 yo M

ED Presentations

• 1992 - 2 presentations (foot injuries)

• 1995 - 1 presentation (hand injury)

• 1999 - 1 presentation

• 2002 - 1 presentation (hand infection, known now to be hep c +, track marks noted)

• 2004 - 6 presentations (boxer’s # x 2; ear lac; cough & fever LWBS; cellulitis R hip; cellulitis L ankle)

• 2005 - 3 presentations (Nov 25th: pneumonia; Dec 11th: SOB LWBS)

• 2006 - 3 presentations (Aug 25th: 8th&8th R foot abscess; Aug 26th: admitted for I&D abscess; Sept: infection not resolving AMA; Oct 5th: R foot ulcer not resolving; Nov 11th: Pneumonia)

• 2007 - 2 presentations (fever and diarrhea; pneumonia)

Total ED Visits over 15 years: 18

ED Presentations

• Jan 2009

• Sees GP for progressive dysphasia

• GI referral with scope

• Dx: Candida Esophagitis (no HIV test ordered)

• March 2009

• Fam Dr refers to ED b/c of SOB + cough

• Admitted to MTU

• Eventual diagnoses: HIV, AIDS, PJP pneumonia, Candida esophagitis

• HIV test +, struggles on ward for several days on 96% FiO2, resp rates in the 30’s

• Numerous ICU assessments but managed without intubation

• Discharged two weeks after admission

Estimated cost to the health care system: A LOT!

Outline

• Background

• Epidemiology

• Rapid HIV Testing

• Benefits of Early Detection

• Current experiences with HIV screening

Objectives

• Understanding of HIV epidemiology in Canada, Alberta, and Calgary

• Decrease the fear of ordering rapid HIV tests in the ED

• Understand why early diagnosis is important in patients with HIV

• Up to date with what has been done so far in the U.S. with HIV screening in the ED

• Develop an understanding of the resources available to us in Calgary

• Stimulate discussion on both HIV testing and HIV screening in Calgary emergency departments

BackgroundBackground

Background

• Until the past 3-4 years the primary model of HIV testing has been “Voluntary Counseling and Testing” (aka VCT’s)

• Client initiated HIV testing and counseling has been limited by:

• Low coverage of services

• Patent fears of stigmatization

• Perception by people even in high prevalence areas that they are not at risk

World Health Organization: www.who.int

Background

CDC Recommendations• Non targeted, opt-out rapid HIV testing

in all healthcare venues (including EDs) where the prevalence is >/= 0.1%

• Separate written consent should NOT be required (general consent to medical care should be sufficient)

• Prevention counseling should NOT be required with HIV diagnostic testing or screening programs

MMWR 2006, 55(RR14): 1-17

Background

Arguments for using the emergency department as a screening site:

• Many with HIV do not know they have the virus

• The population at highest risk are less likely to have family doctors and the ED is often their primary means of accessing medical care

• Patients with untreated HIV are at risk for developing medical emergencies

• Knowledge of a person’s HIV status does have implications for ED management in non-specific presentations (e.g. Headache + Fever)

Background

Concerns raised• Cost

• Time

• Resources

• Counseling availability

• Consent to testing (legal and ethical concerns)

• Patient acceptance

• Not an emergency medicine issue (concerns that this may negatively impact the care of other patients)

Background

Approach to Testing1. Non-targeted opt-out rapid HIV

screening

2. Non-targeted opt-in rapid HIV screening

3. Emergency physician recommended rapid HIV testing (e.g. targeted testing based on clinical presentation and/or risk factors)

Ethical ConcernsEthical Concerns

Ethical Concerns

• Confidentiality

• Counseling (pre/post testing)

• Forced testing

• Stigmatization of those testing positive

Ethical Concerns

Areas of discrimination

• Insurance

• Housing

• Education

• Employment

• Travel

• Social

Ethical Concerns

What do our governing bodies think?• CMA recommends that “all pregnant

women in Canada should routinely be tested for HIV unless they take the initiative to decline testing.” (2002)

• CPS recommends “that HIV testing should be routinely offered to all women as early as possible during each pregnancy... accompanied by appropriate confidentiality, counseling and informed consent.” (2001)

Canadian HIV/AIDS Legal Network 2007; www.aidslaw.ca

Ethical Concerns

Human Rights Law requires that HIV testing include:

1.Informed consent

2.Pre and post test counseling

3.Guaranteed confidentiality of test results

Canadian HIV/AIDS Legal Network 2007; www.aidslaw.ca

Ethical Concerns

“Canadian courts have affirmed the right to freedom from medical testing or treatment without informed consent. Performing an HIV test in the absence of informed consent could result in legal liability, and provinces should refrain from adopting policies that lead foreseeably to testing without informed consent or to a greater risk of HIV testing being done without informed consent.”

L. Stoltz & Shap, HIV Testing and Pregnancy: Medical and Legal Parameters of the Policy Debate (Ottawa: Health Canada, 1999)

EpidemiologyEpidemiology

Global Epidemiology

2008 UNAIDS Report on the Global AIDS Epidemic

U.S. Epidemiology

• HIV Seroprevalence in urban U.S. emergency departments ranges between 1-4%

• 25-30% of people with HIV do not know they are infected

• 39% of people with HIV in the U.S. do not receive a diagnosis until late in their disease course

Ann Emerg Med 2008; 51(3): 303-9Clin Inf Dis 2003; 37: 1699-704NEJM 1999; 340:969

Canadian Epidemiology

• Public Health Agency of Canada, 2008

• U.S. Numbers:

• ~ 40 000 new cases annually

• > 1 million have received a diagnosis of AIDS since it was first recognized

Canadian Epidemiology• Estimated number of people living with

HIV in Canada by year with confidence intervals

58 000 in 2005

Canadian Epidemiology

• Prevalence of HIV in all of Canada: 0.1-0.5%

• Approximately 16,000 (27% of those infected) people living in Canada have HIV and are unaware of their diagnosis

Canadian Epidemiology

• Public Health Agency of Canada, 2008

Southern Alberta Clinic: HIV Risk Factors In new patients

20081998

Rapid HIV TestingRapid HIV Testing

Rapid HIV Testing

• Canada

• INSTITM (Biolytical Laboratories)

• According to the manufacturer a sensitivity of 99.5% and specificity of 99.3%

• Cost: $20 (30 second test, turn around time with courier to CLS ~ 2 hours)

• U.S.A.

• Ora-quickTM

• According to the manufacturer specificity of 99.8% with oral fluid; 100% with whole blood

www.biolytical.com

AIDS 2006, 20:1655-60;

Rapid HIV Testing

• CDC sponsored study of 12, 343 patients

• Tested ora-quick oral fluid and blood samples against ELISA and western blot

• 4 different study populations (HIV clinic, L&D wards, high risk behavior in both low and high prevalence populations)

AIDS 2006, 20:1655-60

Rapid HIV Testing

False False PositivesPositives

False False NegativeNegative

ss

SensitiviSensitivityty

SpecificiSpecificityty

PPVPPV NPVNPV

Rapid Oral

45/12, 010

3/327 99.1% 99.6% 85.7%99.99

%

Rapid Blood

3/12, 010 1/327 99.7% 99.9% 96.5%99.97

%

AIDS 2006, 20:1655-60

Rapid HIV Testing

• Walensky et al 2008 (USHER Trial)

• Rapid oral testing in a convenience sample of 849 patients*

• 39 (4.6%) had a positive test

• 5 were confirmed infected with Western blot

• Specificity ~ 96% (FP rate > 3%)Ann Intern Med 2008; 149(3):

153-60

Rapid HIV Testing

• FMC + PLC see ~ 150,000 per year

• A test with a specificity of:

• 96% would result in 6000 FP’s per year

• 99% would result in ~ 1,500 FP’s per year

• 99.6% would result in ~ 600 FP’s per year

Rapid HIV Testing

• What would be nice would be:

• A rapid test that can distinguish between both acute and non-acute HIV infections

• A test with a sufficiently high specificity so that the number of false positives are minimized

Are There any Benefits to Early

Detection?

Are There any Benefits to Early

Detection?

Early Detection

Benefits• Reduced transmission

secondary to behavior modification

• Preservation of immune function

• Prolongation of disease free survival

Late Presenters

• 41% of HIV positive patients acquire AIDS within a year after their diagnosis of HIV (suggesting missed opportunities of HIV diagnosis)

N Engl J Med 2005; 352(6): 570-85

Late Presenters

• North Carolina

• 13% of 1292 newly diagnosed men had AIDS at diagnosis

• Boston

• 85% of 217 newly diagnosed patients had CD4 counts of less than 200 and 55% had CD4 counts less than 50

• Alabama

• 49% of newly diagnosed patients had CD 4 counts less than 200 and 35% were diagnosed after requiring hospitalization

Sex Trans Dis 2007; 34: 846-8; AIDS Care 2008; 20:977-83; Am J Med 2007; 120:370-3

Late Presenters

Mortality Rate Mortality Rate (per 1,000 (per 1,000

PYRS)PYRS)

Late Late PresentersPresenters

Non-Late Non-Late PresentersPresenters

n 2,023 4,782

Overall 5.6 1.7

During First Year After Diagnosis

24.4 0.3

Eur J Pub Health 2008; 18:345-7

Late Presenters

Calgary• Over the last ten years 35% of

new HIV diagnoses have been in patients with CD4 counts < 200

• Late diagnosis patients more often come from socially marginalized groups such as IDU, aboriginals, and immigrants/refugees

Southern Alberta Clinic

Early Detection

Behavior Modification• A meta-analysis from eight

studies found a 68% reduction in high risk sexual practices in patients aware of their HIV infection compared with those unaware

J Acquir Immune Defic Syndr 2005; 39:446-53

Early Detection

Early Antiretrovirals• Evidence for early ART:

• One RCT in progress (START trial)

• Sub-study of the SMART trial (J Infect Dis 2008; 197: 1133-44)

• When to start consortium (Lancet 2009; 373: 1352-62)

Early Detection

When to Start Consortium• Methods

• Analysis of 18 cohort studies

• Compared AIDS related mortality and morbidity based on CD4 counts at time of combination ART initiation

• Results

• 21 247 patients prior to combined ART

• 24 444 followed from the start of therapy

• Deferring combination ART to CD4 counts of 251-350 was associated with higher rates of AIDS and death than if treatment was started with CD4 counts in the range of 351-450 (HR 1.28; 95% CI 1.04-1.57)

• Conclusions

• CD4 count of 350 should be the minimum threshold for initiation of antiretroviral treatment

Lancet 2009; 373:1352-63

Early Detection

Lancet 2009; 373:1352-63

Early Detection

SMART Trial• RCT conducted by 318 sites in 33 countries

• Sub-group analysis from the SMART trial compared two ART strategies in HIV infected adults naive to ART with CD4 cell counts > 350 (n = 477)

• Viral suppression strategy (n = 249)

• CD4 count guided interruption of ART strategy (AKA drug conservation) (n = 228)

• Results

• HR 3.47 of DC group incurring opportunistic disease or death (77% greater chance compared to the viral suppression group)

• All cause mortality:

• Viral Suppression: 1.0 events per 100 person years

• Drug Conservation: 4.9 events per 100 person years

• Conclusions

• Earlier treatment of patients with HIV significantly decreases their morbidity and mortality from the disease

J Infect Dis 2008; 197:1133-44

So What’s The Experience been so

far?

So What’s The Experience been so

far?

Prenatal Experiences

Alberta Experience• Alberta uses an “opt-out” strategy for

prenatal HIV testing

• 45 000 undergo screening annually in Alberta (>95% of all pregnant women with antenatal care)

• 4.7% opted out in 1999

• 4.3% opted out in 2002

• 3.6% opted out in 2002

Clin Infect Dis J, 2007; 45: 1640-43

Prenatal Experiences

Alberta Experience• Samples from all women receiving

prenatal care were tested for HIV

• Patients who opted out still had their blood anonymously tested for HIV between Aug 2002 & Dec 2004

• HIV seroprevalence in the “opt-out” specimens was 3.3 times higher

• 3 were positive of 4324 samples

Clin Infect Dis J, 2007; 45: 1640-43

ED Experiences

Lyss et al 2007• Opt-in, both targeted and non-targeted testing in

Chicago’s busiest ED

• 35% of non-targeted and 48% percent of targeted accepted testing

• 58% of patients diagnosed with HIV were identified through targeted testing

• 50% in both groups denied any traditional risk factors

• Test was 99.94% specific

• Of those infected with HIV 45% of non-targeted and 82% of targeted patients had CD4 counts < 200 cells/uL (P<0.001)

J Acquir Immune Defic Syndr 2007; 44(4): 435-42

ED Experiences

Three Experimental Testing Sites in the U.S.

• Los Angeles & New York (Started April 2004)

• Oakland (Started January 2005)

MMWR 2007; 56(24): 597-601

ED Experiences

Testing Protocols

• NY & LA

• Pre-test info, HIV testing, & test results provided exclusively by HIV counselors

• Posters in waiting room promoting “free HIV testing”

• Positive and negative results provided by counselors

MMWR 2007; 56(24): 597-601

ED Experiences

Testing Protocols

• Oakland

• Triage nurse attempted to ask all eligible patients and those specifically requesting to be tested

• Written consent obtained

• Negative results given by nurses

• Positive results given by ED physicians

MMWR 2007; 56(24): 597-601

ED Experiences

Preliminary Results

• HIV testing offered to 34,627 (18%) of 186,415 patients triaged at the three sites (opt-in, non-targeted)

• 48% Oakland

• 4% LA

• 2% NYMMWR 2007; 56(24): 597-601

ED Experiences

Preliminary Results

• Overall 19,556 (56.5%) of those offered testing agreed to be tested

• 98% LA

• 84% NY

• 53% Oakland

MMWR 2007; 56(24): 597-601

ED Experiences

Preliminary Results

• Proportion testing positive

• 0.8% LA

• 1.0% Oakland

• 1.5% NY

• At least one risk factor reported in 49 (52%) of those who tested positive

MMWR 2007; 56(24): 597-601

ED Experiences

• If a risk based approach to do testing had been used for testing 48% of those testing positive in the study would not have been diagnosed

• 88% of persons with newly diagnosed infection were linked to health care services

MMWR 2007; 56(24): 597-601

SummarySummary

Summary

• Having a low threshold for testing is ok with our ID department and follow-up at SAC will be available to patients with positive rapid HIV tests

• Knowledge of a patients HIV status is important for patients who have non-specific complaints

Summary

• Early diagnosis of HIV is key to limiting transmission and improving morbidity, mortality, and quality of life of those infected

40% of patients with HIV are diagnosed late• Rapid HIV tests are highly specific and sensitive but some

smaller centers have experienced lower test specificity particularly in low prevalence areas

• Opt-out testing is the best way to pick up new HIV cases but it is not yet known if and where this method of screening should be applied

Physician targeted HIV screening misses ~ 50% of cases

Where do we go from here?

Options:

A. Ignore the CDC recommendations because they don’t apply to us, prevalence is too low, not relevant to emergency medicine

B. Lower our thresholds for testing, especially in those we perceive as high risk or have symptoms consistent with HIV or AIDS

C. Devise and trial a screening program and reassess after we have some data to show if this works

Discussion & Questions?

Discussion & Questions?