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HIV Testing in Acute Care HIV Testing in Acute Care Settings Settings Rich Rothman, MD, PhD, FACEP Rich Rothman, MD, PhD, FACEP [email protected] [email protected] CDC, DHHS, OraSure Technologies, Abbott CDC, DHHS, OraSure Technologies, Abbott Historical Perspective Historical Perspective Recent Urgent Care and Recent Urgent Care and Emergency Department Programs Emergency Department Programs Using Rapid Test Using Rapid Test

HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott Historical

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JHU Emergency Department  Maryland: 19 th population; 3 rd AIDS incidence  Baltimore: 50% HIV+ patients live in Baltimore City  55,000 visits/year  > 75% African American  40% uninsured individuals  15% injecting drug use  14% unrecognized STDs in patients years Kelen G., et al. Ann Emerg Med 2002; 9:368-9; Rothman RE (unpublished data); Mehta S., et al. Clin Infect Dis 2001; 32:655-9

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Page 1: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

HIV Testing in Acute Care SettingsHIV Testing in Acute Care Settings

Rich Rothman, MD, PhD, FACEPRich Rothman, MD, PhD, [email protected]@jhmi.edu

CDC, DHHS, OraSure Technologies, Abbott CDC, DHHS, OraSure Technologies, Abbott

Historical PerspectiveHistorical Perspective

Recent Urgent Care and Emergency Recent Urgent Care and Emergency Department Programs Using Rapid TestDepartment Programs Using Rapid Test

Page 2: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

U.S. Emergency DepartmentsU.S. Emergency Departments

115 million visits/year115 million visits/year 24/724/7 ‘‘Safety net’ Safety net’

– Minority populationsMinority populations– UnderinsuredUnderinsured– Foreign bornForeign born– Substance abusers (IDU)Substance abusers (IDU)– High risk sexual behaviorHigh risk sexual behavior

Page 3: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

JHU JHU Emergency Department Emergency Department

Maryland: 19Maryland: 19thth population; 3 population; 3rdrd AIDS incidence AIDS incidence Baltimore: 50% HIV+ patients live in Baltimore CityBaltimore: 50% HIV+ patients live in Baltimore City

55,000 visits/year55,000 visits/year > 75% African American> 75% African American 40% uninsured individuals40% uninsured individuals 15% injecting drug use 15% injecting drug use 14% unrecognized STDs in patients 18-31 years14% unrecognized STDs in patients 18-31 years Kelen G., Kelen G., et al. Ann Emerg Medet al. Ann Emerg Med 2002; 9:368-9; Rothman RE. 2004 (unpublished data); Mehta S., 2002; 9:368-9; Rothman RE. 2004 (unpublished data); Mehta S., et al. Clin Infect Diset al. Clin Infect Dis 2001; 32:655-9 2001; 32:655-9

Page 4: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

0%

2%

4%

6%

8%

10%

12%

14%

1988 1992 2000 2001 2003Year

Historical Trends in HIV Historical Trends in HIV Prevalence at JHU EDPrevalence at JHU ED

6.0%6.0%

11.4%11.4%

8.9%8.9%

11.8%11.8%10.9%10.9%

Page 5: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Overall Rates of Overall Rates of Unrecognized HIV Seropositivity in JHU EDUnrecognized HIV Seropositivity in JHU ED

(as % of ED population negative/untested)(as % of ED population negative/untested)

0%

1%

2%

3%

4%

5%

1988 1992 2000 2001 2004

Year

3.8%3.8%3.6%3.6%

2.8%2.8%

1.8%1.8%

Perc

ent

of E

D p

atie

nts

with

Pe

rcen

t of

ED

pat

ient

s w

ith

new

ly id

entif

ied

HIV

new

ly id

entif

ied

HIV

2.3% (UCC)2.3% (UCC)

Page 6: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

National PerspectiveNational Perspective USPHTF USPHTF

– HIV screening recommended for all person at high risk for HIV screening recommended for all person at high risk for infectioninfection

– Beneficial effects associated with HIV CTR lead to early Beneficial effects associated with HIV CTR lead to early disease detectiondisease detection Improve prognosis for those treated with HAARTImprove prognosis for those treated with HAART Reduce OIReduce OI Reduce high risk behaviorsReduce high risk behaviors Reduce HIV transmissionReduce HIV transmission

Emergency Medicine (SAEM) PHTFEmergency Medicine (SAEM) PHTF

– Similar evidence based evaluations for ED ApplicabilitySimilar evidence based evaluations for ED Applicability

Page 7: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

ED Testing for HIVED Testing for HIV

Significant Disease Burden exists in many centersSignificant Disease Burden exists in many centers– Baltimore, Maryland 11.4-14%Baltimore, Maryland 11.4-14%– Bronx, New YorkBronx, New York 7.8% 7.8%– Atlanta, GeorgiaAtlanta, Georgia 2.0% 2.0%

Testing for HIV is EDs is feasibleTesting for HIV is EDs is feasible– Consent: 50%Consent: 50%– Follow-up: 70%Follow-up: 70%– Rapid testing: Increased turn around time and reporting of Rapid testing: Increased turn around time and reporting of

results (80%)results (80%)

Cost analysis suggests that $ testing in EDs is Cost analysis suggests that $ testing in EDs is comparable to that spent in publicly funded health comparable to that spent in publicly funded health care clinicscare clinics

Page 8: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Late 90’s - 2000Late 90’s - 2000 National Survey (95 Academic EDs)National Survey (95 Academic EDs)

– Routine HIV testing not routinely Routine HIV testing not routinely performedperformed

CDC Qualitative Survey CDC Qualitative Survey – Majority physicians supported concept of Majority physicians supported concept of

preventive servicespreventive services– Lack of time major obstacleLack of time major obstacle

Page 9: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

DevelopmentsDevelopments Availability of rapid bedside testAvailability of rapid bedside test

Revision of CDC HIV CTR guidelinesRevision of CDC HIV CTR guidelines

Streamline counselingStreamline counseling Rationale for routine testingRationale for routine testing

– Many patients don’t fully disclose riskMany patients don’t fully disclose risk– Targeted testing may introduce stigmaTargeted testing may introduce stigma– Increased rates of acceptance with routine testingIncreased rates of acceptance with routine testing

Page 10: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Rapid TestingRapid Testing

Testing Integrated into Routine Care in UCCTesting Integrated into Routine Care in UCC

Provider drivenProvider driven15 different staff members15 different staff members

Department of Emergency Medicine and Department of Emergency Medicine and Pathology Pathology The Johns Hopkins University School of MedicineThe Johns Hopkins University School of Medicine

Page 11: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Characteristics of 687 Participants Characteristics of 687 Participants of Rapid Point-of-Care HIV Testingof Rapid Point-of-Care HIV Testing

CharacteristicsCharacteristics Number (%)Number (%)

African AmericanAfrican American 617 (89.8)617 (89.8)No Primary Care PhysicianNo Primary Care Physician 499 (72.6)499 (72.6)

UninsuredUninsured 346 (50.4)346 (50.4)

Page 12: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Detection of Unrecognized HIV Detection of Unrecognized HIV Infection Among 687 ParticipantsInfection Among 687 Participants

2.3%

97.7%

HIV (+) HIV(-)

Page 13: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Previous HIV Testing in 16 HIV (+) Previous HIV Testing in 16 HIV (+) ParticipantsParticipants

31%

57%

6% 6%

Never Been Tested Tested: NegativeTested: intermediate Tested: Unknown

Page 14: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Follow-up of Referral on 15Follow-up of Referral on 15** HIV Positive HIV Positive Patients Identified by Rapid HIV TestingPatients Identified by Rapid HIV Testing

60%40%

Enter into Care, as Scheduled Enter into Care, after Contacted

* 1 HIV positive patient who died was excluded

Page 15: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Stage of Disease in Newly Identified HIV+ Stage of Disease in Newly Identified HIV+ Patients (N = 15)Patients (N = 15)

33% of newly diagnosed HIV+ patients had a 33% of newly diagnosed HIV+ patients had a CD4 Count < 200 (cells/mm3) CD4 Count < 200 (cells/mm3)

60% of newly diagnosed HIV+ patients had a 60% of newly diagnosed HIV+ patients had a viral load of > 10,000 (copies/ml)viral load of > 10,000 (copies/ml)

Page 16: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

4 Month Validation Study for JHU for 4 Month Validation Study for JHU for OraQuick AdvanceOraQuick AdvanceRapid HIV1/2 Antibody Rapid HIV1/2 Antibody

Test (oral fluid)Test (oral fluid)

NN SensitivitySensitivity SpecificitySpecificity

PositivePositivePredictive Predictive ValueValue

Negative Negative Predictive Predictive ValueValue

204204 100.00%100.00% 99.02%99.02% 99.07%99.07% 100.00%100.00%

100% of patients received test results during visit100% of patients received test results during visit 4 out of 5 new HIV+ patients entered long term care4 out of 5 new HIV+ patients entered long term care

Page 17: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Routine ED Testing at BedsideRoutine ED Testing at Bedside

Early Pilot Data:Early Pilot Data:

– 230 tested230 tested– 10 (4.3%) positive10 (4.3%) positive– 8 (80%) entered into care8 (80%) entered into care

Page 18: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

ConclusionsConclusions Significant disease burden remains in USSignificant disease burden remains in US Need innovative approaches (ED testing) Need innovative approaches (ED testing)

to access populationto access population ED stream-lined rapid testingED stream-lined rapid testing

– Easy to administerEasy to administer– Easy to interpretEasy to interpret– Well acceptedWell accepted

Page 19: HIV Testing in Acute Care Settings Rich Rothman, MD, PhD, FACEP CDC, DHHS, OraSure Technologies, Abbott  Historical

Challenges/Barriers to ED based Challenges/Barriers to ED based HIV testingHIV testing

ED cultural issuesED cultural issues Time (provider)Time (provider) Resources Resources

Education of providers Education of providers Logistics of testing: provider or laboratory Logistics of testing: provider or laboratory Arranging follow-upArranging follow-up

State regulations State regulations QA/QC reporting and time requirementsQA/QC reporting and time requirements

Programmatic costsProgrammatic costs