Statewide Implementation of a Rapid Testing Algorithm

- New Jersey -

Eugene Martin, Ph.D.UMDNJ – Robert Wood Johnson Medical School

NHPC Annual MeetingNHPC Annual MeetingAtlanta, GAAtlanta, GA

August 23-26, 2009August 23-26, 2009

Goals for Today

1. Why move to a rapid testing algorithm? 2. Selecting a Rapid Testing Algorithm? 3. What so unique about New Jersey?4. Validation studies: 2004-2008

• Does an RTA work?

5. Implementation Strategy - Rapid HIV Verification in NJ.6. The first 10,0007. So what? Are we getting more folks into treatment?

Why Move to Rapid Confirmation?

NJ Statewide Data - 2004NJ Statewide Data - 2004– ProblemProblem

• Preliminary Positive Preliminary Positive clients fail to return for clients fail to return for results (21.8%)results (21.8%)

• NAP succeeds ONLY NAP succeeds ONLY 20% of the time in 20% of the time in locating these clientslocating these clients

– SolutionSolution• Confirmatory testing Confirmatory testing

on-site, same dayon-site, same day

326

244

82

47

11

0

50

100

150

200

250

300

350

Number

Disposition of Confirmed HIV + Clients

Confirmed HIV + Result retuned to client Did Not Receive ResultsReferred to NAP Found by NAP

Designing an RTA: – How is your program organized?How is your program organized?

• Centrally organized or independent labs?Centrally organized or independent labs?

– How much How much • Confidence do you have in each labs ability to handle Confidence do you have in each labs ability to handle

multiple assays?multiple assays?• Experience do your laboratories have in sorting out Experience do your laboratories have in sorting out

‘discordant results’?‘discordant results’?

– SupportSupport• What will happen if there is a problem?What will happen if there is a problem?

Is it better to be definitive or efficient?

• Definitive (Maximize identification of infected via POCT testing)– Some believe - program

credibility hangs on ‘getting it right’

– A 3 test RTA will allow you to resolve more discordant events; BUT

– Downside: QC costs and Operator Errors for seldom used tests

• Efficient (2 Test RTA, Centralize problem resolution)– If we ID 98% of infected clients in

a single visit, and successfully connect them to healthcare way ahead.

– Less to remember, less to forget in a two-test algorithm

– Downside: A very small number will not be resolvable at the time of initial testing.

What is so unique about New Jersey?

• The face of the NJ HIV epidemic is a bit different from urban centers like San Francisco and New York City– Although NJ is a high prevalence state, the face of HIV is made up largely

of women and minorities.– The NJ epidemic is characterized by urban pockets of infection, drug

abuse and poverty– Historically,

• 5th in the US in cumulative reported AIDS cases• 3rd in the US in cumulative reported pediatric AIDS cases• 34,915 persons living with HIV or AIDS (12/31/08)

Unique Characteristics – Area:

• New York State: 54,475 square miles New York State: 54,475 square miles • New Jersey: 7,836 sq. mi> New Jersey: 7,836 sq. mi> • Greater Los Angeles: 469.1 sq mi> Greater Los Angeles: 469.1 sq mi> • San Francisco: 47 sq. milesSan Francisco: 47 sq. miles

– Population: • New York State ~ New York State ~ 19.49 million 19.49 million • Greater LA (2007) ~17.78 millionGreater LA (2007) ~17.78 million • New Jersey ~ 8.69 million New Jersey ~ 8.69 million • San Francisco ~ 4.18 millionSan Francisco ~ 4.18 million

– Scale: Drive End to End in NJ 3 hrs. (WDrive End to End in NJ 3 hrs. (WE 1 ½ hours)E 1 ½ hours)

– A mixture of urban/suburban and rural A mixture of urban/suburban and rural communities communities

• North – urbanNorth – urban• South – ruralSouth – rural

– Many different venues perform rapid testingMany different venues perform rapid testing

RTA strategy

• In light of this, we believed that – Our testing strategy needed to recognize that disordered lives relate poorly to

scheduled encounters. – Efficient screening and immediate connection to healthcare are more likely to

be successful then requiring individuals to keep appointments at some point in the future.

• Build on the existing, centralized rapid testing program• Take advantage of the centralized, technical and professional

resources

• OUR GOAL:“Screen today If necessary, connect with a healthcare provider today!”

New Jersey ‘sRapid HIV Sites – Widely available

AIDS Coalition of Southern New JerseyAtlantic City Health DepartmentBergen County Health DepartmentBurlington County Health DepartmentCamden AHECCamden County Health DepartmentCheck-MateEast Orange Health DepartmentEric B. Chandler Health CenterFamCareHenry J. Austin Health CenterHope HouseHorizon Health CenterHunterdon County Health DepartmentHyacinth FoundationMartin Luther King OutreachMorristown Memorial HospitalNewark Community Health CenterNJCRIOcean County Health DepartmentPaterson Health DepartmentPlainfield Community Health CenterProceedRobert Wood Johnson Medical SchoolTrinitas Hospital

6/5/2006

UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES

Primary Satellite fixed mobile

Pale colors indicate pending sites

AIDS Coalition of Southern New JerseyAtlantic City Health DepartmentBergen County Health DepartmentBurlington County Health DepartmentCamden AHECCamden County Health DepartmentCheck-MateEast Orange Health DepartmentEric B. Chandler Health CenterFamCareHenry J. Austin Health CenterHope HouseHorizon Health CenterHunterdon County Health DepartmentHyacinth FoundationMartin Luther King OutreachMorristown Memorial HospitalNewark Community Health CenterNJCRIOcean County Health DepartmentPaterson Health DepartmentPlainfield Community Health CenterProceedRobert Wood Johnson Medical SchoolTrinitas Hospital

6/5/2006

UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES

Primary Satellite fixed mobile

Pale colors indicate pending sites

UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES

Primary Satellite fixed mobile

Pale colors indicate pending sites

Rapid HIV Testing in NJTesting Began 2003

• 23 primary sites23 primary sites• 32 satellite licenses32 satellite licenses• Western Blot Western Blot

confirmation at state lab confirmation at state lab (PHEL) in Trenton(PHEL) in Trenton

Over 70 CTS sites, Over 70 CTS sites, includingincluding::

• Hospitals/EDsHospitals/EDs• FQHCsFQHCs• CBOsCBOs• Health departmentsHealth departments• Mobile vansMobile vans• PrisonsPrisons

History of our RTA Selection

1. Oraquick (Oral or Fingerstick) were both in use in NJ from 2004 on. 2. StatPak was introduced in NJ at a significant number of sites 2008

INITIAL SCREENING: EITHER OraQuick (FS or O) or StatPak

VERIFICATION: Trinity Unigold

1. Two stage process to minimize:– Issues of training– Issues of competency assessment – Issues of required QC– A discordant situation in stage two would immediately bring the specimen and the client to the

attention of clinicians for definitive follow-up– Healthcare linkage could be achieved on the basis of two tests taking less than ½ hr.

2. Since UniGold was not labeled for HIV-2 detection, we opted to initially screen by Oraquick or StatPak and verify by UniGold. If it turned out that there was a problem due to HIV-2 detection, it would have triggered central support.

NJ Rapid Testing Algorithm (RTA) 1st Test:

OQ (Oral or FS) or Clearview Stat-Pak

Non-Reactive (-)Client considered

HIV Negative

Reactive (+)2nd Test Performed

Trinity Unigold

2nd Test Non-Reactive (+ -) 2nd Test Reactive (+ +) Client considered HIV positive

NJ HIV Workup:Follow-up –>

Plasma: RNA PCRSera: EIA & Wblot

LINK TO CARE ASAP

Phlebotomy: 2 tubes (EIA/wblot RNA)

Laboratory Validation – 2004-8• Goal – Validating the approach• Could a second, independent rapid HIV test reliably

identify false positive HIV tests?• How often would it miss a true HIV positive?

– 2004: In blind testing, we -• Confirmed all Western blot positive sera obtained in the previous year

(363) at NJ Public Health Labs.• Identified (8) sera as false positives.

– 2005-8 - Using residual sera and plasma samples • Confirmed that a second, independent rapid HIV test reliably

identified unknown false positive HIV tests.

Outcome: Rapid-Rapid Works and Works Well

Rapid-Rapid Implementation– PLAN – Spring, 2008

• December, 2008: 3 pilot sites began the ‘roll-out’ • Sites of high prevalence first, lower prevalence later• Policies, Procedures, Counseling Messages and Forms were completed for the

entire system available before training• Available on the ‘web’: http://www.njhiv1.org

– EXPECTATIONS: • Doesn’t eliminate Western blot confirmation, BUT allow immediate linkage to care

reliably!• Less than 1 in 100 would later be removed from care because of a failure to

confirm

– UNKNOWNS: What will be the real world performance of a rapid test in a confirmatory setting?

• Does reducing the delay really improve the linkage to care?

Status of Rapid-Rapid in New Jersey

August, 2009

05/03/23 NJ HIV – May, 2009

LEGEND TRADITIONAL RAPID TESTING ALGORITHM

Rapid Testing PROGRAM

COMMUNITY BASED ORG. (CBO)

MEDICAL CTR. ER

MOBILE VAN

PRISONS

Distribution – Rapid Testing - NJ

Timeline - RTA Implementation

0

2000

4000

6000

8000

10000

12000

Date 1/31/2009 3/9/2009 4/14/2009 5/14/2009 6/6/2009 7/4/2009

Initial Rapid HIV Test

Oraquick (FS)Oraquick (O)StatPak (FS)

Outcome• Between 12/2008 – 8/2009

– 16 Licensed facilities (23 sites) implemented over 8 months– More than 10,000 rapid HIV tests performed as a part of the RTA

• 85 Preliminary Positives • 78 Verified by a second Unigold rapid test

– No one has been removed from care because of a false referral– All discordants resolved centrally– Five False Positives: 3 Oraquick, 2 Clearview StatPack – Two False Negatives: Unigold failure. Identified because of the

mandatory Western Blot. • Operator issue statewide RTA advisory, follow-up by technologists and

no repeats.• Cost: Delayed connection to care.

OUTCOMES

RAPID-RAPID SUMMARYRapid-Rapid Start Date

Total Tested VIA RTA StatPak (FS) Oraquick (O) Oraquick (FS) Prelim Pos

UniGold Confirmed

Wblot Confirmed

Wblot Pending

Refused Wblot Discordants OQ Disc StatPak Disc UniGold Disc

Same Day Connected to Care

NJCRI 12/10/2008 1253 0 1095 158 25 24 24 0 0 1 1 0 0 24NEWARK COMM. 1/6/2009 772 772 0 0 5 5 5 0 0 4 0 1 0 5PROCEED 12/4/2008 1157 0 0 1157 14 13 11 2 1 1 0 0 1 5HENRY J. AUSTIN (FQHC) 1/21/2009 970 970 0 0 10 9 9 0 0 1 0 1 0 8PLAINFIELD H.C. (FQHC) 2/21/2009 768 768 0 0 4 4 3 1 0 0 0 0 0 4PATERSON H.D. 2/12/2009 2456 2456 0 0 14 12 12 0 1 2 0 1 1 5E. ORANGE H.D. 2/28/2009 522 0 391 131 5 4 3 0 1 1 1 0 0 2ERIC B. CHANDLER (FQHC) 4/1/2009 177 177 0 0 1 0 0 0 0 1 0 1 0 0RWJMS 4/1/2009 440 440 0 0 2 2 2 0 0 0 0 0 0 2CheckMate - 701 5/4/2009 211 211 0 0 0 0 0 0 0 0 0 0 0 0Hyacinth 5/31/2009 312 312 0 0 3 3 2 1 0 0 0 0 0 3Catholic Charities (JAILS - 2) 5/31/2009 334 334 0 0 0 0 0 0 0 0 0 0 0 0Burlington County Family Planning 6/6/2009 126 126 0 0 0 0 0 0 0 0 0 0 0 0Bergen County HD 6/28/2009 141 141 0 0 2 2 2 0 0 0 0 0 0 0Atlantic City HD 7/27/2009 100 100 0 0 0 0 0 0 0 0 0 0 0 0Burlington County HD 6/6/2009 366 366 0 0 0 0 0 0 0 0 0 0 0 0

14-Aug-09 16 facilities 10105 7173 1486 1446 85 78 73 4 3 11 2 4 2 58

Discordant Analysis SITE INITIAL RAPID 2ND RAPID WESTERN

BLOTRNA RESULT WEEK DESCRIPTION

NJCRI OQ oral (Prelim. Pos)

UniGold Neg Wblot neg RNA neg Week of 2.7-2/14/2009

FALSE POS OQ

Paterson SP FS (Prelim. Pos)

UniGold Neg Wblot neg RNA negative Week of 2/21-8/2009

FALSE POS SP

East Orange OQ oral (Prelim. Pos)

UniGold Neg Wblot neg RNA neg Week of 3/14-3/20/2009

FALSE POS OQ

Paterson StatPak FS (Prelim. Pos)

UniGold Neg Wblot pos RNA pos Week of 5/20-7/2009

FALSE NEG UG

HJA StatPak FS (Prelim Pos)

UniGold Neg Wblot indeterminant (p17 only)

RNA neg Week of 5/20-7/2009

FALSE POS SP

Proceed OQ FS (Prelim. Pos)

UniGold Neg Wblot positive (all bands +)

RNA 98,000 Week of 5/24-30/2009

FALSE NEG UG

Eric B Chandler StatPak FS (Prelim Pos)

UniGold Neg Wblot neg RNA neg Week of 4/1-4/4/2009

FALSE POS SP

Rapid-Rapid Testing NJ

Rapid Verification

UniGold Confirmed

False Pos

• Rapid-Rapid Verification: – Specificity of program:

• OQ (either O or FS): 99.94 %• StatPak: 99.95%

– 7% of Initial Prelim. Pos (StatPak or OQ) are not ‘verified’ – i.e. False Pos

Prel. Pos. (OQ or SP) 85Unigold Verified 78

Western blot OutcomeRefused Western blot 3Confirmed Res 73Pending 4Did Not Confirm 5

85 OQ - 3 SP -2

Discordants 7 8%False POS 5 6%False NEG 2 3%

Who Gets Linked to Care

0

10

20

30

40

50

60

70

80

90

Num

ber

Prelim. Pos UniGold Confirmed Same Day Connected toCare

Rapid-Rapid NJ 2009 • 74% of ‘verified’ HIV positives receive appts on the same day

• 26% DID NOT receive appts on the same day!!

• Site Specific Issues - Ongoing – NJCRI: 1253 RTA’s, 25 Prelim. Pos, 25

Appts on same day– Proceed: 1157 RTA’s, 14 Prelim. Pos, 5

Appts on same day• How to improve linkage?

HIV Coordinator Survey

• Surveyed: HIV coordinators at rapid-rapid sites in May, 2009 (10 sites).

• Satisfaction: 60% of clients Positive or Very Positive, 20% lukewarm, 20% didn’t understand

• Site Types: Health Depts. (2), FQHC’s (4), CBO’s (3), Med. School (1)

Linkage to Care - SurveyAPPT Site of Rapid-RapidSame Day Appt FQHC HD

Med. Sch. CBO

>90% 4 1 1>75-90%

>50<75% 1 2 110 <25%>10%

PHYSICIAN Site of Rapid-RapidSame Day Visit FQHC HD

Med. Sch. CBO

>90% 2 1>75-90% 1

>50<75% 1 110 <25% 1>10% 1 1 1

• It’s not too difficult in NJ to schedule a physician appointment – 6/10 sites could schedule appt 90% of time on same day as RTA positive

• Obtaining an appointment on the same day was more difficult --- only 3/10 sites were able to accomplish this linkage.

Conclusions - Opportunities• Rapid-Rapid Works … even in low prevalence

settings!• Rapidly verifying a preliminary positive and

referring a verified positive to care seldom results in an error.

• Getting a client into care expeditiously needs to be a programmatic goal.

Thanks To:

RWJMSRWJMS• Evan Cadoff, MD Evan Cadoff, MD • Eugene Martin, Ph.D.Eugene Martin, Ph.D.• Gratian Salaru, MDGratian Salaru, MD

• Sharon Holswade, MBASharon Holswade, MBA• Claudia Carron, RN Claudia Carron, RN • Maryann Garrihy, MTMaryann Garrihy, MT• Franchesca Jackson, BSFranchesca Jackson, BS• Nisha Intwala, MTNisha Intwala, MT

• Lisa MayLisa May• Karen WilliamsKaren Williams

NJDHSS/DHASNJDHSS/DHAS• Sindy Paul, MD, MPHSindy Paul, MD, MPH• Linda Berezny, RNLinda Berezny, RN• Maureen WolskiMaureen Wolski• Aye Maung MaungAye Maung Maung

NORTHWESTERN UNIVNORTHWESTERN UNIV• Rebecca CadoffRebecca Cadoff

Site coordinators and counselors throughout New JerseySite coordinators and counselors throughout New Jersey

Rapid confirmation trial

Negative WB Pos Discordant

– 15,923 OraQuick tests 15,923 OraQuick tests statewidestatewide

– 363 prelim positive 363 prelim positive samples to state lab samples to state lab for confirmatory for confirmatory testingtesting

• 355 Western Blot 355 Western Blot positivepositive

• 8 Western Blot 8 Western Blot negativenegative

– A second rapid test – Unigold identified all 8 false positive rapids

July 1, 2004 through April 19, 2005