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Robert Wood Johnson Medical School 2014 DHSTS HIV Coordinator Update April 28, 2014
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Page 1: Robert Wood Johnson Medical School April 28, 2014.

Robert Wood Johnson Medical School

2014 DHSTS HIV Coordinator Update

April 28, 2014

Page 2: Robert Wood Johnson Medical School April 28, 2014.

Administrative issuesJoanne Corbo, MBA – HIV Program Manager

Page 3: Robert Wood Johnson Medical School April 28, 2014.

Website for NJ HIV Rapid Testing Support: njhiv.org

NJ HIV Rapid Testing Support Administrative Issues

Page 4: Robert Wood Johnson Medical School April 28, 2014.

One Time Events

Requests should be sent 10 business days in advance (No exceptions) Must use current form (electronic version on NJ HIV.org) Send to Sonya Thompson/copy to Joanne Corbo Approvals done by Sonya/PMO based on strict criteria for target population/prevalence (Criteria: zip code etc.) Results for One Day Events must be sent to Sonya Thompson/copy to

Joanne Corbo within three business days of the event (electronic version on NJ HIV.org)

NJ HIV Rapid Testing Support Administrative Issues

Page 5: Robert Wood Johnson Medical School April 28, 2014.

NJ HIV Rapid Testing Support Administrative Issues

Page 6: Robert Wood Johnson Medical School April 28, 2014.

NJ HIV Rapid Testing Support Administrative Issues

Page 7: Robert Wood Johnson Medical School April 28, 2014.
Page 8: Robert Wood Johnson Medical School April 28, 2014.

NJ HIV Rapid Testing Support Administrative Issues

One-Day Event Results ReportSubmit one form per event within three business

days of event

Date of Event:

Sponsoring Agency:Testing Agency (if different than sponsoring agency):

Zipcode of Testing location:

Target # #

Population Positive Negative

  0 0

  0 0

  0 0

  0 0

  0 0

  0 0

  0 0

  0 0

  0 0

  0 0

TOTAL 0 0

* General Population is any non targeted group

Please complete the entire form. Totals will automatically add for you. "SAVE AS" naming the file with your agency name and date of event.Email to Joanne Corbo at [email protected] and Sonya Thompson at [email protected] within three business days.

Page 9: Robert Wood Johnson Medical School April 28, 2014.

Test logs:

RWJ test logs due the 10th of the month May also be sent as they are completed Please make sure logs are complete

Site Number, Contact Information, shipment number Test information complete: Pos, Neg, Temperature, Start Time End Time, Operator Initials If doing second test for another site indicate second test and site number of first site

Fax to 732-235-9012 or 732-743-3632

NJ HIV Rapid testing Support Administrative Issues

Page 10: Robert Wood Johnson Medical School April 28, 2014.

NJHIV Positive Tracking Form Use new form included in packet (available on NJ HIV.org) Must be sent in as completed to RWJ Fax to 732-235-9012 or 732-743-3632

NJ HIV Rapid Testing Support Administrative Issues

Page 11: Robert Wood Johnson Medical School April 28, 2014.
Page 12: Robert Wood Johnson Medical School April 28, 2014.

Discordant work up/ procedure:

If second rapid or confirmatory does not match first rapid the result is discordant

Draw blood for work up:Two white top tubes (must be spun down and frozen upside down)One serum separator (must be spun down and refrigerated)

You must report all discordant results to RWJ Call 732-236-7013. Leave a message with contact information

so RWJ pick up samples and process.

NJ HIV Rapid Testing Support Administrative Issues

Page 13: Robert Wood Johnson Medical School April 28, 2014.

RWJ License renewals: License renewals sent with a checklist Coordinator must sign checklist to indicate all items

necessary for regulatory compliance are in place at the site

Send copy of standing order indicating it has reviewed and is current must be included

Copy of standing order template included in packet (available on NJ HIV.org)

NJ HIV Rapid testing Support Administrative Issues

Page 14: Robert Wood Johnson Medical School April 28, 2014.

Checklist for License Renewal:

Site Name___________________________

We have the current signed RWJ NJ Rapid HIV Testing Support Program Policy Manual available at our testing location.

We are using the current signed Exposure Control Plan provided in the RWJ NJ Rapid HIV Testing Support Program Policy Manual.

We have a current signed Exposure Control Plan available at our testing location if we are not using the plan provided in the RWJ NJ Rapid HIV Testing Support Program Policy Manual.

We have a copy of the standing order for performing Rapid HIV Testing signed by our current Medical Director or Authorized Physician at our testing location. The standing order has to be reviewed this year; We have documented that it is current and that the medical director (who signed it) has not changed.

We have attached a copy of the standing order with our license application for RWJMS records.

Signed by:

________________________________________________________

Site Testing Coordinator

NJ HIV Rapid testing Support Administrative Issues

Page 15: Robert Wood Johnson Medical School April 28, 2014.

Standing Order Template

To Whom It May Concern: This standing order shall constitute a request for rapid HIV testing for screenings performed at: Name of Testing Site:Address of Testing Site:  In cases where a client receives a preliminary positive result using a rapid HIV test, this authorizes:HIV Western Blot and/or a second Rapid HIV test (for all preliminary positives); and follow-up testing as appropriate to the clinical setting—which may include:Additional HIV serologyHIV nucleic acid testing   Signature ___________________________________ 

Print Name____________________________________ Medical Director 

NJ HIV Rapid Testing Support Administrative Issues

Page 16: Robert Wood Johnson Medical School April 28, 2014.

Revised Frequently called Number List

NJ HIV Rapid Testing Support Administrative Issues

Page 17: Robert Wood Johnson Medical School April 28, 2014.

NJ HIV Rapid Testing Support Administrative Issues

Page 18: Robert Wood Johnson Medical School April 28, 2014.

Updated RWJ Rapid HIV Support Contact List

NJ HIV Rapid Testing Support Administrative Issues

Page 19: Robert Wood Johnson Medical School April 28, 2014.

NJ HV –> Grant from Division of HIV STD & TB Services Linda Berezny, RN – PMO

• Dept. of Pathology & Lab Medicine – Robert Wood Johnson Medical School◦ Evan Cadoff, MD – Professor & Chairman ◦ Eugene Martin, Ph.D. – Professor◦ Gratian Salaru, MD – Asst. Professor

Joanne Corbo, MBA, MT – Program Manager◦ TECHNICAL

Latasha Adams, MT Moeen Ahmed, MT Claudia Carron, RN Aida Gilanchi, MT Franchesca Jackson, BS Jaclyn Kollinger, MT Nisha Patel, MT

◦ ADMINISTRATIVE Lisa May Karen Williams

Oversight of CTS Laboratory Activities

Page 20: Robert Wood Johnson Medical School April 28, 2014.

RWJ Sites: African American Office of Gay

Concerns Atlantic City Health Department AtlantiCare Mission Health (Atlantic

City Corrections) Bergen County Health Department Buddies of NJ Burlington County Health Department Camden AHEC Camden County Health Departments Catholic Charities (Union County Jail

and Hudson County Jail) Checkmate, Inc City of Trenton City of Vineland Complete Health Care, Inc. Cumberland County Health

Department Dooley House East Orange Health Department Eric B. Chandler Health Center

Rapid HIV Sites Trained on Stat-Pak by RWJ:

• FamCare• Hamilton Township STD Clinic• Henry J. Austin Health Center• Hispanic Family Center• HiTops Inc• Horizon Health• Hunterdon Health Department• Hyacinth Foundation• Iris House• John Brooks Recovery• JSAS• Kean University• Kennedy Health• La Casa Don Pedro• Liberation in Truth • Middlesex County Public Health

Department • NAP Newark• NAP Trenton • Neighborhood Health• Newark Community Health

Center

• Newark STD Clinic• New Horizon Health Center• NJCRI• NJ React• North Hudson Community

Action Corporation(9 sites)• Oasis Drop In Center• Ocean County Health

Department• Ocean Health Initiatives• Paterson Department of Health• Proceed• Robert Wood Johnson Medical

School• Saint James Social Services • Salem County Health

Department• South Jersey AIDS Alliance

(OASIS) • Visiting Nurse Association of

Asbury Park• Well of Hope • William Paterson University• Woodbridge Department of

Health

Page 21: Robert Wood Johnson Medical School April 28, 2014.

Non-RWJ Sites: Asbury Park Community Health Center/Visiting

Nurse Association Atlantic County Health Department Atlanti-Care Regional Medical Center Cape May County Health Department Cooper Medical Center-ER Cooper Medical Center-EIP/Camden County Jail Gloucester County Health department Greater Northern Jersey Planned Parenthood (10

Sites) Hoboken Family Planning- 3 sites Hurtado Health Center (Rutgers) Jersey City Medical Center JFK Medical Center Monmouth Regional Medical Center Morristown Memorial Hospital Newark Beth Israel Ocean County Family Planning Our Lady of Lourdes Planned Parenthood Metro Planned Parenthood of Central NJ

Rapid HIV Sites Trained on Stat-Pak by RWJ: (Continued)

• Planned parenthood of Hamilton• Planned Parenthood of East Orange• Planned Parenthood of Mercer County• Planned Parenthood of Southern NJ• Raritan Bay Medical Center• Saint John’s Clinic• Saint Joseph’s Medical Center• Saint Michaels Medical Center• South Jersey Family Medicine ( 7 sites)• Trinitas Hospital• UMDNJ University Hospital ER & STOP• University of Princeton Health Center

(McCosh Infirmary)• Women’s Health & Counseling Center -

Somerville • Zufall Health

Page 22: Robert Wood Johnson Medical School April 28, 2014.

LEGEND Symbol

Rapid Testing PROGRAM

COMMUNITY BASED ORG. (CBO)

 MEDICAL CTR. ER  

MOBILE VAN

JAILS

Distribution of Testing Locations Tracks Prevalence

NJ HIV – May, 2009

Page 23: Robert Wood Johnson Medical School April 28, 2014.

Where are we headed NEXT?

Evan Cadoff, MD ...Gene Martin, PhD … Gratian Salaru, MD

Page 24: Robert Wood Johnson Medical School April 28, 2014.

• Background Failure to return (2005)

Missed Opportunities – AHI in NJ NAAT data (2012)

• Category C Outcomes Expansion of RTA sites in NJ Training in RTA 4th Generation Lab-based Testing Transition to 4th Generation POC Testing

• Current limitations on 4th Gen POC Testing• Master plan (2014-2015)

• Build out of 4th Gen. POC• Collaboration to facilitate linkage (Orthogonal confirmation of 4th Gen. Lab-

based Positives)• Validation of iSTOC – is there a way to objectively read rapid tests

Agenda

Page 25: Robert Wood Johnson Medical School April 28, 2014.

Traditional: ◦ EIA or IF confirmed by traditional methods: HIV Western blot,

IFA or Aptima Rapid Testing Options:

1. Rapid HIV Screen confirmed by traditional methods (Western blot, IFA)

2. Rapid HIV Screen confirmed by an orthogonal rapid tests “Rapid-Rapid” Model

Clearview StatPak confirmed by Trinity Unigold “Rapid-2-Rapid” Model

1. Clearview StatPak is performed at Site #12. Transportation of Client to Site #2 (Typically a medical care entity)3. Patient Navigator at Site #2 performs second orthogonal rapid4. If HIV POS Laboratory Intake

3. Rapid Screen Alone – Rare in NJ

Screening for HIV in NJ

Page 26: Robert Wood Johnson Medical School April 28, 2014.

FRANCISCO --- 2005IDSA – SAN

Page 27: Robert Wood Johnson Medical School April 28, 2014.

RWJ Sites: 97 Non RWJ Sites: 64

New Jersey Rapid Testing

Rapid HIV Testing NJRWJ sites:

 

  60 Primary  24 satellites  13 mobileNon RWJ site:

 

  64 sites including 12 ERSTesting volume

Rapid-Rapid format: 2013 Tested 48,708

PRELIM POS 450UG PERFORMED 439UG CONFIRMED 426

From Inception 175,630PRELIMINARY POS 1,503

“PRESUMPTIVE POSITIVES” 1,407

Page 28: Robert Wood Johnson Medical School April 28, 2014.

When compared against current rapid HIV tests, NAAT tells us we’re missing between 6-8% of those infected when we screen for antibodies using one of the traditional rapid HIV tests

Those with the highest risk of infecting others are the ones that are being missed!!

The same issues with patient return and process completion occur with NAAT that occur with traditional testing!!!

Solution: A test that picks up p24 Ag COULD identify a substantial proportion of the same population. A POCT device could increase the pickup without losing the ability to link patients to care.

28

NAAT Testing of 2nd gen. Rapid HIV Negative Individuals

E.G. Martin et al. / Journal of Clinical Virology 58S (2013) e24–e28

Page 29: Robert Wood Johnson Medical School April 28, 2014.

Program Dates DescriptionRapid Tested

NAAT Tested

AHIHIV Ab+

% HIV Ab + % Inc in Yield % Yield AHI

Maryland 6/06-3/08

HIV Ab neg adults seen at two STD clinics (6/06--3/08); multiple venues 7/07-3/08)

  58,925 7 1,709 2.90% 0.41% 0.01%

North Carolina

11/02-10/03

HIV Ab neg persons in North Carolina seeking HIV testing at 110 publicly funded sites (n = 109,250)

 108,66

723 583 0.54% 3.95% 0.02%

Los Angeles

2/04-4/04HIV Ab neg men seeking HIV testing at three STD clinics (n = 1712)

  1,698 1 14 0.82% 7.14% 0.06%

NEWARK, NJ

2/10 to 1/12

HIV Ab neg adults receiving testing and counseling at two high risk urban hospitals in Newark, NJ

12,390 6,785 8 116 0.94% 6.90% 0.12%

Seattle King County

9/03-1/05

HIV Ab neg MSM seeking HIV testing through Seattle-King County (n = 3525)

  3,439 5 81 2.36% 6.17% 0.15%

Atlanta 10/02-1/04

2202 adults receiving HIV testing and counseling at three high risk urban sites in Atlanta, Georgia

  2,136 4 66 3.09% 6.06% 0.19%

San Francisco

10/03-7/04

HIV Ab neg persons seeking HIV testing at San Francisco Municipal STD clinic (n = 3075)

  2,722 11 105 3.86% 10.48% 0.40%

29

NAAT Testing of Antibody Negative Blood

Page 30: Robert Wood Johnson Medical School April 28, 2014.

0

20

40

7 48 19

Receipt of Pooled RNA Results

42%

30

Pooled RNA Screening after EIA

Patel et al, CDC , Archives Int Med 2010

Page 31: Robert Wood Johnson Medical School April 28, 2014.

31

Acute HIV Infection and Assay Sensitivity

Acute HIV

Infection

Page 32: Robert Wood Johnson Medical School April 28, 2014.

Because individuals with AHI are highly infectious, have engaged in high risk behaviors, and are often unaware of their status they contribute substantially to the spread of HIV.

Although the duration of AHI is short (typically 3-4 weeks), studies have consistently shown that ~ 50% of new HIV transmissions are caused by onward transmission within the first six months from an individual with AHI.

40-90% develop symptoms of Acute HIV

50%-90% who have symptoms seek medical care

Of those diagnosed with Acute HIV, 50% of patients seen at least 3 times before they are diagnosed

LINKAGE AND TREATMENT OPPORTUNITY!

SYMPTOMS - ACUTE HIV INFECTION

◦ Rash &/or fever(s), possibly in combination with:

◦ Malaise◦ Loss of Appetite◦ Weight loss◦ Sore Throat◦ Mouth Sores◦ Joint Pain◦ Muscle Pain◦ Swollen lymph nodes◦ Diarrhea◦ Fatigue◦ Night sweats◦ Nausea/vomiting◦ Headache◦ Genital Sores

AHI – Acute HIV Infection

Page 33: Robert Wood Johnson Medical School April 28, 2014.

Why is this Important?

HIV RNA in Semen(Log 10

copies/ml)

Risk of Transmission Male to Female - BlueReflects Genital Viral Burden – YellowEffect of ART – Theoretical - Red

(1/30-1/200)

(1/1000 – 1/10,000)

(1/500 - 1/2000)

(1/100-1/1000)

5

4

3

2

Acute Infection

Asymptomatic Infection

HIV Progression AIDS

Cohen and Pilcher, JID 191:1391, 2005

Page 34: Robert Wood Johnson Medical School April 28, 2014.

4th Gen. Assays:Sensitivity vs. Lost to Linkage

Point of Care - Based Laboratory - Based

34

Page 35: Robert Wood Johnson Medical School April 28, 2014.

HIV Tests have come a long ways

35

Page 36: Robert Wood Johnson Medical School April 28, 2014.

Substantially more sensitive than 3rd Gen. HIV assays, earlier generation rapid HIV tests, and confirmatory assays

Somewhat more sensitive than POC-based 4th Gen. rapid HIV assay (Alere Determine Combo assay)

They identify a significant proportion of acutely infected individuals (~90%)

May be used in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects (i.e., children as young as 2) and in pregnant woman

Permit the identification of established HIV infections without the need to send-out for additional testing

36

The Upside of Lab-based 4th Gen. HIV Tests

Page 37: Robert Wood Johnson Medical School April 28, 2014.

Less sensitive than NAAT tests – (individual or pooled); therefore MISSING some cases of AHI.

Although the manufacturer claims it is ~ 35 minutes to an initial result, the reality is that in many laboratories the average time to an initial single result is much longer.

Unfortunately, both FDA-approved lab-based assays report a single combined specimen result, so neither can differentiate initially between recent and established HIV infections.

When used in conjunction with the new confirmatory algorithm they provide identification of individuals who have HIV antibodies, but require an additional NAAT test to ‘rule in’ AHI.

As of today, the only available 4th gen. test that can on a preliminary basis identify recent infection is the standalone rapid test: The Determine Combo.

37

The Downside of Lab-based 4th Gen. HIV Assays:

Page 38: Robert Wood Johnson Medical School April 28, 2014.

38

Consider Turn Around Time to a Confirmed Result!

Manutac et al. JCV. 58S (2013) e44-47

Architect package Insert:

Fully-automated, random-access (no Control brackets) Stat capability HIV Combo assay: 29 minute time to first result >150 tests per hour on i2000SR >50 tests per hour on i1000SR

Page 39: Robert Wood Johnson Medical School April 28, 2014.

Avg.: 57.7 min

Page 40: Robert Wood Johnson Medical School April 28, 2014.

40

Proposed CDC Testing Algorithm

4th Generation HIV1/2 EIA

If repeatedly reactive

HIV + HIV-1 -/ HIV-2 - ANTIBODIES NEGATIVE or IND

RNA Testing

RNA +Acute HIV Infection

RNA - NEGATIVE

HIV-1/2 Differentiation Assay – BIORAD MULTI-SPOT

HIV-1 +/ HIV-2 –HIV-1 antibodies detected

HIV-1 -/ HIV-2 +HIV-2 antibodies detected

HIV-1 +/ HIV-2 +HIV antibodies detected

Additonal Testing Required to rule out a

dual infecton

Is it reproducible?

Logistic delays?

Page 41: Robert Wood Johnson Medical School April 28, 2014.

4th Gen. Point –of-Care HIV Screening

Highlights Alere Determine Ag/Ab Combo

Tests for the simultaneous and separate qualitative detection of free HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2.

It is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2, including an acute HIV-1 infection, and may distinguish acute HIV-1 infection from established HIV-1 infection when the specimen is positive for HIV-1 p24 antigen and negative for anti-HIV-1 and anti-HIV-2 antibodies.

41

Alere Determine™ HIV-1/2 Ag/Ab Combo Package Insert 027332530 Rev: 04 2013/09

Control Line

p24 Antigen Result

Sample Pad

HIV Antibodies Result

Lot number

Name of TestPatient Identification

Page 42: Robert Wood Johnson Medical School April 28, 2014.

Day: 0 5 7 12 14 19 21

Determine Combo (4th gen)

Ab

Ag

Earlier detection

Seroconversion panels

Determine HIV-1/2 (3rd gen)

AbDay: 0 5 7 12 14 19 21

Panel AS PRB943 (BBI, Seracare)

Page 43: Robert Wood Johnson Medical School April 28, 2014.

Ab Nonreactive. Dismissed.

Ag Reactive. Presumably Recent infection.

Seroconversion panels

Determine HIV-1/2

Determine Combo

Ab

Ab

Ag

Panel AS PRB943 (BBI, Seracare)

Day: 12

Page 44: Robert Wood Johnson Medical School April 28, 2014.

Seroconversion panels: FDA approved assays

44

* Modified from Silvina M, et al. Performance of the Alere DetermineTM HIV ½ Ag/Ab Combo Rapid Test with specimens from HIV-1 serocoverters from the US and HIV-2 Infected individuals from Ivory Coast. J Clin Virol 2013: Published Online 05 August 2013. DOI:10.1016/j.jcv.2013.07.002

4th Generation Lab Assays18.5-20 Days Before Western Blot positive

Page 45: Robert Wood Johnson Medical School April 28, 2014.

Order of sensitivity to acute HIV infection:◦ Individual NAAT – Aptima > Pooled NAAT >4th

Gen. Tests Lab-based 4th Gen: Architect/Biorad

>POCT–based 4th Gen: Determine Combo More than half of HIV transmission is thought to

occur during the earliest phase of infection Weighing the potential benefit of slightly

improved sensitivity versus the immediacy of the result is a decision that needs to be driven by a careful assessment of the circumstances involved in particular screening programs!

45

Summary

Page 46: Robert Wood Johnson Medical School April 28, 2014.

Category C outcomes

Page 47: Robert Wood Johnson Medical School April 28, 2014.

Rapid-Rapid Monthly Test Volume 2013

Use of an RTA in NJ

48,708 2013 Rapid-Rapid Test Volume

2.2% Percent Refuse Unigold Verification

5.3%Percent of Prelim Positive Results not Verified by Unigold

62.9%Percent UG Verified Connected to Care on Same Day

2.3% Percent UG Failed to Verify of UG Performed

Jan-

13

Feb-

13

Mar-1

3

Apr-1

3

May-1

3

Jun-

13

Jul-1

3

Aug-1

3

Sep-

13

Oct-1

3

Nov-1

3

Dec-1

30

1000

2000

3000

4000

5000

6000

Rapid-Rapid Monthly Test Volume 2013

TotalTest

Page 48: Robert Wood Johnson Medical School April 28, 2014.

175,630 RTA Testing Volume SINCE INCEPTION

5.7% Percent Refuse Western blot

2.5% Percent Refuse Unigold Verification

3.9%Percent of Prelim Positive Results not Verified by Unigold

Rapid-Rapid Site Surveys• GOAL: Simplify the process. Maximize

linkage and re-engagement. • More clients complete testing and are

linked to care on the same day using an RTA.

• Average time to lab intake for HIV+ positives is < 2 business days

 2013 New Pos Re-EngagedAlready in

CareClient

RefusedDenied

Charity Care No ShowBus Days to Lab Intake

344 POS from Apr - Dec

SUBTOTAL 188 89 11 21 4 31 1.8

55%

26%

3%6%

1% 9%

2013 RTA POS Distribution

New Pos

Re-Engaged

Already in Care

Client Refused

Denied Charity Care

No Show

Page 49: Robert Wood Johnson Medical School April 28, 2014.

NJ Hospitals have been slow to adopt 4th Gen. HIV

Category C project encouraged the transition by supporting ED testing in 2013:◦ St. Joseph’s Medical Center (89% complete)

Contract: 2000 tests To Date: 1782 tests, 7 Positives 0 AHI, 7 Established Infections, Several FP Architects

◦ Our Lady of Lourdes (80% complete) Renewed Contract: 3600 tests To Date: 2881 tests, 18 Positives 3 AHI, 9 Established Infections, 3 FP Architect, 3 FP StatPak

◦ Jersey Shore Univ. Medical Center (30%) Contract: 2400 To Date: 70 tests, 2 Positive 0 AHI

Summary of 4th Gen. Lab-based HIV Testing

Page 50: Robert Wood Johnson Medical School April 28, 2014.

Increase RTA availability in NJ:- Added 11 facilities including 8 hospitals and 1 multi-facility FQHC- Currently RTA testing exceeds 48,000 tests per year at rapid-rapid

facilities - Expand the program to include additional ‘Rapid-2-Rapid’ screening

ONLY sites- Reduces QC costs at sites with relatively few positives

Recruit Mod. Complex. Facilities to implement 4th gen. POC testing

◦ 3 hospitals have agreed ◦ 2 additional facilities have agreed◦ 1 site begun – RWJMS

Question: How to integrate 4th gen. POC and lab-based?

◦ Consider using Determine Combo as an orthogonal confirmation expediting identification of AHI at hospitals

Lay the Groundwork for Expanded Use of Orthogonal Testing:

Page 51: Robert Wood Johnson Medical School April 28, 2014.

OVERALL GOAL APPROACH OUTCOMES

Expand RTA by an additional 9 sites, currently performing Traditional HIV testing estimated to test 29,000/year

1. Approach Non-RWJ laboratory directors utilizing existing HIV site coordinators to  gain entry and begin educational  process with Bioanalytical Lab Directors

2. Encourage laboratory representation at various state planning meetings related to Linkage to Care and RTA testing.

3. Publish and Present information about RTA guidelines and “Presumptive Positives”

 

1. Eleven sites added:• Monmouth Regional Med Ctr./Jersey

Shore Medical Center• Trinitas Hospital• Camden County Jail• Raritan Bay Medical Center• Jersey City Medical Center• St. Joseph's• Our Lady of Lourdes • City of Trenton• UMDNJ/UH ER• Newark Beth Israel• North Hudson Community

Action (Multi-site FQHC)

2. 2013 Rapid-Rapid Testing 48,000• Navigator - 67 (R2R)

conducted; 96% positive (4% discordant) and all +s (100%) enrolled in care

3. Ms. Corbo has joined the NJ HIV Planning Group, joined numerous collaborative meetings

4,        Since 2005:• Abstracts: – 44

• 29 posters • 15 platform presentations

• 2013-4• 2 papers • 3 platform presentations

 

Impact of Category C – Innovative Grant on Testing

Page 52: Robert Wood Johnson Medical School April 28, 2014.

OVERALL GOAL APPROACH OUTCOMES

Prepare to Implement Point-of-Care 4th Generation Testing in the absence of CLIA WAIVER

1. Validate assay using available Performance Panels

2. Develop procedures, forms, training program

3. Identify method for Proficiency Testing

4. Set-up ‘Pilot Site’

1. Assay performance validated2. Procedures, forms and training program

completed3. Pilot site: RWJ – 003 Site (Mod. Complexity)

trained. Testing has begun. 

Prepare to transition existing Lab-based 4th generation testing to POC-based 4th generation tests

1. Approach existing Lab-based 4th gen. sites and their non-RWJ Bioanalytical Lab Directors regarding interest in licensing Determine prior to CLIA-Waiver

2. Consider using Determine Combo as an orthogonal confirmation expediting identification of AHI

1. Requests initiated to:• Jersey Shore Medical Ctr. -

Neptune• Our Lady of Lourdes – Camden• St. Joseph’s Med. Ctr. - Paterson

Transition selected POC 2nd generation testing (StatPak) to POC-based 4th gen. tests (Determine Combo)

1. Approach higher prevalence locations to transition initial HIV screen to Determine Combo

1. Requests accepted by:• NJCRI – Newark• Complete Healthcare• Neighborhood Health   

Impact of Category C – Innovative Grant on Testing

Page 53: Robert Wood Johnson Medical School April 28, 2014.

THE ENDThanks!

53

Page 54: Robert Wood Johnson Medical School April 28, 2014.

Site Number Site Description MONTH

Clients Tested by StatPak

Prelim Positive

UniGold Performed

UniGold Confirmed

UniGold Refusal

Number of Discordant

NOTES

6364 CTR Walk -IN Jan. 87 6 6 6 0 0  

6365 Emergency Room Jan. 43 0 0 0 0 0  

6587Community Outreach Jan. 26 5 4 4 1 0  

6518 Lennard Clinic Jan. 0 1 1 1 0 0  

Rapid-Rapid Tracking Form – Monthly Test Summary

Page 55: Robert Wood Johnson Medical School April 28, 2014.

SITE Number

IF R-2-R please indicate screening SITE Number Date

Positive

Client CTS

Number

NEW POS

RE-ENGAGED

ALREADY IN-Care

Appt. Date

Appt.

KEPT

Bus Days to Lab Intake No Show Narrative

6364 1/9/1418543

4x   1/17/14 yes 5

Client couldn’t link the same day because client didn’t have any identification. Client stated it was lost; he had no insurance which meant he had to apply for charity care which requires I.D. Client returned on January 17th with I.D. and was linked to care the same day.

6364 1/15/1418545

5x   1/15/14 yes 0

Client was linked to care the same day. Client currently in care.

6364 1/27/1418548

4X   1/27/14 Yes 0

Client was linked to care the same day. Client currently in care.

6364 1/27/1418548

7X 1/30/14 yes 3

Client stated he had to go out of town for a few days and when he returned on the 30th he would commit to care. Client came in on the 30th and was linked to care.

6364 1/29/1418549

2X 1/29/14 Yes 0

Client was linked to care the same day. Client currently in care.

6364 1/30/1418549

9X 1/30/14 Yes 0

Client was linked to care the same day. Client is currently in care.

6587 1/8/1418584

2X 1/8/14 Yes 1 Client was linked to care the same day. Client is currently in care.

6587 1/16/1418584

3X 1/17/14 Yes 1 Client was linked to care on the 17th the next business day and is

currently in care.

6587 1/22/1418585

0X 1/22/14 Yes 5

Client was linked to care the same day. Client is currently in care.

6587 1/29/1418585

9x No No -

Client refused linkage to care stated he wasn’t interested. Patient Navigator will follow up with client.

6518 1/15/1417387

7x 1/24/14 Yes 7

Client was a Rapid to Rapid referral from the Lennard Clinic. Although client was tested and referred from the Lennard Clinic on 1/15/14 he didn’t come in for confirmatory testing until the 24th. Client stated he couldn’t stay to be linked to care on the 24th and would return on the 27th. Client returned and was linked to care on the 27th

6587 1/301418586

5X No No -

Client refused Unigold testing client became very angry and stormed out the mobile unit after she received a positive stat-pak. Client was referred to Partner Services for confirmatory testing.

Rapid-Rapid Tracking Survey – Positive Data

Page 56: Robert Wood Johnson Medical School April 28, 2014.

175,630 RTA Testing Volume SINCE INCEPTION

5.7% Percent Refuse Western blot

2.5% Percent Refuse Unigold Verification

3.9%Percent of Prelim Positive Results not Verified by Unigold

Rapid-Rapid Site Surveys• GOAL: Simplify the process. Maximize

linkage and re-engagement. • More clients complete testing and are

linked to care on the same day using an RTA.

• Average time to lab intake for HIV+ positives is < 2 business days

 New Pos

Re-Engaged

Already in Care

Client Refused

Denied Charity Care No Show

Bus Days to Lab Intake

2013 (344 POS from Apr - Dec)

SUBTOTAL 188 89 11 21 4 31 1.8

55%

26%

3%6%

1% 9%

2013 RTA POSITIVE Distri-bution

New PosRe-EngagedAlready in CareClient Re-fusedDenied Char-ity CareNo Show

Page 57: Robert Wood Johnson Medical School April 28, 2014.

RTA & QA Training Provided RWJ Sites: Non-RWJ Sites:

African American Office of Gay Concerns

Atlantic City Health Department

AtlantiCare Mission Health (Atlantic City Corrections)

Bergen County Health Department

Buddies of NJ

Burlington County Health Department

Camden AHEC Camden County Health Departments

Catholic Charities (Union County Jail and Hudson County Jail)

Checkmate, Inc

City of Trenton

City of Vineland Complete Health Care, Inc.

Cumberland County Health Department

Dooley House

East Orange Health Department

Eric B. Chandler Health Center

FamCare Hamilton Township STD Clinic

Henry J. Austin Health Center

Hispanic Family Center

HiTops Inc Horizon Health Hunterdon Health Department

Hyacinth Foundation

Iris House John Brooks Recovery

JSAS Kean University La Casa Don Pedro

Liberation in Truth

Middlesex County Public Health Department

NAP Newark NAP Trenton Neighborhood Health

Newark Community Health Center

Newark STD Clinic

New Horizon Health Center

NJCRI NJ React

North Hudson Community Action Corporation(9 sites)

Oasis Drop In Center

Ocean County Health Department

Ocean Health Initiatives

Paterson Department of Health

Proceed Robert Wood Johnson Medical School

Saint James Social Services

Salem County Health Department

South Jersey AIDS Alliance (OASIS) – in licensing process

Visiting Nurse Association of Asbury Park

Well of Hope William Paterson University

   

Asbury Park Community Health Center/Visiting Nurse Association

Atlantic County Health Department

Atlanti-Care Regional Medical Center

Cape May County Health Department

Cooper Medical Center-ER

Cooper Medical Center-EIP/Camden County Jail

Gloucester County Health department

Greater Northern Jersey Planned Parenthood (10 Sites)

Hoboken Family Planning- 3 sites

Hurtado Health Center (Rutgers)

Jersey City Medical Center

JFK Medical Center

Monmouth Regional Medical Center

Morristown Memorial Hospital

Newark Beth Israel

Ocean County Family Planning

Our Lady of Lourdes

Planned Parenthood Metro

Planned Parenthood of Central NJ

Planned parenthood of Hamilton

Planned Parenthood of East Orange

Planned Parenthood of Mercer County

Planned Parenthood of Southern NJ

Raritan Bay Medical Center

Saint John’s Clinic

Saint Joseph’s Medical Center

Saint Michaels Medical Center

South Jersey Family Medicine ( 7 sites)

Trinitas Hospital University Hospital - Newark ER & STOP

University of Princeton Health Center (McCosh Infirmary)

Women’s Health & Counseling Center - Somerville

Zufall Health    

Page 58: Robert Wood Johnson Medical School April 28, 2014.

ARTICLES: Since 2004 - 16

1. Paul SM, Cadoff EM, and Martin E. Rapid Diagnostic Testing for HIV – Clinical Implications. Clinical Virology and Infectious Disease. 2004.

2. Paul S, Cadoff E, and Martin E. Rapid Diagnostic Testing for HIV: Clinical Implications of a New Diagnostic Tool. New Jersey AIDSLine. 2005; 1:3-9. http://ccoe.umdnj.edu/online/AIDSLine/06HC02-DE02/contents/article.htm

3. Paul S, Cadoff E, Martin E, Wolski M, Nichol L, Williams R, Harvey-Talbot M, Bruccoleri P, Maung A, Martin R, and Berezny L. Rapid HIV Testing in New Jersey Hospital Emergency Departments. New Jersey AIDSLine, 2005:2(1):15-16.

4. Shah MB, Paul SM, Bishburg, E, and Martin EG. Update on HIV and Hepatitis C Virus Co-Infection. New Jersey AIDSLine. 2(2): 3-10, 2005. http://ccoe.umdnj.edu/online/AIDSLine/07HC08-DE02/contents/index.htm

5. Gentz M, Paul SM and Martin EG. 2(4): 4-11, 2006. Hepatitis B and HIV Co-infection. New Jersey AIDSLine, http://ccoe.umdnj.edu/online/AIDSLine/08HC02/index.htm.

6. Jafa K, Patel P, MacKellar DA, Sullivan PS, Delaney KP, Sides TL, Newman AP, Paul SM, Cadoff EM, Martin EG, Keenan PA and Branson BM for the OraQuick Study Group. (2007) Investigation of False Positive Results with an Oral Fluid Rapid HIV-1/2 Antibody Test. PLoS ONE 2(1): e185. doi:10.1371/journal.pone.0000185. http://www.plosone.org/article/fetchArticle.action?articleURI=info%3Adoi%2F10.1371%2Fjournal.pone.0000185

7. Paul SM, Martin RM, Lin Y, Lu SE, Cadoff EM and Martin EG. Voluntary Rapid HIV Testing in Emergency Departments in New Jersey. Garden State Focus. 53(3): 23-25, November/December 2006.

8. Cadoff EM, Salaru G, Marone R, Gaur S, Paul SM and Martin EG. Integrating Rapid HIV Testing in Emergency Care Improves HIV Detection. Point of Care. 6(3): 1-7, 2007.

9. Martin, EG and MA Newton. Rapid HIV Testing. In Czech and Slovaks in an International and Global context: Proceedings of the 23 th SVU World Congress. Editors: M. Rechcigl, V. Papusck and M. Bauer. Univ. of S. Bohemia, 2008, 537-542.

10. Paul SM and Martin EG. HIV Test Recommendations, Assay Selection. ADVANCE for Administrators of the Laboratory, 17(7): 86-92, 2008.

11. Paul, SM and Martin, EG. HIV Testing Update. New Jersey AIDSLine, 9(1):14-28, 2009.

12. Wesolowski1 LG, Ethridge SF, Martin EG, Cadoff EM and MacKellar DA. Rapid Human Immunodeficiency Virus (HIV) Test Quality Assurance Practices and Outcomes among Testing Sites Affiliated with 17 Public Health Departments. Journal of Clinical Micro. October 2009 47: 3333-3335; doi:10.1128/JCM.01504-09. Epub 2009 Aug 19.

13. Martin EG, Salaru G, Paul, SM and Cadoff EM. Use of a Rapid HIV Testing Algorithm to Improve Linkage to Care. Journal of Clinical Virology. 2011. Dec; 52 Suppl 1:S11-5. Epub 2011 Oct 7. PMID: 2198325

14. Stevinson K., Martin EG, Marcella S, Paul SM. Cost Effectiveness Analysis of the New Jersey Rapid Test Algorithm for HIV Testing In NJDHSS Funded Testing Sites. Journal of Clinical Virology. 2011. 52S: S29-33. Epub 2011 Nov 9. PMID: 22078147

15. Martin EG. Current US HIV Public Health Strategies: Reflections on an Era of Globalization and Transatlantic Collaboration. Proceedings of the 26th SVU World Congress. Volume 1. Editors: Z. David, K. Raska and E.G. Martin. Czechoslovak Society of Arts and Sciences (SVU). 2012. ISBN 978-0-615-80114-8

16. Martin, EG, Salaru G, Mohammed D, Coombs R, Paul S and Cadoff E. Finding those at risk: AHI in Newark, NJ. Journal of Clinical Virology. 58S (2013) e24– e28 http://dx.doi.org/10.1016/j.jcv.2013.07.016

17. Mohammed DY, Martin EG, Sadashigie C, Jaker M, and Paul SM An Anonymous Unlinked Survey of the Sero-Prevalence of HIV/HCV antibody in an Urban Emergency Department’ Journal of Clinical Virology. 58S (2013) e19– e23. http://dx.doi.org/10.1016/j.jcv.2013.08.025

Since 2005 ABSTRACTS: – 44 absracts – 29 posters - 15 PLATFORM PRESENTATIONS:

NJ HIV Presentations and Publications:


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