Steven Saunders, Director, HIV Prevention, NJDOH - - PowerPoint PPT Presentation

Steven Saunders, Director, HIV Prevention, NJDOH errol.saunders@doh.state.nj.us

Wit ithout t the Rapid id-Rap apid id Testin ing g Alg lgorit ithm, hm, Lin inkage ge to Ca Care re on the Sa Same or r Ne Next Business iness Day Would ld Not Be Be Po Possi sibl ble BUT, changing testing strategies alone won’t solve all the problems, it’s only one tool. NJ rethoug ught ht it its whole le appr proac ach h to te testing ing and li linkage ge entir irel ely, y, in inclu ludi ding ng RTA.

 Principle:

• The use of two different immunoassays employing different HIV

antigens to search for HIV antibodies. (Term: ORTHOGONAL ASSAYS)

• Evaluated in trials in NJ from 2004-Present.
• More than 100,000 have been tested in New Jersey using an RTA
• It successfully verifies a true HIV + >99.5% of the time!

 Practice:

• CDC Surveillance issued guidance in November, 2011 permitting

the ‘Presumptive Diagnosis’ of individuals positive by rapid screening utilizing 2 different assays.

• The designation of PRESUMPTIVE DIAGNOSIS means that additional

testing CD4, viral load will affirm the diagnosis

• 120 test

t sites s acr cross ss state te & 6 & 60,000 tests ts/yr /yr

• Combina

binatio tion n of blood

• d testing,

ting, oral Or Orasure ure and rapid d testing ing

• Ov

Overal rall l test t result lt deliver very y rate only y c.

• c. 65%
• Movement

vement towar ard d Rapid Testing ng only

• Te

Testing ng at at CB CBOs Os was as an an initi tial al rap apid d tes est with h ei either her

• n
• n-site

ite or referra rral l for Wb blood

• d draw
• Even

n with a p predominantl

• minantly

y rapid d testing ing program ram by y 20 2009 09, o

• ver

eral all, l, 22 22% of prel eliminary iminary positives tives fai ailed ed to return rn for their r test t results lts

• Jumped

ped to 45% f for rapid d testi ting ng CBOs Os

 Movement in NJ to rapid testing only by 2009,

eliminating the need to return for initial screening test results

 Elimination of Wb as sole confirmatory test  Adoption of Rapid-Rapid testing algorithm (RTA)

for higher volume test sites

 Establishing eight Navigator Programs within HIV

care settings to perform 2nd rapid test for non RTA test sites

 Local Linkage to Care Collaboratives covering all 21

counties

Ha Harnes ness s the e collec ecti tive ve imp mpact ct of share ared d go goals s among ng the diverse verse organ ganizati zations

• ns that provid
• vide

e HI HIV and d related ated servi rvices ces to solve ve the probl blem em

• f linking

king new ewly y diagnosed gnosed patien ents ts to care e and d re-engaging engaging those se lost to care

• Commo

mmon n Agenda da among all local providers – shared goals and how to achieve them

• Shared

ed Measuremen urement among all local providers – vigilantly keeping track of linkage to care on the client-level

• Mutual

ually ly Reinfo forcing cing Act ctivi ivitie ties – each agency providing its own services using their unique skills and resources

• Conti

tinuous nuous Commun munica cati tion

• n – regularly sharing

results with each other

• Back

ckbone bone Or Organization nization – mobilize, coordinate and facilitate to keep goal in sight and progress moving

• Expand

nd HIV testing ing targe geting ting thos

• se

e who do not know w their r status, tus, especi cial ally ly among

• ng partne

ners rs of HIV+ V+

• Fully

y impl pleme ement nt RT RTA t to the e ex extent ent possibl sible

• Linking

nking HIV+ V+ who are not in ca care on the same or next t busine iness ss day

• Address

ess and reduce ce stigma gma within hin prov

• vider

der agencies cies

• Assign

gn one liaison

• n as the agency

cy lead in local cal co collaborations aborations

• Ensur

ure e transpor nsportation tation to faci cili litate tate a s succe ccessful ssful linka kage ge

• Succes

ess s is measure sured d at the client-level evel

• Linkag

nkage e to care e is the e ultimate mate outcome me measure sure

• Eve

very ry collaborating borating age genc ncy y plays ys a role e in linkag kage e to care (initi tial al and/or d/or reengagement) ngagement)

• Vigi

gilant ant follow-up of each agency’s role in linking king a particul rticular ar clien ent

• An MOA

OA was developed loped in Camde den n and anothe ther r is in development elopment for Atlantic, ntic, Cape May y and Cumbe berla rland nd Counti nties es

• Each

ch agency cy lists s its servi vice ces s with h a co contac tact t numbe mber r (ce cell) ) to permit it direct ct co communi mmunica catio tion n and linkage kage with no red tape. .

• Typ

ypes of service vice offer ered ed by y agenc ncies es incl clude ude transpor sportati tation

• n on demand,

and, preventi vention

• n servic

vices es targeting eting high-ri risk sk popula ulatio tions, ns, bi-li lingu ngual l ca capacity city and legal service vices.

• s. In Atlantic

tic City y the list also incl clude udes s mental tal health, th, dental al, , and drug g treatme tment nt on demand. nd.

• Lead

ad age genc ncy y fund nded ed wi with Categori egories es B an B and d C CDC Pr Preve venti ntion

• n fund

nds s to supp pport

• rt Pa

Patient ent Na Navi vigat gator

• r
• Navi

vigat gator

• r employed
• yed by EIP/I

P/ID D Clinic c and d wo works ks embedde edded d wi within n a care e setting ing

• Eight Navigator Programs established in NJ’s

high ghest est preva valen ence e cities: s: Camden en, , Atlanti ntic c City, , Jersey rsey City, , Neptune tune Pa Paters erson,

• n, Elizabeth

abeth and d Ne Newa wark rk (2) 2)

Prim imary ry func nction ion is is Lin inkage ge to C Care

• Na

Navi vigator gator Program gram activiti ivities: es:

• Provide 2nd rapid test for patients testing + on their

1st rapid test at CBOs – same or next business day

• Immediately enroll confirmed +s into care (initial

work-up CD4, VL on same day as 2nd rapid test)

• Partner Services for new and existing clinic patients

using CE and Social Networking

• Re-engagement of lost to care patients
• Treatment adherence and prevention counseling
• Collaborative Point Person and MOA Manager
• Advocate for routine (hospital-wide) HIV screening

• Each

ch agency cy prov

• vides

des its own servi vice ces s using ng their ir unique que skills ls and resour

• urce

ces

• Initial Stat-Pak rapid HIV test at CBO
• Second, Unigold confirmatory rapid HIV test at

Patient Navigator clinical site

• Immediately begin HIV medical care with initial

HIV work-up (CD4, VL, etc.) since Navigator is part of ID practice

• Social networking, lost to care, Navigator works

with CBOs who have access to target communities and individuals

• On-going HERR prevention for positives at CBOs

• 1st + rapid test conducted in a non clinical setting is

not immediately followed by a second rapid in a clinical setting

• Second rapid + is not followed by an immediate linkage

to care (lab tests for VL and CD4)

• Patient lost to care, referred by collaborative or not
• HIV+ who does not access ARV as soon as medically

possible

• HIV+ who does not have an undectable viral load, not
• therwise medically explained
• Out of care HIV+ pregnant women who does not

experience the collective resources of the collaboration

• Preliminary data, July - November 2012
• Six Collaboratives reporting
• Majority African American (60%) male (69%)
• 17% Hispanic
• 20% were 18-25 years old
• 240 total HIV tests (1st & 2nd); 86 positive (36%)
• 47 of 240 total were 2nd rapids, 43 positive (91%)
• 74% of confirmed positives had initial HIV lab work-

up within two working days

• 17 partners tested, 4 positive (24%)
• 7 social contacts tested, 1 positive (14%)
• 88 patients re-engaged in care

Quality Assurance is expensive.

• 1. The majority of specimens run for a second

rapid in an RTA are run to comply with QA requirements

 Quality Control  Proficiency Testing  Competency Assessment

• 2. Operators who use specimen types infrequently

can be easily confused - particularly when they are under stress

• 3. CONCLUSION: It doesn’t make sense to make

every site an RTA site

4th Generation HIV Screening in Massachusetts: A Partnership between Laboratory and Program

NASTAD Webinar December 4, 2012

Tammy Goodhue and Barry Callis Massachusetts Department of Public Health Bureau of Infectious Disease, Office of HIV/AIDS

Massachusetts Department

• f Public Health (MDPH):

 Set a goal to transition from 3rd to 4th Generation

HIV screening for all serum samples:

– Collected at all Office of HIV/AIDS (OHA) funded Prevention & Screening sites statewide – Tested at the Hinton State Laboratory Institute (HSLI)

 Endeavored to accomplish this goal within six

months (January – June 2012)

 Successfully made this transition within the

allotted time

OHA Prevention & Screening System Overview

OHA-funded HIV testing is offered:

• At 75 program locations
• In 27 cities/towns across MA
• During a variety of hours
• By ~ 275 individuals
• Using rapid & conventional sample collection methods

Hinton State Laboratory Institute

Laboratory & Program Partners

MDPH

• Hinton State Laboratory Institute
• Bureau of Infectious Disease
• Office of HIV/AIDS
• Division of STD Prevention

Capacity Building Vendors

• Justice Resource Institute
• AdCare Educational Institute

Prevention & Screening Program Sites (Statewide)

• Managers
• Front-Line Staff

Transition Components

Laboratory:

 Algorithm development  Collaborative laboratory

service negotiation

 Test and algorithm

validation

 Results language

development

 IT systems configuration  Specimen handling

procedure modifications Program:

 Sample shipping

standardization

 Client messaging

development

 Acute infection response

system development

 Curriculum & supportive

materials development

 Training delivery  Technical assistance

delivery

Research & select shipping carrier Dec Oct Sep Aug July June April March Feb Jan May Nov

Transition Timeline

2012

Shipping Materials & Policy Dev. Algorithm & Results Dev. Training & Support IT, Other Logistics Setup, pilot & trouble-shoot new system Statewide training & roll-

• ut (site by site)

Monitor shipping system, trouble-shoot & renegotiate with shipping carrier; provid feedback & technical assistance to testing sites as needed Research; select tests & design algorithm Setup, pilot, & validate tests and algorithm; provide feedback for supporting sites Phase out use of previous tests & algorithm over 2 wks; use new tests & algorithm exclusively; provide data for trouble-shooting with shipping carrier & test sites Select & educate training team; develop curriculum & knowledge assessment; logistics Mandatory in-person trainings Web trainings Knowledge assessment analysis & follow-up;

• ngoing individualized support; group support

Lab reporting IT systems rebuild & testing Research; modify specimen handling procedures & results documentation systems Use new procedures and systems exclusively Modify and create policies & documents Additional modification & creation Refinement of contractual expectations; site preparation and implementation

4th Gen EIA

(antigen/antibody)

Reactive HIV-1 & HIV-2 Negative Multispot

(antibody)

HIV-1 Positive HIV-2 Positive HIV-1 & HIV-2 Non-reactive NAAT

(HIV-1 RNA)

HIV-1 Positive HIV-1 Non-reactive

New HIV Testing Algorithm

Lab Report Language Interpretation

• Negative. HIV-1 p24 antigen, HIV-1

and HIV-2 antibodies not detected. If client did not have risk in the two weeks before the test or since, the client does not have HIV.

• Positive. HIV-1 antibodies detected.

The client has HIV-1.

• Positive. HIV-2 antibodies detected.

The client has HIV-2.

• Positive. A reactive HIV

antigen/antibody test and a positive HIV-1 RNA test indicate acute HIV-1 infection. The client has HIV-1 and the test result indicates that s/he was recently infected (likely 2-8 weeks before taking the test).

• Negative. HIV antibodies not
• detected. No detectable HIV-1 RNA.

HIV-2 infection cannot be excluded.** The client does not have HIV-1. The client should be retested in two weeks to rule out possibility of acute HIV-2.

New HIV Testing Algorithm Results

Collection – Results: Timeframe

 The time between sample collection and

results delivery was cut in half (from 14 days to 7 days)

– Shipping – Sample processing & testing – Backup results system

Rapid vs. 4th Gen Conventional Testing: OHA Guidelines

 Pre-test assessment:

– Exposure risk (type of risks, date of last risk) – Likelihood to return for results – Need for hepatitis C, STI screening

 Encourage 4th Gen conventional:

– Recent (less than 8 weeks) or continuous risk – Likely to return for result – Also drawing blood for hepatitis or STI testing

Preparing and Shipping Samples

 HIV samples MUST be centrifuged  HIV samples MUST NOT be refrigerated  HIV samples MUST be received by the

State Lab 1-2 days after collection

 All samples MUST be shipped by

CampusShip on the day that they are collected with few negotiated* exceptions

 If samples are received more than 2 days

after collection, they will not be tested

Post-Test Sessions: Risk Reduction and Linkages

 Continue with established processes for

– Risk reduction planning – Supportive referrals to prevention services, DIS, and medical care as needed

 Solidify and enhance process for linkage to

clinicians and DIS re: acute infections

– Acute infections require a tailored clinical protocol which includes extraordinary effort to ensure client is immediately linked with clinician and DIS

Script for Submission Errors

 Serum samples submitted in error will not be

processed – a new blood draw is needed

 Contact clients immediately and directly

Script: Due to our error in submitting your sample for processing, we need to re-take your blood sample. Re-taking your sample is not suggestive of your result or quality of testing technology used to process samples by the HSLI.

Results

Between June 21st and November 15th 2012:

 HSLI tested 4,850 serum specimens using the new algorithm.

Of those:

 88 samples tested reactive on the Biorad antibody/antigen test

and continued to supplemental Multispot testing. Of those: – 85 samples tested positive for HIV-1. – 0 samples tested positive for HIV-2. – 3 samples tested non-reactive for both HIV-1 and HIV-2 and continued to supplemental NAAT. Of those:

• 2 samples tested non-reactive.
• 1 sample tested positive for HIV-1 indicating

acute infection.

Lessons Learned

 Implementing a new standardized shipping system is

time-intensive

– Understanding new test parameters and requirements – Researching, negotiating, and setting up systems – Training and monitoring program sites; trouble-shooting

 Program sites need multiple engagements

– Training and technical assistance for all levels of staff – Providing supportive materials with specific, concrete examples – Conducting quality assurance monitoring and offering support – Disseminating updated information

 Relying on a multi-disciplinary team to plan and

implement the transition is critical to success

– Understanding implications of using new technology – Identifying laboratory and program systems needs – Providing feedback throughout transition for course-correction – Offering various supports during implementation

Acknowledgments

MDPH Bureau of Infectious Disease



Kevin Cranston



Bob Carr



• H. Dawn Fukuda



Kathy Hsu



Brenda Cole



Barry Callis



Michael Gaucher



Bernadette Green



Eddy DeBortoli



Dennis Canty



Agnes Lubega



Lauren Santoli



Loc Tran MDPH Hinton State Laboratory Institute



Tracy Stiles



Arthur Kazianis



Barbara Werner Justice Resource Institute



Lynley Rappaport



Mali Cantor



Carmen Negron



Libby Zobel AdCare Educational Institute



Denise Henry All Prevention and Screening Program Staff throughout MA

Contact

Arthur Kazianis, HSLI Test, Algorithm, Laboratory Systems questions 617-983-6372 Arthur.Kazianis@state.ma.us Barry Callis, OHA Prevention & Screening Vendor, Shipping System questions 617-624-5316 Barry.Callis@state.ma.us Tammy Goodhue, OHA Project Management, Training, Messaging questions 617-624-5338 Tammy.Goodhue@state.ma.us

IMMEDIATE REFERRAL TO HIV CARE AFTER A REACTIVE HIV SCREENING TEST

Kama Brockmann, PhD, LCSW

Specialist for HIV Testing in Healthcare Settings California Department of Public Health / Office of AIDS

kama.brockmann@cdph.ca.gov 916-449-5964 Amy Kile-Puente

Chief, HIV Prevention Program Section California Department of Public Health / Office of AIDS

amy.kile-puente@cdph.ca.gov 916-449-5805

BACKGROUND:

 2010 HIV Diagnostics Conference

 Presentation of updated HIV testing algorithm

HIV screening tests more sensitive and specific than HIV

“confirmation” tests – Western blot and IFA

Supplemental tests necessary HIV care settings retest new patients – must have their

• wn positive HIV test results on file

Cost of redundant test that does not provide any

additional information.

 Is there a way to decrease HIV “confirmation” tests

a patient receives?

ISSUES:

 Is it legal in California?  HIV Counseling and Testing Sites  Healthcare Settings  Who is responsible to verify client/patient at

HIV Care site?

 Will HIV Care sites accept patients?  Surveillance

IMPLEMENTATION:

 Policy Letter

http://www.cdph.ca.gov/programs/aids/Documents/HIVTesti ngConfTestiGuidance.pdf

IMPLEMENTATION:

Expanded HIV Testing in Healthcare Settings CDC (PS 10-10138) Request for Applications

Plan n for provi viding ding prelimi mina nary y posi sitive and/or

• r confirma

mator

• ry

y posi sitive results to patients nts. Applicants must discuss how patients will be informed of a preliminary HIV positive diagnosis in the case of rapid HIV testing or a confirmatory HIV diagnosis in the case of conventional HIV screening. The explanation must include: who will disclose the diagnosis to the patient, where the disclosure will take place and how the patient will be linked to HIV medical care services. This should include a clause in the general consent for treatment that allows for follow up if the patient does not return for HIV screening results and a plan for the implementation of the follow-up.

If the venue is providing rapid HIV testing, applicants must indicate if the venue will also provide confirmatory HIV testing or refer the patient to HIV medical care services for confirmatory testing. OA prefers that patients receiving a preliminary HIV positive diagnosis be immediately referred to HIV medical care services for HIV confirmation testing. (See Guidance for HIV Confirmation Testing in HIV Testing Venues – Attachment 10.)

IMPLEMENTATION:

CDC 12-1201 Category A

 Information for

Program Planning

UPTAKE:

 Expanded HIV Testing Sites

 Primary Care Settings  Emergency Department

 12-1201 Category A HIV Counseling and

Testing Sites

GOING FORWARD:

 Continue Technical Assistance to Local Health

Jurisdictions and other Contractors

 Years 2-5 of 12-1201 Category A  New testing algorithm

More healthcare settings may move to conventional

testing.