PLEASE COMPLETE THE EVALUATION FORM ! ! IN YOUR FOLDER!!

1. THANK YOU!AETC Education and Training Center for your support of the NJ HIV COORDINATOR’S MEETING PLEASE COMPLETE THE EVALUATION FORM !! IN YOUR FOLDER!!

2. NJ HIV COORDINATORS MEETING May 16, 2017 New Jersey Hospital Association

3. Afternoon Agenda: Rutgers - RWJMS • INTRODUCTION: Dr. Martin • NJ HIV Map – 2017 Update • REGULATORY Update: A Changing Landscape: Dr. Salaru • Clinical Laboratory Licensure – CHANGE IN NJ REQUIREMENTS • The HIV Quality Assurance Program – NO CHANGE • RWJ – Administrative Program Logistics – Joanne Corbo • Cicatelli Associates – Beth Hurley • Sustainable Billing – Billing Survey Starts Today • PROGRAM Update – Drs. Martin • REFRESHER: The NJ Rapid Test Algorithm and Linkage To Care • Determine Combo: Year 2 • 2016-7 Initiatives: • Pooled NAAT QA project • HIV/Syphilis Screening Pilot • HIV/HCV Screening Pilot • INSTI Pilot • What’s coming?

4. AFTERNOON INTRODUCTIONS Eugene Martin, Ph.D. Co-Director, NJ HIV

5. NJ HIV - Rapid Testing Support 2016 DISCORDANT RUTGERS – RWJMS Eugene Martin, Ph.D. Co-Director NJ HIV ,PI - DHSTS grant Gratian Salaru, MD Co-Director NJ HIV’ PI - DMHAS MOA Parisa Javidian, MD - BLD Tom Kirn, MD, Ph.D. Joanne Corbo, MT (ASCP), MBARapid HIV Program Manager Latasha Adams BS,MT Moeen Ahmed BS,MT Aida Gilanchi, BS,MT NishaIntwala, BS,MT (ASCP) Franchesca Jackson, BS DAS Mobile HIV Counselor • Marianela Moreno Administration: • Lisa May • Karen Williams Aida Gilanchi, BS,MT 21 SOLO DISCORDANTS

6. NJ HIV: Rapid DHSTS HIV Testing Sites

7. REGULATORY Update: A Changing Landscape Gratian Salaru, MD Co-Director, NJ HIV

8. Regulatory oversight: RUTGERS -RWJMS • CURRENTLY • CLIA Certificate held by Rutgers - RWJMS (Parisa Javidian, MD) for all “RWJMS” sites: 103 • CLIA Certificate held by Others – 44 • On January 9, 2017, Governor Christie signed into law amendments to the New Jersey Clinical Laboratory Improvement Act (Act), N.J.S.A. 45:9-42.26 et seq. See New P.L.2016, Chapter 86, Senate, No. 976. The amendments to the Act took effect immediately upon enactment. • WHAT’S CHANGED?

9. NJ CLIS Guidance and its significance • NJ Clinical Lab Improvement Service (CLIS) Laboratory License is no longer required from sites performing POC tests with an existing CLIA Certificate (Waived or Mod. Complexity) • No significant impact on our ability to support and sustain rapid ID screening • Proficiency Testing Program – Internalized the review and corrective action decisions regarding performance failures. • Competency Assessment – Provided by our Med. Tech. liaisons and is the responsibility of CLIA laboratory director • QC requirements are part of test procedures

10. NJ HIV Mission • A Common Quality Assurance Platform for Rapid ID Screening in NJ

11. NJ HIV Quality Assurance Program • Procedures for infectious disease screening • Acquisition of inventory for all DHSTS sites • Reagent lot-to-lot validation utilizing side-by-side comparison with mixed titer performance panels • Develop and oversee QC procedures for all DHSTS sites • Competency Assessment (6, 12 month): (elements) • Proficiency Testing Program • NJ RTA program • Statewide Discordant Oversight • Data acquisition on behalf of DHSTS

12. WHAT IS IT GOING TO MEAN?Walgreens Healthcare Clinics to Offer: Testing Services for STIs: Including HIV, Hepatitis and Others • Walgreens Healthcare Clinics in: Cincinnati, Cleveland, Columbus (Ohio), Dallas, Denver, Houston, Kansas City, Knoxville, Las Vegas, Louisville, Memphis, Nashville, Orlando, Philadelphia, Phoenix, Tucson, Washington D.C., and Wichita to offer testing services for (STIs), • Clinics in Houston prescribing PrEP for HIVprevention April 25 • “Ongoing collaboration” with health departments and local AIDS service organizations to help provide free HIV testing as part of an ongoing effort to broaden the reach of HIV information and testing in non-traditional settings and to support local organizations’ outreach efforts. • How will this impact our efforts • Testing vs. Screening • Will DHSTS be competing with Walgreen’s? • Working together… What does it mean exactly?

13. ADMINISTRATIVE ISSUES: Joanne Corbo – NJ HIV Program Manager

14. Website for NJ HIV Rapid Testing Support:njhiv1.org

15. Change In Regulations Sites Under the Oversight of RWJMS • Day to Day Operations Do Not Change • All Quality Assurance Activities Continue • Training, Monthly visits, Recertification and Proficiency Testing • Test Under the RWJ CLIA Certificate (no NJ license required) • CLIA Certificate in testing area • Procedure Manual in Testing Area • Standing order is still needed

16. Test Logs • RWJ test logs are due the 10th of the month • They 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

17. Supplies • SUPPLY ORDERS For ALL Sites are based on average monthly test volume (basically a Standing Order) • SUPPLY ORDERS For ALL Sites Not Under the RWJ License • Will be filled based on average testing volume • Will be delivered the last two weeks of the month • If anything is need above the normal or if you need to decrease your order let us know prior to the 15th of the month. • We pay for each delivery so please help us be cost efficient • Call Lisa May at 732-743-3624 or Karen Williams at 732-743-3630 for any additional items or special situations requiring additional supplies. All orders must be approved by management before delivery

18. Forms/Protocols • New NJ Positive Tracking form- In Packet • 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 • Do NOT Fax Evaluation WEB Forms to RWJ. WE can only accept de-identified information • R2R Protocol Updated- Will be emailed

19. One Time Testing Events • DHSTS re-examined the value of One Time Event testing • After DHSTS and RWJ review of the results of OTEs • Rarely if ever yield the desires outcome of finding a positive test result and linking that patient immediately to care.  • As of January 1, 2017, unless an OTE can be justified by a recent prior event at the same venue wherein at least one positive test result was obtained, or it is part of a National Testing Awareness Campaign or similar annually recurring event (e.g., World AIDS Day, National HIV Testing Day, National Black HIV/AIDS Day, Gay Pride events, National Latino HIV Day) it will no longer be supported and such requests automatically denied by RWJ.  • To increase collaboration and maximize all available resources sites that want to test on a one-time-only basis • Should work collaboratively with other local agencies to utilize one of the many mobile HIV testing vans designed for this type of outreach testing.  • Your agency would invite another agency with their van and their van testing staff to the event in question where both agencies would be co-participating in the event.

20. New Testing Sites/ Outreach All New Testing sites and Outreach locations need to be approved by DHSTS Contact Joanne Corbo or your PMO for application or questions

21. Discordant Work Up 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) • No longer have to freeze upside down • Two gold top serum separators (must be spun down and refrigerated) • You must report all discordant results to RWJ • Call Discordant Hotline (Usually Dr. Martin) 732-236-7013. • Leave a message with contact information so RWJ can pick up samples and process ASAP.

22. Changes to Alere Determine

23. New Alere Determine Control Pipette Added fill line indicator on outside of pipette

24. New Alere Determine Control Pipette Using a disposable pipette to draw up control solution into pipette. In a vertical position touch the disposable pipette to the sample pad and depress the bulb on the disposable pipette to release the control reagent into the Sample Pad Do not use Chase Buffer with control reagents! Start timer and read results between 20 and 30 minutes Dispose of disposable pipette in bio hazardous waste.

25. Alere Determine Label Changes • Alere moved manufacturing of Determine from Israel to Scarborough, Maine in April 2017 • We will begin to see this product in June • No Change in product • Minor Label Change to reflect the new manufacturing location

26. Current Alere Determine Label Expiration date and Lot number Shows Manufacturing location: Orgenics Ltd. in Israel Expiration date and Lot number

27. NewAlere Determine Label • Shows New Manufacturing location: Alere in Scarborough, Maine • Expiration date and Lot Number and Date of manufacture LOT EXPIRATION DATE LOT NUMBER MANUFACTURE DATE

28. AAB Proficiency Testing Survey • Will be shipped TODAY to RWJ sites for delivery Wednesday or Thursday • Results must be sent to RWJ by Wednesday May 24th • Do not enter results online. Fax results to your liaison at 732-235-9012 • RWJ will enter results and submit them • Take care when filling out results form. Look at the test strips when entering results. Avoid cross outs on the results form. • We know the form is confusing. Please call us with questions. We have developed a guide to assist you. • Proficiency tests are critically important. Failure of Proficiency testing could result in your site not being able to test.

29. NEW FORM - AAB Proficiency Testing Survey New Form With bubble entry for positive or negative results

30. Proficiency Testing Guide

31. NJ HIV Rapid Testing Support Administrative Issues Proficiency Testing For RWJ Licensed Sites

32. Questions?

33. Sustainable Billing:The Billing Survey - We Need Your Help! Beth Hurley Cicatelli Associates

34. Capacity Building Assistance Program for High-Impact HIV Prevention Beth Hurley, MPH Project Director CAI

35. CBA Program for High Impact HIV Prevention Overview: • CAI, through the CDC’s High Impact HIV Prevention Project, provides capacity building assistance (CBA) related to high-impact HIV prevention for healthcare organizations (HCOs) • Goals for HCOs: • Strengthen HCO and clinical setting’s systems to raise HIV detection and provide HIV testing support services • Provide HCO staff with improved methods of HIV test counseling

36. CBA Services:Examples of Trainings and TA for HIV Testing • HIV Screening in Key Populations - Targeting Strategically • New HIV Testing Technologies • Enhanced HIV Outreach Strategy • HIV Couples Testing • Partner Notification • Integration of Peer Support into Multidisciplinary Teams

37. Billing for HIV Testing: Capacity Assessment • Stay ahead of transforming healthcare environment • Understand agency’s structure for facilitating reimbursement of HIV testing services • Help us help you! Data informed case for continued HIV testing funding

38. Due JUNE 7th!

39. Program Update Eugene Martin, Ph.D.

40. Rapid HIV Testing: The epidemic is changing. How are we responding?

41. BACKGROUND & Perspective It’s not just a question of how sensitive a test is… it’s also a question of how often we test, how well we test, how effectively we link the affected into care, and how well we retain clients in care…

42. Effective screening IS NOT definitive diagnosis DIAGNOSIS SCREENING GOAL: Identify who is likely to be affected and rapidly link them to care for follow-up Minimize unnecessary referrals Maximize the rate of linkage into care Personalize the linkage to keep folks connected Orthogonal confirmation (RTA) Presumptive diagnosis Minimize missed calls Likely diagnosis (<1:200 are wrong) • GOAL: Definitively determine who is affected and who is not • Sensitivity of the assay • Specificity of the assay • No limits • Take however long it takes to arrive at the correct diagnosis. • Spare no expense

43. 2012: Optimal Testing, Early Treatment & Improved Adherence! Optimal Testing Frequency Annual number of new HIV infections over 20 years for MSM in New York City Early Treatment and Improved Adherence Test-and treat interventions may increase the numbers of patients initiating ART early, BUT without stabilizing the back end of the treatment continuum (i.e., care retention and ART adherence), test-and-treat strategies will fall short of their potential! Sorenson et al. 2012 http://dx.doi.org/10.1371/journal.pone.0029098

44. US HIV Incidence and Transmission Goals, 2020 & 2025 Goal for 2020: 90/90/90. Incidence 21,000 Goal for 2025: 95/95/95. Incidence 12,000 would achieve tipping point with mortality dropping below 2020

45. Why is this Important? Why earlier? 5 Risk of Transmission Male to Female - Blue Reflects Genital Viral Burden – Yellow Effect of ART – Theoretical - Red (1/30-1/200) HIV RNA in Semen (Log10 copies/ml) 4 (1/100- 1/1000) 3 (1/500 - 1/2000) (1/1000 – 1/10,000) 2 HIV Progression AIDS Acute Infection Asymptomatic Infection Cohen and Pilcher, Amplified HIV transmission and new approaches to HIV prevention JID 191:1391, 2005

46. Post-testing information for persons seeking HIV testing after a recent exposure Evaluated the intervals between reactivity of the Aptima HIV-1 RNA test (Aptima) and 20 US Food and Drug Administration-approved HIV immunoassays using 222 longitudinally collected plasma specimens from HIV-1 seroconverters from the United States. https://www.ncbi.nlm.nih.gov/pubmed/27737954

47. HIV Acquisition and Aptima Reactivity • The interval to detection is shorter with each new class of HIV tests • Currently: 44 days for laboratory-based screening tests that detect both antigen and antibody compared with 65 days for the Western blot test to identify an HIV infection. • Providers who test and retest persons at risk due to repeated or ongoing HIV exposure should consider using tests with the shortest possible window periods APTIMA will be positive within 7 – 33 days for 99% of infections. Mean: 13 days • Limitations: Impact uncertain • This is a PLASMA-based study and DOES NOT reflect fingerstick performance on rapid tests!! • Mode of exposure on eclipse period • Other viral co-infections on window periods • Impact of other viral subtypes (HIV-1 Subtype B)

48. DISCORDANT Work-UP Current Initial Rapid Screen DAYS AFTER THE APTIMA TURNS POSITIVE!BUT REMEMBER: PLASMA NOT FINGERSTICK!!AND IT DOESN’T COUNT THE VARIABLE ECLIPSE PERIOD Current2nd Confirmatory RTA Initial Screen 2007-2015 Initial Screen 2003-2016 Original Confirmatory Assay

49. PROGRAM REVIEW & UPDATES

50. The second year with Determine Combo