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2014 DHSTS HIV Coordinator Update

2014 DHSTS HIV Coordinator Update. April 28, 2014. Administrative issues. Joanne Corbo, MBA – HIV Program Manager. NJ HIV Rapid Testing Support Administrative Issues. Website for NJ HIV Rapid Testing Support: njhiv.org. NJ HIV Rapid Testing Support Administrative Issues.

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2014 DHSTS HIV Coordinator Update

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  1. 2014 DHSTS HIV Coordinator Update April 28, 2014

  2. Administrative issues Joanne Corbo, MBA – HIV Program Manager

  3. NJ HIV Rapid Testing Support Administrative Issues Website for NJ HIV Rapid Testing Support: njhiv.org

  4. NJ HIV Rapid Testing Support Administrative Issues 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)

  5. NJ HIV Rapid Testing Support Administrative Issues

  6. NJ HIV Rapid Testing Support Administrative Issues

  7. NJ HIV Rapid Testing Support Administrative Issues

  8. NJ HIV Rapid testing Support Administrative Issues 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

  9. NJ HIV Rapid Testing Support Administrative Issues 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

  10. NJ HIV Rapid Testing Support Administrative Issues 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.

  11. NJ HIV Rapid testing Support Administrative Issues 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)

  12. NJ HIV Rapid testing Support Administrative Issues 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

  13. NJ HIV Rapid Testing Support Administrative Issues 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 serology HIV nucleic acid testing Signature ___________________________________ Print Name____________________________________ Medical Director

  14. NJ HIV Rapid Testing Support Administrative Issues Revised Frequently called Number List

  15. NJ HIV Rapid Testing Support Administrative Issues

  16. NJ HIV Rapid Testing Support Administrative Issues Updated RWJ Rapid HIV Support Contact List

  17. Oversight of CTS Laboratory Activities 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 • MoeenAhmed, MT • Claudia Carron, RN • Aida Gilanchi, MT • FranchescaJackson, BS • Jaclyn Kollinger, MT • Nisha Patel, MT • ADMINISTRATIVE • Lisa May • Karen Williams

  18. Rapid HIV Sites Trained on Stat-Pak by RWJ: 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 • HiTopsInc • 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

  19. RapidHIV Sites Trained on Stat-Pak by RWJ: (Continued) 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 • 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

  20. Distribution of Testing Locations Tracks Prevalence NJ HIV – May, 2009

  21. Where are we headed NEXT? Evan Cadoff, MD ...Gene Martin, PhD … Gratian Salaru, MD

  22. Agenda • 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

  23. Screening for HIV in NJ • Traditional: • EIA or IF confirmed by traditional methods: HIV Western blot, IFA or Aptima • Rapid Testing Options: • Rapid HIV Screen confirmed by traditional methods (Western blot, IFA) • Rapid HIV Screen confirmed by an orthogonal rapid tests • “Rapid-Rapid” Model • ClearviewStatPak confirmed by Trinity Unigold • “Rapid-2-Rapid” Model • ClearviewStatPak is performed at Site #1 • Transportation of Client to Site #2 (Typically a medical care entity) • Patient Navigator at Site #2 performs second orthogonal rapid • If HIV POS  Laboratory Intake • Rapid Screen Alone – Rare in NJ

  24. FRANCISCO --- 2005 IDSA – SAN

  25. New Jersey Rapid Testing RWJ Sites: 97 Non RWJ Sites: 64

  26. NAAT Testing of 2nd gen. Rapid HIV Negative Individuals • 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. E.G. Martin et al. / Journal of Clinical Virology 58S (2013) e24–e28

  27. NAAT Testing of Antibody Negative Blood

  28. Pooled RNA Screening after EIA Patel et al, CDC , Archives Int Med 2010

  29. Acute HIV Infection and Assay Sensitivity Acute HIV Infection

  30. AHI – Acute HIV Infection • 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 • 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!

  31. Why is this Important? 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 Acute Infection Asymptomatic Infection HIV Progression AIDS Cohen and Pilcher, JID 191:1391, 2005

  32. 4th Gen. Assays:Sensitivity vs. Lost to Linkage Point of Care - Based Laboratory - Based

  33. HIV Tests have come a long ways

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

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

  36. Consider Turn Around Time to a Confirmed Result! 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 Manutac et al. JCV. 58S (2013) e44-47

  37. Avg.: 57.7 min

  38. Proposed CDC Testing Algorithm 4th Generation HIV1/2 EIA Is it reproducible? Ifrepeatedly reactive HIV-1/2 Differentiation Assay – BIORAD MULTI-SPOT HIV-1 -/ HIV-2 - ANTIBODIES NEGATIVE or IND HIV + HIV-1 +/ HIV-2 – HIV-1 antibodies detected Logistic delays? RNA Testing HIV-1 -/ HIV-2 + HIV-2 antibodies detected HIV-1 +/ HIV-2 + HIV antibodies detected Additonal Testing Required to rule out a dual infecton RNA - NEGATIVE RNA + Acute HIV Infection

  39. 4th Gen. Point –of-Care HIV Screening • 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 infectionwhen the specimen is positive for HIV-1 p24 antigen and negative for anti-HIV-1 and anti-HIV-2 antibodies. Lotnumber Patient Identification Nameof Test Control Line p24 Antigen Result HIV Antibodies Result Sample Pad Highlights Alere Determine Ag/Ab Combo Alere Determine™ HIV-1/2 Ag/Ab Combo Package Insert 027332530 Rev: 04 2013/09

  40. Earlier detection Seroconversion panels Determine HIV-1/2 (3rd gen) Ab Day: 0 5 7 1214 19 21 Determine Combo (4th gen) Ag Ab Day: 0 5 7 12 14 19 21 Panel AS PRB943 (BBI, Seracare)

  41. AbNonreactive. Dismissed. Ag Reactive. Presumably Recent infection. Seroconversion panels Determine HIV-1/2 Ab Determine Combo Ag Ab Day: 12 Panel AS PRB943 (BBI, Seracare)

  42. Seroconversion panels: FDA approved assays 4th Generation Lab Assays 18.5-20 Days Before Western Blot positive * 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 ClinVirol 2013: Published Online 05 August 2013. DOI:10.1016/j.jcv.2013.07.002

  43. Summary • 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!

  44. Category C outcomes

  45. Use of an RTA in NJ

  46. 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

  47. Summary of 4th Gen. Lab-based HIV Testing • 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

  48. Lay the Groundwork for Expanded Use of Orthogonal Testing: • 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

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