Routine HIV Testing Community Of Practice Session #2
Routine HIV TestingCommunity of PracticeSession #2Presenters:Denver Prevention Training CenterBroward Community & Family Health Centers, Inc.20 March 2016
Communities of Practice Routine HIV Testing CoP Series - Led by faculty fromthe Denver Prevention Training Center Four 60 minute sessions scheduled for: February 11,March 10, April 14, and May 5 at 1:00 PM Eastern Time Invitation to our Electronic Medical Record CoP –March 22, 1:00 – 2:00 PM ET.
Karen Wendel, MD, Director of STD/HIVPrevention and Control
Objectives Describe the evolution of HIV testing Review time from HIV infection to positive testingby testing method Review CDC HIV testing algorithm and rationale Discuss limitations of 4th generation point-of-careHIV testingresults4
Evolution of HIV Tests 1st generation Whole viral lysate Detects IgG antibody(Ab) 2nd generation Synthetic peptides Detects IgG Ab 3rd generation Synthetic peptides Detects IgM and IgG Abs 4th generation Detects p24 antigen (Ag)allowing detection ofHIV-1 infection beforeseroconversion Detects IgM and IgG AbsCDC. Laboratory Testing for the Diagnosis of HIV Infection:Updated Recommendations. June 27, 2014.http://stacks.cdc.gov/view/cdc/234475
HIV Ab/Ag Tests1st generationIgG AbLabbasedtestingCLIA orescent assay(IFA),GS HIV-1 WesternBlot*,CambridgeBiotech HIV-1Western Blot*2nd generationIgG Ab3rd generationIgM & IgG Ab4th generationIgM, IgG Ab, andp24 AgMultispot,Chembio DPP,Avioq HIV-1 MicroelisaSystem*,MedMira Reveal G2Rapid HIV-1*,GeeniusBio-Rad GS HIV-1/2Plus O,Siemens ADVIACentaur, EnhancedOrtho VitrosBio-Rad GS Ag/AbCombo,Siemens ADVIACentaur Ag/AbCombo,Abbott ArchitectAg/Ab Combo,BioPlex 2200 HIVAg/AbINSTI HIV-1/HIV-2 ,UniGold Recombigen#,Clearview STAT-PAK,Clearview COMPLETE,OraQuick ADVANCERapidINSTI HIV-1/HIV-2 ,UniGoldRecombigen#Alere DetermineCombo Ag/Ab RapidTest *Test for HIV-1 only; # 3rd generation test functioning as second generation test; Testsometimes classified 2nd gen but does detect IgMhttp://www.cdc.gov/hiv/pdf/testing Advantages&Disadvantages.pdf Clinical Laboratory Improvement Amendments of 1988 (CLIA)http://www.biolytical.com/articles/36
HIV-1 Nucleic Acid Amplification Tests (NAT) Qualitative tests Quantitative tests Off-label use for -hiv-1-quant-dx-assay7
HIV Testing: Time to IV-Based-on-Test-Used.jpg
CDC algorithm for HIV testing9CDC. Laboratory Testing for the Diagnosis of HIV Infection: UpdatedRecommendations. June 27, 2014. http://stacks.cdc.gov/view/cdc/23447
Why Use 4th Generation HIV Tests 64 specimens fromrecently infectedindividuals 35 samples with( )HIV RNA/(-)HIV Abincluding a 3rdgeneration HIV test 28/35 (80%) werepositive with 4thgeneration Ag/Abcombo test—Architect Test performance onsamples from recentlyinfected individualsAssay% Detected1st or 2nd gen IA12.5OraQuick Advance17.2Western blot12.5Multi-Spot28.1Uni-Gold34.43rd gen IA42.24th gen IA89.1Gen, generation; IA, ImmunoassayPandori et al. J Clin Microbiol.2009;47(8):2639-4210
Estimated Heterosexual HIV Transmission Risk*Acute infection can account for 10%–50% of all new HIV-1 transmissions,especially in persons with multiple sex partnersCohen M. JID. 2005;191:1391–3; Koopman JS et al. J Acquir Immune Defic Syndr Hum Retrovirol.1997: 14(3):249-58;Brenner BG et al. J Infect Dis. 2007: 195 (7): 951-9.; Prabhu VS et al.AIDS.2009;23(13):1792-4.; Jacquez et al. J Acquir Immune Defic Syndr.1994;7(11):1169-8411
HIV-1/2 Antibody DifferentiationImmunoassay Faster lab turn around than the Western blot Distinguishes between HIV-1 and HIV-2 morereliably than the Western blot Able to detect disease earlier after infection thanthe Western blot Current differentiation assay is Multispot New differentiation assay to replace Multispot inDecember 2016 is Geenius12
4th Generation Point-of-Care HIV Testing Determine HIV -1/2Ag/Ab Combo Separate results forHIV p24 antigenand HIV s/PremarketApprovalsPMAs/UCM364701.pdf13
Determine HIV-1/2 Ag/Ab Combo Package insert Sensitivity 99.9% with serum, plasma, and whole blood Specificity 98.9-100% with serum, plasma, and whole blood In CDC studies on plasma specimens collected duringseroconversion, Determine Combo detected infection: 1-2 weeks before other rapid tests 1-3 days before 3rd generation laboratory tests 3-4 days after 4th generation laboratory tests There are limited data on the sensitivity of rapid HIVtests when used with whole blood specimens.http://www.cdc.gov/hiv/pdf/testing aleredetermineinfosheet.pdf14
Systematic Review: Determine HIV-1/2 Ag/AbCombo Test Review of 4 studies with 17,381 participants Studies sites: Australia, Swaziland, United Kingdom,and Malawi Analysis of cases of acute infection p24 component evaluated in all 4 studies 26 acute infections were missed—0% sensitivity 35 false positive HIV-1 p24 results—0% positive predictive value Antibody component evaluated in 2 studies In one study, 0 of 3 cases of acute HIV detected In one study, 2 of 8 cases of acute HIV detectedLewis et al. AIDS 2015,29:2465-247115
Point-of-Care HIV Testing Confirmation of a positive result Standard algorithm Data are insufficient to recommend the use of theDetermine Combo as the initial assay in thelaboratory algorithm.16
Case 1: Non-CDC Algorithm Testing 35 year old man with a positive point-of-careDetermine HIV-1/2 Ag/Ab Combo test result inoutreach is sent to a primary care provider. Further testing ordered HIV viral load (NAT) CD4 count Results HIV viral load: Not detected CD4: 35017
Case 1: How do You Proceed What do you tell the patient? A. It looks like you don’t have HIV. The point-of-care test waswrong B. We need to do more HIV testing to clarify your HIV status C. I believe you have HIV based on your point-of-care HIVtest and cd4 count. Let’s repeat your viral load. What do you order next? Repeat HIV viral loadLab-based 4th generation HIV testHIV genotypeRepeat HIV point-of-care test18
Case 2 Results: HIV -1/2 Ag/Ab Combo test positive HIV-1/HIV-2 antibody differentiation immunoassaynegative HIV-1 viral load 345,000 Diagnosis A) False negative antibody differentiation immunoassay B) Acute HIV infection C) Chronic HIV infection19
Routine HIV Testing@ BCFHC’s Primary CareCentersAndrea BrooksBroward Community & Family Health Centers, Inc.Partnerships for Care (P4C) Program LeadMarch 10, 2016
Key Discussion Topics Overview of BCFHCIntegration of Routine HIV TestingSelecting Testing TechnologiesBCFHC’s Next Steps
Who is BCFHC? Established in 1998 in Broward County, FLMission: “To provide accessible comprehensive highquality primary care services to all persons with dignityand respect.”4 Primary Care Centers1 Dental Center (Opening May 2016)88 Employees47% Federally Funded
BCFHC Patients DemographicsTotal Patient Population1: 8,416PLWHA2: 327Patients by RaceHawaiian/PacificIslander, 1%Black/AfricanAmerican,49%Patients by EthnicityNonHispanic,77%Asian, 2%Amer.Indian/Alask.Native, 1%Unreported/Refused,14%More thanOne Race, 1%2PatientWhite, 34%1BCFHCHispanic,22%2015 HRSA Uniform Data Set (UDS) Report.with HIV diagnosis and at least one visit between 01/01/15 and 12/31/15.Unreported/Refused, 1%
Integration of Routine HIV Testing Routine HIV testing introduced by Primary Care Provider TO WHO:
Routine HIV Testing Diagram
Lab Based Test vs. Rapid TestPROSLab Based (HIV 1/2 antigen /antibodycombinationimmunoassay) Rapid Test (ClearviewCOMPLETE HIV1/2) CONSMore acceptable amongst pts whenintroduced by PCPEasier to include with other labsCDC recommended testingtechnologyNo need for additional lab testprior to linking to care CLEARVIEW Free of charge forpatient and BCFHCSame day result Potential lost to care (pts. don’treturn for lab visit)Potential delayed entry into care forHIV Increased lab cost for uninsured pts.Increased organizational costAdditional documentation requiredAdditional training required for“testers”
Lab Based Test vs. Rapid Test Lab based testing for routine testing of patients Conducted by MA along with other labs Lab costs for insured patients is billed to insurance Lab costs for uninsured/self-pay patients currently covered bygrant funding Rapid testing for community members/non-patients Conducted by Certified C&T Staff (Outreach, some MAs, someStaff Nurses, HIV Care Team Staff) Tests kits provided by State DOH No cost to patients
Additional Training Needed All Staff needed additional HIV education and training onroutine testing “workflow”Rapid Testing Staff (Outreach, Medical Assistants, StaffNurses HIV Care Team) needed additional HIV specifictrainings HIV 500/501 Training through local DOH (which includescompletion of in-house HIV C&T practicum)CLEARVIEW Complete Training through local DOH)Annual HIV 501 Update through local DOHPCP need additional basic HIV care trainingAll Staff given access to P4C trainings/webinars
Additional Support Needed Expanded documentation options in EHR Wanted to document and track “decliners”Update system to reflect multiple technologiesUpdate workflowEstablished standing orders for HIV patientsRevise Data Collection Forms Include “risk” questions in Patient H&P form
Routine HIV Testing Outcomes2,040 Routine HIV tests conducted in 2015Monthly Average: 170 tests r-15Mar-15Feb-150Jan-15# of tests250
Routine HIV Testing Outcomes 35% of patients aged15-65 years in need ofHIV testing were testedfor HIV
Next Steps Increased compliance with testing workflow across sites Sustainability planning specific to lab costs for uninsured HIP for high-risk negatives
WE NEED YOU!Participate as Health Center co-presenter.Contact:Victor Ramirez,P4C HIV TAC Collaborative Training Coordinatorvramirez@mayatech.com
Thank you for participating in this CoP webinar. We hope that youare able to find the information provided useful as you continueyour P4C project. We ask that you take a few moments to completethe feedback survey you will receive in a message following thiswebinar.
Thank you for participating in today’s CoP webinarPlease email if you have any question(s):P4CHIVTAC@mayatech.com
INSTI HIV -1/HIV-2 , UniGold Recombigen #, Clearview STAT-PAK, Clearview COMPLETE, OraQuick ADVANCE Rapid. INSTI HIV- 1/HIV-2 , UniGold Recombigen# Alere Determine Combo Ag/Ab Rapid Test *Test for HIV -1 only; # 3. rd. generation test functioning as second generation test; Test sometimes class
Anonymous HIV testing (without giving your name) is available at certain public testing sites. HIV testing is a routine part of health care but you have the right to decline an HIV test. If you wish to decline HIV testing, inform the health care provider. HIV Testing for Young People Aged 13-18:
Jul 25, 2011 · Multispot HIV-1/HIV-2 2004 Reveal G3 2003 OraQuick Advance 2002 Clearview Complete HIV 1/2 2006 Clearview HIV 1/2 Stat Pack 2006 . Rapid HIV Test Results without Rapid Test Kits . On-board Refrigeration of Multiple Different Assays . . COMPLETE HIV-1/2 (-5) HIV-1/2 STAT-PAK
HIV medication costs approximately 15,000 Euro per year. In Finland, the place of domicile of the HIV positive person pays for the medication. How will HIV affect my life? HIV will not affect your work, studies or hobbies. A person with HIV can date, get married and have children. HIV will not stop you from living a full life.
Epi Profiles Summary: St. Louis HIV Care Region 2017 Epidemiologic Profiles of HIV, STD, and Hepatitis in Missouri 63 Figure 5. HIV disease deaths*, by selected race and year of death, St. Louis HIV Care Region, 2008-2017† *Includes deaths that have occurred among those diagnosed with HIV disease in the St. Louis HIV Care Region.
enzyme-linked immunosorbent assay (ELISA) technique, antibody, HIV-1 or HIV-2, screening (rapid test when used with -92 modifier) or 3. G0435 Infectious agent antigen detection by rapid antibody test of oral mucosa transudate, HIV-1 or HIV-2, screening (rapid oral fluid test, without -92 modifier) Note: These codes can only be claimed with use of
living with HIV, and community advocates responsible for promoting the best interests and care of adults living with HIV. They should be read in conjunction with other published British HIV Association (BHIVA) guidelines. Of note, the term 'HIV' refers to HIV-1 throughout these guidelines. 1.2 Methodology 1.2.1 Guideline development process
The Routine Universal Screening for HIV (RUSH) program provides non-medical case management services, opt-out HIV testing and linkage to care for emergency department (ED) patients. The program entails automatically adding an HIV screening for any patient aged 16 years or older, having an IV inserted, or having blood drawn for other reasons,
Year 12 Opportunities for Prospective Applicants Thanks to the outreach work of universities and colleges, professional bodies and widening participation charities, there now exist a wide range of opportunities for UK maintained-sector students to explore Higher Education in the years before they come to apply. While many providers offer opportunities for KS4 pupils, or even younger year .
