Why Is This Study Being Done?

1. Why Is This Study Being Done? • How well does OraQuick work with Oral Fluid? • False Positives found in Minnesota • Why did they happen?

2. Oraquick False Positives • Minnesota oral OraQuick • 7/2000 (35/10,000) in the first 2 years • 15/266 (600/10,000) next 3 months • New Jersey fingerstick OraQuick • 6/11,000

3. Study Subject Recruitment

4. Case study Flowchart

5. CDC TESTING

6. False Positive rate >1.5%(phase 2 of study) • Additional Testing • Hepatitis A, B and C • Epstein-Barr virus • Cytomegalovirus (CMV) • Herpes simplex virus (HSV) type 1 and 2 • Syphilis • Antinuclear antibodies (ANA) • Rheumatoid factor • Pregnancy • Immunoglobulin testing

7. Oral OraQuick StudyInformed Consent • MUST be obtained • By certified personnel ONLY

8. Informed Consent • Legislation requires that patients be informed of all important aspects of a treatment and/or procedures, • Failure to obtain adequate informed consent constitutes medical malpractice.

9. Components of Informed Consent • The purposes, procedures, and duration of the research. • Any procedures which are experimental. • Any reasonably foreseeable risks, discomforts, and benefits of the research. • Any potentially beneficial alternative procedures or treatments. • How confidentiality will be maintained.

10. CRITICAL POINT!! • The client may withdraw AT ANY TIME! • EVEN after they leave!

12. Study Summary • What? A study of oral OraQuick. • Why? False Positives reported. • Who? Fingerstick -, Oral + AND controls • How? • Test oral and fingerstick, • Complete questionnaire, • Collect additional specimens

13. Intro Why is this study being done? Why have you been asked to take part in this study? Who may take part in this study? And who may not? What will you be asked to do if you take part in this research study? How long will the study last and how many subjects will take part in it? What are the risks and/or discomforts you might experience if you take part in this study? Are there any benefits for you if you choose to take part in this research study? Consent Form

14. What are your alternatives if you don’t want to take part in this study? Who will be allowed to look at your research records from this study? Will there be any cost to you to take part in this study? Will you be paid to take part in this study? What will happen if you do not wish to take part in the study or if you later decide not to stay in the study? Who can you call if you have any questions? What are your rights if you decide to take part in this research study? Consent Form

15. Conclusion • Patient's comprehension of the information provided is sometimes limited, rendering the consent not truly "informed.” • Interventions that may prove beneficial: • Providing written materials to accompany oral conversations (copy of consent form–unsigned). • Asking patients to recap discussions about the procedure.

16. NOTE • The counselor is responsible for obtaining the informed consent. • Each Center/Site (but not individual counselor) will receive compensation for the extra work/time involved in the study.

17. OraQuick Advance

18. OraQuick Advance • Very similar to OraQuick • Easy to use • Quick • Changes • Controls • Oral Fluid Specimen (OMT)

19. Quality Control • Kit Controls - Now includes THREE • HIV-1 Positive Control – black capped • HIV-2 Positive Control – red cap/line • Negative Control – white capped • Three results on log sheet!! • Check EXPIRATION DATES!! • NOTE: Place black mark on HIV1 vial

20. Oral Fluid Specimen

21. Collection of Oral Fluid • Put on gloves • Do not touch flat pad • IMPORTANT: Absorbent packet must be included! • Label both device & vial • Uncap vial & place in holder • Swabbing outer gums above teeth, BOTH top & bottom gums • Demonstrate • Do NOT swab: • Inside of cheek • Roof of mouth • Tongue

22. Oral Fluid Collection Technique • DO NOTSWAB • Roof of the mouth • Inside of the cheek; or • The tongue

23. Técnica de Colección de Fluido Oral • Que hacer: • Posicionar La almohadilla lisa encima de los dientes enfronte de la encía exterior. • Frotar solo una vez alrededor de la encía superior. • Frotar solo una vez alrededor de la encía inferior • NO frotar: • El Paladar • El área adentro de la mejilla. • la lengua

24. Testing of Oral Fluid • Insert pad into LABELED vial • Do NOT remove once inserted • Start timer • Read results after 20 minutes but not more than 40 minutes • >40 minutes = INVALID • Record results – indicate Oral on log

25. Insert new log sheet

26. Case study Flowchart

27. Label with CTS number • 1 Red/Gray top tube • If Oral or Fingerstick Positive, send to Ken Earley (State Lab) for confirmation of preliminary positive

28. Label with CDC numbersWatch Gender - M/F 1. Red/Gray top tube 1 2. Red/Gray top tube 2 3. Red/Gray top tube 3 4. White top tube 5. Oraquick Oral Device 6. Oraquick Fingerstick Device 7. Orasure 1 8. Orasure 2 9. Consent form

29. Tube storage • Store tubes at room temperature – NOT above 100 °F . • White top tube: Do not use if the stuff on the wall is not white! • Do not use tubes after their expiration dates.

30. Collection tubes • The flow properties of the gel barrier are temperature-dependent. Do NOT REFRIGERATE before spinning! • Blood samples must be centrifuged between 20 minutes and two hours after collection! WAIT AT LEAST 20 MIN!

31. Centrific Centrifuge • Six tubes • Rotor accepts 7, 10, and 15mL tubes • No tube cushions are needed

32. HOW TO OPERATE • Place tubes in centrifuge • Incomplete seating – the tube can break or the top may come off – NOT GOOD! • Balance (we’ll talk about it) • Close lid • Set timer dial to 10 minutes • Centrifuge starts automatically, reaches set speed in 15 seconds and stops after set time

34. Procedure - IMPORTANT • Balance tubes to minimize the chance of breakage. • Match tubes with similar tubes of the same fill level and place them opposite of one another.

35. Handling • Check for possible spills/breakage • If tube breaks, wait 10 minutes before opening centrifuge. • Use tweezers or clamp to remove damaged tube. NEVER remove broken tubes by hand! • Remove tubes from centrifuge

36. Shipping OraQuick/Orasure Devices • Complete specimen submission form • Put FedEx tracking number on form • Fax form to all three numbers on form • Include form in box • We will pick up your blood samples!

37. THE END

39. Why Have You Been Asked to Take Part in This Study? • Because you have requested a rapid HIV test.

40. Why Is This Study Being Done? • We are evaluating a rapid HIV test that uses oral fluid. • Patients may have a positive oral fluid test and a negative fingerstick test (it is more likely that the negative fingerstick test is the correct result). • To find out why some people with negative fingerstick tests have positive oral fluid rapid HIV test results and others do not. • To do this, we need participants who have positive and negative oral fluid tests.

41. Yes People over 18 who have negative rapid HIV blood tests (fingerstick) may take part in this study No Diagnosed with HIV Treated with anti-retroviral drugs (AIDS drugs) Ever got an HIV or AIDS vaccine Who May Take Part in This Study? And Who May Not?

42. How Long Will the Study Last and How Many Subjects Will Take Part in It? • 1 minute (first part) • up to 30minutes (second part)

43. Duration of Study The study will last in the State of New Jersey until we get: • 50 people who have negative HIV fingerstick tests and positive HIV OMT oral fluid tests. • 150 people with negative fingerstick bloodandoral fluid tests.

44. What Are the Risks And/or Discomforts You Might Experience If You Take Part in This Study? • If blood is drawn, there may be: • Bruising. • Bleeding. • Infection (rare). • Oral fluid samples: • Salty taste in your mouth.

45. Continued…. • No follow-up visit = no results of the test (confirmatory). • If you have a confirmatory HIV test, you may not learn your test result for three weeks. • Embarrassing questions about possible risks for HIV infection. • You do not have to answer any questions you are uncomfortable with. • Tests may be done for some serious diseases. • If these tests are done, you could learn that you have a serious disease.

46. Extra testing related issues • If they are done (they may be not needed), these tests will be done (probably) some months after your blood is drawn. • If name/way to contact exists - contact to arrange a F/U visit for results. • If anonymous- no way to give the results of any tests, so NOT included in study = can’t get an oral OMT

47. Tests That Might Be Performed on Blood • Hepatitis A, B and C • Epstein-Barr virus • Cytomegalovirus (CMV) • Herpes simplex virus (HSV) type 1 and 2 • Syphilis Antinuclear antibodies (ANA) Rheumatoid factor Pregnancy

48. Confidentiality • Personal information is confidential • CDC receives de-identified information • Law requires reporting of positive, confirmed results for HIV and/or other diseases tested • Only persons involved in the study will see the information, de-identified

49. Potential benefits • Help medicine with the validation of a non-invasive, fast testing method • If you, or someone you know needs a rapid HIV test, it will be done like this; no needles, just a swab

50. A Study of HIV Testing Using Oral Fluid – Summary Sheet • If you want a rapid HIV test today, it will be done on a drop of blood from a fingerstick. • We need volunteers for a study that’s looking at an oral (mouth) version of this test. We’re studying the oral version because some HIV-negative people tested with the oral version got wrong results that said they were HIV-positive. So, we want to compare the blood and oral results in more people. • What we want volunteers for: ·You’ll get the rapid fingerstick HIV test result even if you don’t want to do the study. ·We want you to volunteer to do the oral test, too.