Why Is This Study Being Done?

• How well does OraQuick work with Oral Fluid?

• False Positives found in Minnesota

• Why did they happen?

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

Fingerstick rapid HIV test

Positive Negative

Exclude from study Oral Fluid Rapid HIV test

Positive

CASEBlood -Oral +

Return PRELIMINARYresult to client

schedule confirmatory result follow-up

Negative

CONTROL if neededBlood -Oral -

return result to client

Study Subject Recruitment

Case study Flowchart

FINGERSTICK -ORAL TEST +

CASE FOR STUDY

LABEL the 2 OraQuicksSHIP TO CDC

DRAW BLOOD4 Red/Gray top tubes

1 White top tubeSPIN IN CENTRIFUGE

FREEZE UPSIDE-DOWN

WE'LL PICK-UP AS A BATCHCASE & 3 CONTROLS

Collect 2 OraSure Label & ship to CDC

C ASEFS -

O M T +

E IA -R N A -

E IA -R N A +

E IA +R N A +

E IA +R N A -

re turn resu ltsrepeat a t 3 w eeks F /U

if E IA /R N A +

N egative

re turn resu ltsrepeat a t 3 w eeks F /U

Indeterm inate

re turn resu ltscounse l

re fer H IV care

EXC LU D E

Positive

W ester B lotSerum /O ral

C onfirm atory H IVE IA serum and oral

H IV R N A PC R P lasm a

C O N TR O LFS -

O M T -

CDC TESTING

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

Oral OraQuick Study

Informed Consent

• MUST be obtained

• By certified personnel ONLY

• 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.

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.

Components of Informed Consent

CRITICAL POINT!!

• The client may withdraw AT ANY TIME!

• EVEN after they leave!

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

Consent Form

• 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 • 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?

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.

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.

OraQuick Advance

OraQuick Advance

• Very similar to OraQuick1. Easy to use

2. Quick

• Changes1. Controls

2. Oral Fluid Specimen (OMT)

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

Oral Fluid Specimen

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: a) Inside of cheekb) Roof of mouthc) Tongue

Oral Fluid Collection Technique

DO NOT SWAB • Roof of the mouth• Inside of the cheek; or• The tongue

Técnica de Colección de Fluido Oral

NO frotar: • El Paladar• El área adentro de la mejilla.• la lengua

Que hacer:

1. Posicionar La almohadilla lisa encima de los dientes enfronte de la encía exterior.

2. Frotar solo una vez alrededor de la encía superior.

3. Frotar solo una vez alrededor de la encía inferior

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

• Insert new log sheet

Case study Flowchart

FINGERSTICK -ORAL TEST +

CASE FOR STUDY

LABEL the 2 OraQuicksSHIP TO CDC

DRAW BLOOD4 serum RED/GRAY top tubes1 plasma PPT WHITE top tube

SPIN IN CENTRIFUGEFREEZE UPSIDE-DOWN

WE'LL PICK-UP AS A BATCHCASE & 3 CONTROLS

Collect 2 OraSure Label & ship to CDC

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

Label with CDC numbersWatch Gender - M/F

1. Red/Gray top tube 1 2. Red/Gray top tube 23. Red/Gray top tube 34. White top tube5. Oraquick Oral Device6. Oraquick Fingerstick Device7. Orasure 1 8. Orasure 29. Consent form

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.

• 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!

Collection tubes

Centrific Centrifuge

• Six tubes• Rotor accepts 7, 10,

and 15mL tubes• No tube cushions

are needed

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

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.

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

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!

THE END

Why Have You Been Asked to Take Part in This Study?

• Because you have requested a rapid HIV test.

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.

Who May Take Part in This Study? And Who May Not?

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

How Long Will the Study Last and How Many Subjects Will

Take Part in It?

• 1 minute (first part)

• up to 30 minutes (second part)

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 blood and oral fluid tests.

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.

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.

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

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

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

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

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.

• If the oral test is positive, and for some people with a negative oral test, we’ll want more:

·Answer questions about your HIV risk factors, about other diseases that you might have, and about your teeth and mouth. This might take about 15 minutes.

·We’ll collect blood—about two tablespoons worth. You might get a bruise from getting blood drawn. You could get an infection, but that hardly ever happens.

·We’ll collect more oral samples. This might leave a salty taste in your mouth.

·We might be doing tests for other diseases on this extra blood and oral fluid. If we do, we might call you (even in a few months) if you need to see a doctor about the results.

·We’ll give you a $20 grocery store coupon. Only the people who do the extra stuff get the coupon.

• Everything stays confidential with a code number, just like your HIV blood test. But if we find that you have hepatitis, syphilis or HIV, we have to give information about you to the health department.

 Don’t do this if you don’t want to.• You can get a rapid blood test today anyway.• If you want to do this:

· Ask your HIV counselor any questions you want about this study.

·Don’t do it if you don’t want to.

·Don’t let anyone talk you into it.

·If you say yes now, you can change your mind later and say no.

·Lots more details are in the consent form. You’ll need to sign it.