Increasing Our Reachthrough Rapid HIV Testing

Bernard M. Branson, M.D.Chief, Lab Determinants and Diagnostics

SectionCenters for Disease Control and Prevention

040,000 0 2,000,000

1,442,847 786,9371,147,25126,46522,5141997 1,147,25122,5149,843

27,947 1,374,7091996 708,2201,442,84726,4658,023

What if rapid HIV tests wereused in all public testing sites?

Additional, Rapid Test

HIV PositiveStandard testing

HIV Negative

Additional, Rapid Test

Standard testing

1998 1,442,847 856,8761,147,25126,46522,514 1,091,04518,1189,843

1,442,847 903,8391,147,25126,46522,514 995,95216,04811,1921999

1,442,847 913,0571,147,25126,46522,514 1,028,27416,22310,5932000

OraQuick: Oral fluid, serum, whole blood

FDA-approved November 7, 2002 for use with fingerstick whole

blood specimens

Obtain fingerstick blood specimen

Similar loop is used with several rapid tests

Insert loop into vial and stir

Test develops in 20 minutes

Positive Negative

Reactive Control

Positive HIV-1/2

Read results

Oral fluid specimens reduce hazards, facilitate testing in field settings

Rapid Test Performance: Serum

Sensitivity Specificity

OraQuick 100% 100%

SUDS 97.9% 94.5%

HIV 1- 2 EIA - 95.1%

206 HIV+, 194 HIV- stored sera

Rapid Test Performance: Prospective Study

False Negative

Sensitivity

False Positive

Specificity

OraQuick 0/73 100% 2/1639 99.9% OraQuick Oral 0/72 100% 18/1569 98.9% SUDS 1/72 98.6% 6/1641 99.6%

1649 Clients at Testing Site /STD Clinics

CDC experiences with rapid HIV testing outside the US

HIV Testing in Kenya is Done on Site by a Trained Counselor, Supervised by a

Laboratory Technician

Two different, rapid, simple whole blood tests are used for every client

Confirmed results in 15 to 20 minutes

Tests used at present: Abbott Determine Trinity Biotech UniGold

Increase in Demand for VCT in Malawi with Same Day Results using Rapid

Tests

230 272 245420

542

8411103

1633 1602

1922

Jan Feb March April May

1999 (1-2 week wait) 2000 (same day results)

VCT Clients in Malawi: Waiting period versus same day results

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

92 93 94 95 96 97 98 99 2000 2001

Waiting period Same day results

Rapid Increase in Utilization of VCT in Kibera, March 2001 – March 2002

0

200

400

600

800

1000

1200

1400

Female Male

• KICOSHEP served 12,157 VCT clients at 5 sites in the Kibera slum and at 17 medical camps

Outcomes with rapid HIV testing in the U.S.

Cook County Jail (CCJ) Female Intake

Largest single-site jail in the U.S. 100,000 detainees each year 15% females:

80+ females through intake area daily 50% released in < 36 hours

Study period: October 2000 – May 2001

Cook County Hospital Emergency Department

(CCH-ED)

Busiest emergency department in Chicago 120,000+ patient visits per year January 2001 conventional HIV testing Study period: June 2001 – February 2002

Eligibility and Acceptance

CCJ Intake

# Approach 3055

# Eligible 2289 (75%)

# Accept RT 988 (43%)

CCH -ED

7072

6038 (85%)

1652 (27%)

CCJ Intake

CCH ED

# rapid tested 988 1652

# received results 985 (99.7%) 1640 (99.3%)

# new HIV+ 9 (0.9%) 46 (2.8%)

# entered care 2 (22%) median 50 days

36 (80%) median 13 days

Rapid Test Outcomes

CCJ N=9

CCH N=46

No previous test 4 (44%) 26 (57%)

Risk Factors

MSM 0 14 (30%) IDU 1 (11%) 6 (13%) Sex Partner IDU 0 3 ( 7%) Sex Partner HIV+ 0 3 ( 7%) No identified risk 2 (22%) 22 (48%)

CharacteristicsRapid Test Positive Patients

CCJ – Female Intake None of RT patients came

to Screening Clinic for CT results

Difficulties in patient follow-up

CCH – ED Many HIV+ patients without

risk factors Second phlebotomy not a

deterrent Many patients had no

additional blood drawn Little need for psych support

Surprises

HIV Screening in Acute Care Settings

Cook County ED, Chicago 2.8% Grady ED, Atlanta 2.7% Johns Hopkins ED, Baltimore 3.2%

New HIV+

Perinatal Screening: MIRIAD Study

Testing of pregnant women in labor for whom no HIV test results are available; 12 hospitals in 5 cities: Atlanta, Chicago, Miami, New Orleans, New York

To date 1771 women screened 12 new HIV infections identified No false positives, no false negatives

Bethany HospitalBethany Hospital

Rapid test performed on Labor and Delivery unit.

Eligible patients are determined here in the Labor and Delivery Triage area.

The rapid test is done on this counter, extra supplies are stored below.

OB physicians and Midwives share MIRIAD testing at Provident.

Provident HospitalProvident Hospital

Cook County HospitalCook County Hospital

Clerks on each shift access HIV results from the computer system.

Eligible patients are offered rapid testing and consented in the Triage area.

Boxplot of Turn Around Times

060

120180240300360420480540600660720780840900960

Bethany CCH Provident St. Bernard

Reasons for Delay in Reasons for Delay in Delivering Rapid Test Delivering Rapid Test

ResultsResults

Out of sight out of mind (when sent to lab) Shift change Patient sleeping Getting blood to the laboratory and getting

result back

OraQuick Outreach to High Risk Persons of Color

Patrick Keenan MDUniversity of Minnesota Medical

SchoolDepartment of Family Practice and

Community Health

OraQuick Research Study (7/22/02) N = 115

On-site group pretest counseling. Individual testing and post-test

counseling. Testing procedure:

Oral fluid OraQuick (research only) Fingerstick OraQuick (results given) Fingerstick neg -> OraSure backup Fingerstick pos -> venous EIA/WB

Client Survey Results I

“I have tested for HIV in the past and I prefer receiving my results the same day”

Strongly agree or agree = 97%Disagree or strongly disagree = 3%

Client Survey Results II

“It would have been better to wait a week before getting any results”

Agree or strongly agree = 3%Disagree or strongly

disagree = 97%

Client Survey Results III

“I found the rapid testing stressful”

Agree or strongly agree = 33%Disagree or strongly

disagree = 67%

Client Survey Results IV

“I would rather have my finger stuck than have blood drawn from my vein”

Agree or strongly agree = 88% Disagree or strongly disagree = 7% No difference = 5%

Client Survey Results V

“I would recommend rapid testing to a friend”

Agree or strongly agree = 94% Disagree or strongly disagree = 6%

Client Survey Results: VI

“I understand the results of my test.”

Agree or strongly agree = 99% Disagree or strongly disagree = 1%

GAY & GAY & LESBIAN LESBIAN CENTERCENTER

GAY & GAY & LESBIAN LESBIAN CENTERCENTER

STD STD CLINICCLINIC

STD STD CLINICCLINIC

13

1

3

2625%

1.1%* 0.4%*

98.5%*

*Percentage of correct results obtained, does not include 13 “invalid” test results.

Correct

Invalid

False Negative

False Positive

Untrained Users 1– 279 Patient specimens

74

12

13

565

Untrained Users – 664 Evaluation panel specimens

11%

2.2%*

2.0%*

95.8%*

*Percentage of correct results obtained, does not include 74 “invalid” test results.

Correct

Invalid

False Negative False

Positive

Lessons Learned

Client Acceptance Levels

Testing & Counseling Unit

Logistics

Personnel Issues

Confirmatory Testing

For Western blot: Venipuncture for whole blood Oral fluid specimen Dried blood spots on filter paper