Download Implementation of acute HIV infection screening in STD

Implementing screening for acute HIV
infection in STD clinics already using rapid
HIV antibody testing, New York City, 2007
Kathleen D. Gallagher, MPH1
Pragna Patel, MD MPH2, Alexis Kowalski, MPH1, Ellen Klinger, MPH1,
Kathy Gombel3, Tim Sullivan3, Monica Parker3, PhD, Susan Blank, MD MPH1,2
1New
York City Department of Health & Mental Hygiene (NYC DOHMH)
2Centers for Disease Control & Prevention (CDC)
3New York State Department of Health (NYS DOH)
Acute HIV Infection (AHI)



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Highly infectious and often symptoms not
recognized
Not detectable by routine antibody tests, requires
direct detection of HIV virus
Important to diagnose as it poses high impact
opportunity to interrupt the spread of disease
Screening all STD clinic-based testers could have
large impact on decreasing new HIV infections
Number of days needed for HIV
detection – virus & antibody
HIV Virus
HIV Antibody
Exposed and
infected with HIV
11
0
10
Period
when
AHI test
can
detect 3-4 week mark when oral swab
HIV
and WB can start to detect HIV
22
28
20
30
Acute HIV Infection
40
50
60
# of Days
70
80
90
100
New York City Dept. of Health
STD Clinics
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10 clinics - 136,109 visits in 2006
All patients offered HIV antibody testing
Confirmatory blood routinely collected for all
testers; discarded if rapid test negative
Individual tests for HIV virus available on a
case-by-case basis as part of routine care
Project Objective
 Develop system to screen and identify AHI:
 Acceptable to patients
 Clinically useful
 Operationally feasible
Methods
 National CDC-sponsored feasibility study
 Convenience sample at 3 of our STD clinics
 Eligibility Requirements:
 Confidential HIV antibody tester
 >18 yrs of age
 Signed research consent
 Routinely collected whole blood specimens
tested for HIV RNA via nucleic acid amplification
testing (NAAT) at Wadsworth Lab
AHI screening enrollment NYC STD
clinics, June-October 2007
Enrolled
Ft. Greene
N = 1015
Chelsea
N = 745
Morrisania
N = 1895
Total
N = 3655
June
July
August
Sept.
Oct.**
71%
56%
48%
41%
21%
42%
29%
37%
31%
19%
88%
89%
82%
86%
85%
69%
56%
55%
52%
39%
**Enrollment hours changed
Antibody & NAAT
results for AHI
Enrollees
ACCEPT
N = 3655
Rapid Antibody
Test
N = 3336
Conventional
Antibody Test
N = 19
EIA-NEGATIVE
N = 19
NAATN = 19
NEGATIVE
N = 3621
PRELM. POS
N =15
NAAT+
N = 14
NAAT UNSAT
N=1
*Data: June 4, 2007 – October 31, 2007
NAAT+
N=6
(4 CASES)
NAATN = 3614
NAAT UNSAT
N=1
Descriptive Epi

Difference between those who accepted
AHI and those who refused AHI were
examined:
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Gender
Race/ethnicity
Sexual risk factor
Age group
Significant p<0.001
Operational Issues
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Shipping requirements limited enrollment hours
Consenting process added additional time to
clinic visit
NAAT results take 5-7 days to return and
introduced the need for participants to retrieve
results
Summary
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Due to the limitations of HIV antibody testing we
are missing acutely infected individuals
Pooled HIV NAAT is an economical way to
screen rapid antibody negative specimens for
HIV virus
Additional consent form posed a barrier in NYC
With opt-in testing more worried well than truly
high risk patients accepted additional HIV NAAT
Why continue HIV NAAT?
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Routinizing pooled HIV NAAT screening as part
of standard consent would allow testing of all
high risk individuals
Identified 4 cases of acute HIV out of 3621
pooled rapid HIV negative samples (0.11%)
NYC DOHMH clinics performed 53,169 HIV
antibody tests in 2006
Adding HIV NAAT could help us identify ~50
acutely infected individuals each year
Lessons Learned
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Simplify consent process
Decrease test turn around time - time between
testing and receiving results
Reduce the labor intensity of specimen
processing
Next Steps
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Work to incorporate new language into current
NYS HIV consent form to allow for routine HIV
NAAT
Streamline specimen packaging for local pickup and testing
Collaborate with local Public Health Lab (PHL)
to create infrastructure for HIV NAAT
Develop electronic mechanisms for data
exchange with local PHL
Acknowledgements
 Pragna Patel, MD MPH
 NYC DOHMH
 Chelsea, Ft. Greene, Chelsea clinic staff
 Public Health Laboratory
 Alexis Kowalski (Project Coordinator)
 NYS DOH Wadsworth Center
 Tim Sullivan
 Kathy Gombel
Contact Information
 Kathleen Gallagher
 [email protected]
 (212) 788-6614