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8/3/2019 409 Toward Elimination of Perinatal HIV Transmission in the US
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Toward Elimination of PerinatalHIV Transmission in the U.S.
Margaret A. Lampe, RN, MPHDivision of HIV/AIDS Prevention
Centers for Disease Control & Prevention
Ryan White CARE Act Grantee Meeting
August 30, 2006
The findings and conclusions in this presentation are those of theauthor and do not necessarily represent the views of CDC.
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Number of cases0
200
400
600
800
1000
Numberofcases
19861985 1987 1988 1989 1990 1991 1992 19941993 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
Estimated Number of Perinatally Acquired AIDSCases, by Year of Diagnosis, 1985-2004 United States
PACTG 076 &
USPHS ZDV Recs
~95%reduction
CDCHIV
screeningRecs
Year of Diagnosis
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Background
Rates of perinatal HIV Transmission of < 2% are possible with:
1. Earlyidentification of maternal HIV infection
2. 3 part (antenatal, peripartum and neonatal) antiretroviralregimen
3. Pre-labor cesarean section if a maternal viral load of
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Perinatal HIV TestingBalance Shifting
Benefits versus risks of testing pregnantwomen for HIV have shifted over years
BENEFITS RISKS
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CDC/USPHS Guidelines for PerinatalTesting in the U.S.
First edition, 1985 No treatment
Growing stigma
Second edition, 1995
AZT prophylaxis reduces MTCT universal counseling/voluntary testing
Marked decline in perinatal cases
Third edition, 2001
Maternal treatment advances allows both
mothers and babies to benefit HIV screening should be a routine part of
prenatal care for all women.
Repeat testing 3rd trimester women at riskand in high prevalence areas
Consider rapid HIV testing for women inlabor with unknown HIV status
BENEFITSRISKS
BENEFITSRISKS
BENEFITS
RISKS
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Implementation of recommended prenatal
screening tests, 1998/1999Test Frequency (%)
(n=5,144)
Hepatitis B 96.5
Syphilis 98.2
Rubella 97.3
HIV 57.2
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Canadian Results, 1999-2001
Province Policy N %Tested
Alberta Opt-out 37,963 98
New &Lab Opt-out 4,770 94
Quebec Opt-in 73,781 83
B Columbia Opt-in 41,739 80
Ontario Opt-in 129,758 54
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Dear Colleague Recommendations
April 22, 2003 No child should be born in the U.S. whose
HIV status (or mothers status) is unknown
Routine, opt-out screen prenatally Rapid, opt-out test at labor and delivery for
women with no prenatal test result in themedical record
Newborn testing
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Advancing HIV PreventionStrategy 4: Further Decrease Perinatal
HIV TransmissionApril, 2003
Work with partners to promote routine, voluntaryprenatal testing, with the option to decline
Develop guidance for using rapid tests during laborand delivery or postpartum
Develop guidance for routine screening of infantswhose mother was not screened
Monitor integration of routine prenatal testing intomedical practice
Case control study to assess reasons why perinatalHIV infections occurring
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Rapid HIV Testing in L&D:An important safety net
Even when begun in labor, ARV prophylaxis canreduce MTCT by up to 50% (rates of ~25% withoutinterventions, & 9-13% with ARVs).
good-performing rapid HIV tests are now availablein the U.S.
L&D Rapid testing has been shown to be bothacceptable & feasible, with some logistical challenges(MIRIAD study- JAMA, July, 2004)
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The rapid test is doneon this counter, extrasupplies are stored
below.
OB physicians and
midwives share MIRIADtesting
L&D Point-of-Care Testing Station
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Turnaround Times for Rapid Test Results,Point-of-Care vs Lab Testing
Point-of-care testing: median 45 min
(range 30 min 2.5 hours)
Same test in Laboratory: median 3.5 hours
(range 94 min 16 hours)
MMWR 52:36, Sept 16, 2003
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Impact ofAdvancing HIV Prevention
on Perinatal Activities
Changes in state legislation on perinatal
HIV testing (work with ACOG) All states being asked to provide estimate of
prenatal HIV testing rates to CDC
Perinatal screening chart reviews underwayin 16 states
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Continued Efforts in
Perinatal HIV PreventionContinue to:
o Work with states to promote universal prenatal
HIV testing and to streamline testing procedures
o Develop methods for the ongoing estimation andfeedback on recommended perinatal screening
testso Support & monitor implementation of rapid HIV
screening for women in labor with undocumentedprenatal HIV status
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Four FDA-approved Rapid HIV Tests
Sensitivity
(95% C.I.)
Specificity
(95% C.I.)
OraQuick Advance
- whole blood- oral fluid
- plasma
99.6 (98.5 - 99.9)99.3(98.4 - 99.7)
99.6 (98.5 - 99.9)
100 (99.7-100)99.8 (99.6 99.9)
99.9 (99.6 99.9)
Uni-GoldRecombigen
- whole blood
- serum/plasma
100 (99.5 100)
100 (99.5 100)
99.7 (99.0 100)
99.8 (99.3 100)
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Four FDA-approved Rapid HIV Tests
Sensitivity
(95% C.I.)
Specificity
(95% C.I.)
Reveal G2
- serum- plasma
99.8 (99.2
100)99.8 (99.0 100)
99.1 (98.8
99.4)98.6 (98.4 98.8)
Multispot
- serum/plasma
- HIV-2
100 (99.9 100)
100 (99.7 100)
99.9 (99.8 100)
P iti P di ti V l f Si l T t
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Positive Predictive Value of a Single TestDepends on Specificity & Varies with
Prevalence
Test Specificity
HIV Prevalence
Predictive Value, Positive Test
10% 99% 98%92%5% 98% 96%85%2% 95% 91%69%1% 91% 83%53%
0.5% 83% 71%36%
0.3% 75% 60%25%0.1% 50% 33%10%
OraQuick Single EIAReveal
99.9% 99.8%99.1%
97%95%87%77%63%
50%25%
Uni-Gold
99.7%
In practice, the specificity and actual PPV may differ from these estimates.
Trade names are for identification only and do NOT imply HHS or CDC endorsement
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Prevalence of Diseases Screened for in Newborns
Tyrosinemia: 1 in >300,000
Maple-syrup urine disease: 1 in 175,000
Homocystinuria: 1 in 100,000Galactosemia: 1 in 60,000
Phenylketonuria: 1 in 14,000
Hypothyroidism: 1 in 4,000
Perinatal HIV exposure, US 1 in 670Perinatal HIV infection, US 1 in 2,680 to 1 in 33,500
(according to interventions)
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Positive Predictive Value:Newborn Screening
Specificity PPV
PKU 99.7 2.65%
Galactosemia 99.7 0.57%
Hypothyroidism 98.3 1.77%
AdrenalHyperplasia
99.0 0.53%
Newborn Screening results , 1993Arch Pediatr Adolesc Med, July 2000
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OIG Report: Reducing ObstetricianBarriers to HIV Testing
(2002)
CDC should facilitate the development and
states implementation of protocols for HIVtesting during labor and delivery in order topromote testing in this setting as thestandard of care.
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Perinatal HIV Rapid Testing Protocol TeamConvened by CDC
Obstetrics
Pediatrics Nursing
Public health practice
Health education and
training
Blood screening
Laboratory science Epidemiology
Rapid HIV testingtechnology
Care and support ofHIV- infected pregnantwomen
10 individuals with expertise in:
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Rapid HIV-1 Antibody Testing DuringLabor & Delivery for Women of
Unknown HIV Status
A Practical Guide and Model Protocol
January 30, 2004
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Purpose of Model Protocol
Practical guidance to:
Clinicians
Laboratorians
Hospital Administrators
Public Health Professionals
Policy Makers
Provide general structure of a rapid HIVtesting protocol, can be adapted locally
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Contents Overview:
Planningconsiderations for getting started Choosing type of test Location (L&D or Lab) Training
Key elements of a local protocol Eligibility Opt-out approach Interpreting preliminary and confirmatory results Providing positive and negative results
Intrapartum clinical care Follow up of HIV + women and exposed
neonates HIV Reporting
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Contents Overview:
Management Considerations Key players & stakeholders Ensuring proficiency & competency
References & Resources
Appendixes Dear Colleague Letter Provider guides for opt-out and opt-in (sample
consent form) Provider Formula: C3 R3
Confidentiality, Comfort, Consent Reason, Results, Rx
Boxed Case Studies
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CDC Recommendation
Hospitals should adopt a policy of routine,
rapid HIV testing using an opt-outapproach for women who haveundocumented HIV test results whenpresenting to labor & delivery.
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National Implementation Plan
Rapid Testing in L&D
1. Promote with key partners
2. Train & build capacity
3. Monitor & evaluate
4. Technical Assistance
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Regional Strategic Planning Workshops
FXBC- strategic planning with invited hospitalteams of leaders
Plenary presentations from CDC with theevidence and making the case.
Lessons from the field.
Facilitated SWOT Analysis
Facilitated Action Plan Follow-up technical assistance
Fed well
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Revised Recommendations for Adults Adolescents
and Pregnant Women in Health Care Settings.
PROPOSED Updates forPregnant Women, Fall 2006
Universal opt-out HIV screening Include HIV in panel of prenatal screening tests
Consent for prenatal care includes HIV testing Notification and option to decline
Second test in 3rd trimester for pregnant women: Known to be at risk for HIV
In key jurisdictions In high HIV prevalence health care facilities
Opt-out rapid testing for women withundocumented HIV status in L&D Initiate ARV prophylaxis on basis of rapid test result
Newborn testing if mothers status unknown
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Conclusion
Until all pregnant women with HIV accessscreening prenatally, the promise of ACTG
076 and other clinical trials cannot berealized.
Rapid testing provides a last opportunity to
reduce the impact of missed preventionopportunities
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CDC Resources on the Web
http://www.cdc.gov/hiv/projects/perinatal/
Opt-out prenatal testing
Rapid testing at labor and delivery
Advancing HIV Prevention initiative
Perinatal HIV Prevention grantees