Toward Elimination of Perinatal HIV Transmission in the U'S'

1
Toward Elimination of Perinatal HIV Transmission
in the U.S.
Ryan White CARE Act Grantee
Meeting August 30, 2006

• Margaret A. Lampe, RN, MPH
• Division of HIV/AIDS Prevention
• Centers for Disease Control Prevention

The findings and conclusions in this presentation
are those of the author and do not necessarily
represent the views of CDC.
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Estimated Number of Perinatally Acquired
AIDS Cases, by Year of Diagnosis, 1985-2004
United States
PACTG 076 USPHS ZDV Recs
CDC HIV screening Recs
95 reduction
Number of cases
Number of cases
1986
1985
1987
1988
1989
1990
1991
1992
1994
1993
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
Year of Diagnosis
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Background

• Rates of perinatal HIV Transmission of lt 2 are
  possible with
• Early identification of maternal HIV infection
• 3 part (antenatal, peripartum and neonatal)
  antiretroviral regimen
• Pre-labor cesarean section if a maternal viral
  load of lt1000 copies/ml is not achieved
• Approximately 144-236 infants acquired HIV
  infection via MTCT in the U.S. in 2002 MMWR June
  2, 2006 / 55(21)592-597
• In 2000, 40 of HIV-infected infants mothers
  not tested until birth or later

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Perinatal HIV TestingBalance Shifting
BENEFITS
RISKS

• Benefits versus risks of testing pregnant women
  for HIV have shifted over years

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CDC/USPHS Guidelines for Perinatal Testing 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 risk and in
  high prevalence areas
• Consider rapid HIV testing for women in labor
  with unknown HIV status

BENEFITS
RISKS
RISKS
BENEFITS
RISKS
BENEFITS
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Implementation of recommended prenatal screening
tests, 1998/1999
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Canadian Results, 1999-2001
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Dear Colleague RecommendationsApril 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 the medical
  record
• Newborn testing

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Advancing HIV Prevention Strategy 4 Further
Decrease Perinatal HIV TransmissionApril, 2003

• Work with partners to promote routine, voluntary
  prenatal testing, with the option to decline
• Develop guidance for using rapid tests during
  labor and delivery or postpartum
• Develop guidance for routine screening of infants
  whose mother was not screened
• Monitor integration of routine prenatal testing
  into medical practice
• Case control study to assess reasons why
  perinatal HIV infections occurring

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Rapid HIV Testing in LD An important safety net

• Even when begun in labor, ARV prophylaxis can
  reduce MTCT by up to 50 (rates of 25 without
  interventions, 9-13 with ARVs).
• good-performing rapid HIV tests are now
  available in the U.S.
• LD Rapid testing has been shown to be both
  acceptable feasible, with some logistical
  challenges (MIRIAD study- JAMA, July, 2004)

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LD Point-of-Care Testing Station

• The rapid test is done on this counter, extra
  supplies are stored below.
• OB physicians and midwives share MIRIAD testing

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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 5236, Sept 16, 2003
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Impact of Advancing 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 underway in 16
  states

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Continued Efforts in Perinatal HIV Prevention

• Continue to
• Work with states to promote universal prenatal
  HIV testing and to streamline testing procedures
• Develop methods for the ongoing estimation and
  feedback on recommended perinatal screening tests
  
• Support monitor implementation of rapid HIV
  screening for women in labor with undocumented
  prenatal HIV status

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Four FDA-approved Rapid HIV Tests
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Four FDA-approved Rapid HIV Tests
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Positive Predictive Value of a Single Test
Depends on Specificity Varies with Prevalence
Predictive Value, Positive Test
OraQuick
Single EIA
Reveal
Uni-Gold
HIV Prevalence
10
99
98
92
97
5
98
96
85
95
2
95
91
69
87
1
91
83
53
77
0.5
83
71
36
63
0.3
75
60
25
50
0.1
50
33
10
25
99.9
99.8
99.1
99.7
Test Specificity
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 gt300,000
• Maple-syrup urine disease 1 in 175,000
• Homocystinuria 1 in 100,000
• Galactosemia 1 in 60,000
• Phenylketonuria 1 in 14,000
• Hypothyroidism 1 in 4,000
• Perinatal HIV exposure, US 1 in 670
• Perinatal HIV infection, US 1 in 2,680 to 1 in
  33,500
• (according to interventions)

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Positive Predictive Value Newborn Screening
Newborn Screening results , 1993 Arch Pediatr
Adolesc Med, July 2000
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OIG Report Reducing Obstetrician Barriers to HIV
Testing(2002)

• CDC should facilitate the development and
  states implementation of protocols for HIV
  testing during labor and delivery in order to
  promote testing in this setting as the standard
  of care.

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Perinatal HIV Rapid Testing Protocol
TeamConvened by CDC
10 individuals with expertise in

• Blood screening
• Laboratory science
• Epidemiology
• Rapid HIV testing technology
• Care and support of HIV- infected pregnant women

• Obstetrics
• Pediatrics
• Nursing
• Public health practice
• Health education and training

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Rapid HIV-1 Antibody Testing During Labor
Delivery for Women of Unknown HIV StatusA
Practical Guide and Model ProtocolJanuary 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 HIV testing
  protocol, can be adapted locally

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Contents Overview

• Planningconsiderations for getting started
• Choosing type of test
• Location (LD 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-out approach for
  women who have undocumented HIV test results when
  presenting to labor delivery.

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National Implementation PlanRapid Testing in LD

• Promote with key partners
• Train build capacity
• Monitor evaluate
• Technical Assistance

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Regional Strategic Planning Workshops

• FXBC- strategic planning with invited hospital
  teams of leaders
• Plenary presentations from CDC with the evidence
  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 for Pregnant 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 with undocumented
  HIV status in LD
• 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 access
  screening prenatally, the promise of ACTG 076 and
  other clinical trials cannot be realized.
• Rapid testing provides a last opportunity to
  reduce the impact of missed prevention
  opportunities

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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