409 toward elimination of perinatal hiv transmission in the us

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

409 toward elimination of perinatal hiv transmission in the us

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