Toward Elimination of Perinatal HIV Transmission in the U.S. Margaret A. Lampe, RN, MPH Division of HIV/AIDS Prevention Centers for Disease Control & Prevention.

Toward Elimination of Perinatal HIV 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 the author and do not necessarily represent the views of

CDC.

Number of cases

0

200

400

600

800

1000

Nu

mb

er

of

case

s

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% reductio

n

CDC HIV

screening Recs

Year of Diagnosis

Background

Rates of perinatal HIV Transmission of < 2% are possible with:

1. Early identification of maternal HIV infection2. 3 part (antenatal, peripartum and neonatal) antiretroviral

regimen 3. Pre-labor cesarean section if a maternal viral load of

<1000 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

Perinatal HIV TestingBalance Shifting

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

BENEFITS RISKS

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

BENEFITSRISKS

BENEFITS RISKS

BENEFITS

RISKS

Implementation of recommended prenatal screening tests, 1998/1999

Test Frequency (%)

(n=5,144)

Hepatitis B 96.5

Syphilis 98.2

Rubella 97.3

HIV 57.2

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

“Dear Colleague” RecommendationsApril 22, 2003

No child should be born in the U.S. whose HIV status (or mother’s 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

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

Rapid HIV Testing in L&D: 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.

L&D Rapid testing has been shown to be both acceptable & feasible, with some logistical challenges (MIRIAD study- JAMA, July, 2004)

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

OB physicians and midwives share MIRIAD testing

L&D Point-of-Care Testing StationL&D Point-of-Care Testing Station

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

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

Continued Efforts in Perinatal HIV Prevention

Continue to:

o Work with states to promote universal prenatal HIV testing and to streamline testing procedures

o Develop methods for the ongoing estimation and feedback on recommended perinatal screening tests

o Support & monitor implementation of rapid HIV screening for women in labor with undocumented prenatal HIV status

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-Gold Recombigen

- whole blood

- serum/plasma

100 (99.5 – 100)

100 (99.5 – 100)

99.7 (99.0 – 100)

99.8 (99.3 – 100)

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)

Positive Predictive Value of a Single Test Depends 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 EIA

Reveal

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

Prevalence of Diseases Screened for in NewbornsPrevalence of Diseases Screened for in Newborns

Tyrosinemia: 1 in >300,000

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)

Positive Predictive Value: Newborn Screening

Specificity PPV

PKU 99.7 2.65%

Galactosemia 99.7 0.57%

Hypothyroidism 98.3 1.77%

Adrenal Hyperplasia

99.0 0.53%

Newborn Screening results , 1993 Arch Pediatr Adolesc Med, July 2000

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.”

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 testing

technology Care and support of

HIV- infected pregnant women

10 individuals with expertise in:

Rapid HIV-1 Antibody Testing During Labor & Delivery for Women of

Unknown HIV StatusA Practical Guide and Model Protocol

January 30, 2004

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

Contents Overview: Planning—considerations 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

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

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.”

National Implementation PlanRapid Testing in L&D

1. Promote with key partners

2. Train & build capacity

3. Monitor & evaluate

4. Technical Assistance

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

“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 L&D Initiate ARV prophylaxis on basis of rapid test result

Newborn testing if mother’s status unknown

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

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