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.

Estimated Number of Perinatally Acquired AIDS Cases, by Year of Diagnosis, 1985-2004 United States
1000
PACTG 076 & USPHS ZDV Recs CDC HIV screening Recs ~95% reduction

800
Number of cases

600 400

200 Number of cases 0

1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004

Year of Diagnosis

Background
Rates of perinatal HIV Transmission of < 2% are possible with:
1. 2.

3.

Early identification of maternal HIV infection 3 part (antenatal, peripartum and neonatal) antiretroviral regimen 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 Testing Balance Shifting

BENEFITS

RISKS

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

CDC/USPHS Guidelines for Perinatal Testing in the U.S.

First edition, 1985 No treatment Growing stigma

BENEFITS

RISKS

Second edition, 1995 AZT prophylaxis reduces MTCT universal counseling/voluntary testing Marked decline in perinatal cases
BENEFITS RISKS

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

RISKS

BENEFITS

Implementation of recommended prenatal screening tests, 1998/1999

Test
Hepatitis B Syphilis Rubella HIV

Frequency (%) (n=5,144) 96.5

98.2 97.3 57.2

Canadian Results, 1999-2001

Province Alberta New &Lab Policy Opt-out Opt-out N 37,963 4,770 %Tested 98 94

Quebec

Opt-in

73,781
41,739

83
80

B Columbia Opt-in

Ontario

Opt-in

129,758

54

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 the medical record Newborn testing

Advancing HIV Prevention Strategy 4: Further Decrease Perinatal HIV Transmission April, 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)

L&D 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

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

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

Four FDA-approved Rapid HIV Tests

Sensitivity (95% C.I.) Specificity (95% C.I.)

OraQuick Advance - whole blood - oral fluid - plasma Uni-Gold Recombigen - whole blood - serum/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)

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 100 (99.9 100)

- HIV-2 100 (99.7 100)

99.9 (99.8 100)

Positive Predictive Value of a Single Test Depends on Specificity & Varies with Prevalence
Predictive Value, Positive Test HIV Prevalence 10% 5% 2% 1% 0.5% 0.3% 0.1% Test Specificity
OraQuick Reveal Uni-Gold Single EIA

99% 98% 95% 91% 83% 75% 50% 99.9%

92% 85% 69% 53% 36% 25% 10% 99.1%

97% 95% 87% 77% 63% 50% 25% 99.7%

98% 96% 91% 83% 71% 60% 33% 99.8%

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 Newborns

Tyrosinemia: Maple-syrup urine disease: Homocystinuria: Galactosemia: Phenylketonuria: Hypothyroidism: Perinatal HIV exposure, US Perinatal HIV infection, US (according to interventions) 1 in >300,000 1 in 175,000 1 in 100,000 1 in 60,000 1 in 14,000 1 in 4,000 1 in 670 1 in 2,680 to 1 in 33,500

Positive Predictive Value: Newborn Screening

Specificity 99.7 99.7 98.3 99.0 PPV 2.65% 0.57% 1.77% 0.53%

PKU Galactosemia Hypothyroidism Adrenal Hyperplasia

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 Team Convened by CDC

10 individuals with expertise in:

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

Rapid HIV-1 Antibody Testing During Labor & Delivery for Women of Unknown HIV Status
A 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:

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

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 Plan Rapid Testing in L&D

1.
2. 3. 4.

Promote with key partners

Train & build capacity Monitor & evaluate 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 mothers 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