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 .

”  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 . 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.CDC/USPHS Guidelines for Perinatal Testing in the U. 2001  Maternal treatment advances allows both mothers and babies to benefit  “HIV screening should be a routine part of prenatal care for all women.S.

2 .2 97.3 57.144) 96.5 98.Implementation of recommended prenatal screening tests. 1998/1999 Test Hepatitis B Syphilis Rubella HIV Frequency (%) (n=5.

770 %Tested 98 94 Quebec Opt-in 73.739 83 80 B Columbia Opt-in Ontario Opt-in 129.963 4. 1999-2001 Province Alberta New &Lab Policy Opt-out Opt-out N 37.758 54 .781 41.Canadian Results.

opt-out test at labor and delivery for women with no prenatal test result in the medical record  Newborn testing . 2003  No child should be born in the U. opt-out screen prenatally  Rapid.“Dear Colleague” Recommendations April 22. whose HIV status (or mother’s status) is unknown  Routine.S.

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 . voluntary prenatal testing.Advancing HIV Prevention Strategy 4: Further Decrease Perinatal HIV Transmission April. 2003      Work with partners to promote routine.

Rapid HIV Testing in L&D: An important safety net  Even when begun in labor. 2004)  .S. L&D Rapid testing has been shown to be both acceptable & feasible. with some logistical challenges (MIRIAD study. ARV prophylaxis can reduce MTCT by up to 50% (rates of ~25% without interventions. & 9-13% with ARVs). July.JAMA.  ―good‖-performing rapid HIV tests are now available in the U.

extra supplies are stored below.L&D Point-of-Care Testing Station  The rapid test is done on this counter.  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. 2003 . Sept 16.5 hours) Same test in Laboratory: median 3.5 hours  (range 94 min – 16 hours)  MMWR 52:36.

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

5 .9) 100 (99.99.5 – 100) 100 (99.) Specificity (95% C.7 (99.8 (99.99.3 – 100) .9) 100 (99.9 (99.5 – 100) 99.) OraQuick Advance .6 (98.99.3 (98.6 (98.0 – 100) 99.9) 99.7-100) 99.serum/plasma 99.5 .plasma Uni-Gold Recombigen .whole blood .6 – 99.I.oral fluid .I.6 – 99.4 .9) 99.8 (99.whole blood .7) 99.Four FDA-approved Rapid HIV Tests Sensitivity (95% C.

) Reveal G2 .) Specificity (95% C.8 (99.7 – 100) 99.Four FDA-approved Rapid HIV Tests Sensitivity (95% C.4) 98.1 (98.0 – 100) 99.4 – 98.I.6 (98.8 (99.8 – 100) .8 – 99.I.2 – 100) 99.plasma 99.8) Multispot .serum/plasma 100 (99.9 – 100) .9 (99.HIV-2 100 (99.serum .

9% 92% 85% 69% 53% 36% 25% 10% 99. Trade names are for identification only and do NOT imply HHS or CDC endorsement .3% 0.1% 97% 95% 87% 77% 63% 50% 25% 99.7% 98% 96% 91% 83% 71% 60% 33% 99. Positive Test HIV Prevalence 10% 5% 2% 1% 0.5% 0.1% Test Specificity OraQuick Reveal Uni-Gold Single EIA 99% 98% 95% 91% 83% 75% 50% 99. the specificity and actual PPV may differ from these estimates.8% In practice.Positive Predictive Value of a Single Test Depends on Specificity & Varies with Prevalence Predictive Value.

680 to 1 in 33.000 1 in 175.Prevalence of Diseases Screened for in Newborns Tyrosinemia: Maple-syrup urine disease: Homocystinuria: Galactosemia: Phenylketonuria: Hypothyroidism: Perinatal HIV exposure.500 . US (according to interventions) 1 in >300. US Perinatal HIV infection.000 1 in 4.000 1 in 100.000 1 in 60.000 1 in 670 1 in 2.000 1 in 14.

Positive Predictive Value: Newborn Screening Specificity 99.77% 0.53% PKU Galactosemia Hypothyroidism Adrenal Hyperplasia Newborn Screening results . July 2000 .57% 1.7 98.0 PPV 2. 1993 Arch Pediatr Adolesc Med.7 99.3 99.65% 0.

” .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.

infected pregnant women .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.

2004 .Rapid HIV-1 Antibody Testing During Labor & Delivery for Women of Unknown HIV Status A Practical Guide and Model Protocol January 30.

can be adapted locally .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.

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. Rx Boxed Case Studies . Consent  Reason. Comfort. Results.

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. 4. 2. 3. 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 .

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 .“Revised Recommendations for… Adults Adolescents and Pregnant Women in Health Care Settings”.

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 .

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