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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
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
BENEFITS
RISKS
Benefits versus risks of testing pregnant women for HIV have shifted over years
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
Quebec
Opt-in
73,781
41,739
83
80
B Columbia Opt-in
Ontario
Opt-in
129,758
54
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
Even when begun in labor, ARV prophylaxis can reduce MTCT by up to 50% (rates of ~25% without interventions, & 9-13% with ARVs).
The rapid test is done on this counter, extra supplies are stored below.
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)
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
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
OraQuick Advance - whole blood - oral fluid - plasma Uni-Gold Recombigen - whole blood - serum/plasma
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)
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
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
Newborn Screening results , 1993 Arch Pediatr Adolesc Med, July 2000
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
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
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.
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
Opt-out prenatal testing Rapid testing at labor and delivery Advancing HIV Prevention initiative Perinatal HIV Prevention grantees