INTRODUCTION

Reducing the risk of perinatal HIV transmission is a public health priority in New Jersey. The risk of vertical HIV transmission without appropriate obstetrical care is 25%. With prenatal education and testing, antiretroviral agents starting in the second trimester, and an elective caesarian section at 38 weeks gestational age if the viral load is greater than 1,000, the risk of transmission can be reduced to 1%-2%.¹

Children exposed to and infected with HIV through mother-to-child transmission have been reported in every county in New Jersey. Of the 1,335 pediatric HIV/AIDS cases reported to date, 93.5% are the result of vertical HIV transmission. An ongoing concerted effort to minimize the risk of vertical transmission in New Jersey has been successful. Perinatal HIV transmission has decreased from 94 children (24.5%) in 1992 to two children (1.4%) in 2006.

Continued success in preventing HIV transmission from mother-to-child depends on knowing the mother’s HIV status through HIV testing as part of routine prenatal care, proper obstetrical care, and pediatric care of the newborn.

HIV Counseling and Testing of Pregnant Women and Newborns

The most recent Centers for Disease Control and Prevention (CDC) recommendations for HIV testing of pregnant women include opt-out testing of pregnant women in the first and third trimesters as part of routine prenatal care.² In addition, CDC recommends that women who present in labor with unknown HIV status should be offered opt-out rapid HIV testing. CDC recommends postpartum, rapid testing of the newborn as soon as possible after birth if the mother's HIV status is unknown. ³

New legislation takes effect in New Jersey in June 2008 (P.L. 2007 C218) which will have a significant effect both on providers caring for pregnant women and on the women in care. Medical management of pregnant women and pregnant women with HIV infection is rapidly evolving. These legal and medical management issues pose a challenge as clinicians must keep up-to-date. This article will discuss the practical impact of the new law on delivery of care to pregnant women and will highlight recent changes in clinical management.

While routine offering of HIV testing to pregnant women has been the New Jersey lawformany years, the new legislation,which goes into effect June 30, 2008, states that HIV testing should be included in routine prenatal testing using an “opt-out” approach. With the“opt-out” approach, the HIV test will be done routinely along with the standard battery of prenatal blood tests, unless the woman declines.The provider must give the patient information about HIV/AIDS, the benefits of testing for her and her baby, the available medical treatment for her, and interventions which reduce the infant’s risk of HIV infection.

This approach to testing does not make any assumptions about behavior that could have increased a pregnant woman’s risk for HIV. It only assumes that she has had unprotected sex (in order to get pregnant) and could be at risk for HIV. For clinicians who have been routinely offering HIV testing to pregnant women, the legislation will not mean a major change.

A separate written informed consent is no longer required, but if a woman declines the routine HIV test, it should be noted in the medical record.

The legislation tries to assure that women know they are being tested for HIV by specifying the information they should be given. However, it leaves open to the clinician the options of how to deliver the information. It must be provided either orally, in person or, presumably, by video; or in writing through a pamphlet; and the woman must be offered an opportunity to ask questions. If clinicians have not previously made HIV information available, they will need to decide when and how the HIV information is given to their patients.

Some written support materials that would meet the standard set in the legislation currently are available to clinicians.

The American College of Obstetricians and Gynecologists (ACOG) has a small tear-off pad which details a number of the prenatal tests including HIV (ACOG, 2007, “HIV and Other Important Pregnancy Tests”). The ACOG tear pads are available in Spanish, French, Russian, and Chinese as well as English. The One Test. Two Lives. campaign from the Centers for Disease Control and Prevention (CDC) also includes patient handouts discussing prenatal tests including HIV (CDC, One Test. Two Lives. and “Helpful Tests,” available at http://www.cdcnpin.org).

Materials can be ordered from ACOG (http://www.ACOG.org or 800-762-2264) or requested free of charge from the National Prevention Information Network (NPIN). The One Test. Two Lives. materials also include a handout that describes how a clinician can respond if a patient is unsure about HIV testing.

The François-Xavier Bagnoud Center at UMDNJ has also developed a “script” for providers that offers suggestions for information sharing in prenatal settings (available in summer 2008 at http://www.fxbcenter.org). The NewJerseyDepartment of Health and Senior Services (NJDHHS) is developing guidelines based on the legislation for information that needs to be given to pregnant women about HIV testing.

ONE TEST. TWO LIVES. CAMPAIGN:   The One Test. Two Lives. campaign from the Centers for Disease Control and Prevention (CDC) gives obstetric providers new tools to help ensure all patients get tested for HIV early in their pregnancy. Perinatal transmission accounts for 91% of all AIDS cases among children in the United States. Antiretroviral therapy during pregnancy can reduce the transmission rate to 2% or less. The transmission rate is 25% without treatment. One Test. Two Lives provides a variety of resources for providers – as well as materials for their patients – to help encourage universal prenatal testing for HIV. Mission Statement: The mission of the One Test. Two Lives. campaign is to help prevent transmission of HIV from mother to child and promote optimal maternal health. NOW AVAILABLE: Free Educational Materials for Office and Patients CDC Resource Kit: HIV Screening of Pregnant Women (information sheets, pamphlets, posters): download or order free materials. CONTACT: CDC National Prevention Information Network (NPIN) at 800-458-5231 or E-mail: info@cdcnpin.org CDC Prenatal HIV Testing Information http://www.cdc.gov/1test2lives

CDC RECOMMENDATIONS

The New Jersey law closely follows the CDC’s Revised Recommendation for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings (2006).The CDC urges that testing be done “as early as possible” in pregnancy and again, in some situations, in the third trimester. Early testing provides the opportunity to intervene with antiretroviral therapy for the woman’s health, if appropriate, and to prevent perinatal transmission. Legally,as well as ethically, the testing must be voluntary and free of coercion, and a woman may not be denied care if she declines HIV testing. The CDC also recommends that, if a woman declines a prenatal HIV test, the clinician should inquire as to the reason and offer the test again at a subsequent visit.²

THIRD TRIMESTER TESTING

Another key component of the New Jersey law is repeat HIV testing in the third trimester of pregnancy. The CDC recommends a second HIV test in the third trimester in geographic areas like New Jersey with elevated HIV incidence (>17 cases per 100,000 person-years). Surveillance has shown that an increasing proportion of women whose HIV was undiagnosed at delivery had seroconverted during pregnancy, increasing the risk of HIV transmission to the infant.² The New Jersey legislation follows CDC’s recommendation for third trimester testing. While repeat HIV testing has been done for medical indications in New Jersey, routine third trimester testing will be a new and challenging requirement for OB providers. Like HIV testing in early pregnancy, third trimester testing uses an opt-out approach, including HIV with other tests, unless the woman declines.

The legislation and the CDC are silent about the specific timing of third trimester testing. The NJDHSS may make recommendations in its regulations or “best practices” documents, but OB clinicians will need to decide how best to integrate third trimester testing into routine care.

Should the test be done early in third trimester when other routine tests are done or should it be done closer to 34 weeks in order to lengthen the interval between the first and second HIV tests? Those issues will need to be resolved in the coming months.