1
Introduction

One of the most promising victories in the battle against AIDS was the finding, in 1994, that administration of zidovudine (known as ZDV, and previously as AZT) during pregnancy and childbirth could reduce by about two-thirds the chance that the child of an HIV-positive mother would be infected (Connor et al., 1994). Because 6,000 to 7,000 HIV-infected women give birth every year, and others have to carefully consider whether they should get pregnant, the potential impact of these findings was monumental. The ''ACTG 076 results," referring to the AIDS Clinical Trials Group protocol number 76, quickly led the Public Health Service (PHS) to develop guidelines for treatment of pregnant women (CDC, 1994)1 and, in 1995, guidelines about counseling and testing of pregnant women for HIV infection (CDC, 1995b).

The 1995 PHS guidelines called for universal counseling of pregnant women about the risk of AIDS, the benefits of HIV testing, and voluntary testing. The approach was endorsed by the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and other professional groups. The essence of the PHS guidelines also has been adopted by most states, either by policy or by legislation. Medical practice has changed in line with these recommendations, with an increasing proportion of women tested for HIV during prenatal care. As a result of these and other changes, there has been a substantial reduction—approximately 43% from a peak in 1992 to 1996—in the number of newborns diagnosed with AIDS. A reduction of this magnitude in only a few

1  

Updated guidelines were issued in 1998 (CDC, 1998d).



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--> 1 Introduction One of the most promising victories in the battle against AIDS was the finding, in 1994, that administration of zidovudine (known as ZDV, and previously as AZT) during pregnancy and childbirth could reduce by about two-thirds the chance that the child of an HIV-positive mother would be infected (Connor et al., 1994). Because 6,000 to 7,000 HIV-infected women give birth every year, and others have to carefully consider whether they should get pregnant, the potential impact of these findings was monumental. The ''ACTG 076 results," referring to the AIDS Clinical Trials Group protocol number 76, quickly led the Public Health Service (PHS) to develop guidelines for treatment of pregnant women (CDC, 1994)1 and, in 1995, guidelines about counseling and testing of pregnant women for HIV infection (CDC, 1995b). The 1995 PHS guidelines called for universal counseling of pregnant women about the risk of AIDS, the benefits of HIV testing, and voluntary testing. The approach was endorsed by the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and other professional groups. The essence of the PHS guidelines also has been adopted by most states, either by policy or by legislation. Medical practice has changed in line with these recommendations, with an increasing proportion of women tested for HIV during prenatal care. As a result of these and other changes, there has been a substantial reduction—approximately 43% from a peak in 1992 to 1996—in the number of newborns diagnosed with AIDS. A reduction of this magnitude in only a few 1   Updated guidelines were issued in 1998 (CDC, 1998d).

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--> years certainly represents great progress, yet it is far less than the ACTG 076 findings can offer. Two years after the publication of the ACTG 076 findings, Congress addressed perinatal transmission issues in the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act Amendments of 1996 (P.L. 104-146). This legislation set forth a series of conditions regarding routine practices leading to a determination by the Secretary of Health and Human Services that could make Ryan White CARE Act formula funds to the states contingent upon mandatory HIV testing of newborns. Nationally, more than $500 million (the 1998 appropriation for the Title II program, which supports health care and support services, continuation of health insurance, pharmaceutical treatments, and other services through the states) is at stake in this decision (HRSA, 1998a). The Ryan White Care Act Amendments Of 1996 According to P.L. 104-146, the Secretary of Health and Human Services is required by October 1998 to determine whether HIV testing of all infants born in the United States whose mothers have not undergone prenatal HIV testing has become "routine practice." This is an important determination; if it is affirmative, all Ryan White funding to the states after April 2000 becomes contingent upon states demonstrating one of the following: a 50% reduction (or a comparable measure for states with less than ten cases) in the rate of new AIDS cases resulting from perinatal transmission, comparing the most recent data to 1993 data; at least 95% of women who have received at least two prenatal visits prior to 34 weeks of gestation have been tested for HIV; or a program for mandatory testing of all newborns whose mothers have not undergone prenatal HIV testing. To determine whether HIV testing of infants as described above has become "routine practice," the Secretary is required to consult with states and other public and private experts as to whether the following are routine practice in the United States: testing of infants whose mothers have not received prenatal HIV testing; release of HIV test results of newborns to parents, legal guardians, or health care providers; disclosure of HIV test results of pregnant women conducted by the state (such as anonymous seroprevalence surveys) to the pregnant women involved; provision of appropriate HIV counseling in disclosing test results under (2) and (3) and

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--> prevention of insurers from discontinuing coverage on the basis of HIV or having been tested for HIV. Organization Of The Report This report is intended primarily to address the particular questions posed in the Institute of Medicine's (IOM's) congressional mandate: "the extent to which State efforts have been effective in reducing the perinatal transmission of the human immunodeficiency virus, and an analysis of the existing barriers to the further reduction in such transmission." The committee also intends this report to be useful to national, state, and local policy makers, as well as health care providers and public health practitioners who want to give the most effective and appropriate care to all women and children, and to do everything possible to prevent perinatal transmission of HIV. In the interest of a full and complete analysis, the report therefore takes up other issues raised by the Ryan White CARE Act Amendments of 1996. To this end, the report aims to provide a complete analysis of (1) the impact of current approaches to reducing perinatal transmission, as well as the barriers to further reducing such transmission; (2) ways to increase prenatal testing, improve therapy for women and HIV-infected children, and generally reduce perinatal HIV infections; and (3) the ethical and public health issues associated with screening policies as prevention tools, and their implications for prevention and treatment opportunities for women and infants. Despite the focus of the Ryan White CARE Act Amendments on newborn screening, the congressional mandate for this IOM study does not call for an evaluation of that option. As a result, the committee has not made any recommendations about mandatory newborn testing per se, but notes the limited role it can play in preventing transmission of HIV from mother to child, the focus of this report. In its analysis, the committee has found it helpful to consider a chain of factors affecting perinatal transmission, as illustrated in Figure 1.1. Although precise data are not available for all of these proportions, the committee found this to be a helpful organizing framework, and it is used throughout this report. The chain is intended for heuristic purposes and is not a complete representation of all of the possible paths to HIV infection or interventions. Pregnancy termination is possible, for instance, at many stages in the chain. Women who are not tested as part of prenatal care may be tested during labor and receive some benefit from treatment, and children whose HIV status is detected after birth can be kept from breast-feeding. Following this introduction, Chapter 2 provides historical and other background information on population-based screening and surveillance, HIV testing generally, prenatal and newborn screening for other conditions, and special considerations needed when the condition in question is concentrated in minority

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--> The proportion of women …   who are HIV-infected who become pregnant who do not seek prenatal care who are not offered HIV testing who refuse HIV testing who are not offered the ACTG 076 regimen who refuse the ACTG 076 regimen who do not complete the ACTG 076 regimen whose child is infected despite treatment FIGURE 1.1 Chain of events leading to an HIV-infected child. communities. Chapter 3 provides relevant information on the descriptive epidemiology of HIV and AIDS in women and newborns. Chapter 4 summarizes the scientific and clinical information about the detection and treatment of HIV infection in pregnant women and newborns, and includes a summary of current official clinical screening and treatment guidelines. The committee accepted these as they stand, and did not attempt to make clinical recommendations. Chapter 5 described the current context of services for women and children affected by HIV and AIDS. The committee's conclusions and recommendations are concentrated in the final two chapters. Chapter 6 reviews the implementation and impact of the PHS voluntary prenatal screening recommendations in terms of (1) their implementation in official guidelines and statements of medical professional organizations, as well as in state law and regulations; and (2) actual testing rates and provider practices. This chapter concludes that although extensive efforts have been made to implement the recommendations, and there have been major successes, there are still substantial gaps in the number of women who are not tested for HIV, largely because either they receive no prenatal care or their prenatal care providers do not advise them to be tested. The final chapter begins with the committee's central recommendation—that HIV testing, with patient notification, should be a routine and universal component of prenatal care—and a series of more specific recommendations related to the establishment of this approach in prenatal care. The infrastructure must include, for instance, education of prenatal care providers; the development and implementation of practice guidelines, clinical policy performance measures, and Medicaid managed care contract language for prenatal HIV testing; efforts to improve coordination of care and access to high-quality HIV treatment; interventions

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--> to overcome pregnant women's concerns about HIV testing and treatment; and efforts to increase utilization of prenatal care, as described above. The chapter also includes recommendations regarding the resources and infrastructure needed to implement these approaches, and for preventing perinatally transmitted HIV through means other than prenatal testing and treatment. The Committee's Approach The committee's analyses and recommendations are based on a wide variety of quantitative and qualitative information. The committee began by reviewing the major official reports and scientific and medical articles relating to perinatal HIV diagnosis and treatment, HIV testing and screening, and related subjects from the United States and abroad. Prominent among these are government and medical association practice guidelines for testing and treatment of pregnant women, infants, and others, as well as a variety of scientific articles dealing with diagnosis and treatment of HIV, the consequences of HIV testing, and ethical issues. The committee also reviewed a 1991 IOM report on prenatal and newborn HIV screening (IOM, 1991). Although the report's conclusions are outdated because of developments in the intervening seven years, its analytical and ethical framework remain useful. The committee has also reviewed a variety of statistical reports on HIV/AIDS trends, especially relating to women and perinatal transmission, from the Centers for Disease Control and Prevention (CDC) and other sources. For information on laws, regulations, and the implementation of perinatal transmission prevention efforts at the state level, the committee relied upon a survey and analysis of relevant state policies and laws prepared by CDC and the Georgetown Law Center (Gostin et al., in press). In addition, the committee reviewed information from many state health departments and HIV/AIDS programs on the implementation and effect of the voluntary testing guidelines. To further add to the knowledge base for this report, the committee commissioned background papers in the following areas: a history of prenatal and newborn HIV testing in New York State; a history and analysis of screening for sickle cell disease; a report on the context of services for women and children affected by HIV/AIDS; and a report of the experiences of an HIV-positive peer counselor for pregnant women and new mothers. In addition, the committee solicited and received informal reports from a large number of knowledgeable individuals. Finally, the committee organized a series of workshops and field visits to discuss the issues with the people affected by and concerned with the current and proposed policies: women who are HIV-infected or at risk of HIV infection, health care providers, and state and local policy makers. In particular, the committee convened workshops in Washington, D.C., on February 11 and April 1, 1998. Groups of committee members and staff made site visits to New York City and Newark, New Jersey; to Birmingham and rural Greene County, Alabama;

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--> and to San Antonio, Texas, in April and May 1998. The findings from these field visits are summarized in the appendixes of this report. The committee organized a discussion of these issues with practitioners at the Florida HIV Conference in Orlando in April 1998 and at the Summer 1998 Correctional HIV Consortium Educational Update in Atlanta in June 1998. Committee members and staff also attended other national and local meetings at which perinatal transmission issues were discussed, and had numerous discussions with knowledgeable individuals.