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HIV Screening of Pregnant Women and Newborns 1 INTRODUCTION The changing face of the epidemic of human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) has caused policymakers and health planners to look carefully at the growing burden of disease among women and children. Concerns about these populations and the possibility of medical benefit from early identification of infection have led to proposals for prenatal and newborn HIV screening. To assess the appropriateness of such screening, the National Institute of Child Health and Human Development (NICHD) and the Centers for Disease Control (CDC) requested the Institute of Medicine to establish a committee to address this issue in light of both current needs and possible future developments and to offer guidance in the formulation of rational screening policy. The Committee on Prenatal and Newborn Screening for HIV Infection began its deliberations in January 1989. Its membership included collective expertise in obstetrics, pediatrics, health law and medical ethics, epidemiology, genetic screening, public health, and health policy (see Appendix D). To supplement its expertise, the committee reviewed a variety of scientific, medical, and policy articles (see the list of references) germane to prenatal and newborn HIV screening policy; heard from pediatric and obstetrical experts during its four meetings on the diagnosis, course, and treatment of HIV infection in pregnant women and children; and convened a public conference to provide a broad view of the technical, legal, medical, and ethical questions inherent in screening policy development and implementation. Appendix A contains the program of the conference and a summary of its presentations and discussions. In the quest for sound, reasonable HIV screening policy for pregnant women and newborns, the committee sought instruction from past experience with mass screening programs (see the discussion "Principles and Pitfalls of Mass Population Screening" in the conference summary in Appendix A). It also explored the general tenets and principles that have
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HIV Screening of Pregnant Women and Newborns guided program development in genetic screening (Lappé et al., 1972; National Research Council, 1975; President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1983) and public health screening (North, 1982). Consideration of the current magnitude of the problem of HIV infection and AIDS among women and children and the distribution of infection (see Chapter 2) provided perspective as the committee reviewed the various prenatal and newborn screening policy options. In addition, current HIV diagnostic capacity (in particular, the reliability and validity of available screening tools) and medical therapy for asymptomatic HIV-infected individuals framed discussions about the possible benefits of neonatal and prenatal screening, as well as their inevitable costs. The committee also evaluated the various forms that screening could take and the relative merits of the different approaches. Chapter 3 discusses the distinction between testing and screening, the technical characteristics (e.g., sensitivity and specificity) of screening tests, an algorithm for HIV testing, and the range of screening formats. The committee carefully analyzed the potential goals of screening newborns for HIV infection and whether at present they could be accomplished. Several considerations guided this analysis—for example, the difficulty in differentiating (with available HIV-antibody tests) between newborns who are truly infected and those who only carry passively acquired maternal antibody, the uncertain magnitude of medical benefit from early therapeutic intervention and aggressive medical management of asymptomatic HIV-infected infants, and uncertainties regarding long-term therapeutic risks. Anticipating continued technological improvement in the ability to diagnose HIV infection in young infants and to treat asymptomatic infection in early infancy, the committee examined various developments that might lead to a shift in policy. Chapter 4 reviews the possible goals of neonatal HIV screening and includes the committee's judgment of whether these objectives are currently achievable. It also offers direction for future policy should HIV diagnostic technology and treatment for young infants improve. The committee then assessed the likelihood that the potential goals of screening pregnant women for HIV infection could be achieved at this time. As pan of its assessment, the committee reviewed extant HIV testing recommendations (CDC, 1987a; American Academy of Pediatrics, Task Force on Pediatric AIDS, 1988; American College of Obstetrics and Gynecology, 1988; American Medical Association, 1989) for pregnant women with identified risk factors for infection. It also considered whether there were circumstances that might warrant an extension of these recommendations to all pregnant women in defined geographic areas without regard to risk status for the benefit of early diagnosis and
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HIV Screening of Pregnant Women and Newborns treatment of infection. Current treatment options and standards of care for HIV-infected nonpregnant adults also provided a framework for evaluating the possible clinical benefits for pregnant HIV-infected women identified through screening. Additionally, the committee was mindful of the need to weigh carefully the benefits and costs of conducting prenatal HIV screening. Apart from the personal costs (i.e., psychological and social ramifications for the individual), there are societal costs that include the possible diversion of resources from other health programs to support the screening effort. Whether limited health care dollars should be spent on HIV disease in preference to other pressing and underfunded health problems is a complex economic, ethical, legal, and political question. Some might interpret the committee's recommendation for prenatal HIV screening as suggesting that this effort should be a preferred use of limited funds. In fact, the committee did not have the resources or the charge to conduct an economic analysis of this issue. Its conclusion, therefore, is unavoidably predicated on untested assumptions about the efficient and fair allocation of health resources. Chapter 5 distills the committee's deliberations on screening pregnant women for HIV infection and presents the resulting conclusions and recommendations. The epidemiological underpinnings of prenatal screening policy formulation and the committee's suggested methodologies for ascertaining when such screening is epidemiologically justified are discussed in Chapter 6. The chapter also reviews the committee's recommended approach to policy implementation. Chapter 7 lays out the specific components (e.g., education and counseling, partner involvement and notification, services infrastructure for HIV-infected women and children, health care provider education and training, laboratory capacity, and program evaluation) of a prenatal HIV screening program that should be considered before screening is initiated. Throughout its deliberations, the committee was constantly aware that the conclusions and recommendations it was making would need to be reevaluated in the future. HIV policymaking is by definition a dynamic process that requires diligent attention to technological developments and changing epidemiological trends.
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