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HIV Screening of Pregnant Women and Newborns EXECUTIVE SUMMARY Mandatory HIV testing and screening have not been generally implemented in this country for civilian, noninstitutionalized populations or populations at risk. Such programs have been rejected largely because of the powerful psychological and social impacts (including the threat of discrimination in employment, housing, access to health care, and insurance, as well as stigmatization and ostracism by friends, family, and others) that an antibody-positive test result may produce for an individual.1 In light of these potentially adverse social consequences, the HIV test (unlike, for example, a complete blood count [CBC]) does not qualify as a benign, routine medical test that may be performed under the conditions of general or presumed consent, which govern many, but not all, tests routinely conducted in medical practice. Thus, the committee concludes that individuals (or their legally recognized representatives) should have the right to consent to or refuse HIV testing (except when such testing is conducted anonymously for epidemiological purposes). The committee found no compelling evidence to suggest that women and children should constitute an exception to this principle. (Chapter 3) History has revealed that mandatory screening programs are frequently inflexible, often because they are legislated, and that program modification over time proves difficult. Testing and screening policies for HIV infection must be responsive to advances in diagnostic technology, scientific understanding of the disease, and medical therapy. Voluntary HIV screening (with specific informed consent) permits greater flexibility than mandatory screening in accommodating change. The committee 1 Screening in populations with a low prevalence of infection is also likely to yield an increased proportion of false-positive results.
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HIV Screening of Pregnant Women and Newborns opposes any mandatory newborn or prenatal HIV screening program (other than anonymous screening for surveillance purposes). (Chapter 3) Given present uncertainty regarding the benefits and risks of early therapeutic intervention for asymptomatic HIV-infected infants and the difficulty in distinguishing infants with only maternal HIV antibody from those who are truly infected, the committee concludes that, at present, insufficient medical benefits have been demonstrated from newborn HIV screening to justify its implementation. All infants at risk of adverse health outcomes because of poverty, social circumstances, or parental risk factors would benefit from comprehensive primary care. The rationale that HIV screening will identify infants for intensive primary care is not sufficient by itself to warrant screening of all newborns. Nevertheless, the committee encourages providers and medical centers to develop an aggressive primary care system for all infants at increased risk of adverse health outcomes. (Chapter 4) The committee endorses the continuation of anonymous newborn HIV screening for surveillance purposes. This approach provides unbiased epidemiological data for monitoring national and local trends in the distribution of HIV infection, particularly among childbearing women. These data are also useful in planning and evaluating public health interventions, targeting community outreach and prevention campaigns, and anticipating health care resource needs. (Chapter 4) The committee concludes that screening pregnant women for the purpose of early diagnosis and treatment is both an achievable and compelling objective.2 This conclusion rests on the fact that available therapies for HIV disease, a life-threatening condition, have been shown to delay progression and minimize symptoms of disease in nonpregnant adults. However, current treatment regimens (e.g., zidovudine therapy and Pneumocystis carinii pneumonia [PCP] prophylaxis) may need slight modifications for HIV-infected pregnant women. (Chapter 5) Concern for potential fetal toxicity has not been absent from discussions of appropriate management and treatment of HIV-infected pregnant women. To date, there are insufficient data on zidovudine therapy during pregnancy to draw conclusions about short-term fetal toxicity or adverse pregnancy outcomes related to such therapy. There is 2 Specific circumstances under which screening should take place are described in subsequent recommendations.
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HIV Screening of Pregnant Women and Newborns additional uncertainty regarding zidovudine's long-term effects and potential toxicities for the infant. Similarly, the fetal and neonatal risks associated with trimethoprim-sulfamethoxazole or aerosolized pentamidine therapy (i.e., PCP prophylaxis) during pregnancy have not been delineated. Despite these uncertainties, however, The committee finds that the health risks inherent in deferring antiretroviral treatment or PCP prophylaxis of severely immunocompromised HIV-infected pregnant women (i.e., those with CD4+ cell counts below 200) outweigh the potential fetal or neonatal risks at this time. Therefore, the committee recommends that HIV-infected pregnant women with severely depressed CD4+ cell counts be offered therapy for which they would otherwise be eligible if they were not pregnant. The decision to initiate treatment during pregnancy should always be made in concert with the patient, with full disclosure of the associated risks and benefits of therapy. Whether to receive treatment, however, ultimately remains the woman's choice. (Chapter 5) Targeting only ''at-risk'' pregnant women for HIV screening might be perceived as discriminatory and stigmatizing because African-American and Hispanic women and children have been disproportionately affected by the HIV epidemic. The committee strongly opposes any HIV screening of pregnant women based on racial or ethnic background. It is also concerned about screening that is narrowly focused on small geographic units. This type of screening could single out areas of highly concentrated HIV infection in women and children, which might engender further discrimination and stigmatization of already disenfranchised or disadvantaged populations. Geographic units selected for screening purposes should be sufficiently large (e.g., states or counties) to limit the opportunity for such discrimination and stigmatization.3 (Chapter 5) A substantial number of HIV-infected women would necessarily be missed if a "selective" approach to prenatal HIV screening (offering testing only to a subset of pregnant women defined by self-acknowledged HIV risk behaviors) were pursued. For that reason, and in view of the favorable cost comparisons between "selective" and "universal" screening, a "universal" approach (offering testing to all pregnant women within a particular geographic area) is preferable. Universal prenatal screening would limit further discrimination and stigmatization because HIV testing would be offered to all pregnant women in an area without regard to risk status. Furthermore, it would not require that women disclose socially unaccepted or illicit behavior in advance of testing. The committee recommends 3 See the discussion in Chapter 6.
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HIV Screening of Pregnant Women and Newborns voluntary HIV screening (with specific informed consent) for all pregnant women in high-prevalence areas.4 The HIV test should be discussed with and offered to every pregnant woman seeking prenatal care in these areas; written informed consent should be a prerequisite to testing. Women who receive no prenatal care or who have not had an opportunity to be tested prior to delivery should be offered HIV testing at the time of labor and delivery or during the postpartum period. Additionally, in areas where prevalence levels may not warrant prenatal screening of all pregnant women at this time, health care providers should continue to offer voluntary HIV testing to pregnant women who have identified risk factors for HIV infection, in accordance with current HIV testing recommendations (e.g., those of the Centers for Disease Control, the American College of Obstetrics and Gynecology, and other such groups). (Chapter 5) All pregnant women should be informed about HIV infection, its modes of transmission, risk-associated behaviors, and ways of reducing one's personal risk of infection. (Chapter 5) The threshold prevalence approach (discussed in Chapter 6) involves a judgment about what HIV prevalence level among childbearing women must be reached before the yield from screening all pregnant women is considered sufficient to justify the costs of the screening effort. The committee found that data regarding the specific costs and benefits of HIV screening were inadequate to support the choice of one threshold prevalence value for use in all states. Rather, the committee recommends that individual state (or county) public health authorities be the final judge of whether prenatal screening at various HIV seroprevalence levels is an efficient or appropriate use of resources, particularly in the likely event that other public health programs may be competing for the same pool of limited resources. In most cases, state (or county) HIV seroprevalence rates among childbearing women and the availability of adequate resources for mounting a prenatal screening program should be considered together. (Chapter 6) Formulating HIV screening policy through legislative or regulatory routes does not permit the flexibility and latitude required to respond to new developments in diagnostic technology and medical therapy, as well as to increased understanding of the pathogenesis and natural history of HIV infection in women and children. Moreover, when screening policy is legislated, the ability to modify policy in response to screening program 4 High-prevalence areas are defined in Chapter 6.
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HIV Screening of Pregnant Women and Newborns experience is limited. Therefore, the committee recommends that prenatal HIV screening policy be implemented as a standard of medical practice, which constitutes a more malleable alternative to legislation or regulation and implies a threat of liability for health care provider noncompliance. (Chapter 6) A thorough examination of the reproductive options available to an HIV-infected pregnant woman is an important task of the posttest counseling session. Traditionally (i.e., in the context of genetic screening), counselors have assumed a nondirective or neutral posture toward re-productive counseling, and the committee found no compelling reason to recommend a change in this stance in the context of HIV screening. The committee affirms that reproductive counseling should validate the woman's right to make the reproductive choice that conforms to her personal values, beliefs, and desires. Ultimately, the woman must decide whether to continue or terminate an existing pregnancy in the face of HIV infection. (Chapter 7) In at least one instance, the committee recommends that a woman's HIV test result be shared-with her child's medical caregiver. This prospect should be discussed with the woman during the informed consent process. The diagnosis of HIV infection in a mother has important implications for the clinical management and appropriate medical follow-up of her child. The mother should be informed, during the pretest counseling session and in advance of any disclosure, of the importance of releasing her HIV test results to the pediatric caregiver, and she should be encouraged to do so to provide more effective medical management of her infant. (Chapter 7) A well-functioning, coordinated voluntary partner notification system should be an integral part of a prenatal HIV screening program and, if not already established, should be developed in parallel with screening. A major benefit to such a system is that it provides another avenue to engage male partners in counseling and educational efforts connected with prenatal screening, as well as an opportunity to refer them for HIV testing and diagnostic evaluation. (Chapter 7) The committee decries the inherent inadequacies in the current health services delivery and financing system and recognizes that prenatal HIV screening may identify more women and children who need care than the system can currently accommodate. Nevertheless, it believes that the benefits of screening pregnant women for HIV infection in high-prevalence areas are sufficient to justify proceeding with program implementation,
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HIV Screening of Pregnant Women and Newborns even though the present health and social services infrastructure may not be completely adequate. (Chapter 7) In mounting a screening program, state public health authorities must be firmly committed to the construction and expansion of health and social services for all HIV-infected women and children in tandem with screening program implementation; otherwise the necessary system of follow-up services is unlikely to be developed. (Chapter 7) The committee deplores discrimination against HIV-infected women and children in the provision of health care services. State policymakers should assess the extent of such discrimination and develop a mechanism for expeditiously redressing any discriminatory actions. If HIV screening for pregnant women is to achieve its goals, there must be some assurance that identified women and their children will not be denied access to needed health care by virtue of their infected status. (Chapter 7 ) Health care providers who offer HIV testing to their patients have an obligation to render appropriate treatment or to ensure that a referral is made and that such treatment is ultimately received. Additionally, it is imperative that when a woman seeks care and is offered an HIV test, the provision of needed health services must not be contingent on submission to testing; that is, if a pregnant woman refuses to be tested, she should still be eligible to receive care. (Chapter 7) To fulfill the responsibility of securing a meaningful informed consent for HIV testing and for offering supportive counseling, health care providers will need instruction and training in a variety of areas related to HIV infection and its treatment. Health care professional societies, training institutions, and public health authorities should cooperate to institute comprehensive HIV education and training, as well as continuing education programs, for the health professions . (Chapter 7) The availability of high-quality laboratory facilities and qualified technicians to perform the HIV serologic test series on collected blood specimens is critical to a successful screening program. The committee recommends, as part of any state-level screening effort, that states require laboratories to participate in a publicly sponsored (e.g, state or federal)
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HIV Screening of Pregnant Women and Newborns quality assurance and performance evaluation program.5 In addition, sates should be responsible for informing providers of the recommended laboratories to which they should forward their HIV test specimens. (Chapter 7) A well-articulated, carefully designed evaluation plan is an essential component of any prenatal HIV screening program and must be an integral part of program planning. A comprehensive evaluation process offers an opportunity to ascertain whether program goals have actually been achieved and whether they need to be modified. This ability to adjust program objectives and design is particularly important for HIV screening, given that diagnostic technology and medical therapy continue to evolve. The committee recognizes the considerable resources, talent, and effort that will be required to plan and conduct a thorough screening program evaluation. Because prenatal HIV screening programs have national relevance and importance, federal support, in the form of additional funds specifically earmarked for evaluation, is needed to ensure careful monitoring and assessment of program effects. (Chapter 7) 5 States may seek guidance in monitoring laboratory quality assurance and performance from CDC's Model Performance Evaluation Program, which was developed to assess and improve the analytic quality of HIV-antibody testing.
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