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--> Executive Summary One of the most promising victories in the battle against AIDS was the finding, in 1994, that administration of the antiretroviral drug zidovudine (known as ZDV, and previously as AZT) during pregnancy and childbirth could reduce the chance that the child of an HIV-positive mother would be infected by about two-thirds (Connor et al., 1994). The ''ACTG 076 results," referring to the AIDS Clinical Trials Group protocol number 76, quickly led the Public Health Service (PHS) to develop guidelines about counseling and testing of pregnant women for HIV infection (CDC, 1995b). The 1995 PHS guidelines called for counseling all 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 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). Depending on a determination by the Secretary of Health and Human Services about these practices, Ryan White CARE Act formula funds to the states could become contingent upon mandatory HIV testing of newborns.
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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 Chain of events leading to an HIV-infected child. P.L. 104-146 also calls on the Institute of Medicine (IOM) to "conduct an evaluation of 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." In its analysis, the committee has found it helpful to consider a chain of factors affecting perinatal transmission, as illustrated in Figure 1. Public Health Screening Programs Disease screening is one of the most basic tools of modern public health and preventive medicine. As screening programs have been implemented over the years, a substantial body of experience has been gained. In practice, when screening is conducted in contexts of gender inequality, racial discrimination, sexual taboos, and poverty, these conditions shape the attitudes and beliefs of health system and public health decision makers as well as patients, including those who have lost confidence that the health care system will treat them fairly. Thus, if screening programs are poorly conceived, organized, or implemented, they may lead to interventions of questionable merit and enhance the vulnerability of groups and individuals. Through the experience with public health screening programs, a series of characteristics of well-organized public health screening programs has evolved (Wilson and Jungner, 1968). The committee's summary of the relevant characteristics is as follows: The goals of the screening program should be clearly specified and shown to be achievable. The natural history of the condition should be adequately understood, and
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--> treatment or intervention for those found positive widely accepted by the scientific and medical community, with evidence that early intervention improves health outcomes. The screening test or measurement should distinguish those individuals who are likely to have the condition from those who are unlikely to have it. There should be adequate facilities for diagnosis and resources for treatment for all who are found to have the condition, as well as agreement as to who will treat them. The test and possible interventions should be acceptable to the affected population. Descriptive Epidemiology Of The Perinatal Transmission Of HIV In 1997, women accounted for 21% of AIDS cases in adults, and the proportion of all cases that are among females continues to grow. At least two-thirds of AIDS in women can be attributed to injection drug use either directly or through sex with drug users. Although a subset of women with HIV have injected drugs or have had sex with a known injection drug user, an increasing proportion of women have become infected through sexual activity with men whose risk behaviors were unknown to them. AIDS is more prevalent in African-American and Hispanic women, in women in the Northeast and the South, and in women in large cities. Approximately 6,000 to 7,000 HIV-infected women give birth every year. Trend data show a relatively steady national rate of HIV prevalence in childbearing women between 1989 and 1994, the last year for which data are available. Perinatal transmission accounted for at least 432 AIDS cases in the United States in 1997. The number of perinatally acquired AIDS cases rose rapidly in the late 1980s and early 1990s, peaked around 1992, and subsequently declined by approximately 43% by 1996. Such data on perinatal AIDS cases reflect the number of children born with HIV infection in previous years, and more recent data are not available because of reporting delays. Changes in the number of perinatal AIDS cases, therefore, are not direct estimates of the impact of prevention activities on perinatal transmission of HIV. Pediatrics AIDS cases are concentrated in eastern states, and especially in the New York metropolitan area. In 1996, three states alone—New York, New Jersey, and Florida—reported 330 cases. This represents 49% of the diagnosed cases, even though only 15% of children are born in those states (CDC, 1996b; Ventura et al., 1998). In contrast to the concentration of perinatal AIDS cases in the Northeast, they are far less common in most geographical areas. In 1997, 39 states had fewer than ten perinatally transmitted AIDS cases (CDC, 1997c).
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--> Natural History, Detection, And Treatment Of HIV Infection In Pregnant Women And Newborns Perinatal transmission can occur antepartum (during pregnancy), intrapartum (during labor and delivery), and postpartum (after birth), but most mother-to-infant transmission appears to occur intrapartum. The ACTG 076 protocol showed that antiretroviral therapy could reduce perinatal transmission to 8% in some populations (Connor et al., 1994), and subsequent studies have suggested that rates of 5% or lower are possible. To maximize prevention efforts, women must be identified as HIV-infected as early as possible during pregnancy. Early diagnosis of HIV infection allows the mother to institute effective antiretroviral therapy for her own health. This treatment is also capable of significantly reducing perinatal transmission. HIV-infected pregnant women can also be referred to appropriate psychological, social, legal, and substance abuse services. Babies born to HIV-positive mothers can be started on ZDV within hours of birth, as in the ACTG 076 regimen. Mothers who know they are HIV-positive can be counseled not to breast-feed their infants. In terms of preventing perinatal transmission, newborn HIV testing has fewer benefits than maternal testing. When maternal serostatus is unknown, however, newborn HIV testing permits early identification and evaluation of exposed infants, allows for initiation of Pneumocystis carinii pneumonia (PCP) prophylaxis in the first months of life to prevent life-threatening bouts of PCP infection, may prevent transmission through breast-feeding or in future pregnancies, and could lead to mothers being treated for their own infection. The Context Of Services For Women And Children Affected By HIV/AIDS Women and children in the United States, including those at risk for or with HIV/AIDS, receive their health care from a variety of sources. Their care is financed by a mixture of public and/or private insurance and public funds. Its content and quality are influenced by public and professional organizations. Its oversight and regulation are achieved through a combination of national, state, and local authorities. Major modifications in Medicaid and welfare programs, the increasing number of uninsured, and the growing presence of managed care in both the public and the private sectors, are having a significant impact on the health care system, affecting not only the availability of quality services, but access to those services as well. The federal government, with support from state and sometimes local governments, as well as foundations, charitable agencies, and other groups, has established special programs to provide HIV- and AIDS-related care to women and children. All states and territories have an AIDS program funded by the
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--> Centers for Disease Control and Prevention (CDC) and Health Resources and Services Administration (HRSA). Moreover, an array of federal, state, and local laws, regulations, policies, institutions, and financing mechanisms shapes the services in any given locality and determines who has access to those services. The complex patterns of medical care, financing mechanisms, program authority, and organizations that influence care make it difficult to institute uniform policies for reducing perinatal HIV transmission. In addition, the multiple lines of funding responsibility and accountability have made it extremely difficult to educate providers and convince them of the necessity of testing all pregnant women, as called for in the PHS counseling and testing guidelines (CDC, 1995b). The resulting structure of the health care system presents a number of barriers to the treatment of HIV-positive women, which include—using the prevention chain as a framework— financial and access barriers that may discourage women from seeking prenatal care, time constraints that may discourage physicians from counseling pregnant patients about the importance of testing, prenatal care sites that may not have the staff to overcome the language and cultural barriers that may cause women to refuse testing, and financial and logistical problems that may make testing and treatment difficult. Implementation And Impact Of The Public Health Service Counseling And Testing Guidelines Since the publication of the ACTG 076 findings in 1994, there has been a concerted national effort to bring the benefits of HIV testing and appropriate treatment to as many women and children as possible. Reviewing the results of these efforts, the committee must make a qualified response to its congressional charge to assess "the extent to which state efforts have been effective in reducing the perinatal transmission of HIV." The committee interprets this charge to include the efforts of national as well as state and local health agencies, and professional organizations at both levels. The data reviewed indicate that, on the whole, there have been substantial public and private efforts to implement the PHS recommendations, prenatal care providers are more likely now than in the past to counsel their patients about HIV and the benefits of ZDV and to offer and recommend HIV tests, women are more likely to accept HIV testing and ZDV if indicated, and there has been a large reduction in perinatally transmitted cases of AIDS.
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--> The number of children born with HIV, however, continues to be far above what is potentially achievable, so much more remains to be done. There is substantial variability from state to state in the way that the PHS guidelines have been implemented, but no evidence to suggest that any particular approach is more successful than others in preventing perinatal HIV. Recommendations Universal HIV Testing, with Patient Notification, as a Routine Component of Prenatal Care To meet the goal that all pregnant women be tested for HIV as early in pregnancy as possible, and those who are positive remain in care so that they can receive optimal treatment for themselves and their children, the committee's central recommendation is for the adoption of a national policy of universal HIV testing, with patient notification, as a routine component of prenatal care. There are two key elements to the committee's recommendation. The first is that HIV screening should be routine with notification. This means that the test for HIV would be integrated into the standard battery of prenatal tests and women would be informed that the HIV test is being conducted and of their right to refuse it. This element addresses the doctor–patient relationship, and can reduce barriers to patient acceptance of HIV testing. Most importantly, this approach preserves the right of the woman to refuse the test. If it is followed, women would not have to deal with the burden of disclosing personal risks or potential stereotyping; the test would simply be a part of prenatal care that is the same for everyone. Routine testing will also reduce burdens on providers such as the need for costly extensive pretest counseling and having discussions about personal risks that many providers think are embarrassing. A policy of routine testing might also help to reduce physicians' risk of liability to women and children, where providers incorrectly guess that a woman is not at risk for HIV infection. The second key element to the recommendation is that screening should be universal, meaning that it applies to all pregnant women, regardless of their risk factors and of prevalence rates where they live. The benefit of universal screening is that it ameliorates the stigma associated with being "singled out" for testing, and it overcomes the problem that many HIV-infected women are missed when a risk-based or prevalence-based testing strategy is employed (Barbacci et al., 1991). Making prenatal HIV testing universal also has broad social implications. First, if incorporated into standard prenatal testing procedures, the costs of universal HIV screening are low, and the benefits are high. Assuming that the marginal cost of adding an ELISA test to the current prenatal panel is $3 per
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--> woman and the prevalence of HIV in pregnant women is 2 per 10,000, the committee's calculations in Appendix K show that the cost of routine prenatal testing is $15,600 per HIV-positive woman found. Even if the cost of the test is $5 and the prevalence 1 per 10,000, the cost per case found is $51,100. Taken in the context of the cost of caring for an HIV-infected child, even though not all women found to be HIV-positive will benefit, these figures indicate the clear benefits of routine prenatal HIV testing. Second, universal screening is the only way to deal with possible geographic shifts in the epidemiology of perinatal transmission. Although perinatal AIDS cases are currently concentrated in eastern states, particularly New York, New Jersey, and Florida, there have been shifts in the prevalence of HIV in pregnant women, including an increase in the South in the early 1990s. Changes in the regional demographics of drug use can also lead to changes in the distribution of HIV infection in pregnant women. Given the uncertainty of these trends, the committee considered universal testing the most prudent method to reduce perinatal transmission despite possible regional fluctuations. Third, it would help to reduce stigmatization of groups by calling attention to a communicable disease that does not have inherent geographic barriers or a genetic predisposition. Focusing on the communicable disease aspect may allow national education programs that would otherwise be difficult, discouraging infected individuals from hiding themselves and thus not benefiting from care, and discouraging a "blame the victim" mentality. Incorporating Universal, Routine HIV Testing into Prenatal Care The following changes in health systems and public policy are needed by state health departments, health systems, and professional organizations to bring about the major change called for in the committee's central recommendation. The committee believes it is also important that these approaches be evaluated carefully, and that successful models be disseminated widely in the professional community. Education of Prenatal Care Providers One way to achieve the goal of universal HIV testing in prenatal care is for federal, state, and local health agencies, professional organizations, regional perinatal HIV research and treatment centers, AIDS Health Education Centers, and health plans to increase efforts to educate prenatal care providers about the value of testing in pregnancy. In particular, The committee recommends that health departments, professional organizations, medical specialty boards, regional perinatal HIV centers, and health plans increase their emphasis on education of prenatal
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--> care providers about the value of universal HIV testing and about avenues of referral for patients who test positive. Improved Provider Practices A variety of specific clinical policies facilitate HIV testing, such as inclusion of HIV tests in the standard prenatal test panel and no longer requiring counseling as a prerequisite for HIV testing. In particular, The committee recommends that professional organizations update their clinical practice guidelines to facilitate universal HIV testing, with patient notification, as a routine component of prenatal care. In addition to their direct influence on clinical practices, guidelines of this sort issued by professional organizations have an important role to play in determining the standard of care. In addition, The committee recommends that all health care plans and providers develop, adopt, and evaluate clinical policies to facilitate universal prenatal HIV testing. Clinical policies to implement the committee's recommendation for universal, routine testing with patient notification might include, for example, the inclusion of an HIV test on the checklist of clinical tests for which blood is drawn at the first prenatal visit, standing orders, and procedures to ensure that positive test results are delivered in a timely and appropriate way. Performance Measures and Contract Language Health care plans and providers increasingly are being held accountable for the services they provide through performance indicators in such areas as cost, quality of care, and patient satisfaction. In order to take advantage of this approach, The committee recommends that health care plans and providers adopt performance measures for a policy of universal HIV testing, with patient notification, as a routine component of prenatal care. To implement this recommendation, groups that develop performance measures, such as the National Committee for Quality Assurance (NCQA), should develop and adopt specific performance indicators for prenatal testing. Given the committee's emphasis on universal HIV testing as a routine component of prenatal
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--> care, the proportion of women in prenatal care actually tested would be an appropriate performance measure. Health care plans must, however, ensure patient confidentiality and guard against coercive testing when patients refuse to be tested. Another approach to integrating public health goals and clinical practice is the development of contract language for managed care plans. In particular, The committee recommends that health care purchasers adopt contract language supporting a policy of universal HIV testing, with patient notification, as a routine component of prenatal care. If universal HIV testing with patient notification is to become a routine component of prenatal care, contracts should not allow health insurers to deny benefits under "pre-existing conditions" or similar clauses based on the client's HIV status. Improving Coordination of Care and Access to High-Quality HIV Treatment Prenatal HIV testing can achieve its full value only if women who are found to be positive receive high-quality prenatal, intrapartum, and postnatal care for themselves and their children. Thus, The committee recommends efforts to improve coordination of care and access to high-quality HIV interventions and treatment for HIV-positive pregnant women. Without linkage to specialty care for HIV-positive women, the committee's recommended policy of universal HIV testing, with patient notification, as a routine component of prenatal care would violate one of the fundamental criteria for public health screening programs, that is, there should be adequate facilities for diagnosis and resources for treatment for all who are found to have the condition, as well as agreement as to who will treat them. Addressing Concerns about HIV Testing and Treatment To enhance acceptance of HIV prenatal testing as a routine component of prenatal care, providers should understand the constellation of reasons why some pregnant women refuse HIV testing. Thus, The committee encourages the development of outreach and education programs to address pregnant women's concerns about HIV testing and treatment.
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--> Resources and Infrastructure Development and dissemination of policy goals will not, in and of themselves, achieve universal testing and optimal treatment—a comprehensive infrastructure is needed. Maintaining this infrastructure requires federal funding, a regional approach, and an ongoing surveillance program. Federal Funding Successful perinatal HIV centers consistently rely upon federal funding for research and for services through HRSA's Ryan White program to maintain the infrastructure they need to succeed. The efforts called for in the earlier recommendations in this chapter will require similar or higher levels of investment. Thus, The committee recommends that federal funding for state and local efforts to prevent perinatal transmission, including both prenatal testing and care of HIV-infected women, be maintained. The administration and Congress should examine current budgets thoroughly for adequacy, particularly in light of the expanded programs recommended by the committee. Maintaining current program levels is the minimum requirement. The Ryan White CARE Act Amendments of 1996 (section 2625), for instance, authorized $10 million per year in grants to the states to carry out a series of outreach and other activities that would assist in making HIV counseling and testing available to pregnant women. Congress, however, never appropriated funds for this purpose. Doing so now would go a long way toward building the infrastructure needed to lower perinatal transmission rates. As discussed in Chapter 1, The Ryan White CARE Act Amendments of 1996 set up a decision-making process that could result in states losing significant amounts of AIDS funding unless they demonstrate substantial increases in prenatal HIV testing or a substantial decrease in HIV transmission rates, or institute mandatory newborn testing. If the national goal is to prevent HIV transmission from mothers to children, the federal government should support prenatal testing and other state-based prevention efforts. The Ryan White CARE Act Amendments of 1996, paradoxically, could actually undermine them. Regional Approach HRSA currently funds a system of "HIV Programs for Children, Youth, Women and Families" through Title IV of the Ryan White CARE Act. Federal research funds in these and other centers also provide for both direct care and an infrastructure to support it. Many of these programs serve as de facto regional
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--> centers for specialized treatment of HIV-infected women and affected children, and to a lesser extent, for coordination of prevention activities. There is, however, no coordinated, regional approach. Thus, The committee recommends that a regional system of perinatal HIV prevention and treatment centers be established. The regional centers would help to assure optimal HIV care for all pregnant women and newborns, directly to those referred to the centers, and indirectly by working with primary care physicians who retain responsibility for the medical care of HIV-infected women. Moving beyond current practices, the regional centers would also help to develop and implement strategies to improve HIV testing in prenatal care, as discussed above. Defining the organization, funding, and operations of the recommended regional approach is beyond the scope of this report. To advance this plan, HRSA's Bureau of HIV/AIDS and its Maternal and Child Health Bureau, which together have authority and funding to deal with prenatal care and HIV treatment, should convene a national working group to implement this regional approach. The members of the working group should include representatives of CDC for their prevention authority, National Institutes of Health (NIH) because many of the existing centers receive significant research funding, and Health Care Financing Administration (HCFA) because of its oversight of Medicaid. State and local health authorities, representatives of managed care organizations, and representatives of the prenatal care providers should also be involved. Surveillance Surveillance systems are needed to support policy development and program evaluation regarding perinatal transmission of HIV. Thus, in order to support the previous recommendation about performance measures, and to generally guide prevention efforts, The committee recommends that federal, state, and local public health agencies maintain appropriate surveillance data on HIV-infected women and children as an essential component of national efforts to prevent perinatal transmission of HIV. The universal testing approach that the committee recommends, as well as the call for health plan performance measures, should facilitate the development of appropriate public health surveillance systems.
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--> Other Approaches to Preventing Perinatal HIV Transmission Although the committee's charge was focused on prenatal HIV testing and appropriate care, other ways to prevent perinatal transmission of HIV should also be considered. In particular, the committee calls attention to the following areas. Primary Prevention of HIV Infection Since perinatal transmission begins with infected mothers and their partners, primary prevention of HIV can contribute markedly to preventing perinatal transmission by lowering the number of HIV-infected women and their male partners. There are many established approaches to primary prevention: HIV/AIDS education programs, behavioral interventions, partner notification, treatment and prevention of sexually transmitted diseases, and community programs. Beyond more general HIV prevention efforts, prevention and treatment programs targeting drug users appear to be especially vital for preventing perinatal HIV transmission. Averting Unintended Pregnancy and Childbearing Among HIV-Infected Women Pregnancies that are intended—consciously and clearly desired—at the time of conception are in the best interest of the mother and the child (IOM, 1995b). If a woman is infected with HIV, unintended pregnancy and childbearing clearly have special significance. For these reasons, preconception counseling represents an important opportunity to identify HIV-infected women who are considering pregnancy. Some women who know they are HIV-infected choose to become pregnant, especially now that the ACTG 076 regimen is available, but others become pregnant unintentionally. More women learn their HIV status through the course of their pregnancy. Nevertheless, improved knowledge of the consequences of unintended pregnancy (including HIV transmission) and the ways to avoid it, as well as access to contraception, can help to ensure that all pregnancies are intended (IOM, 1995b), and this would reduce, to some extent, the number of children born with HIV infection. The committee does not want to restrict reproductive choice (Faden et al., 1991), but notes that interventions for such women who choose to terminate unintended pregnancies can also be beneficial in reducing the number of children born with HIV infection. Increasing Utilization of Prenatal Care Roughly 15% of HIV-infected pregnant women, many of whom are drug users, receive no prenatal care. Efforts to increase the proportion of women, especially drug users, who receive prenatal care should therefore be a high priority.
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--> Prenatal Care: Reaching Mothers, Reaching Infants (IOM, 1988) recommends activities to (1) remove financial barriers to care; (2) make certain that basic system capacity is adequate for women; (3) improve the policies and practices that shape prenatal services at the delivery site; and (4) increase public information and education about prenatal care. Enhanced HIV Prevention in Correctional Settings Correctional settings—prisons and jails—offer a unique opportunity for prevention activities targeted to hard-to-reach women at risk for, or already infected with, HIV. The prevalence of HIV infection among incarcerated women is far higher than in the community at large: 4% of female state prison inmates nationwide are known to be HIV-positive; in nine states the proportion exceeds 10%. Women are more likely than men to be incarcerated for drug-related offenses, so female inmates are more likely than male inmates to be infected or at risk for HIV infection. Many interventions could be introduced in correctional settings either for primary prevention of HIV transmission or, particularly, for prevention of perinatal transmission among HIV-infected pregnant women. Interventions should focus on HIV testing and treatment, drug testing and treatment, prenatal care, and efforts to ensure continuity of care for HIV-positive patients who leave the correctional setting. Development of Rapid HIV Tests Because reporting of conventional HIV tests takes about one to two weeks, an accurate rapid test, with results available in hours, might have applications in prenatal, labor, and delivery settings to prevent perinatal transmission in some groups of patients. Women and newborns identified with a rapid test late in pregnancy or intrapartum could receive the intrapartum or postpartum component of the ACTG 076 regimen, respectively. In the prenatal setting, a rapid test might be especially valuable for women who are unlikely to return for test results. According to the committee's site visits and workshops, these women are more likely to be adolescents, drug users, undocumented immigrants, and/or homeless. In the labor and delivery setting, a rapid test might be valuable for women who have not been tested previously or have not received prenatal care. The prevalence of HIV infection is elevated in women who have not received prenatal care, and the labor and delivery setting offers the last opportunity to interrupt HIV transmission through administration of intrapartum therapy and advice to avoid breast-feeding. Since this is not an ideal time to obtain consent to testing and to discuss the implications of a positive result, program design and implementation would need to address these issues.
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--> Conclusions If the promise of the ACTG 076 findings, that perinatal transmission of HIV can largely be prevented, is to be fulfilled, the United States needs to adopt a goal that all pregnant women be tested for HIV, and those who are positive remain in care so they can receive optimal treatment for themselves and their children. In order to meet this goal, the United States should adopt a national policy of universal HIV testing, with patient notification, as a routine component of prenatal care. Adopting this policy will require the establishment of, and resources for, a comprehensive infrastructure. This infrastructure must include (1) education of prenatal care providers; (2) the development and implementation of practice guidelines and the implementation of clinical policies: (3) the development and adoption of performance measures and Medicaid managed care contract language for prenatal HIV testing; (4) efforts to improve coordination of care and access to high-quality HIV treatment; (5) interventions to overcome pregnant women's concerns about HIV testing and treatment; (6) and efforts to increase utilization of prenatal care, as described above.
Representative terms from entire chapter: