7 Recommendations

As discussed in the preceding chapter, there have been substantial public and private efforts since the publication of the AIDS Clinical Trials Group protocol number 76 (ACTG 076) results to implement the Public Health Service (PHS) recommendations for prenatal HIV testing. As a result, women are more likely than in the past to be offered and accept HIV testing in prenatal care and to use zidovudine (ZDV) if indicated. There has also been a large reduction in perinatally transmitted cases of HIV infection. The number of children born with HIV infection, however, continues to be far above what is potentially achievable, and the medical care that some HIV-infected women receive is, regrettably, substandard.

To improve this situation, the committee recommends a national policy of universal HIV testing, with patient notification, as a routine component of prenatal care, as detailed below. Following an analysis of this proposed approach, the committee offers in this chapter a series of more specific recommendations relating to HIV testing as a routine component of prenatal care, which are intended to support this central recommendation. The focus thus is on one element of the chain in Figure 1.1: to increase the number of pregnant women who are tested for HIV. This chapter also includes recommendations for improving treatment of HIV-infected women and their children; and for preventing perinatal transmission of HIV through means other than prenatal testing (earlier in the chain); and regarding the resources and infrastructure needed to implement these approaches.

Universal HIV Testing, With Patient Notification, As A Routine Component Of Prenatal Care

Based on its review of the benefits and risks of prenatal HIV testing and appropriate interventions and treatment for HIV-infected mothers and their children,



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--> 7 Recommendations As discussed in the preceding chapter, there have been substantial public and private efforts since the publication of the AIDS Clinical Trials Group protocol number 76 (ACTG 076) results to implement the Public Health Service (PHS) recommendations for prenatal HIV testing. As a result, women are more likely than in the past to be offered and accept HIV testing in prenatal care and to use zidovudine (ZDV) if indicated. There has also been a large reduction in perinatally transmitted cases of HIV infection. The number of children born with HIV infection, however, continues to be far above what is potentially achievable, and the medical care that some HIV-infected women receive is, regrettably, substandard. To improve this situation, the committee recommends a national policy of universal HIV testing, with patient notification, as a routine component of prenatal care, as detailed below. Following an analysis of this proposed approach, the committee offers in this chapter a series of more specific recommendations relating to HIV testing as a routine component of prenatal care, which are intended to support this central recommendation. The focus thus is on one element of the chain in Figure 1.1: to increase the number of pregnant women who are tested for HIV. This chapter also includes recommendations for improving treatment of HIV-infected women and their children; and for preventing perinatal transmission of HIV through means other than prenatal testing (earlier in the chain); and regarding the resources and infrastructure needed to implement these approaches. Universal HIV Testing, With Patient Notification, As A Routine Component Of Prenatal Care Based on its review of the benefits and risks of prenatal HIV testing and appropriate interventions and treatment for HIV-infected mothers and their children,

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--> the committee believes that all pregnant women should be tested for HIV as early in pregnancy as possible, and those who are positive should remain in care so that they can receive optimal treatment for themselves and their children. In order to meet this goal, 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. Routine with notification means that the test for HIV would be integrated into the standard battery of prenatal tests, and that women would be informed that the HIV test is being conducted and of their right to refuse it. The HIV test can be readily added to the list of tests for which blood already is drawn, such as complete blood count, blood type, and syphilis. Providers have reported that, in the context of prenatal care, pre-test counseling following standard HIV protocols (CDC, 1994) is too onerous and that, therefore, many of their patients remain untested. Eliminating the requirement for extensive pre-test counseling, while requiring the provision of the basic information to all patients, would likely increase the proportion of women tested for HIV. The committee therefore recommends that pre-test counseling consist primarily of notification that HIV testing is a regular part of prenatal care for everyone, and that women have a right to refuse it. Patients' explicit written consent to be tested should not be necessary, but some professional guidelines say that refusal should be documented in the patient's medical record to protect the provider from liability. This recommendation is not intended to diminish more extensive counseling when providers feel it is warranted. Under the proposed policy, women found to be HIV-positive would receive extensive counseling and be referred for treatment for themselves and to prevent perinatal transmission. For the small proportion of women who test positive, PHS counseling and testing guidelines suggest that post-test counseling include information about the clinical implications of a positive test result; the benefit of, and ways to obtain, HIV-related medical interventions and treatment; the interaction between pregnancy and HIV infection; the risk for perinatal HIV transmission and ways to reduce this risk; transmission to partners; and the prognosis for infants who become infected (CDC, 1995b). Refusal of the HIV test at the initial prenatal visit should not necessarily be taken as final, but providers should assess the clinical circumstances and, in some cases, counsel women at later prenatal care visits about the benefits of HIV testing. At its site visits, the committee learned of many cases in which pregnant women, later identified as HIV-positive, initially refused testing, but eventually agreed after repeated discussions with their providers. Patients who continue to refuse testing should never be coerced or denied services, and providers should understand that for some women a positive test may lead to severe consequences, such as discrimination, eviction from housing, and domestic violence. Also, there may be clinical indications for repeating the HIV test later in pregnancy. The committee's de-emphasis of pre-test HIV counseling also should not be

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--> taken to undermine the need for health care professionals to counsel their patients in routine encounters about the risks of sexually transmitted diseases or methods for preventing them (IOM, 1997), or in practices where providers decide routine pre-test counseling is appropriate. Rather, providers should not allow the requirements for pre-test HIV counseling to become a barrier to testing itself. Clinical policies to implement universal HIV testing, with patient notification, as a routine component of prenatal care, will have to be developed, as discussed below. These policies should be tailored to the needs of the patients served by the practice, and should include the protection of confidentiality. The committee's recommendation is in concert with recent analyses and policy changes in other countries. In April 1998, for instance, in Intercollegiate Working Party for Enhancing Voluntary Confidential HIV Testing in Pregnancy in the United Kingdom recommended that "testing for HIV infection should be integrated within established antenatal testing such as for hepatitis B, rubella and syphilis." (Intercollegiate Working Party, 1998). A recent clinical trial in Scotland showed an increase in testing from 18% to 90% of pregnant women when the approach was switched from opt-in (non-directive patient choice) to opt-out (routine, with notification) (Simpson et al., 1998). In September 1998, Alberta Health will begin to promote a policy of routine HIV testing, as part of the standard battery of prenatal exams for all pregnant women in Alberta, Canada (Pilon, 1998). Rationale for the Committee's Recommendation The discussion of public health screening programs in Chapter 2 sets out a series of policy options ranging from completely mandatory to voluntary, and Chapter 6 shows how current laws and policies implement a wide variety of approaches to prenatal HIV screening. Rather than this patchwork approach, the committee believes that a policy of universal, routine testing with notification reflects an appropriate balance among public health goals, justice, and individual rights. This policy would increase HIV testing, and hence improve outcomes, by striking a balance in the doctor/patient interaction as well as in the broader society. There are two key elements to the committee's recommendation. The first is that HIV screening should be routine with notification. 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. Women would not have to deal with the burden of disclosing personal risks or potential stereotyping because 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 pre-test 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

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--> liability to women and children when providers incorrectly guess that a woman is not at risk for HIV infection. The second key element of 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 alleviates the problem of many HIV-infected women being missed when a risk-based or prevalence-based testing strategy is employed (Barbacci et al., 1991). The PHS guidelines (CDC, 1995b), many state laws and regulations, and professional society recommendations all already call for universal testing. 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 woman and the prevalence of HIV in pregnant women is 2 per 10,000, the committee's calculations show that the cost of routine prenatal testing is $15,600 per HIV-positive woman found.1 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,2 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 considers 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 1   In other words, if 10,000 women were tested to identify two positive cases, the aggregate cost of the screening program would be $31,200, or $15,600 per HIV-infected woman found. This calculation includes the cost of confirmatory tests when necessary, but does not account for the unknown proportion of women whose HIV status was known before pregnancy or would have been detected through other means. 2   The lifetime costs of treating perinatally acquired HIV infection have been estimated at $65,000 to $200,000 (Ecker, 1996; Gorsky et al., 1996; Myers et al., 1998). In addition, there may be reduced costs associated with early detection of HIV infection in the mother.

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--> 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. The committee prefers universal HIV testing, with patient notification, as a routine component of prenatal care testing to policies that require providers to counsel or offer HIV tests to all women in prenatal care. As noted in Chapter 2 for screening programs in general, and in Chapter 6 for prenatal HIV testing, there is no evidence that making a program "mandatory," in and of itself, leads to more testing. Routine testing with patient notification thus is likely to be at least as or more effective in meeting public health goals, and less onerous. Incorporating Universal, Routine HIV Testing Into Prenatal Care As documented in Chapter 6, prenatal care providers are generally aware of and agree with PHS and other recommendations for universal testing. Yet there is great variation among providers in the proportion of women actually tested. Provider and patient surveys (see Chapter 6), the committee's workshops and field visits, and the committee members' own experience have indicated the need for a number of changes in health systems and public policy focused on health care provider behavior. In this light, the committee makes the following general recommendations, although precise actions should vary across states and clinical practices, and according to current practices, the nature of the epidemic, and available resources. The first condition for these recommendations to be successful, is strong leadership in the public health and medical community, especially at the local level. The committee is aware of the extensive efforts that have been made at the national and state level to develop guidelines, recommendations, laws, and regulations to implement the ACTG 076 findings. The committee's site visits, on the other hand, have revealed a number of instances in which local public health officials and leaders of the medical community have missed opportunities to educate themselves about and encourage prenatal HIV testing, monitor progress, or enforce existing laws or regulations (Appendixes E, F, and G). It is also important, the committee believes, that these approaches be evaluated carefully, and that successful models be disseminated widely in the professional community. Education of Prenatal Care Providers Although most prenatal providers are aware of and agree with the need for offering HIV tests to pregnant women, their awareness and attitudes do not always translate into action. In addition to the demands of pre-test counseling, lack of knowledge about HIV therapies and the lack of a referral network, for instance, may deter physicians in private practice from offering HIV tests. One

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--> 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 (AHECs); and health plans to increase efforts to educate prenatal care providers about the value of testing in pregnancy. They also must ensure that providers are linked to sources of information and referral for women who test positive. In addition, academic and residency training programs in family medicine, pediatrics, obstetrics/gynecology should include the knowledge, skills, and techniques for prevention of perinatal HIV transmission. 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 care providers about the value of universal HIV testing and about avenues of referral for patients who test positive. Through its workshops and site visits, the committee found many examples of existing provider education programs initiated by state and local health departments and professional organizations. Nearly all states have sent material about the ACTG 076 results and the PHS counseling and testing guidelines (CDC, 1995b) to prenatal care providers. Provider education programs have been designed to explain the risks of perinatal transmission, the importance of universal prenatal testing, the benefits of interventions, and the availability of referral sites. These efforts should be continued and enhanced. California and New Jersey developed their education programs as a result of legislation mandating that providers counsel and offer voluntary HIV testing to all pregnant women (see Appendixes D and E). California recently devised and disseminated comprehensive clinician education and resource materials (including interactive teaching materials for use with patients) and made available a toll-free physician help line. Similar educational programs need to be developed and evaluated in other states. It has been difficult, however, to get physicians to participate, because many do not think that HIV is common enough in their practices to warrant the time (see Appendixes E and G). It is important for provider education programs to overcome physicians' apparent tendency to offer HIV tests only to pregnant women who report, or in whom they suspect, HIV risk behaviors. Risk-based counseling and testing strategies are ineffective because they fail to identify as many as half of HIV-infected women (Barbacci et al., 1991). Belief that they are not at risk is the most common reason for patients' refusal of an HIV test, according to the committee's workshops and site visits. Many who deny risk do so because they are unaware of their partners' risk history.

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--> Education programs also should address providers' confusion about HIV testing algorithms and interpretation of results. In low-prevalence areas, false positive results from initial screening with an ELISA (enzyme-linked immunosorbent assay) can account for at least two-thirds of all positive tests (if the prevalence of HIV in pregnant women is less than 5 per 10,000). By contrast, the rate of false positives in high-prevalence areas (200 per 10,000, for example) is about 5% (see Appendix K). Confirmatory testing with Western blot or immunofluorescence lowers false positives to almost zero. There are still problems with interpretation of indeterminate results, however, and providers need to know how to counsel women about the need for follow-up testing. Laboratories, under most circumstances, do not report initial positive results to patients until after confirmatory testing. Nevertheless, the committee was informed of several cases in which pregnant women were told of their positive initial ELISA test results, which turned out to be false positives, by providers who did not understand the need for confirmatory test results (Appendix G). Education programs should also stress providers' potential malpractice liability for failing to offer an HIV test. As prenatal HIV testing increasingly becomes recognized as the standard of care, courts may rule that providers are negligent if they do not offer a test to a pregnant woman who later gives birth to an HIV-infected baby, or at least document the refusal of a test (King, 1991). As documented in Chapter 2, fear of malpractice has served as a powerful incentive for prenatal care providers to initiate other screening programs. Improved Provider Practices Information available to the committee through its workshops, site visits, and correspondence suggests a wide array of approaches to promote prenatal HIV testing by changing provider practices. Approaches include the preparation or dissemination of practice guidelines, such as those discussed in Chapter 6. There is also a variety of specific clinical policies that 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. Clinical practice guidelines offer a means to facilitate HIV testing in the prenatal setting. Practice guidelines are "systematically developed statements to assist practitioners and patient decisions about appropriate health care for specific clinical circumstances" (IOM, 1990, 1992). Practice guidelines can be developed by federal or state health agencies, or by professional organizations, through a process of reviewing the relevant scientific and clinical literature and building consensus among pertinent professional and patient organizations. As described in Chapter 6, state and local health departments and a number of professional organizations have already prepared practice guidelines to implement the PHS counseling and testing guidelines (CDC, 1995b). Accepting this approach,

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--> 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 used by the courts. The committee's recommendation for universal HIV testing with patient notification in the context of prenatal care is different from most existing practice guidelines, so professional organizations should consider rewriting their guidelines to be consistent with the committee's approach. Relevant state laws and regulations should also be reconsidered. The development of clinical policies represents another approach to promoting prenatal HIV testing and appropriate care. Clinical policies are usually developed within a clinical department, practice, or health plan, and can be based on national standards. Clinical practice guidelines to implement the committee's recommendation for universal, routine testing with notification might, for example, include 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. Practice guidelines might also include clear identification of the essential components of post-test counseling for patients who test positive. Thus, The committee recommends that all health care plans and providers develop, adopt, and evaluate clinical policies to facilitate universal prenatal HIV testing. Institutional changes can lead to rapid increases in HIV test use. Kaiser Permanente of Northern California, for example, was able to increase test use throughout its service area from 50% to 63% in one year (from 1994 to 1995) by improving providers' ability to provide counseling and testing—for example, by ensuring access to educational materials and laboratory testing (Limata et al., 1997). In Southern California, prenatal HIV testing among pregnant Kaiser members rose from 55% to 85% between 1994 and 1997 (Pettiti, 1998). A provider survey conducted in Massachusetts found the adoption of an HIV clinical practice policy to be the single most important predictor of the occurrence of HIV prenatal testing (Allen et al., unpublished). The availability of patient educational materials can also help to improve prenatal HIV testing rates, according to the committee's site visits and workshops. The need for clear and readily accessible patient educational materials is even greater under the committee's recommendation for routine prenatal testing with notification. As a result of its support for minimal pre-test counseling to reduce provider burden, the committee foresees greater emphasis on educational materials to inform patients about the test and its implications for the health of the

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--> mother and child. Educational efforts oriented to the public at large also should be undertaken to underscore the importance of HIV prenatal testing. The New Jersey Department of Health and Senior Services, for example, has developed a public education campaign that includes the use of posters, postcards, videos, and public service announcements (Appendix F). To encourage HIV prenatal testing among adolescents and immigrants, who are among the hard-to-reach populations (see below), educational materials and public service announcements should be tailored to individuals of different ages, cultures, and languages. Outreach and counseling conducted by nurses, counselors, and other staff would increase the proportion of women tested by minimizing the burden of HIV counseling on physicians. Physicians at many of the sites visited by the Institute of Medicine (IOM) committee believed that counselors and nurses were more successful at counseling patients than they themselves. The Group Health Cooperative of Puget Sound, a large Kaiser-affiliated HMO (health maintenance organization) based in Seattle, Washington, recently took steps to improve HIV testing of pregnant women by (1) communicating with providers about the PHS recommendations, (2) integrating HIV education and counseling into prenatal classes usually given by registered nurses, (3) having test results available for review and discussion at the first visit with a prenatal care provider (midwife, obstetrician/gynecologist, or family practice physician), (4) making written support material for counseling and testing available to medical and nursing care providers, and (5) clearly defining appropriate steps for care of HIV-positive pregnant women (BlueSpruce, 1998). Performance Measures and Contract Language Health care plans and providers increasingly are held accountable for the services they provide through performance indicators such as measures of cost, quality of care, and patient satisfaction (IOM, 1996a). Performance measures for preventive services such as childhood immunizations and mammography screening are common. Another way to integrate public health goals and clinical practice is to develop contract language for managed care plans, especially those serving Medicaid populations. 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. Performance measures are established by health care plans as a result of requirements for accreditation, participation in Medicaid or Medicare, and market demand. In the market-driven approach, health care plans voluntarily supply information relating to performance measures to enable purchasers to compare plans. If providers do not meet performance goals within the plan, the plan faces

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--> sanctions or consequences, such as loss of accreditation, loss of participation in Medicare or Medicaid, and/or loss of market share. With respect to HIV prenatal testing, few, if any, health care plans currently hold their providers accountable for a high rate of HIV prenatal testing. 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. The Group Health Cooperative has decided to measure "the proportion of pregnant women with chart documentation of informed consent or refusal for HIV antibody testing within three months of the initiation of pregnancy." The long-term goal, or "optimal performance," has been set at 95%. This is compared to approximately 50% in mid-1997, before the program described above was put into place. The Jefferson County (Alabama) health department has a reporting system that could be used to measure HIV testing rates in its prenatal clinics, but it does not link performance to specific rewards or sanctions (Appendix F). Health plans can be held accountable for offering prenatal HIV tests or actually performing them. Estimating the proportion of women who are offered tests can be cumbersome because it relies on chart review, but some have suggested that this approach is preferable where testing is not mandatory, so that voluntary testing does not de facto become mandatory. It is usually easier to calculate the proportion of women who are actually tested because laboratory data frequently are computerized (Appendix D). Given the committee's emphasis on universal routine testing, 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. In 1997, as documented in Chapter 5, most women, and more than one-half of all Medicaid recipients were enrolled in some sort of managed care plan. The essence of managed care is that some entity is responsible for maintaining the health of every individual. This can be a major advantage when it comes to incentives to provide preventive services, such as prenatal care. Under fee-for-service systems, no one can be held responsible for pregnant women getting

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--> prenatal care. With managed care, the responsibility is clear, and plans can be held accountable for the services they provide, although few actually are. Thus the contracts that govern the care provided to patients in managed care systems can be powerful tools, and are especially important for increasing the number of women covered by Medicaid managed care. Current Medicaid managed care contracts, however, are limited by what the states specify, and in most states, financing rather than public health agencies develop the contracts. Thus no one asks for contract provisions relating to perinatal transmission or other prevention issues (Wehr et al., 1998). Fewer than half the states that have Medicaid managed care contracts require HEDIS data, for instance. Managed care and insurance contracts typically do not mention specific conditions, but in 1996, 18 states mentioned HIV or AIDS in their contracts. Of those, ten are limited to a reference to counseling and testing as a covered service, usually only in the context of family planning services. Only one state, Florida, specifically assures access to the ACTG 076 protocol (Wehr et al., 1998). A number of things could be specified in Medicaid managed care contracts. At a minimum, managed care organizations could be required to report what they tell their providers about prenatal testing and counseling and ZDV use. Managed care organizations could also be required to report on the proportion of women counseled and tested (or documented refusal), and the proportion of HIV-infected pregnant women who receive ZDV (whether there was a HEDIS question on this or not). Since many women qualify for Medicaid when they become pregnant, offering an HIV test could be a required part of the intake process (Wehr et al., 1998). 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. In its workshop and site visits, however, the committee heard many unfortunate instances of inferior-quality HIV treatment and poor linkage to specialty care for women diagnosed with HIV. Thus, The committee recommends efforts to improve coordination of care and access to high-quality HIV interventions and treatment for HIV-positive pregnant women. This recommendation has two components. First, HIV testing in pregnancy should be seamlessly linked to specialty care for HIV-infected women identified in the prenatal setting. Without linkage, 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, that is, there should be adequate facilities for diagnosis and resources for treatment

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--> Ryan White Comprehensive AIDS Resources Emergency (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. The Congress, however, never appropriated funds for this purpose. Appropriating these funds now would go a long way towards 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 process that could result in states' losing substantial 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. In other words, under certain conditions, mandatory newborn testing would be required (to maintain federal funding) if current voluntary prenatal testing fails. The logic of this approach is unclear; newborn testing may confer benefits for HIV-infected newborns, but cannot prevent perinatal transmission. If the national goal is to prevent HIV transmission from mothers to children, the federal government should support, not undermine, prenatal testing and other state-based prevention efforts. The Ryan White CARE Act Amendments of 1996, paradoxically, could have the opposite effect. Regional Approach Health Resources and Services Administration (HRSA) currently funds a system of "HIV Programs for Children, Youth, Women, and Families" through Title IV of the Ryan White CARE Act. Many of these programs serve as de facto regional centers for specialized treatment of HIV-infected women and affected children and, to a lesser extent, coordination of prevention activities. Federal research funds in these and other centers also provide for both direct care and an infrastructure to support it. In FY 1998, HRSA funded 44 comprehensive direct service programs in 23 states, the District of Columbia, and Puerto Rico. Most are located in urban areas, but some serve rural areas (HRSA, 1998b). There is, however, no coordinated, regional approach. Thus, The committee recommends that a regional system of perinatal HIV prevention and treatment centers be established. This goal might be reached by expanding the mandate of existing centers, or by establishing new centers in areas not now covered. The regional centers would 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

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--> would also help to develop and implement strategies to improve HIV testing in prenatal care, as discussed above. As discussed above, optimal care for HIV-infected pregnant women and their babies is complex, and must be coordinated throughout the prenatal, intrapartum, and postnatal periods. Obstetric as well as prenatal care is necessary, as is care for the mother's own HIV disease. The committee's workshop and site visits have shown that substantial efforts to improve coordination of care and access to high-quality HIV treatment are still necessary, despite recent successes. To effectively identify HIV-infected women and prevent transmission, moreover, this infrastructure must include the education of prenatal care providers; the development and implementation of practice guidelines; the implementation of clinical policies, the development and adoption of performance measures and Medicaid managed care contract language for prenatal HIV testing; interventions to overcome pregnant women's concerns about HIV testing and treatment; interactions with HIV prevention programs and drug treatment programs; and efforts to increase utilization of prenatal care, as discussed in this chapter. A Ryan White-funded program in Tampa, Florida, for example, provides nurse case managers for all pregnant women who are HIV-positive, whether they are being cared for by public or private providers. These case managers ease the baby's transition into a Title IV program, and provide supplementary services in conjunction with regular care providers. The program also works to improve compliance with Florida's law, which requires that all women in prenatal care be counseled and offered an HIV test. It is estimated that nearly all women who receive prenatal care in the public sector are tested, compared to 85% to 90% of the women in the private sector. To address this discrepancy, the program works with private sector physicians and group practices by sending nurses who visit offices, do chart audits, and make recommendations on how to improve testing rates. These nurses are viewed as individuals who can help the practices with HIV testing and who can link women and children with specialized HIV care when necessary, as well as "government auditors" (see Appendix H). Defining the organization, funding, and operations of the recommended regional approach is beyond the scope of this report. Steps are needed, for instance, to ensure that regional centers do not allow private providers to "dump" patients and to not overly burden mothers with long distances to travel. 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 Centers of Disease Control and Prevention (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

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--> 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 HIV transmission. Chapter 3 of this report illustrates how epidemiologic surveillance data can help to focus attention on critical dimensions of a public health problem. Such analyses are hampered, however, by the lack of national HIV prevalence data and the discontinuation, in 1994, of the Survey of Childbearing Women. Chapter 6 shows how data from provider and patient surveys, clinical and health plan records, and other sources such as birth certificates can be used to monitor the performance of providers and identify bottlenecks in prevention activities. Data of this sort, however, are not universally available, and often are defined differently from one population to another. 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. The Ryan White CARE Act Amendments of 1996 could make it difficult to maintain the recommended surveillance system. The Act states that continued federal funding to the states could be contingent upon (see Chapter 1): 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; and ensuring that at least 95% of women who have received at least two prenatal visits prior to 34 weeks of gestation have been tested for HIV. The first of these measures is imprecise. Does the "rate of new AIDS cases" refer to the number per year, the proportion of all newborns with AIDS, the proportion of children born to HIV-infected mothers who have AIDS, or some other concept? Children born with HIV infection may not progress to AIDS for years, so monitoring new AIDS cases per se reflects prevention efforts far in the past. How should it be determined whether any specific case was the result of

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--> "perinatal transmission"? What should be the role of newborn HIV prevalence data in states with mandatory HIV reporting? Because of this imprecision, states would likely choose the most favorable statistic they have available to avoid the loss of federal funds. The law recognizes that in states with few cases of perinatal AIDS (less than ten) an alternative measure is needed because of the inherent statistical variation in rates based on small numbers, but fails to specify such a measure. In 1997, 39 states had fewer than ten perinatally transmitted AIDS cases (Chapter 3). The second measure is overly precise. The restriction to "women who have received at least two prenatal visits prior to 34 weeks of gestation" seems to be based on the ACTG 076 protocol, but as Chapter 4 illustrates, women who start prenatal care late can also benefit from ZDV use. Since most health plans' data systems do not record prenatal care utilization in this much detail, the only way to compile these statistics would be to review individual medical charts, which is very costly. Birth certificates could be changed to include similar information, but currently only record prenatal care by trimester, and this information would have to be validated. 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 be also considered. A detailed discussion of these interventions would be beyond the scope of this report, yet the committee believes that the following areas offer possibilities for preventing HIV infection in children, and should be included in a prevention package. Primary Prevention of HIV Infection Primary prevention of HIV refers to the avoidance of HIV infection in the general population before it occurs. 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 of HIV: HIV/AIDS education, behavioral interventions, partner notification, treatment and prevention of sexually transmitted diseases, and community programs (IOM, 1994, 1995a, 1996b; NRC, 1989, 1990, 1991, 1995; CDC, 1997b, 1998b; NIH, 1997). Beyond more general HIV prevention efforts, HIV prevention programs targeting drug users, as well as increasing drug treatment slots for HIV-infected pregnant women, appear to be especially vital. Injection drug use in women or their partners is the primary cause of perinatal AIDS, accounting for about 70%

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--> of perinatal AIDS cases (Chapter 3). Drug treatment programs have higher HIV prevalence rates (2.9%) than at other testing sites, such as HIV counseling and testing sites, sexually transmitted disease clinics, and family planning programs (CDC, 1997d). Engaging drug abusers in drug treatment, needle exchange, and related programs is pivotal to primary prevention of HIV. Drug abuse treatment, and HIV prevention education given in the context of drug treatment, have been documented to reduce HIV risk behaviors, for example, drug use, risky injection practices, and number of sexual partners (IOM, 1995b, 1996b). Women found to be drug users in mandatory drug testing (see Chapter 2) need opportunities for treatment, not just identification and threats of removing their children. Similarly, needle exchange programs are effective in preventing HIV transmission (NRC, 1995). Targeted prevention programs also are essential in correctional settings, as discussed below. Averting Unintended Pregnancy and Childbearing Among HIV-Infected Women As a general proposition, 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. Couples are increasingly being urged to plan their pregnancies (AAP and ACOG, 1997), and part of this planning process should be a visit to a health care provider to ensure that the women enters pregnancy in optimal health. Such a preconception visit usually includes advice about nutrition, folic acid, weight, and tests for infectious and chronic diseases. Insofar as women and their partners avail themselves of this opportunity, preconception visits provide an early opportunity to obtain HIV testing for the woman and her partner. For those found to be HIV-positive, it provides a chance to consider avoiding pregnancy, and/or to be counseled about antiretroviral therapy during 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 in 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. To be most effective, however,

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--> women must know their HIV status to be able to take action, and this requires testing. The more women know their HIV status early in pregnancy, the better able they will be to consider whether to continue a pregnancy as well as the benefits of antiretroviral therapy. After giving birth, HIV-infected women, like all women, should be counseled about contraception and given referrals for follow-up visits that support the woman's contraceptive choice. This is important for all women, but especially for women for whom the consequences of an unintended pregnancy are particularly great. If such a program proves successful, it would be appropriate to implement comparable programs more broadly, but with clear provisions for women's right to refuse testing. Increasing Utilization of Prenatal and Preconceptional Care The purpose of prenatal care is to improve pregnancy outcomes, particularly for women at increased medical or social risk (IOM, 1988). Since the publication of the ACTG 076 results, the prenatal setting offers the additional opportunity for combating perinatal HIV transmission by HIV testing and by initiating effective treatment for women who test positive. Yet roughly 15% of HIV-infected pregnant women, many of whom are drug users, receive no prenatal care (Chapter 6). Therefore, increasing the proportion of women, especially drug users, who receive prenatal care should be a high priority. The 1988 IOM report Prenatal Care: Reaching Mothers, Reaching Infants 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. The improvements in prenatal care coverage documented in Chapter 6 show that progress is being made, but it is troubling that prenatal care utilization is especially limited among those women most likely to be infected with HIV. Some recent policy changes at the federal and state level do not augur well for improving access to prenatal care, although their full impact is not yet known. The 1996 federal welfare reform legislation creates bureaucratic barriers to the receipt of Medicaid for low-income women, both those who receive cash benefits under the new state welfare programs and those who continue to be Medicaid-eligible when they find employment. The legislation also prohibits undocumented immigrants and certain categories of legal immigrants from receiving Medicaid, despite the fact that any child born to them in the United States automatically becomes a U.S. citizen. With respect to drug abuse and pregnancy, several states have passed legislation mandating drug testing (prenatal or neonatal) and/or drug abuse treatment (see Chapter 2). Such legislation can have a chilling effect on the willingness of pregnant drug users to seek prenatal care, even in states where such laws have not

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--> been passed, according to the committee's site visits. Women also fear losing custody of their children if their drug use is discovered. Enhanced HIV Prevention in Correctional Settings Correctional settings—prisons and jails—offer a unique opportunity for prevention activities targeted at hard-to-reach women at risk for, or already infected with, HIV. The total number of incarcerated women was 74,730 in 1996, a threefold increase from 1985 (Bureau of Justice Statistics, 1997). The prevalence of HIV infection among incarcerated women is far higher than in the general community: 4% of female state prison inmates nationwide are known to be HIV-positive, with the proportion exceeding 10% in nine states. Women are more likely than men to be incarcerated for drug offenses. In Rhode Island, for instance, nearly half of incarcerated women are imprisoned for drug-related charges (Flanigan, 1998). Consequently, they generally serve shorter sentences and return to the community, where many will re-offend. The proportion of pregnant women in correctional settings who are HIV-infected is not known, but can be inferred to be higher than that in the general community. The median age of incarcerated women (31 years) places them squarely in the reproductive period. Furthermore, 6.1% of women in state prisons in 1994 were pregnant upon admission. Women in correctional settings thus represent an important population for targeted prevention efforts. Despite the relatively high-prevalence of HIV and pregnancy, only 85% of pregnant women received a gynecological exam related to pregnancy upon admission, and only 69% received any prenatal care while incarcerated. Many interventions could be introduced in correctional settings either for general primary prevention of HIV transmission or for prevention of perinatal transmission among HIV-infected pregnant women in particular. Interventions could 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. Given the realities of the correctional system, however, utmost care must be taken so that interventions are seen to be in the best interest of those incarcerated. Interventions that take advantage of prisoners to protect others, especially if the interventions lack confidentiality and may put prisoners at risk for harm, can be counter productive. The Rhode Island prison system provides a model comprehensive HIV testing and care program that is integrated with the community. The proportion of HIV-positive women in Rhode Island prisons at any given time is between 8% and 12% (Flanigan, 1998). As outlined to the committee at one of its workshops, Rhode Island mandates HIV testing for all individuals upon prison intake. For infected individuals, complete HIV care is available, and HIV patients are successfully linked to follow-up care in the community (Appendix D; see also Flanigan, 1998). The Rhode Island program has had a tremendous impact on HIV

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--> diagnosis statewide: 28% of HIV-infected women in the state were tested through the correctional system. An even higher percentage (39%) of HIV-infected injection drug-using women were identified through the correctional system. 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 (Minkoff and O'Sullivan, 1998). 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. A truncated version of the ACTG 076 regimen appears to be effective in reducing perinatal transmission, although to a somewhat lesser extent than the full regimen (see Chapter 4). While there is one commercially available Food and Drug Administration (FDA) approved rapid test, its rate of false positives is regarded as too high for use in most settings, though it may be beneficial in settings of high-prevalence (CDC, 1998g). The CDC is currently developing guidelines on the implementation and quality assurance of rapid HIV testing. New rapid tests are expected to become commercially available in the near future and, when used in conjunction with existing rapid tests, would have lower false positive rates. 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. There is a higher prevalence of HIV infection in women who have not received prenatal care (Lindsay et al., 1991c; see also Chapter 6). The labor and delivery setting offers the last opportunity to interrupt HIV transmission via 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. Bellevue Hospital Center in New York City has applied for permission from the state department of health to launch a voluntary, rapid testing demonstration program (as an alternative to the mandatory newborn testing program). Under this program, all women in labor and delivery who previously have not been tested for HIV will be offered a test. Since women who do not agree to prenatal testing at this public hospital are considered to be a population with higher HIV prevalence, the positive predictive value of a test is higher than in other settings. When the test is positive, antiretroviral therapy is to be offered beginning immediately in the intrapartum period, even though the woman's status must be confirmed by more definitive tests.

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--> A rapid test also may have broader application for HIV prevention in general, because many individuals fail to return for test results with conventional testing. In 1995, for example, 25% of individuals testing HIV-positive at publicly funded clinics did not return for their test results (CDC, 1997b). Sexually transmitted disease clinics and drug abuse treatment programs are among the sites that should introduce an accurate rapid testing program for the purpose of primary HIV prevention (CDC, 1998g). Population Groups That May Face Additional Barriers The following section focuses on the issues involved with testing and coordinating care for HIV-positive pregnant women who are adolescents or immigrants. Another important special population is drug-using pregnant women, a topic covered later in this chapter. While there certainly are problems in the coordination of their care, the larger problem is drawing drug-using women into prenatal care in the first place. As documented in Chapter 6, drug users are substantially less likely than others to receive prenatal care. Women in prisons and jails are another population requiring special attention, and these issues have been taken up earlier in this chapter. Adolescents Adolescents are a critical, yet underrecognized, population that needs coordinated HIV services. An estimated 25% of HIV-infected adults nationwide acquired their infection as adolescents (Rosenberg et al., 1994). Among the barriers to accepting and complying with HIV treatment are the lack of linkages between testing and treatment programs; adolescents' perception of invincibility and difficulty understanding the abstract concepts of disease latency and probabilities of transmission. Adolescents may also be injection drug users, which makes them more likely to become HIV-infected, and more difficult to reach. In addition, some adolescents have chosen to leave their home or have been forced out. Apart from the multiplicity of problems created by homelessness, frequent changes of address or no home address jeopardize Medicaid eligibility. A nationally recognized comprehensive treatment program for adolescents in New York City, the Adolescent AIDS Program of Montefiore Medical Center, has been successful in treating HIV-positive adolescents who are pregnant and reducing perinatal transmission of HIV. The program attributes its success in prevention of perinatal transmission to these features: labor-intensive outreach to adolescents and health care professionals to encourage testing with linkage to treatment; lack of financial barriers to testing and treatment through sliding fee scales and help with obtaining Medicaid and other public financing programs; accessibility to the program through subsidized transportation; a "one-stop shopping"

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--> approach enabling teenagers to receive counseling, testing, treatment, and medications for HIV at the same site—both during and after pregnancy (although obstetrical services are available through referral); and understanding the special needs and fears of adolescents. Immigrants Although they do not have higher HIV infection rates, many immigrant women face multiple barriers to the prevention of perinatal HIV transmission (Appendixes E, G, and H). The most formidable are cultural, financial, and legal, including potential loss of U.S. residency rights or citizenship. Many immigrants, particularly those who are undocumented, are reluctant to seek prenatal care because they distrust the health care system and fear being reported to the Immigration and Naturalization Service, which may lead to deportation. The foreignness of the language and the institutional atmosphere also lead to avoidance. Some minority groups equate hospitals with death. The cost of prenatal care is another obstacle. Many providers and programs provide free care or care at reduced cost, but federal law explicitly prohibits undocumented immigrants from receiving Medicaid. Finally, the cost of treatment is yet another barrier. Few immigrants have private insurance or Medicaid, so the only avenues for uninsured women to pay for care is through programs such as health department clinics and community health centers that serve low-income, Medicaid-ineligible people. Children born to undocumented immigrants, however, are covered under Medicaid by virtue of being born in the United States, which confers U.S. citizenship. Nevertheless, in South Texas, undocumented mothers of children born in the United States do not seek care for their children because their use of Medicaid would interfere with other family members' residency or citizenship petitions in the future (Appendix G). Even with the new program of federally funded state child health insurance programs (CHIPs, described in Chapter 5), a substantial fraction of low-income women and children will remain uninsured and HIV-infected children will be born ineligible for Medicaid. Continued support for public health clinics and neighborhood health centers and innovative insurance programs can help to provide prenatal and HIV testing care for these populations. The committee has seen examples of perinatal HIV centers that have been able to provide care for uninsured women, using combinations of private and governmental resources. 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 that they can receive optimal treatment for themselves and their

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--> children. 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 that includes education of prenatal care providers; the development and implementation of practice guidelines; the implementation of clinical policies, the development and adoption of 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 to overcome pregnant women's concerns about HIV testing and treatment; and efforts to increase utilization of prenatal care, as described above