6
Implementation and Impact of the Public Health Service Counseling and Testing Guidelines

Since the publication of the ACTG 076 (AIDS Clinical Trials Group protocol number 76) findings (Connor et al., 1994) 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. Federal and state public health agencies, as well as many professional organizations, have issued a series of guidelines, recommendations, and policies about HIV counseling and testing in prenatal care, and some states have passed laws regarding pre- and postnatal HIV testing. As a result of these efforts, and in direct response to the ACTG 076 findings themselves, many providers have changed their prenatal care practices. Despite these efforts, however, prenatal testing remains far from universal, and many HIV-infected women continue to receive substandard health care. Surveillance data, as discussed in Chapter 3, indicate substantial reductions in perinatally acquired AIDS cases since 1992, part of which have been attributed to prenatal HIV testing and treatment with zidovudine (ZDV). In response to the committee's congressional charge to assess "the extent to which state efforts have been effective in reducing the perinatal transmission of HIV," this chapter describes the efforts to implement the Public Health Service (PHS) guidelines, and attempts to estimate their impact.

The committee's analysis is based on a combination of statistical and anecdotal information drawn from the published literature, government reports, workshop presentations, and site visits. Although the information is not drawn from nationally representative studies, the committee believes that there is enough consistency in the information that is available to draw general conclusions.



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--> 6 Implementation and Impact of the Public Health Service Counseling and Testing Guidelines Since the publication of the ACTG 076 (AIDS Clinical Trials Group protocol number 76) findings (Connor et al., 1994) 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. Federal and state public health agencies, as well as many professional organizations, have issued a series of guidelines, recommendations, and policies about HIV counseling and testing in prenatal care, and some states have passed laws regarding pre- and postnatal HIV testing. As a result of these efforts, and in direct response to the ACTG 076 findings themselves, many providers have changed their prenatal care practices. Despite these efforts, however, prenatal testing remains far from universal, and many HIV-infected women continue to receive substandard health care. Surveillance data, as discussed in Chapter 3, indicate substantial reductions in perinatally acquired AIDS cases since 1992, part of which have been attributed to prenatal HIV testing and treatment with zidovudine (ZDV). In response to the committee's congressional charge to assess "the extent to which state efforts have been effective in reducing the perinatal transmission of HIV," this chapter describes the efforts to implement the Public Health Service (PHS) guidelines, and attempts to estimate their impact. The committee's analysis is based on a combination of statistical and anecdotal information drawn from the published literature, government reports, workshop presentations, and site visits. Although the information is not drawn from nationally representative studies, the committee believes that there is enough consistency in the information that is available to draw general conclusions.

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--> Development Of The Public Health Service Counseling And Testing Guidelines The development of the Public Health Service (PHS) counseling and HIV testing guidelines for pregnant women (CDC, 1995b), released on July 7, 1995, was triggered by the ACTG 076 results a year earlier. The guidelines called for universal counseling and voluntary testing of pregnant women, in lieu of a more targeted approach to either high-risk women or high-incidence states (the guidelines are reproduced in Appendix N). The rationale for universal counseling was that many HIV-infected pregnant women and newborns in low-risk groups and low-prevalence areas were not being tested and treated. The universal approach was seen by the PHS as a means of stimulating the development of a testing and treatment infrastructure in low-prevalence states and regions (Appendix C). The adoption of voluntary, as opposed to mandatory, testing was recommended for a number of reasons: widespread support for the policy, particularly from patients for whom adherence to a demanding drug regimen is essential for prevention of transmission; a concern that mandatory testing might have served as a potential deterrent to prenatal care; the risks of testing positive (e.g., discrimination and domestic violence) might outweigh the benefits in some cases; and experience indicating that greater than 90% of women accept testing when offered (Appendix C). Implementation Of The Public Health Service Guidelines In Law, Regulation, And Policy1 Based on a survey of state activities, Gostin and colleagues (in press) concluded that states have moved rapidly to implement the PHS counseling and testing guidelines (CDC, 1995b), mostly without mandatory or coercive actions. As of June 20, 1998, almost all states had taken steps to implement the PHS guidelines in law, regulation, or policy (see Box 6.1). Only three states (Idaho, Kansas, Vermont) have neither laws nor policies on counseling and testing of pregnant women. Most states have policies, recommendations, or guidelines to prevent perinatal transmission; 45 states have policies on counseling/testing of pregnant women; 38 have policies on treatment of pregnant women; and 22 have policies on testing, monitoring, or treatment of newborns. Only 19 states have adopted laws or regulations on HIV counseling and testing of pregnant women. Four states (Michigan, Mississippi, Tennessee, Texas) have routine "opt-out" procedures, in which a woman will be tested unless she specifically objects. 1   This section is based on Gostin and others (in press), reflecting data on 50 states and territories, but not the District of Columbia. To simplify the exposition, territories are counted as "states."

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--> BOX 6.1 Sample State Laws and Regulations about Perinatal HIV Counseling and Testing In Texas, section 97.135 of the state health code, amended in 1996, requires prenatal care providers to distribute information about HIV provided by the Texas Department of Health, verbally notify women (and note in their medical records that notification was given) that an HIV test will be performed if the patient does not object, advise women that the test is not anonymous, and take a sample of blood and have it tested for HIV infection. In addition, physicians or others who attend births must test new mothers or umbilical cord blood for HIV within 24 hours of delivery for all births, unless the women objects. As of January 1, 1998, the Tennessee HIV Pregnancy Screening Act of 1997 requires all providers who assume responsibility for prenatal care "to counsel pregnant women regarding HIV infection and, except in cases where women refuse testing, to test these women for HIV and to provide counseling for those women who test positive." New Jersey has had a law since 1995 requiring prenatal care providers to provide their patients with information about HIV and AIDS, inform them of the benefits of being tested for HIV, and present them with the option of being tested. The New Jersey Department of Health and Senior Services has no authority to enforce this law, but has undertaken a number of programs to educate providers and patients about its provisions. California statute requires every prenatal care provider to offer HIV information and counseling (the content of which is specified in the law), and to offer an HIV test, to every pregnant patient. The offering must include discussion of the purpose of the test, its risks and benefits, and the voluntary nature of the test. The law also requires that these activities be documented in the woman's medical record. The state has also developed and widely disseminated comprehensive clinician education and resource materials (including interactive teaching materials for use with patients) and has made a toll-free clinician help line available. Since 1996, the New York Department of Health (DoH) has had regulations requiring hospitals, diagnostic and treatment centers, health maintenance organizations, and birthing centers (all of which are regulated by the DoH) to provide HIV counseling and recommend voluntary testing to all women in prenatal care. According to DoH, universal HIV counseling and recommended voluntary testing is now the standard of medical care for all prenatal care settings, whether regulated or not. Pre-test counseling must be provided, and written informed consent for the HIV test must be recorded on a DoH-approved consent form. Three states (Indiana, New Jersey, Rhode Island) have routine "opt-in" procedures, which require prenatal care providers to offer the test. Testing is voluntary with informed consent in the remaining 47 states. According to state policies or laws, prenatal HIV counseling is required in 22 states, is routine in 10 states, and is recommended in 18 states.

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--> Most states have laws governing disclosure of HIV test results. Thirty-seven states require reporting to the state health department. Other states permit disclosure to the person's spouse, or sexual or needle-sharing partner (26 states); to foster agencies or families (9 states); or to the newborn's pediatrician (15 states). Eight states regulate disclosure to insurers. Six states have adopted laws or regulations on HIV testing, monitoring, or treatment of exposed newborns. Only New York State strictly mandates newborn testing; Texas requires it, but allows mothers to refuse. At least six states have provisions permitting testing of infants or minors without parental consent. In two states, a doctor may test a newborn for HIV if he or she determines it is medically necessary. Virtually all states have programs to disseminate educational information to health care institutions (40 states), to providers (41 states), and to pregnant women and the public (31 states). These efforts are aimed at specific socioeconomic (10 states), ethnic (17 states), and age (19 states) groups, and 20 states distribute information in languages other than English. Thirty-seven states incorporate PHS guidelines into state-sponsored HIV programs, mostly through education and training of counselors and health care providers. Eighteen states have reviewed their contracts with managed care organizations regarding HIV issues, and nine states report having required changes in the covered programs to implement the PHS guidelines. Although the issue has not been carefully studied, the committee has identified no evidence that the existence of state laws or policies mandating HIV testing for either pregnant women or newborns has had any effect on offering or accepting tests, or on avoidance of prenatal or other health care. Indeed, in the course of its site visits, the committee heard many instances of providers and patients who were unaware or confused about perinatal HIV testing laws and policies in their states. If many people are unaware of the policies, they are unlikely to change behavior. Implementation Of The Guidelines By Professional Organizations Most organizations representing professionals who provide prenatal or newborn health care have adopted positions that support universal counseling and voluntary testing of pregnant women. The American College of Obstetricians and Gynecologists (ACOG) advocates (1) routine counseling of all pregnant women as part of prenatal care; (2) voluntary testing with consent; and (3) documentation of refusal of testing in the patient's chart. ACOG recommends that pre-test counseling include information about risk behaviors, vertical transmission, availability and effectiveness of therapy, and the potential social and psychological implications of testing positive. The group also recommends, on a voluntary basis, contacting sexual partners of HIV-positive patients, as well as sharing testing

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--> information with health care professionals, including pediatricians (ACOG, 1997; Hale and Zinberg, 1997). The American Academy of Pediatrics (AAP) also calls for universal counseling and voluntary testing of pregnant women, and recommends testing of all newborns whose mothers either are HIV-infected or have unknown HIV status. The AAP's recommendations include these key points: (1) All pregnant women should receive routine HIV education and routine testing, with consent. Consent can take the form of the right of refusal in order to facilitate rapid incorporation of HIV testing into routine practice. (2) All testing programs should evaluate the percentage of women who refuse testing. In cases of poor acceptance rates, programs should analyze why and make changes. (3) Newborn testing should be performed, with maternal consent, when the mother's HIV status is unknown. If the newborn tests positive, the mother should be notified and should receive referral for her testing and treatment. (4) Results of maternal testing should be provided to the pediatric health care provider. (5) Comprehensive HIV-related medical services should be available to all infected mothers, infants, and other family members (AAP, 1995b). The National Medical Association (NMA) position on HIV testing of pregnant women asserts that (1) health care professionals should offer counseling and voluntary HIV testing to all pregnant women on a confidential basis; (2) health care professionals should offer zidovudine (ZDV) therapy to all HIV-infected pregnant women and newborns without attempting to coerce treatment; (3) in HIV-infected women, amniocentesis, fetal scalp electrode placement, or measures that lead to prolonged rupture of the fetal membranes should be avoided, as should breast-feeding; and (4) confidentiality, while extremely important, should not extend to withholding test information from other health care workers, such as pediatricians, for whom the information has medical significance (Appendix C). The American Academy of Family Physicians (AAFP) recommends universal HIV counseling and voluntary testing for all pregnant women, and has adopted as policy the section ''Guidelines for Counseling and Testing for HIV Antibody" from the CDC statement "Public Health Service Guidelines for Counseling and Antibody Testing to Prevent HIV Infection and AIDS" (CDC, 1987). In addition, HIV education is part of state association meetings, and the two AAFP publications also cover HIV issues. The American Medical Association (AMA) is the only professional organization that supports mandatory HIV testing of all pregnant women and newborns, but this policy is not without controversy. In June 1995, the AMA Council on Scientific Affairs reviewed the available scientific data available and recommended that the AMA adopt a policy encouraging physicians to give a high priority to educating all women about HIV infection, and calling for prenatal HIV testing to be voluntary and its acceptance the responsibility of the woman (AMA, 1995). In June 1996, however, the AMA House of Delegates adopted a policy acknowledging that "mandatory testing for HIV of newborns at birth is too late to

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--> prevent perinatal transmission of this virus," but concluding that "there should be mandatory HIV testing of all pregnant women and newborns with counseling and recommendations for appropriate treatment" (AMA, 1996). The House of Delegates reaffirmed this position in 1997 (AMA, 1997). The American College of Nurse Midwives (ACNM) policy is that all women should be counseled on HIV risk behaviors and risk reduction strategies, and following counseling, all women should be offered HIV testing with informed consent. The group opposes mandatory testing as a condition of receiving care, and recommends that women be counseled in a non-directive manner regarding reproductive choices and pregnancy care. ACNM recommends that all HIV-infected women be counseled on the risks and benefits of ZDV therapy during pregnancy, and offered this medication. The college also recommends that all HIV-infected women receive prenatal and perinatal care that minimizes the risk of vertical transmission through utilization of non-invasive techniques, and that HIV-infected women with access to adequate formula supplies should be advised to avoid breast-feeding (ACNM, 1997). The Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) also supports voluntary HIV testing with appropriate counseling, maintenance of confidentiality, and freedom from discrimination based on HIV status (AWHONN, 1995). The Association of Maternal and Child Health Programs (AMCHP), which represents state maternal and child health programs, has incorporated PHS guidelines into its policy on HIV counseling and testing (AMCHP, 1995), which supports early and routine counseling to enable all pregnant women and others of reproductive age to understand the risk of HIV infection and the benefits of early testing, identification, and treatment. In addition, the statement calls for voluntary testing with informed consent as the standard of practice. The AIDS Policy Center for Children, Youth and Families (APCCYF), an advocacy organization for service providers supported by Title IV of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, recommends that routine HIV counseling and voluntary, confidential HIV testing with informed consent be the standard of care for all pregnant women, and supports policies and procedures in all hospitals, clinics, and doctors' offices related to routine HIV counseling and voluntary, confidential HIV testing with informed consent, and follow-up for linkages to care (APCCYF, 1995). Implementation Of Counseling And HIV Testing And Quality Care For HIV-Infected Pregnant Women As indicated in Chapter 1, the committee has organized its analysis in terms of a chain of events needed to prevent perinatal transmission of HIV (Figure 1.1). In the following section, this chain is used to summarize the evidence about the implementation of the PHS counseling and testing guidelines (CDC, 1995b) in clinical practice. In particular, this section covers access to and utilization of

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--> prenatal care; counseling and offering HIV testing in prenatal care; acceptance of prenatal HIV testing; offering, accepting, and complying with ZDV treatment; and provision of quality health care for HIV-infected women. Early Prenatal Care As indicated in Chapter 4, to successfully reduce perinatal HIV transmission, HIV-infected women would ideally be identified early in pregnancy. Late or no prenatal care is thus a significant barrier to identification and treatment of HIV-infected pregnant women. From 1970 to 1995, the percentage of women in the United States receiving prenatal care in the first trimester of pregnancy steadily increased from 68.0% to 81.3%, and the percentage of women receiving late (i.e., at seven to nine months gestation) or no prenatal care declined from 7.9% to 4.2% (NCHS, 1997). Relatively few women receive no prenatal care (1.7% in 1992), but rates increase with parity, are higher in African-American women, and are highest in large cities. In 1992, as many as 8.5% of women living in the largest American cities (i.e., the 22 urban areas with populations of 500,000 or more residents) received no prenatal care. Among African-American urban residents, 11.7% had received no prenatal care (compared to 7.0% of white urban women), but rates are over 20% in some urban areas (for example, 22.1% and 20.7% in Manhattan and Philadelphia, respectively) (DHHS, 1992). This trend is worrisome because HIV infection in women tends to be concentrated in large urban areas in the Northeast. The prenatal care patterns of HIV-infected pregnant women have been assessed in at least three studies. Among the 1,311 HIV-infected pregnant women identified in CDC's State Enhanced Pediatric HIV Surveillance Program (STEP) in four states (New Jersey, South Carolina, Michigan, and Louisiana) from 1993 to 1996, 14% had no prenatal care, and another 23% started care in their third trimester. As many as 35% of drug using, HIV-infected women had no prenatal care (Appendix D; CDC, 1998f). In a study of HIV-infected pregnant Medicaid recipients giving birth from 1985 to 1990, 90% had initiated prenatal or HIV care by 34 weeks' gestation, but only 50% had initiated care by 14 weeks. Fourteen percent of these women received no care until the last few weeks of pregnancy (Turner et al., 1997). Similarly, 14% of HIV-infected women in several counties in Texas received late or no prenatal care (Shakarishvili et al., 1996). These studies would suggest that roughly 15% of HIV-infected women receive no prenatal care. Counseling and Offering HIV Testing PHS guidelines recommend that all pregnant women in the United States be offered and encouraged to accept voluntary HIV antibody testing early in pregnancy (CDC, 1995b). Some states go further, requiring that all women in prenatal

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--> care be offered an HIV test. Meeting this target requires that prenatal care providers be aware of the benefits of maternal HIV screening and adopt practices to ensure that all pregnant women are counseled and offered testing. A total of 22 recent studies (conducted from 1994 to 1997) of prenatal care providers' attitudes and practices regarding HIV counseling and testing have been identified, and are summarized in Table 6.1. These studies were conducted in 22 states, and all involved surveys of prenatal care providers. The specific methods of study varied somewhat (e.g., telephone versus mail administration of survey), as did the sampling (representative versus convenience samples) and the response rates (from 25% to 84%). Many of the studies were unpublished at the time of this review and therefore have not been subject to peer review. Because most of the literature on provider behavior is based on surveys that rely on self-reports, there is a possibility of biased reporting favoring compliance with recommended practice. It is difficult to draw a national picture from the results of these selected states, but there does appear to be significant variation across geographic areas and significant gaps between provider awareness and application of recommended practices. Awareness of CDC's guidelines, state HIV testing laws, and the ACTG 076 results appears to vary among prenatal care providers: In 1997, 60% of prenatal care providers in Oregon were familiar with CDC's recommendations regarding perinatal HIV transmission (Rosenberg et al., undated abstract). In 1996, 92% of Michigan providers were aware of state HIV laws (Michigan Department of Community Health, 1997). In 1996, 93% of Wisconsin providers had read a position paper, attended continuing education programs, or implemented an HIV testing policy (Wisconsin AIDS/HIV Program, 1997). In 1996, 87% of Montana's obstetric providers were aware of CDC recommendations for testing pregnant women for HIV (Montana Department of Public Health and Human Services, 1996). In 1995, 75% of California obstetricians were familiar with state law regarding HIV testing (Segal, 1996). In 1995, 90% of North Carolina providers had heard of the ACTG 076 results, but fewer providers reported familiarity in later years in Colorado (75% in 1996) and Atlanta, Georgia (60% in 1997) (Newton and Bell, 1997; Walter et al., 1998; Nyquist, undated abstract). Provider surveys, on the other hand, indicate substantial variability in clinical practices and significant gaps between recommended and reported practices: In 1997, 94% of providers in New Jersey said they offered HIV testing to all or most of their prenatal patients (Ching et al., 1997).

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--> TABLE 6.1 Summary of Selected Recent Research on Prenatal Care Providers' Attitudes and Behaviors Related to Perinatal HIV Testing Investigator(s) Study Period Geographic Area Methods Results Comments Newton ZB, Bell WC July 21, 1997 Report from Georgia Department of Human Resources Spring 1997 Metropolitan Atlanta, Georgia Survey of a convenience sample of 150 private practice OB/GYNs at nine hospitals in metropolitan Atlanta. No information on RR 60% are aware of the ACTG 076 study, 72% report encounters with HIV+ patients. 77% have policy of routine offer of HIV test to all patients; 6% report testing by risk assessment or patient request. Only 15% report all patients are screened. 55% report lack of information makes implementing ACTG guidelines difficult   Ching S, Paul S, Goldman K May 1, 1997 Abstract and graduate program fieldwork project write-up 1997 New Jersey Mail survey of members of state medical association of OB/GYNs. RR 51% (160/315) 94% report offering HIV testing to all or most pregnant patients, 90% discuss benefits of HIV testing with all or most, 77% report counseling all or most about HIV, 59% provide counseling, discuss benefits of HIV testing, and offer test to all pregnant patients. Gender, years of practice, and number of HIV patients not related to levels of implementation New Jersey requires providers to provide HIV counseling, discussion of HIV test benefits, and a voluntary HIV test offer Bell LJ 1997 Reported in State Disease Prevention and Epidemiology Newsletter July 1997 South Carolina Mail survey of licensed obstetricians. RR 63% of practicing OBs 97% routinely screen pregnant women for HIV. 90% report at least 75% of women accepting test. 21% of OBs test without informed consent   Rosenberg KD, Townes JM, Gonzales K, Modesitt SK, Fleming DW Abstract January 1997 Oregon Mail survey of 208 persons named as birth attendants on randomly selected birth certificates of children born in Oregon between January 1995 and July 1996. RR 80% (167/208). Analysis limited to 159 prenatal care providers 60% familiar with the CDC recommendations, 63% encourage all pregnant patients to be tested, 33% encouraged testing only for those with known risk factors. HIV counseling and screening practices did not differ by provider type, location of practice, specialty, or number of births attended per year. Fewer than one-half of all pregnant women are estimated to have been tested Responding providers attend approximately 40% of Oregon births Partika N, Johnson J November 14, 1997 Unpublished report July 1996 to June 1997 Hawaii Mail survey of 326 OB/GYN and family practice physicians statewide. RR 33% (107/326). 61 reported caring for pregnant women in last year 86% (53/61) offered HIV counseling and testing to most or all of their pregnant patients (76% to 100%). 47% (29/61) report that most or all pregnant women accepted HIV counseling and testing. 29% (18/61) report that less than 50% of women offered HIV counseling and testing accepted it. No explanations for the refusals was offered   Riley CW January 1998 Perinatal HIV Infection White Paper, Virginia Department of Health 1996 Virginia Mail survey of 281 medical practices providing prenatal care in Virginia. 230 in sample were OB/GYN practices 54% of practices report offering HIV tests to 76% to 100% of patients. Among OB/GYN practices; 99% report offering HIV test to 76% to 100% of patients. Less than half (48%) of practices report that 76% to 100% of patients accept HIV tests. 15% report that 10% or fewer patients accept the test. Physicians report that the most common reason women decline testing is that they think that they are not at risk or they have already been tested As of July 1995, providers are required by law to counsel women seeking prenatal care about HIV and to offer voluntary testing

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--> Investigator(s) Study Period Geographic Area Methods Results Comments Wisconsin AIDS/HIV Program April 1997 Unpublished report 1996 Wisconsin Mail survey of 600 physicians (GP/FP, OB/GYN, other M.D. prenatal providers), and 400 nurse practitioners providing prenatal care, nurse midwives, and physician assistants specializing in family practice and OB/GYN. RR 75%. Analyses limited to 591 providing prenatal/obstetric care 93% had read a position paper, attended continuing education, or implemented a policy regarding HIV testing of pregnant women. 93% agreed that all pregnant women in their community should be offered HIV testing. 74% offer HIV testing to all prenatal patients. 57% report a consent rate greater than 75% when they offer HIV testing. Since 1994, 72% of prenatal care providers report increased level of HIV testing According to a 1993 survey, only 39% of prenatal care providers reported that they offered HIV testing to all of their pregnant patients Ohio Department of Health October 31, 1997 Unpublished report Fall 1996 Ohio Mail survey of systematic random sample of Ohio registered OB/GYNs. RR 68% of eligible physicians contacted (393/582) More than 93% offered HIV testing, and most offered it for all pregnant women. Vast majority said that some form of HIV counseling was available to at least some pregnant women, but 14% counsel only patients with positive tests and 9% offered no counseling. Percentage of women tested varied from 0 to 100%, with a median value of 60% Barriers to counseling mentioned were lack of support staff and lack of time Nyquist C Undated abstract Fall 1996 Colorado Mail survey of FPs, OBs, and nurse midwives (members of professional societies). RR 49% (634/1,301). 324 provide prenatal care (about one-third of OBs; two-thirds FPs). 75% stated familiarity with findings of ACTG 076. 90% screen pregnant women for HIV infection, 50% always test for HIV, 75% strongly agree/agree that "all pregnant women should be tested for HIV regardless of stated risk behaviors"   Michigan Department of Community Health 1997; Report of Subcommittee on Perinatal HIV Reduction October 1996 Michigan Survey of 150 OB/GYNs attending a regional ACOG meeting. RR 25%. Survey of 25 M.D.s at the Michigan State Medical Society/Maternal and Child Health Subcommittee. RR 48%. Mail survey of 102 members of the American College of Nurse Midwives practicing in Michigan. RR 49%. A total of 100 providers included in analyses 92% of providers are aware of Michigan's HIV laws, 94% of midwives and 82% of OBs said that they were compliant all the time with the counseling aspects of the law. 68% of midwives and 55% of OBs said they were compliant with the laws in terms of routinely incorporating HIV testing in the care of pregnant patients Michigan law requires all pregnant women be counseled about, and tested for HIV. HIV testing of pregnant women and their infants is voluntary. Written, informed consent for testing must be obtained prior to testing

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--> TABLE 6.3 Summary of Selected Recent Research on the Use of Zidovudine (ZDV) to Prevent Perinatal HIV Transmission Investigator(s) Study Period Geographic Area Methods Results Comments Birkhead GS, Warren BL, Charbonneau TT, et al. Abstract 1998 1997 New York Newborn HIV testing program data from February 1 to October 31, 1997 62% (285/461) of HIV+ women received ZDV treatment during pregnancy and 79% received at least some ZDV treatment (i.e., during pregnancy, intrapartum, newborn within three days)   Michigan Dept. of Health, 1998 1992–1997 Michigan HIV/AIDS surveillance data reported through October 1, 1997 93% of HIV infected women used ZDV prenatally in 1996, an increase from 13% and 30% in 1992 and 1993, respectively. 90% of HIV-exposed babies used ZDV in 1996, an increase from 6% and 14% in 1992 and 1993, respectively   Lindegren ML IOM workshop presentation, April 1, 1998 1995–1996 New Jersey South Carolina Louisiana Michigan STEP project Very few (5%) women have chart-documented evidence of refusal of ZDV when offered. Relatively few (6%) women discontinue using ZDV during pregnancy (as documented in medical chart, so a minimum estimate)   Lindegren ML IOM workshop presentation, April 1, 1998 1993–1996 29 HIV-reporting states Surveillance data ZDV (either prenatal, intrapartum, or neonatal) use increased from under 20% prior to 1994 to more than 80% in 1996 among perinatally exposed/infected children whose mothers were diagnosed HIV+ before/at birth. Roughly 70% of HIV-exposed babies had prenatal ZDV treatment   Lindegren ML IOM workshop presentation, April 1, 1998 1994–1995 Florida, Louisiana, Michigan, Minnesota, New Jersey, Nevada Oregon, Texas ZDV assays of HIV+ SCBW samples from eight states. Positive assay indicates administration of ZDV intrapartum or to newborn to prevent perinatal transmission. Method provides a minimum estimate of ZDV use (e.g., not all HIV+ women had been identified of giving birth) On average, more than one-half of all HIV+ women giving birth in eight states in 1995 received perinatal treatment with ZDV. ZDV use increased substantially between 1994 and 1995   Wiznia AA, Crane M, Lambert G, et al. 1996 Published report February 1994 to August 1995 Bronx, New York ZDV use among HIV+ pregnant women cared for at one hospital. All women were counseled regarding the results of the ACTG 076 trial 75% (37/49) of HIV+ pregnant women chose to use ZDV. Women refusing ZDV were more likely to report injection drug use as their HIV risk factor and to continue to use drugs during pregnancy. 67% (24/36) of women using ZDV received all components of therapy. Twelve women missed the intrapartum dose (because of short labor related to cocaine use). Overall, 52% (24/46) of women who completed their pregnancy took ZDV prenatally, intrapartum, and administered ZDV to their infants Compliance might be improved by using outreach workers, integrating prenatal care with drug treatment programs, or expanding women's support structures

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--> Investigator(s) Study Period Geographic Area Methods Results Comments Paul SM, Cross H, Costa SJ. et al. IOM workshop presentation, April 1, 1998 1993–1996 New Jersey SCBW, enhanced pediatric surveillance Prenatal ZDV use among women known to be HIV-infected increased from 8% to 47% from 1993 to 1996. Known ZDV use in neonates increased from less than 1% in 1993 to 64% in 1996. According to a 1995 SCBW study, women under age 30 were more likely than older women to have used ZDV. Race/ethnicity and volume of HIV + births in hospitals were not correlated to ZDV use   Fiscus SA, Adimora AA, Schoenbach VJ, et al. 1996 Published report 1993–1994 North Carolina SCBW, pediatric surveillance The proportion of HIV-exposed children in North Carolina who were identified and tested increased from 60% to 82% from 1993 to 1994. After results of ACTG 076, ZDV was given to 75% of HIV+ women who delivered infants in North Carolina   without regard to women's experience and perceptions, inadequately tested in women and minorities, promoted for the wrong reasons, and inappropriate while they were feeling well (Siegel and Gorey, 1997). Nevertheless, studies of pregnant women residing in high-prevalence areas suggest that most women would take ZDV if they were to test positive for HIV (Pemberton, 1997; Silverman et al., 1997). Health Care for HIV-Infected Women As Chapter 4 shows, HIV-infected women and their babies now have greatly improved chances of survival because of ZDV and other antiretroviral therapy. With prenatal and intrapartum ZDV therapy, the rate of perinatal HIV transmission has been dramatically reduced and new, more complex therapies promise even greater reductions in mother-to-child transmission. High-risk HIV care centers specializing in maternity and postpartum services for HIV-infected women and their babies have been developed in high-incidence areas of the country. These centers continue to test and improve upon therapeutic approaches. Equally important, the centers give the kind of comprehensive care that is essential to reaching the best possible outcomes for HIV-infected mothers and their infants. While specialty clinics provide a model for quality perinatal HIV care, these services are clearly not uniformly available to infected women and their infants. The committee repeatedly heard testimony about a range of care-related problems women encounter once they have tested positive for HIV. Site visits in Alabama, New York and New Jersey, Florida, and South Texas, as well as testimony by providers and patients from the San Francisco Bay area (see Appendix

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--> C through I), for instance, all point to a similar conclusion: testing does not necessarily lead to care, and even when it does, women are not necessarily receiving the quality treatment and services they need. Getting Timely, Accurate, and Confidential Test Results The committee repeatedly heard reports about the emotional difficulty of receiving positive HIV test results, even under ideal circumstances. For some women, however, the shock is intensified by the circumstances under which they are informed of their status. In Birmingham, Alabama, specialty care providers reported that some private providers test women without their knowledge and then relate positive results over the phone. By the time these women make their way to the specialty clinic, they are already distrustful of the health care system. Rebecca Denison, an HIV-positive mother who founded and is executive director of Women Organized to Respond to Life-threatening Diseases (WORLD) in Oakland, California, spoke of women who received calls from their physicians' offices telling them they had tested positive for HIV and that they should see a specialist since their own provider could not see them or ''could not tell them what the test results mean." The problem of health care providers being ill-equipped to inform and counsel HIV-infected women was also noted in San Antonio, Texas, where a case was cited in which an obviously nervous medical resident could not answer questions about care options. In another instance cited in San Antonio, an HIV-positive woman and her husband were shown lab results that they could not understand, and were given a prescription for ZDV and a pamphlet to read, but the woman's physician could not answer essential questions or give needed support.

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--> Some women who test positive never receive the news that they are infected, or receive the news many months into their pregnancies. In New York City, Newark, New Jersey, and San Antonio, committee members were told of women who test positive being lost to follow-up. This was of particular concern in managed care settings where hospital stays are abbreviated. Finally, in San Antonio, committee members were told of situations where providers simply did not understand the nature of screening results or the need for retests to confirm ELISA results. As a result, women with positive ELISA tests were told they were definitely infected. In one case, a women asking for a retest was told, "The tests are accurate and there is no need for a retest." Getting to High-Risk Specialty Providers Even in some high-incidence areas, specialty providers are not available. In the entire East Bay of the San Francisco Bay area, for instance, there is no obstetrician or perinatologist specializing in the care of HIV-infected pregnant women. This includes high-incidence cities such as Oakland, Richmond, Berkeley, and Fremont. Women seeking specialty care must travel an hour across the bay to San Francisco. For women living in low-incidence and/or rural areas, the difficulty in reaching specialty care is even more pronounced. A Birmingham specialty clinic treats women from northern Alabama who travel four to five hours just to get their care. Getting Appropriate Care from Non-Specialty Providers The committee heard repeatedly about situations in which providers were not well informed about current care practices and therefore could not give HIV-infected women optimal or even adequate care during pregnancy. Keeping up with the latest therapies may be particularly problematic for primary care providers in low-incidence areas, or with low-incidence practices; however, the problem goes beyond these kinds of practices. Rebecca Denison from WORLD gave the following examples from women she has counseled (see Appendix I). When "Kim" asked her doctor if he knew how to manage an HIV pregnancy he said, "Oh, yes. Don't worry. We use gloves during the delivery with everyone." This same doctor, who knew she was HIV-positive, asked her three times, "Now, tell me again why you're not planning to breast-feed?'' "Natalie" had an undetectable viral load on a combination of two drugs when she found out she was pregnant. An obstetrician with no experience with HIV told her to go off her drugs immediately because she was in her first trimester. Almost immediately her viral load went from undetectable to over 130,000 copies/mL. "Kelly" tested positive at age 22, during a planned pregnancy. With an hour of her diagnosis she was told, "We can schedule the abortion today." It was

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--> only after she terminated her pregnancy that she learned there would have been a good chance of the baby being born HIV-free. "Sheila" knew she was HIV-positive when she became pregnant by accident. Her doctor put her on ZDV and d4T, a combination that is contraindicated in any HIV-infected person, pregnant or not. "Sandra" delivered her baby in a high-incidence city to a doctor and medical team who knew she was HIV-positive. "They"—not just the doctor, but the entire medical team—forgot to administer intravenous ZDV. In San Antonio, a case was cited in which a doctor assumed the pharmacy automatically stocked ZDV, which he planned to administer to a pregnant HIV-infected woman during labor. By the time he realized the pharmacy did not have ZDV readily available and ordered it from a specialty HIV clinic, it was too late. The woman delivered without benefit of intrapartum antiretroviral therapy. Availability of Complex Therapies In Birmingham and San Antonio, committee members were told that although high-risk centers provide triple or other multiple therapies, many other providers offer only ZDV. In some instances the reliance on monotherapy seems to reflect a resource shortage, and in others it reflects a concern among providers that multiple therapies are still experimental and that their use may be unethical and/or leave the provider subject to malpractice charges. In testimony at the April 1, 1998 Workshop, Denison noted the importance of continuing research protocols and of incorporating new findings into standard care for HIV-infected women (Appendix D). Standards of Care Even when women receive care from specialty clinics, they and their providers are often faced with difficult decisions about care options. For many basic obstetric procedures, there is no standard of care established for HIV-infected women. There are, for example, no standard recommendations or cost-benefit analyses on cesarean sections, amniocentesis, and fetal scalp monitoring for the HIV-positive mother and her infant. Special Populations There are extra barriers for some special populations to obtaining adequate care for HIV-infected pregnant women and their infants. These special populations include undocumented immigrants, some categories of legal immigrants, substance users, and adolescents. Chapter 7 reviews some of the systemic issues related to receipt of HIV-specific and other care for these populations.

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--> Medicaid While Medicaid provides crucial financing of prenatal care, labor delivery, and postpartum care for HIV-infected women, many states end coverage for all but the poorest women at six weeks postpartum. For an HIV-infected woman, the loss of Medicaid can have devastating effects on her own health and her ability to care for her infant. Providers in Birmingham noted that while specialty clinics thus far have been able to piece together financing for women's medication and treatment for women who are no longer eligible for Medicaid, it is not clear that clinics will be able to continue coverage in the future. A second Medicaid-related issue was raised at the San Antonio site visit, where the move to Medicaid managed care has left both providers and patients confused about care options for HIV-infected women. At issue is whether or not patients can switch to the high-risk HIV care center as a primary provider of maternity services. Women, Infants, and Children Program The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) provides health education and supplemental foods for pregnant women and their infants. Like Medicaid, it is an important source of care for HIV-infected women and their babies. Denison, however, reports that WIC programs, which promote breast-feeding as the best alternative for infant nutrition, in some instances are not sufficiently sensitive to the needs of HIV-infected mothers.3 Strategies To Reduce Perinatal HIV Transmission Inadequate prenatal care among women at high risk for HIV, health care providers' lack of adherence to PHS guidelines, and women's rejection of HIV testing and ZDV use all limit the ability to further reduce perinatal HIV transmission. This section of the report provides estimates of each potential barrier to HIV transmission reduction, and presents a simple model for assessing the implications of different intervention strategies. If a hypothetical population of 7,000 HIV-infected pregnant women all obtained early prenatal care; if their providers were in complete compliance with PHS recommendations regarding counseling, testing, and ZDV treatment; and if the women all accepted HIV tests and ZDV treatment and all pregnancies resulted in a live birth, the committee estimates that 350 HIV-infected babies would be born (that is, the risk of transmission under optimal care is 5%). If, however, 3   The Food and Nutrition Service of the Department of Agriculture is expected to finalize its guidelines related to HIV and breast-feeding and disseminate them to WIC sites in 1998.

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--> prenatal care, provider behavior, or other factors affecting perinatal HIV transmission are not optimal, the number of HIV-infected babies increases. For the purposes of this illustration, the committee's assumptions about current practices are as follows: 85% of HIV-infected women seek prenatal care, 75% of women are counseled regarding HIV testing, 80% of women accept the test, 90% of HIV-infected women are offered ZDV, and 90% of women accept and comply with ZDV treatment when it is offered. Given this scenario, 1,172 babies would be born to the hypothetical cohort of 7,000 HIV-infected women, a 235% increase over the currently achievable state (i.e., from 350 to 1,172 HIV-infected babies).4 If we hold all but one condition constant, changing one parameter at a time, the impact of changes in the current environment can be assessed (for details, see Appendix K): Increasing receipt of prenatal care from 85% to 100% reduces the number of HIV-infected babies by 9% (i.e., from 1,172 to 1,070). Increasing the rate at which providers' offer HIV tests from 75% to 100% reduces the number of HIV-infected babies by 16% (i.e., from 1,172 to 979). Increasing women's acceptance of HIV tests from 80% to 100% reduces the number of HIV-infected babies by 12% (i.e., from 1,172 to 1,027). Increasing providers' offering of ZDV treatment from 90% to 100% reduces the number of HIV-infected babies by 5% (from 1,172 to 1,107). Increasing women's acceptance of ZDV treatment from 90% to 100% reduces the number of HIV-infected babies by 5% (i.e., from 1,172 to 1,107). Given the current environment, the most effective single intervention to reduce perinatal transmission is to increase providers' offering of HIV tests (reduces perinatal HIV transmission by 16%). If providers were in complete compliance with the PHS guidelines (i.e., they offered HIV tests and ZDV treatment to all women), there would be a 24% decrease in the number of HIV-infected babies (from 1,172 to 893). Alternatively, if the current environment remained the same, but all HIV-infected women accepted HIV testing when offered, and accepted and complied with ZDV treatment, there would be a 19% reduction in the number of HIV-infected babies (i.e., from 1,172 to 947). If both providers and HIV-infected women had optimal rates (i.e., if all but prenatal care is set to 100%), there would be a 52% decline in the number of HIV-infected babies (i.e., from 1,172 to 560). Increasing the rate at which providers offer HIV tests from 75% to 100%, and increasing the proportion of women who accept it from 80% to 100%, 4   The model assumes only two HIV transmission rates, 0.25 if women are not treated and 0.05 if they are treated. These transmission rates actually vary according to the HIV-infected woman's clinical state, and the onset and completeness of treatment. The model also assumes that testing rates for HIV-positive women are similar to those observed in the general population of pregnant women.

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--> for instance, would reduce the number of HIV-infected babies by 33%—about 386 children per year. This simplified model illustrates the need for multifacted approaches to significantly reduce perinatal HIV transmission. Even with a multifaceted approach, however, it will be difficult to achieve significant further reductions in the number of HIV-infected babies. As shown in Appendix K, even if the gap were reduced by 50% (e.g., prenatal care increases from 85% to 92.5%), there would only be a 29% decline in the number of HIV-infected babies (i.e., from 1,172 to 830). Here it is assumed that 92.5% of HIV-infected pregnant women obtain early prenatal care, 87.5% of women are offered HIV testing, 90% of women accept testing, 95% of HIV-infected women are offered ZDV, and 95% of women accept and comply with ZDV therapy. To achieve a further 50% decline in the number of HIV-infected babies (i.e., from 1,172 to 580 infected babies) and be within reach of the currently achievable state (i.e., 350 infected babies), the gap between observed and achievable rates would have to close by 78% and rates for factors related to transmission would have to be very high (e.g., 96.7% of women receiving prenatal care). Conclusions 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. In 1995, the PHS published guidelines focusing on universal counseling and voluntary testing of pregnant women (CDC, 1995b). In the ensuing years, professional organizations representing prenatal, obstetrical, and perinatal care providers developed practice recommendations consistent with this approach. Only the American Medical Association chose to adopt a more stringent approach, mandating HIV testing for all pregnant women and newborns. States have also moved rapidly to implement the PHS guidelines. Almost all have taken steps to implement the guidelines in law, regulation, or policy, in most cases without mandatory or coercive actions. Some states have chosen to require counseling about HIV, or the offering of an HIV test, in prenatal care. Texas chose to make HIV testing a routine part of prenatal care, with notification and opportunity for women to refuse. As a result of these efforts, and in direct response to the ACTG 076 findings themselves, many providers have changed their prenatal care practices. As documented in Chapter 3, perinatal AIDS cases fell by about 43% between 1992 and 1997. This decline was due to a number of factors, including a 17% decline in the number of births to HIV-infected women, increased testing and adherence to the ACTG 076 guidelines, better prenatal and intrapartum care, and (for declines that occurred before the publication of the ACTG 076 findings) use of ZDV for women's own health.

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--> Despite the efforts of government and professional organizations, however, prenatal testing remains far from universal, and many HIV-infected women continue to be inadequately treated for their disease because they do not seek prenatal care, because they are not tested for HIV, or because their treatment does not reflect current standards of care. Although there have been substantial improvements in prenatal care coverage in recent years for most women, some 15% of HIV-infected women, especially those who use drugs, receive late or no prenatal care. Prenatal care providers are generally aware of the need for HIV testing, but there are still significant variations across the country in the application of recommended practices. Even in areas where the overwhelming majority of providers agree in principle that HIV testing should be offered to all pregnant women, only 50% to 75% actually offer the test to all women in their practices. Citing a lack of time, resources, legal requirement for pretest counseling, and perceived risk, actual testing practice is often based on providers' assessments of maternal HIV risk, which are not very accurate. On the positive side, the available evidence suggests that when offered, 90% or more of women will accept an HIV test, and acceptance can be enhanced if providers strongly recommend the test and incorporate it into routine practice. For women who are found to be infected, Ryan White Title IV centers provide excellent maternal and child HIV treatment and care for those who have access to them. Despite the complexity of the ACTG 076 regimen and other difficulties, most HIV-infected women do accept and comply with ZDV treatment. Yet testimony to the committee and its own site visits all point to the conclusion that testing does not necessarily lead to care, and even when it does, women are not necessarily receiving the quality treatment and services they need. Given these results, 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. The number of children born with AIDS, however, continues to be far above what is potentially achievable. Much more remains to be done. There is substantial

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--> 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. Starting with the current partial implementation of the PHS guidelines, the committee estimates that the most effective change would be to increase the number of women in prenatal care who are offered HIV testing by their providers and accept it. Increasing the rate at which providers offer HIV tests from 75% to 100%, and increasing the proportion of women who accept it from 80% to 100%, for instance, would reduce the number of HIV-infected babies by 33%—about 386 children per year. To reduce perinatally acquired HIV even further, efforts are needed to increase the availability and utilization of prenatal care, especially in women who use drugs; to improve the coordination and quality of health care for HIV-infected women; and to prevent HIV infection in women initially.