Appendix D Workshop II Summary

Amy Fine

On April 1, 1998, the Institute of Medicine (IOM) Committee on Perinatal Transmission of HIV held a public workshop focusing on the impact of the 1995 Public Health Service (PHS) Guidelines for universal counseling and voluntary testing of pregnant women for HIV. The workshop agenda included five panels, covering the following topics: results from the Centers for Disease Control and Prevention (CDC) surveillance and enhanced surveillance systems; results from the Health Resources and Services Administration (HRSA) data systems; provider practices; results from provider and patient surveys and state data systems; and patient perspectives. Findings and discussion are summarized below.

Results From CDC Surveillance And Enhanced Surveillance Systems

A panel from CDC—including Pascale Wortley, Martha Rogers, Mary Lou Lindegren, and R.J. Simonds—provided an overview of CDC surveillance findings, including presentation and analysis of basic trend data and an analysis of the chain of events needed to achieve prevention success. Most of the data from the presentation are from six CDC studies: (1) The Survey of Childbearing Women (SCBW) is a 1989–1994 population-based survey conducted in 45 states and the District of Columbia. It is based on anonymous newborn heel-stick blood sample. (2) National Pediatrics AIDS Surveillance is conducted in all states and territories and Pediatric HIV Surveillance is conducted in 31 states. Both are population-based surveillance systems. Pediatric HIV surveillance includes information on perinatally exposed infants and monitors their subsequent HIV infection and



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--> Appendix D Workshop II Summary Amy Fine On April 1, 1998, the Institute of Medicine (IOM) Committee on Perinatal Transmission of HIV held a public workshop focusing on the impact of the 1995 Public Health Service (PHS) Guidelines for universal counseling and voluntary testing of pregnant women for HIV. The workshop agenda included five panels, covering the following topics: results from the Centers for Disease Control and Prevention (CDC) surveillance and enhanced surveillance systems; results from the Health Resources and Services Administration (HRSA) data systems; provider practices; results from provider and patient surveys and state data systems; and patient perspectives. Findings and discussion are summarized below. Results From CDC Surveillance And Enhanced Surveillance Systems A panel from CDC—including Pascale Wortley, Martha Rogers, Mary Lou Lindegren, and R.J. Simonds—provided an overview of CDC surveillance findings, including presentation and analysis of basic trend data and an analysis of the chain of events needed to achieve prevention success. Most of the data from the presentation are from six CDC studies: (1) The Survey of Childbearing Women (SCBW) is a 1989–1994 population-based survey conducted in 45 states and the District of Columbia. It is based on anonymous newborn heel-stick blood sample. (2) National Pediatrics AIDS Surveillance is conducted in all states and territories and Pediatric HIV Surveillance is conducted in 31 states. Both are population-based surveillance systems. Pediatric HIV surveillance includes information on perinatally exposed infants and monitors their subsequent HIV infection and

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--> AIDS status. (3) The State Enhanced Pediatric HIV Surveillance Program (STEP) is an enhanced pediatric surveillance system that is conducted in four states (New Jersey, South Carolina, Michigan, Louisiana) with adult and pediatric HIV reporting. This system also includes data on HIV-exposed and HIV-infected children. (4) The Pregnancy Risk Assessment Monitoring System (PRAMS) is a population-based surveillance system based on a sample of women with a recent live birth. Information is gathered through a mailed questionnaire with a telephone follow-up. In 1996, 11 states participated. (5) The Perinatal Guidelines Evaluation Project (PGEP) is an in-depth, ongoing four-site project (Connecticut; North Carolina; Brooklyn, New York; and Miami, Florida) using medical chart reviews and interview data of pregnant and postpartum women. The prenatal study population is restricted to women whose health care providers had discussed HIV with them within the previous 60 days. The postpartum study population was a cross section of women delivering in the study's site hospital. (6) Pediatric Spectrum of Disease (PSD) is an eight-site medical record review of HIV-exposed and infected children in care at participating sites since 1989. HIV/AIDS Trends in Women The HIV/AIDS epidemic in women is concentrated in the Northeast and in the South, with the highest rates found in New York, New Jersey, Florida, Maryland, Connecticut, and Puerto Rico. States with the greatest number of cases include New York, New Jersey, Florida, California, and Texas. While the highest rates were first observed in the Northeast, during the past five years the greatest increase in rates has been in the South. African-American and Hispanic women are disproportionately affected. Over time, the number of cases among women attributable to injection drug use has declined, while the proportion attributable to heterosexual contacts has increased. It is estimated that from 6,000 to 7,000 HIV-infected women delivered infants each year from 1989 to 1995. Trend data from the SCBW showed a relatively steady national rate of HIV seroprevalence for childbearing women between 1989 and 1994. There are, however, important regional variations. In the Northeast, where the epidemic started and peaked earliest, there was a 22% decline in the rate of HIV-infected childbearing women giving birth between 1989 and 1994. In the South, where the epidemic started later, there was a 25% increase between 1989 and 1991, which then leveled off. The West and Midwest have had stable and relatively low rates. HIV/AIDS Trends in Infants and Children Perinatal transmission accounts for virtually all new HIV infections in children. It is estimated that more than 15,000 HIV-infected children have been born to HIV-infected mothers in the United States. By the end of 1997, more than

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--> 7,000 perinatally acquired AIDS cases were recorded nationwide, the vast majority of which were among African-American and Hispanic children. The distribution of perinatally acquired AIDS is highly concentrated, with three-quarters of cases diagnosed in eight states/jurisdictions: New York, Florida, New Jersey, California, Puerto Rico, Texas, Maryland, and Pennsylvania. Many states have very low prevalence: 23 states account for a total of less than 2% of reported perinatal AIDS cases. The number of pediatric, perinatally acquired AIDS cases rose rapidly in the late 1980s and early 1990s, peaked around 1992, and subsequently declined 43% by 1996. According to the CDC, this dramatic decline, coupled with other recent trend data, point to the conclusion that preventive efforts in this country have been successful in reducing perinatal AIDS transmission. Trends by age at diagnosis show that the largest declines are among children diagnosed as infants, with substantial declines also among children diagnosed at ages one to five years. However, for older children, similar levels of decline have not been observed. These findings are consistent with the expectation that efforts to prevent perinatal transmission would be reflected earliest in infants because older children were born before ACTG 076 (AIDS Clinical Trials Group protocol number 76). PCP (Pneumocystis carinii pneumonia) is the most common AIDS-defining condition in children, occurring most prominently in infancy. Since recommendations regarding PCP prophylaxis were evolving during the same period that dramatic declines occurred in perinatally acquired pediatric AIDS cases, it is useful to look at whether declines in pediatric AIDS reflect more than declines in PCP. CDC surveillance findings show substantial declines in AIDS among infants—not only in those with PCP as the presenting diagnosis, but also in those with other opportunistic infections. This indicates that the decline in pediatric AIDS cases is not being driven solely by changes in PCP, but rather appears to reflect declining perinatal transmission rates. In order to estimate the impact of the ACTG 076 results, Byers and colleagues (1998) compared two sets of estimates of children born with HIV infection and children diagnosed with AIDS by year through 1997. The first series is based on extrapolating data through 1994 from the SCBW, and assumes a gradual decline in the number of HIV-infected women giving birth. These "SCBW" estimates, however, assume a constant transmission rate of 21.43%, representing, as a base case, the effect of no progress in preventing transmission. The second series of estimates is based on the number of children reported with AIDS, adjusted for incubation time and reporting delays. This "surveillance" series, therefore, estimates the number of children born with HIV infection or diagnosed with AIDS that could eventually be observed. The surveillance and SCBW estimates are similar through 1990, but taken together indicate a 42% decrease in the number of HIV-infected births in 1995 and a 65% decrease in 1997. In terms of AIDS diagnoses, the estimates suggest a 16% decrease in 1995 and a 29% decrease

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--> in 1997. Byers and colleagues feel that these decreases are consistent with, and in large part reflect, widespread implementation of the ACTG 076 regimen. CDC scientists feel that, collectively, these trend data point to the conclusion that declines in pediatric AIDS, particularly among infants and particularly since 1994, are principally related to declines in perinatal transmission rates with increasing use of maternal and newborn zidovudine (ZDV). While the declines actually precede some of the PHS recommendations, they likely reflect the impact of pregnant women using ZDV for their own health. In addition, since ACTG 076 results were published in February 1994, four months before the PHS recommendations for use of ZDV to reduce perinatal transmission (published in August 1994), some women may have received ZDV in early 1994 based on the clinical trial findings. Also, women were treated for their own health in the 1990s, including as many as 20% of pregnant HIV-infected women. Other factors such as increasing use of therapy among HIV-infected children may also be playing a role by delaying the onset of AIDS; however, it should be noted that the use of combination therapy with potent protease inhibitors was not the standard of care for children during the period of rapid decline. Chain of Events for Prevention Success As a framework for understanding the impact of efforts to prevent perinatal HIV transmission, CDC representatives presented its data in terms of a chain of events or steps that must be taken to ensure prevention success. The chain is based on ensuring timely and complete implementation of the ACTG 076 regimen and includes the following steps: (1) receipt of early prenatal care (depends upon access to and utilization of care); (2) provider offering of counseling and testing (depends upon health care provider knowledge, attitudes, beliefs, and practices); (3) client acceptance of testing; (4) HIV-positive client acceptance of ZDV (depends upon provider offering therapy); (5) ZDV adherence (requires taking ZDV during the antepartum, intrapartum, and postpartum periods); and (6) follow-up care for both mother and baby. Prenatal Care Compared to the general population, HIV-infected women are much more likely to receive late or no prenatal care. Provisional STEP data indicate that only 63% of HIV-infected women giving birth received prenatal care prior to the third trimester. This compares to 95% to 97% of women in the general population (based on National Center for Health Statistics 1994 natality data and PRAMS data from 11 reporting states). As in the general population, prenatal care use among HIV-infected women varies by race and ethnicity, with African-American and Hispanic women likely to have fewer prenatal visits. The strongest predictor of inadequate prenatal care among HIV-infected women, however, is illicit drug

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--> use in pregnancy. Preliminary STEP data indicate that the proportion of HIV-infected pregnant women who receive no prenatal care is 35% for illicit drug users but only 6% for non-drug users. Testing Offered Among childbearing women responding to the PRAMS survey in 1996, approximately 75% said their health care worker talked to them about HIV testing during pregnancy (based on the median for the 11 participating states). PGEP data indicate that pregnant women were offered counseling and testing at an even higher rate: overall 88%. The range for the four sites was from 82% to 92% of women reporting that they were offered testing during prenatal care. Multivariable modeling within each site for factors associated with not being offered an HIV test during pregnancy did not find any predictors except in North Carolina where African-American ethnicity and prior testing history were found to be significant. Finally, a preliminary analysis of PRAMS data indicate that certain groups are more likely to be offered testing than others: African Americans and Hispanics (versus whites); young women aged 15 to 19 (versus women over 35); women with less than a high school education (versus more than 12 years of school); women cared for in public care settings (versus private settings); and Medicaid-eligible (versus non-Medicaid-eligible) women. Testing Accepted PRAMS data indicate a high test-acceptance rate among childbearing women, with 83% of women offered testing actually receiving the test (median of data from five states). Preliminary data from PGEP provide some information on the reasons women give for not being tested, despite receiving counseling from a health care provider. Overall, women who perceived that the provider gave testing little to no importance were three times as likely to not get tested as women who thought the providers were neutral to supportive of getting a test. Among 1,142 interviewees in public prenatal clinics, the most common response among women who did not get tested focused on timing (i.e., not a good time to be tested or to hear results). In a separate study of 1,134 postpartum women, most of whom delivered in university hospitals, the most common reason given by the 212 women who did not get tested was the woman's assessment that she was not at risk, and the second most common reason given was that the woman had already been tested. Women in the prenatal sample were more likely to have attended a public clinic; women in the postnatal sample were more representative of the general public. Other less common reasons cited in the two surveys were fear of certain components of the test (the needle, blood drawing); fear of discrimination or consequences related to health and life insurance; and belief that the woman's partner did not want her to get tested.

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--> Overall, STEP project findings indicate that in 1996, 79% of HIV-infected women giving birth in four states had been identified as infected by the time of their delivery (numerator based on state surveillance data; denominator based on newborn data from survey of childbearing women). Acceptance and Receipt of ZDV by HIV-Infected Women Findings from an enhanced version of the SCBW, which tested blood spots for ZDV, include the following: (1) the prevalence of ZDV use among childbearing women in the eight study states increased substantially between 1994 and 1995, indicating that treatment was widely adopted soon after it was recommended in 1994; (2) on average, in 1995, more than half of all HIV-positive women giving birth in the eight survey states received perinatal treatment with ZDV during labor/delivery or the newborn period (this is a minimum estimate because only ZDV intrapartum or postpartum was measured); (3) if the transmission rate in women receiving ZDV was reduced from 25% to 8% (as in ACTG 076), more than 150 perinatal HIV infections were prevented in these eight states alone in 1995. Population-based pediatric HIV surveillance data from 29 reporting states for 1993 to 1996 shed further light on the extent to which ZDV is being accepted and received among mothers who were diagnosed as HIV-positive before giving birth. These data show that between 1994 and 1996, the proportion of prenatally diagnosed mother–infant pairs receiving some part of the ACTG 076 regimen increased from 36% to 86%. Preliminary STEP project data based on 1995–1996 chart abstractions for approximately 500 HIV-infected women indicate that only 5% of women offered ZDV refused treatment and another 6% discontinued ZDV during pregnancy. Their reasons for discontinuing included non-compliance, toxicity/side effects, and inability to pay. Data from both the PSD study and STEP point to the conclusion that a major reason for not receiving intrapartum ZDV appears to be that the woman's status is unknown at the delivery hospital. A second reason is insufficient time to administer ZDV at the hospital. Finally, with regard to why newborns do not receive ZDV even when their mothers test positive, in preliminary data from the PSD project it appears the most common cause is that providers are not aware of the mother's test result and the second most common cause is parent refusal. CDC Summary and Recommendations In summary, CDC representatives highlighted the following points. Since shortly after the PHS recommendations were published, there have been rapid implementation by health care providers and acceptance of therapies by HIV-infected women, as borne out in several different surveillance studies. This, in turn, has affected perinatal AIDS transmission. Overall, approximately two-thirds of pregnant HIV-infected women are on the ACTG 076 regimen. Among those

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--> not receiving ZDV, lack of prenatal care is the major cause, with illicit drug use being the greatest contributor to the lack of prenatal care. The next biggest reason for not receiving ZDV is that not all women are being offered testing (women in certain high-risk categories are more likely to be offered). This points to the need for education and training to improve provider knowledge, attitudes, and beliefs. While the relative contribution is smaller, some women do refuse to be tested, and some of their reasons—such as fears about potential discrimination or not perceiving themselves at risk—could be addressed. Once women are identified as HIV-positive, there does not appear to be a major problem with providers offering therapy or with women accepting it. Finally, while there is not much data yet on adherence to the ZDV regimen, this is a major concern, especially since there is a move to more complicated regimens. The CDC is currently pursuing two systemic interventions that it hopes will improve the success of prevention efforts: (1) providing states with model Medicaid managed care contract language on prenatal HIV counseling and testing and (2) adding prenatal testing as a HEDIS quality assurance measure for managed care entities. To achieve greater success in preventing perinatal HIV transmission, CDC presenters recommended that efforts be undertaken to (1) improve prenatal care access and utilization, especially for substance-using women; (2) improve provider knowledge, attitudes, and practices, especially in private care and managed care settings; (3) improve client perception of risk and need for testing, and address fears about testing; and (4) develop interventions to improve adherence to medications. Discussion Among the issues raised in the participant discussion was the need to test all women, regardless of their apparent risk, particularly given the increasing numbers of women who become infected through heterosexual relations. This, in fact, is what CDC is working toward. One participant noted that even if the woman herself does not engage in risky behavior, her partner might. Another participant noted the need for a greater focus on factors such as drug use, other addictive behaviors, and multiple partners, all of which can affect infection rates. A participant pointed out the need to go beyond a focus on the individual woman's behavior to address broad policy issues that might affect the ability of women who use drugs to access prenatal care; for example, state laws that call for jailing pregnant drug users or that take the baby away if the mother screens positive for drugs. In response, Dr. Rogers suggested a multitiered approach to perinatal AIDS issues, which would address (1) political/social/legal factors; (2) health delivery system factors; and (3) client behavioral factors. There was a discussion of the need to review policies outside the public health system that could affect the availability of and access to prenatal care—especially for illicit

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--> drug users, but for others as well. For example, national welfare reform legislation may have added more barriers to the ability of women to receive care. A concern was raised about the impact of a shift to Medicaid managed care, which moves women out of public sector prenatal care clinics (where counseling and testing are more likely) and into the private sector, where women may be less likely to receive counseling or testing. A multivariate analysis of factors associated with the receipt of counseling and testing would be helpful in projecting the impact of managed care. Noting that from a public health perspective, testing prior to pregnancy would be ideal, a participant asked about CDC surveillance data and efforts to promote pre-pregnancy testing. Dr. Rogers noted that a very large percentage of CDC's prevention program goes to publicly funded counseling and testing centers, which include family planning, prenatal care, sexually transmitted disease (STD) prevention, and drug treatment clinics. Dr. Wortley noted that for the STEP project, 33% to 40% of the women who delivered were tested prior to pregnancy. Discussion focused next on the impact of state statutes on overall outcomes. Are laws that require prenatal counseling and offering of HIV testing rigorously enforced? Perhaps a more salient question is whether the statutes establish a standard of care to which a physician can be held (i.e., does the statute permit lawsuits against the physician?). One participant noted that the California law has resulted in more testing, probably because providers think testing is mandatory. Another participant noted that as cases are litigated, state law and PHS guidelines are both used to establish a standard of care, so that passing state laws gets a message to private providers. The same participant further noted that in many of the cases in litigation, the issue is really perception of risk. Turning to the impact of prenatal ZDV use on infants, another participant asked if there is any information indicating whether HIV-infected infants born to women who took ZDV in pregnancy actually progress to AIDS more slowly. Dr. Simonds noted that there was not yet enough data from observational cohort studies to really address whether prenatal ZDV exposure prevents or has an effect on the natural history of those children who do become HIV-infected. Ongoing, long-term follow-up studies will provide some of these answers. It was noted that there is confusion in the field regarding how the guidelines apply to treatment for HIV-exposed infants who did not receive ZDV in the prenatal or intrapartum periods. Discussion focused on the guidelines and what is known about the efficacy of newborn treatment that only begins after delivery. Dr. Simonds responded that both the older and the newer guidelines allow—and in a sense encourage—beginning treatment as soon as possible after delivery, but the efficacy of this approach is not yet known. Discussion focused on confidentiality being a deterrent to treatment. It was noted that in some policy discussions there is a sentiment that this is non-issue.

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--> Participants noted, however, that there are instances in which confidentiality makes a critical difference; for example, in one case where a woman was murdered by her boyfriend after finding out she was infected with HIV. Dr. Simonds reported that PGEP will have some data on adverse events such as loss of job, loss of relationships, and domestic violence. Hrsa Data Michael Kaiser and Karen Hench presented information from the Health Resources and Services Administration (HRSA), including an overview of HRSA-funded AIDS prevention and treatment; essential components of a care system to reduce perinatal HIV transmission; findings from a range of HRSA-funded projects; and a more detailed review of the Women's Initiative for HIV Care and Reduction of Perinatal Transmission project (WIN). HRSA is the service branch of the Department of Health and Human Services (DHHS), that reaches historically underserved populations, including low-income populations, and racial/ethnic minorities. Among the HRSA programs are Maternal and Child Health Services Block Grant Programs, Healthy Start, Community and Migrant Health Centers, Health Care for the Homeless, Rural Health Programs and HIV/AIDS Programs. Among HRSA's HIV/AIDS Programs are the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act Programs (Titles I–IV), Special Projects of National Significance (SPNS), and AIDS Education and Training Centers (AETCs), which provide training on implementation of PHS guidelines. While HRSA does not have surveillance data, it does have site-specific service delivery findings that complement surveillance findings presented by CDC. Overall, data from HRSA-funded project sites across the country indicate that (1) with adequate counseling, women accept HIV testing, particularly during pregnancy; and (2) significant advances have been made by HRSA-supported programs in reducing perinatal HIV transmission through voluntary, non-regulated HIV counseling, testing, and perinatal ZDV prophylaxis. Examples were given from select HRSA-funded project sites where 93% to 97% of HIV-infected pregnant women accepted ZDV and where perinatal transmission had been reduced so dramatically that at least three of the project sites have reported no cases of perinatal transmission for periods ranging from six months to four years. Essential Components of the Care System Similar to the chain of prevention events noted in CDC's presentation, HRSA outlined ''essential components" of the care system to reduce perinatal HIV transmission. These include early identification of HIV infection for women of childbearing age, providing HIV counseling and voluntary testing, linking HIV testing

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--> sites and primary care, ensuring access to care, offering ZDV prophylaxis, and maintaining women and infants in care. Acceptance of Counseling and Voluntary Testing Findings from a range of HRSA-funded project sites indicate there is a high testing acceptance rate among women in prenatal care. A small survey of obstetricians and gynecologists in New Orleans found that more than three-fourths of providers reported at least 90% acceptance of HIV testing. Of all women who received pre-test counseling through SPNS adolescent care projects, 91% accepted testing, and 94% of pregnant women accepted testing. At one Cook County site, a 1996 survey indicated that 70% of prenatal and postpartum women were offered HIV testing. Of those offered pre-test counseling, 82% accepted testing, compared to 61% acceptance among those without prior counseling. Access to HIV Care Successful models of care funded by HRSA include: one-stop shopping models in St. Louis, Missouri and Miami, Florida; co-location of a birthing center and a comprehensive care center in New York City; and a publicly funded case management program in northern Virginia that allows women to receive care in a private provider setting. Offering ZDV All HRSA-supported programs are expected to routinely offer ZDV prophylaxis to pregnant women living with HIV. In one rural Wisconsin project, 100% of women receiving prenatal case management accepted and received ZDV. Maintaining Women and Infants in Care Post-delivery care maintenance is essential both for the mother and for the infant. Some successful strategies include home visits by nurses or case managers, family appointments that allow mother and infant to get care at the same time or place, transportation assistance (bus tokens, cab vouchers, rail passes), and the use of peer advocates to help negotiate the care system. Reaching Providers Even if universal access to care is achieved, much would still depend on the provider. HRSA has therefore focused considerable resources on provider preparedness, including provider training and technical assistance, and dissemination

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--> of provider and consumer educational materials, including step-by-step protocols for each phase of the ZDV regimen and a guide for perinatal HIV counseling and testing. Focus Group Findings Various HRSA-supported focus groups have identified barriers to optimal reduction of perinatal HIV transmission. Clients have identified the following barriers to HIV counseling and testing: distrust of providers, concerns about confidentiality of test results, fear of discrimination, fear of losing custody of children, previous negative HIV test, and the perception of not being at risk. With regard to the use of ZDV, client-identified barriers include: concerns about effects of ZDV during pregnancy, mistrust of information from health care providers, judgmental responses from providers when women elect not to take ZDV, fear of providers pressuring women to take ZDV, fear of legal/social consequences of refusing ZDV, and lack of timely availability of ZDV. Systemic barriers identified include: lack of transportation, child care, awareness or understanding of resources, and linkages between providers; limited client knowledge; limited provider knowledge; and a sense of helplessness or hopelessness. Finally, barriers identified by providers include: lack of perceived risk among "private" patients, lack of time, lack of reimbursement for counseling time, and lack of knowledge or training. Women's Initiative for HIV Care and Reduction of Perinatal Transmission HRSA's WIN, which includes ten sites across the country, was developed in FY 1995 in response to ACTG 076 findings. WIN goals include encouraging women to learn their HIV status as early as possible, linking women with a continuum of ongoing comprehensive care services, and facilitating strategies that reduce perinatal HIV transmission. Very preliminary WIN data from 1997 client interviews and 1996 provider interviews, along with some medical chart reviews, provide some interesting information on a range of topics. All clients interviewed were HIV-positive and pregnant. On the issue of quality and content of HIV counseling, 72% of clients reported that they were aware the test was going to be done prior to being tested; 6% reported feeling forced to take the test; 56% of clients reported that they received post-test counseling, and of these, 53% felt it was non-directive/non-coercive; and nearly 75% felt counseling information was clear. Among WIN clients, the ZDV acceptance rate has been very high: 92% for prenatal use, 95% for intrapartum use, and 94% for the use in neonatal period. About three-fourths of respondents said they had been counseled about not breast-feeding their babies; however, none of the WIN mothers did breast-feed.

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--> Results From Provider And Patient Surveys And State Data Systems This panel included presentations from Massachusetts, North Carolina, and New Jersey and from the federal Health Care Financing Administration (HCFA). Massachusetts Deborah Allen, from the state's Title V program, reported on the Massachusetts experience. Incorporation and Implementation of PHS Guidelines The State of Massachusetts has used a variety of interventions to educate providers and promote counseling, testing, and the use of ZDV for HIV-infected pregnant women: (1) soon after ACTG 076 results were published, the state sent a clinical advisory to obstetric, pediatric, and women's health providers; (2) a pocket guide on counseling and testing has been disseminated; (3) provider training has been undertaken statewide; and (4) a media campaign has also been launched. Provider materials are currently being revised to include additional therapies and to promote a model of specialized HIV care for pregnant women (previously, a primary care model was promoted). The Department of Public Health currently provides HIV counseling and testing to 20,000 to 25,000 pregnant women per year. Trends and Challenges Data for 1992 to 1995 indicate two related but separate trends in Massachusetts: (1) the number of HIV exposed infants dropped approximately 44%; and (2) the decline in the number of HIV-infected infants was even greater—approximately 75%. These trends reflect more women knowing that they are HIV-positive, accompanied by a move among HIV-infected women to forgo or delay pregnancy; and the use of ZDV in pregnancy. Despite these gains, challenges remain in the state: (1) in 1995, 15 HIV-infected babies were born in Massachusetts; (2) it is estimated that eight of their mothers did not know their status; and (3) there may be an emerging trend of women opting to become pregnant or to continue pregnancies now that therapies are available. Provider Survey on Counseling and Testing Ms. Allen reported the following findings from a 1996 survey of obstetric and midwife practices in Massachusetts. (1) On average, these providers reported

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--> that in 1995, they offered testing to about 73% of their pregnant patients; they counseled 67%; and they tested about 39%. It is interesting to note that despite the fact that it is not legal to test in Massachusetts without counseling, clearly this is happening in some practices. Also, it is clear that far fewer women are tested than are counseled or offered testing. (2) Having an HIV clinical practice policy in place is the single best predictor of whether a provider counsels, offers, or performs a test. Client characteristics are also predictors of whether women are offered or receive testing in Massachusetts. Specifically, African Americans are more likely to be offered a test; Hispanics are more likely to be tested; and privately insured patients are less likely to be tested. Ms. Allen noted that these findings indicate that providers continue to use a risk assessment model. She observed that providers do not seem to be getting a clear message about what the PHS guidelines say: that is, they think they are following the guidelines when they counsel based on risk. (3) Survey findings indicate that provider attitudes do not seem to make a difference in whether the provider counsels, offers a test, or tests; however, they do make some difference in the likelihood of the practice having a policy in place. Patient Survey on Counseling and Testing In a separate but parallel study conducted among HIV-infected women who had experienced pregnancy, women were asked whether they thought testing should be mandatory. Nearly all—24 of 26 interviewees—said yes, "because of the baby." Ms. Allen noted that this finding should be taken as evidence of the strong feelings HIV-infected women have about their babies, not necessarily as the best public policy to pursue. The patient interview also indicated that HIV-infected women want to have a good relationship with their providers and that providers can greatly influence patients' decisions. However, it appears that often providers do not recognize the importance of this relationship. Finally, Ms. Allen noted that having a case manager can influence women's acceptance of testing, particularly women who are not from the dominant culture. North Carolina Rachel Royce, an epidemiologist from the School of Public Health, University of North Carolina, presented an overview of efforts in her state to prevent perinatal HIV transmission through prenatal HIV counseling and testing. She presented results of a survey of prenatal care providers and a study of women offered testing during prenatal care. Incorporation of Guidelines Immediately after the ACTG 076 results were reported, North Carolina's health officer sent a letter to all prenatal care providers in the state informing

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--> them of the results and giving them a list of consortium centers and providers that could take care of HIV-infected women. In August 1995, North Carolina passed a law requiring providers to counsel women as early in pregnancy as possible, and to offer testing. Study Findings/Implementation of Guidelines Several recent evaluations indicate that around 70% of pregnant women in North Carolina are tested for HIV during pregnancy. Data from the Pregnancy, Infection and Nutrition (PIN) study—a prospective cohort study, based on a sample of women attending prenatal clinics in North Carolina teaching hospitals and health department clinics—indicate that 89% of women interviewed were offered an HIV test during pregnancy. Based on study findings, the researchers project that had testing been universally offered, the proportion tested would have increased from 68% to 75%. PIN data also show that women's perceptions of provider recommendations clearly influence the decision to accept or reject testing. Women who perceive that their provider thinks it is important to get tested are much more likely than others to accept testing. Reasons women gave for refusing testing include the following: they did not believe they had HIV/AIDS (68%); had been tested recently (24%); or did not want to know results (5%). Very few women gave fear of the consequence of getting a test as a reason. Finally, PIN study findings indicate that women are not naive about testing prior to the index pregnancy. In fact, 67% in the study sample were tested prior to pregnancy. Findings from a July 1995 provider survey (conducted prior to passage of the North Carolina law) indicate that while providers said they supported universal offering of testing, their practice varied from this ideal. More specifically, while 93% of respondents said they support universal offering of testing, only 82% of practices had a policy of offering testing to all; 67% of providers reported that they offered testing to all women; and only 54% said they would recommend testing to women with no identifiable risk. The 1995 survey also indicated that providers' HIV testing recommendations and practices are influenced by practice setting and patient's insurance status. Private providers and HMOs were least likely to recommend testing; public health providers were most likely, followed by providers at tertiary care centers. Providers were most likely to recommend testing to public/uninsured and self-pay patients and least likely to recommend testing to privately insured patients. New Jersey Sindy Paul, medical director of the Division of AIDS Prevention and Control, New Jersey Department of Health, presented an evaluation of implementation in her state. In addition to CDC surveillance data, findings from four other

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--> sources were highlighted: the Survey of Childbearing Women (SCBW); the STEP project; a provider survey; and an assessment of pregnant women's knowledge, attitudes, and beliefs regarding the use of ZDV (convenience sample, 170 pregnant women). Incorporation and Implementation of Guidelines Since 1995, New Jersey has had a law requiring mandatory counseling and voluntary testing of all pregnant women. The law stipulates three components: HIV counseling, offering testing, and testing. A physician-to-physician peer education program has been implemented in the state. The New Jersey Department of Health and Senior Services (NJDHSS) funded and collaborated with the Academy of Medicine and the State Medical Society on a statewide symposium on the prevention of perinatal HIV transmission in 1997. The NJDHSS also funds and collaborates with the Academy of Medicine of New Jersey on roving symposia of the topic. Finally, a public education campaign has been undertaken, including the use of posters, postcards, videos, and public service announcements. These discuss the benefits of ZDV in preventing perinatal HIV transmission. Trends/Findings Prevention of perinatal HIV transmission is a public health priority in New Jersey, since it is the state with the highest proportion of women among its cumulative AIDS case reports (27%), and it has the third highest number of pediatric AIDS case reports in the nation (695 as of May 31, 1998). Virtually all of New Jersey's pediatric AIDS cases (94%) and HIV-infected pediatric cases (98%) are the result of perinatal transmission. In New Jersey, HIV seroprevalence among pregnant women peaked in 1991 at 0.56% and declined through 1997, when it was 0.27%. Cumulative seroprevalence rates among childbearing women in New Jersey since 1991 are 1.47% for African Americans, 0.48% for Hispanic women, and 0.10% for whites. While the rate is declining among all racial and ethnic groups, the state's African-American women are disproportionately affected, with rates 14.7 times that of their white counterparts and 3 times greater than that of Hispanic women. Results from New Jersey's Survey of Childbearing Women (SCBW) indicate that the percentage of HIV-infected pregnant women receiving ZDV increased significantly between 1994 and 1995, from 13% to 48%. An analysis of factors associated with ZDV use indicates that women less than 30 years old were more likely than those 30 and older to have used ZDV in pregnancy. It is estimated that ZDV use in New Jersey prevented perinatal HIV transmission to 28 children in 1995. STEP provides information on the use of ZDV during the three perinatal

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--> phases (prenatal, intrapartum, and postnatal/newborn) and also provides follow-up data on outcome. STEP data for the state indicate that between 1993 and 1996, ZDV use during pregnancy increased from 7.6% to 47%; use during delivery increased from 2% to 35%; and use in neonates increased from less than 1% in 1993 to 64% in 1996. Overall, the proportion of women/neonates who received ZDV during pregnancy, delivery, or the neonatal period increased from 8% in 1993 to 67% in 1996. Since a significant proportion of HIV-infected women still do not receive ZDV in pregnancy, two surveys were undertaken to determine the reasons. A provider survey of eligible physician members of the Academy of Medicine of New Jersey (52% response rate) indicates that 94% of respondents offer HIV testing to all or almost all of their patients, 90% discuss the benefits of testing, and 77% offer counseling. Overall, only 59% offer all three components. Respondents were more likely to offer counseling if they felt: it fit into the office routine; it resulted in better outcomes; it was easy; they were confident in counseling; the patients appreciated it; it was the standard of care; or it had been actively promoted by the medical community. Dr. Paul noted that findings from the provider survey lead to the conclusion that improved diffusion and implementation of HIV counseling and testing among obstetrician—gynecologists could be accomplished through peer education. A survey of pregnant women also focused on factors associated with ZDV use. Among a convenience sample of largely young, African-American and Hispanic pregnant women, 57% said they would use ZDV, 41% were unsure, and only 2% indicated they would not use ZDV. Among the factors associated with intention to use ZDV to prevent HIV transmission are positive beliefs about ZDV; recommendation by a doctor or nurse; access to ZDV through the clinic or doctor; and sufficient information to make an informed decision. Evaluators found that conspiracy theories about ZDV were not associated with respondents' reported intention to take ZDV. Based on these findings, Dr. Paul and her colleagues concluded that pregnant women are willing to consider ZDV use if they are given adequate, accurate information. Dr. Paul summarized as follows: (1) there has been a marked improvement in efforts to prevent perinatal HIV transmission in New Jersey; (2) physicians do offer counseling and testing; (3) pregnant women are willing to use ZDV; (4) surveillance and seroepidemiology studies have documented ZDV use; and (5) mandatory counseling and voluntary testing appear to be working in New Jersey. Health Care Financing Administration Theresa Rubin, a regional AIDS coordinator for the Health Care Financing Administration (HCFA) presented information on implementation and evaluation efforts undertaken by the agency.

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--> Incorporation and Implementation of PHS Guidelines Below are examples of HCFA efforts to incorporate and implement PHS guidelines: In March 1994, less than a month after ACTG 076 results were published, HCFA sent a letter to its regional AIDS coordinators informating them of the study results and recommending improved outreach to pregnant women so that they can be evaluated and offered ZDV as early in the pregnancy as possible. In a July 1994 "Medicaid Letter," HCFA conveyed its policy of providing an enhanced federal match of 90% for HIV testing and counseling claimed as a family planning service. In March 1998, HCFA sent a notice to state Medicaid agencies and welfare offices informing these agencies about Ryan White CARE Act provisions relating to counseling and testing of pregnant women for HIV/AIDS. The notice urged Medicaid agencies to work closely with Ryan White grantees to assure optimal counseling and testing. In May 1996, HCFA conducted a survey of regional AIDS coordinators that looked at: state laws addressing HIV counseling and testing of pregnant women; access to HIV testing, counseling and treatment in the state; the nature of HIV provisions in Medicaid managed care contracts; and state Medicaid agency collaboration with other state agencies, providers, and consumers in implementing PHS guidelines. One of the goals of this survey was to help raise awareness of the role of state Medicaid agencies in promoting the PHS guidelines and the need to work with others in the state toward this end. Finally, HCFA also has undertaken a consumer information program (CIP), which started with a four-state pilot in January 1996. In its CIP, HCFA has focused on (1) developing informational materials to alert Medicaid-eligible HIV-infected women, pregnant women, and women of childbearing age to the benefits and implications of ZDV therapy; (2) assisting women in making an informed decision about ZDV therapy and (3) informing women that they may be eligible for Medicaid, which covers this treatment. As part of the campaign, HCFA has developed and disseminated consumer information materials in several languages, including posters, videos, and brochures. A preliminary evaluation of the campaign has been undertaken in the pilot states and results are being analyzed. Patient Perspectives Laquitta Bowers and Kay Armstrong provided preliminary findings from focus groups they are conducting as part of the AIDS Policy Center for Children, Youth and Families (APCCYF) study on HIV testing of pregnant women and newborns. Joseph Kelly provided an update on a review of state efforts. Rebecca Denison provided her perspective as an HIV-positive woman.

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--> AIDS Policy Center for Children, Youth and Families Ms. Armstrong briefly reviewed the methodology used in APCCYF focus groups. Efforts were made to get geographic diversity, with representation from areas with high and moderately high incidence rates. Seven of the eight groups include women only; the other group includes men. Participants are of reproductive age and are sexually active. HIV-positive women, Hispanic women and those at high risk for drug and alcohol use are included and targeted for some of the groups. Ms. Armstrong highlighted the following preliminary findings, based on completion of five of the eight focus groups. When asked about availability and accessibility of HIV counseling and testing, most participants felt that knowing their HIV status could help them improve their own health and that of their child and partner. There appear to be some gender differences in this response, which will be further explored. There appears to be a complex set of factors that influence women's receipt of prenatal care, including current drug and alcohol use and past experience with health care providers. Participants are very concerned about their own health and that of their babies. The way in which HIV testing is conducted is very important. Participants told ''horror stories" about receiving HIV-positive results over the phone or not being informed in advance that they were being tested. Only a few found out they were infected with HIV during pregnancy. Others discovered their HIV status while seeking other medical care. Participants emphasized the emotional impact of such negative experiences. Among participants there is a great fear of HIV disclosure. They do not want to be labeled as HIV-infected. There is stigma and distrust as to how information might be used. Most participants did not trust the government in issues associated with HIV testing. Gender and partner issues were often discussed, with women participants worried about partner and family rejection, as well as partner violence. State Activities Update Joseph Kelly reported that in March 1998, as part of the APCCYF study, NASTAD sent a questionnaire to state health departments to update information on four areas of interest: (1) developments in new state legislative policy, regulation, and practice standards; (2) availability of trend/surveillance data on perinatal HIV transmission; (3) availability of follow-up evaluations/surveys on provider practices, HIV counseling and testing acceptance, and implementation of PHS guidelines; and (4) state contacts for further information. Mr. Kelly also briefly highlighted new information on state legislation, noting that as of April 1, 1998, there was legislation pending in Delaware, Alabama,

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--> South Carolina, and New York that could change existing statutes on the issue of prenatal or newborn testing and counseling. In Indiana, legislation passed in late February that explicitly allows physicians to order confidential HIV testing of newborns if the mother has not been tested and refuses the test and if the physician believes that the test is medically necessary for the newborn. The state health department has been instructed to issue implementation guidance. One consequence of the legislative debate on this topic is a new awareness in Indiana that physicians are not providing HIV counseling to all pregnant women and are not offering tests. As a result, the health department is now pursuing an emergency rule that would try to ensure or compel physicians to counsel pregnant women. Mr. Kelly said it is likely that other states will try to implement similar newborn screening legislation. Discussion During discussion, it was noted that Louisiana may have a similar stipulation that allows physicians to test infants or children if they believe it is medically necessary. One participant noted that in New York, before newborn screening became mandatory, physicians testified that they did not need this kind of law because they had the legal right to test in any case. Rebecca Denison, Respondent Ms. Denison spoke from her perspective as an HIV-positive woman. She chose to become pregnant and is now the mother of two-year-old twins who are HIV-negative. Ms. Denison directs Women Organized to Respond to Life-threatening Diseases (WORLD), an organization started by and for HIV-positive women. In this capacity, she has worked closely with and assisted many HIV-positive women. Ms. Denison started by noting that it is remarkable and heartening to hear meeting participants take seriously the notion of providing medical care to HIV-positive women who want to become pregnant or continue pregnancy. She observed that this is a moving tribute to those who have been willing to look beyond the conventional wisdom and understand what is in the hearts of people who want to become parents. She also reminded participants that beyond all the statistics, there are a lot of emotional issues tied into HIV/AIDS that will never be captured in numbers, but that profoundly affect people's lives. Ms. Denison followed with a series of observations on a number of issues: Expanding therapy options: Ms. Denison noted that it is important to recognize that in practices such as BAPAC in San Francisco, treatment options go well beyond the ACTG 076 protocols. For example, in the past two years, BAPAC has provided clinical care that incorporates the clinical evaluation of

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--> pregnant women for evidence of disease progression with the offering of appropriate combination therapy. In addition, as a pediatric ACTG site, BAPAC has been able to offer pregnant women and their infants access to perinatal/neonatal research trials that improve maternal health and further reduce perinatal transmission rates. Mandatory versus universal testing: It is important to define terms. It is Ms. Denison's impression that most women will accept testing and most prefer being asked rather than being forced. She believes testing should still remain voluntary, even though this is an imperfect approach. Standards of care needed: For many basic obstetric procedures, there is no standard of care established for HIV-infected women; for example, there are no standard recommendations or cost-benefit analyses on cesarean sections, amniocentesis, and fetal scalp monitoring for the HIV-positive mother. Testing does not equal care: Ms. Denison cited several examples of known HIV-positive women receiving unacceptable care from poorly informed physicians. ZDV issues: There are many issues around the use of ZDV, including women's fear of long-term side effects. Ms. Denison noted that of all the women she has talked to, none was told about the National Cancer Institute study findings on potential long-term risks to the children whose mothers took ZDV prenatally. She stressed that women need to be told about the study and then be told that the potential benefit outweighs the risk. It is also important to acknowledge that some infants are still becoming infected even though their mothers took ZDV during pregnancy. Violence: Issues around domestic violence need to be taken seriously. Disclosure can lead to a life-or-death situation for some women with violent partners. Prevention gaps/men's role: There are serious gaps in prevention, particularly with regard to the male role. Current efforts put the burden for prevention on the woman, which is unfair. There is also a need for support groups for heterosexual men who are HIV-positive or who have HIV-positive partners. WIC: The WIC program can be a source of infant formula for some HIV-infected mothers; however, it does not pay the full cost of formula. A more significant problem is that WIC programs "push" breast-feeding, but do not adequately screen for or counsel regarding the HIV status of the mother. Ms. Denison noted that this approach is frightening and needs to be addressed. Welfare reform and immigrants: With welfare reform, undocumented immigrants are cut off from publicly assisted prenatal care. Ms. Denison cited an example from California of an HIV-positive pregnant immigrant who was afraid that accessing care would lead to deportation. Trust is essential: Ms. Dension stressed the importance of trust in the provider-patient relationship. Providers can be extremely judgmental in their attitudes toward HIV-positive women. Women need to feel comfortable going to

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--> their providers when they have problems with complex therapies for themselves or their babies. They need to be supported in the difficult process of caring for themselves and their children. Funding: Finally, noting the importance of access to high quality, specialty care, Ms. Denison stressed the need for sustained and increased funding for comprehensive perinatal HIV/AIDS services such as those provided by BAPAC in San Francisco. Reference Byers Jr. RH, Caldwell MB, Davis S, Gwinn M, Lindegren ML. Projection of AIDS and HIV incidence among children born infected with HIV. Stat Med 17:169–181, 1998. Workshop II Agenda Washington, D.C. April 1, 1998 8:30–8:45 a.m. Welcome and introductions 8:45–10:15 Impact of the Public Health Service voluntary testing recommendations: Results from CDC's surveillance and enhanced surveillance systems   Pascale Wortley   Martha Rogers   Mary Lou Lindegren   R.J. Simonds 10:15–10:30 Break 10:30–11:30 Results from CDC's surveillance and enhanced surveillance systems, (continued) 11:30–12:30 p.m. Impact of the Public Health Service voluntary testing recommendations: Results from HRSA data systems   Michael Kaiser   Karen Hench   Moses Pounds   Lori DeLorenzo   Amelia Birney

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--> 12:30–1:30 Lunch 1:30–3:00 Provider practices   American Academy of Family Practitioners, Marshall Kubota   Association of Women's Health Obstetric, and Neonatal Nurses, Maureen Shannon   American College of Nurse Midwives, Jan Kriebs   Association of Maternal and Child Health Programs, Deborah Allen   American Association of Health Plans, Johanna Daily   National Committee for Quality Assurance, Joseph Thompson   The Miriam Hospital [prison health], Timothy Flanigan   California, Mori Taheripour   California, Gail Kennedy 3:00–3:15 Break 3:15–4:30 Impact of the PHS voluntary testing recommendations: Results from provider and patient surveys and state data systems   Massachusetts, Deborah Allen   North Carolina, Rachel Royce   New Jersey, Sindy Paul   Health Care Financing Administration, Theresa Rubin 4:30–5:30 Patient perspectives: AIDS Policy Center for Children, Youth and Families focus groups   APCCYF, Laquitta Bowers   APCCYF, Kay Armstrong   NASTAD, Joseph Kelly   Respondent: WORLD, Rebecca Denison 5:30 Adjourn