HIV Screening of Pregnant Women and Newborns (1991) / Chapter Skim
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Appendix A: The Conference: Program and Summary
Appendix A: The Conference: Program and Summary
Pages 69-128
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From page 69... ...
It is not intended to present a consensus of opinion on the range of issues pertinent to the development of perinatal HIV screening policy. Rather, the views expressed here are those of the speakers and do not necessarily correspond to the conclusions and judgments reached by the IOM committee.
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From page 70... ...
May 1~15, 1990 Monday. May 14 8:25 Welcome and Opening Remarks Mane McCormick, Associate Professor of Pediatrics, Joint Program in Neonatology, Harvard Medical School and Chair, IOM Committee on Prenatal and Newborn Screening for HIV Infection 8:30 HIV INFECTION AND AIDS IN WOMEN AND CHILDREN Moderator: Kathleen Nolan, Associate for Medicine, The Hastings Center HIV Infection and AIDS in Women: Magnitude of the Problem Tedd Ellerbrock, Medical Epidemiologist, Pediatric and Family Studies Section, Epidemiology Branch, Division of HIV/AIDS, Centers for Disease Control HIV Infection in Infants and Children: Magnitude of the Problem Marta Gwinn, Medical Epidemiologist, Population Studies Section, HIV Seroepidemiology Branch, Division of HIV/ AIDS, Centers for Disease Control HIV Diagnostic Technology: How Good Are the Tests?
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From page 71... ...
WHAT COULD BE ACHIEVED? Moderator: James Curran, Director, AIDS Program, Centers for Disease Control Screening Newborns Larry Wissow, Assistant Professor of Pediatrics, Johns Hopkins University School of Medicine Screening Pregnant Women - Howard Minkoff, Professor and Director, Division of Obstetrics and Maternal-Fetal Medicine, State University of New York Health Science Center at Brooklyn Screening Women of Childbearing Age - Claire Brindis, Co-director, Center for Reproductive Health Policy Research, University of California at San Francisco 12:45 General Discussion
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From page 72... ...
72 APPENDIX A air CONSENT AND COUNSELING Moderator: Peter Selwyn, Assistant Professor of Epidemiology and Social Medicine, Albert Einstein College of Medicine Means and Ends of Informed Consent - Ruth Faden, Director, Program in Law, Ethics, and Health, and Professor of Health Polipy and Management, Johns Hopkins University School of Hygiene and Public Health One HIV Counseling Program for Women of Reproductive Age Ann Sunderland, Social Worker, HIV Perinatal Transmission Study, State University of New York Health Science Center at Brooklyn Directive vs. Nondirective Counseling John Arras, Philosopher in Residence, Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine George Annas, Professor of Health Law and Director, I~w, Medicine, and Ethics Program, Boston University Schools of Medicine and Public Health 3:25 General Discussion 4:10 HIV SCREENING PROGRAM IMPLEMENTATION: PROVIDING THE SERVICES Moderator: Reed Tuckson, Senior Vice President for Programs, March of Dimes Providing Follow-Up Care for Women and Children with HIV Disease Hermann Mendez, Assistant Professor of Pediatrics, State University of New York Health Science Center at Brooklyn Implementing an HIV Screening Program: New Jersey's Experience Christine Grant, Deputy Commissioner of Health, New Jersey State Department of Health
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From page 73... ...
APPEND1XA Professional Education and Standards of Care in Obstetrics - Richard Schwarz, Provost and Vice President for Clinical Affairs, State University of New York Health Science Center at Brooklyn 5:05 General Discussion Tuesday, May 15 8:20 ECONOMIC CONSIDERATIONS IN SCREENING FOR PERINATAL HIV INFECI1ON Moderator: Molly Coye, Head, Division of Public Health Practice, Deparunent of Health Policy and Management, Johns Hopkins University School of Hygiene and Public Health Current Costs and Services Utilization Associated with Pediatric AIDS Jesse Green, Director for Health Policy Research, New York Universigr Medical Center Economic Implications of Early Intervention in Women and Children 73 Peter Arno, Assistant Professor of Epidemiology and Social Medicine, Albert Einstein College of Medicine Financing Strategies for Screening and Follow-Up Care Sara Rosenbaum, Director of Programs and Polipy, Ch~ldren's Defense Fund 9:15 General Discussion 10:00 EVALUATING THE Et-~-eCTIVENESS OF HIV SCREENING Moderator: Sandy Schwartz, Executive Director, Leonard Davis Institute of Health Economics, University of Pennsylvania Program Evaluation: Process and Outcomes - Donald Francis, Centers for Disease Control Regional AIDS Consultant, California State Department of Health Services
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From page 74... ...
Moderator: Carol Levine, Executive Director, Citizens Commission on AIRS for New York City and Northem New Jersey C;onfidentialibr, Disclosure, and Discrimination Larry Gostin, Executive Director, American Society of Law and Medicine Discrimination in Access to Reproductive Health Services Katherine Franke, Supervising Attomey, Fair Housing and Public Accommodations Division, New York City Commission on Human Rights
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From page 75... ...
APPENDIX A Judicial Intervention in Obstetrical Medicine - Patricia King, Professor of Law, Georgetown University Law Center 2:55 General Discussion 75 DEVELOPING POLICY: MOVING TOWARD CONSENSUS Moderator: Neil ~ Hol~man, Professor of Pediatrics, Johns Hopkins University School of Medicine Edward Connor, Associate Director, Division of Allergy, Immunology, and Infectious Diseases, Children's Hospital of New Jersey Sheldon Landesman, Associate Professor of Medicine and Director, AIDS Study Group, State University of New York Health Science Center at Brooklyn Kristine Gebbie, Secretaly, Department of Health, State of Washington Ronald Bayer, Associate Professor, Department of Sociomedical Sciences, School of Public Health, Columbia University 5:30 Summary and Closing Remarks - Neil ~ Holtzman, Professor of Pediatrics, Johns Hopkins University School of Medicine
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From page 76... ...
NEWBORN SCREENING FOR HIV INFECTION: OPPORIIJN~ FOR PREVENTION AND TREATMENT? HIV INFECTION AND AIDS IN WOMEN AND CHILDREN: DIAGNOSIS AND TREATMENT Assessment of proposals for HIV screening of pregnant women and newborns requires an examination of the technology currently available to diagnose HIV infection in women and children.
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From page 77... ...
These assays could be inserted in the current ELISAIWestern Blot algorithm either before or after the Western Blot. Although these HIV antibody tests are useful in screening pregnant women for HIV infection, they are not diagnostic of infection in newborns; that is, they are unable to distinguish between infected and uninfected infants.
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From page 78... ...
Notwithstanding this uncertainty regarding the benefits of intervention, the tendency of most caregivers has been to assume that early recognition of infection in children can lead to more effective medical management and treatment. As noted earlier, perinatally infected children often present with symptomatic disease within the first year of life, and they frequently experience an accelerated decline.
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From page 79... ...
Some guidance in the management of HIVinfected pregnant women can be gleaned from experience in the management of HIV-infected nonpregnant adults. For example, among HlV-infected nonpregnant adults, immunologic function is now generally monitored through serial CD4+ cell counts to predict disease progression and indicate when lo initiate antiretroviral therapy and prophylaxis against opportunistic infection.
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From page 80... ...
Obstetrical experts believe that, in all cases, the maternal benefits should be weighed against the possible fetal risks, and decisions regarding initiation of therapy should be made in concert with the patient. Because infected pregnant women with CD4+ cell counts of less than 200 are at greatest risk of developing PCP, many experts believe that administering prophylactic therapy to this group is appropriate.
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From page 81... ...
Moreover, the clinical significance of the above observation is unclear because control or comparison data from nonpregnant HIVinfected women are lacking. The authors noted that the rate of CD4+ cell decline in the HIV-infected pregnant women was somewhat faster than that in HIV-infected homosexual men or hemophiliacs over the same time period.
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From page 82... ...
PRINCIPT AS AND PINBALLS OF MASS POPULATION SCREENING In the search for an acceptable public policy on prenatal and neonatal HIV screening, it is helpful to look to past experience with mass screening programs. By examining problems in previous screening programs from an historical perspective, and ascertaining the extent to which these problems have relevance to proposals for perinatal HIV screening, it may be possible to avoid repeating mistakes.
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From page 83... ...
Because the benefits and risks of HIV screening are not yet fully understood, some would argue that HIV screening programs should be treated as experiments and subjected to peer and institutional review board evaluation as well as stringent criteria for infonned consent. Others maintain that, given a substantial medical benefit that appears to outweigh harm, screening programs may be implemented but should be carefully monitored A third lesson of the PKU program is to avoid mandating screening programs by law before their adverse consequences are identified and minimized.
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From page 84... ...
If public monies are devoted to HIV screening for political reasons, then HIV screening will occur regardless of whether medical benefit has been demonstrated. Third, if reproductive choices are to be made individually, based on personal values and belief ;,3 then counseling and education needs to precede and follow screening.
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From page 85... ...
Several problems are evident when these criteria are applied tO newborn HIV screening. First, newborn screening is, de facto, maternal screening.
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From page 86... ...
without consent subjects the woman to a range of potentially serious harms, and there Is evidence that concern about these harms may deter some women from seeking health care. Consequently, newborn HIV screening does not qualify as a routine procedure for which consent may be presumed or inferred.
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From page 87... ...
Although available data overwhelmingly suggest that there is little risk of casual transmission of HIV infection without direct mucous membrane or wound contact with contaminated body fluids, in some select cases there may be a reason to let caretakers know that a child is infected. Whether these goals can be achieved by newborn HIV screening depends on the epidemiology, natural history, and nature of transmission of HIV infection in children, and the effectiveness of HIV screening tools and medical interventions.
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From page 89... ...
For example, the prevalence in different geographic regions could determine the aggressiveness with which prenatal HIV screening is carried out and individual risk famors are considered Prevalence of infection in a locale (determined with the use of methodologically sound populaetion estimates) of less than 1 infected woman per 1,000 women, would be considered ~low..
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From page 91... ...
HIV screening instituted for the purpose of changing behavior is also of uncertain meet. Experience has shown that it is very difficult to change risk-taking and sexual behaviors, even among HIV-seropositive individuals.
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From page 92... ...
Infonnation about the status of informed consent in clinical medicine, how consent requirements shift as one moves from a clinical to a public health perspective, and alternative models for consent in the context of screening programs will contribute to fonnulating an appropriate informed consent process for prenatal HIV screening.
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From page 93... ...
in which proceeding without specific patient authorization can be plausibly defended. Committing the necessary staff resources to obtain informed consent for these interventions would entail shifting resources from other competing needs and interests, such as other educational efforts.
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From page 94... ...
The question becomes whether the autonomy interests of pregnant women are, in this instance, validly overridden by the interests of society in controlling the epidemic. This question cannot be answered without examining the extent to which screening of pregnant women would contribute to furthering society's Interests.
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From page 95... ...
Assessment is more difficult and resource intensive, for it involves a determination of the patient's coping mechanisms, suicide nsk, psychiatric problems, and support network One of the major benefits of assessment is that it helps to provide a more meaningful informed consent. Moreover, discussion of support networks offers another opportunity to introduce the notion of including the partner in the process of HIV testing and counseling.
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From page 96... ...
Opponents of directive counseling for HIV-infected women likewise offer several reasons for their position, many of which are grounded in concerns about women's rights. They argue, lost, that women are the 81his controversy is relevant to pre- as well as posttest counseling-that is, not only for a woman's reproductive decisions but also for her decision about whether to be tested at all.
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From page 97... ...
Proponents also assert that nondirective counseling was never intended to alter behavior and therefore cannot be criticized for failing lo do so. What is important in a pregnant woman's self4etermined decision making is not what decision she makes but whether it is informed, and whether it is the right decision for her.
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From page 98... ...
Finally, reproductive decision making is one form of clinical diction making, and it is important to distinguish the general clinical context from the public health context Goals that may be appropriate in the public health context, for example, discouraging HIVinfected women as a group from reproducing, may not be appropriate in the individual encounter. HIV SCREENING POLICY IMPLEMENTATION Perinatal HIV disease occurs predominantly in milieus characterized by a lack of material and personal resources, social disorganization, and drug use.
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From page 99... ...
One state (New Jersey) has approached prenatal and newborn HIV screening by developing a policy of universal HIV education about the virus and its transmission, risk reduction counseling on drug use and sexual behavior, and voluntary testing for all pregnant women and all women contemplating pregnancy.
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From page 100... ...
There are four pediatric residences in the state, one hospital is planning a home for mothers and children, and a pediatric nursing home now has beds for children with HIV disease. Implementing the screening policy as a statewide standard of medical practice rather than by statute or regulatory requirement was considered most likely to achieve the goals of screening without the divisiveness-and extended timed a legislative struggle.
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From page 101... ...
Indeed, the greatest challenge in implementing this policy is to help the office-based obstetrician and pediatrician counsel HIV-infected persons and secure informed consent. New Jersey has developed a clinical protocol, including a draft informed consent form, for the identification and management of asymptomatic pregnant women and children, which can be incorporated into off~ce-based~ practice.
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From page 102... ...
Although the Public Health Serviceti expert panel on the content of prenatal care recommended that HIV testing be offered to all patients before conception and advised practitioners to counsel their patients concerning drug use and safer sexual practices, preconception counseling is clearly not yet the accepted standard of practice in this country. Even if it were, no standards for the content of such counseling have been set.
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From page 103... ...
ECONOMIC CONSIDERATIONS IN SCREENING FOR PERINATAL HIV INFECTION There are three economic aspects of perinatal HIV disease whose examination may inform the development of screening policy for pregnant women and newborns. First, to provide an economic context for the design and implementation of screening programs and early intervention schemes, it is necessary to consider the current costs of pediatric AIDS care, the patterns of health services utilization (particularly inpatient care)
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From page 104... ...
The authors noted, however, that the rate of unnecessa~y days had declined from 64 percent of all hospital days in 1983 and 1984 to 30 percent in 1987, largely because of improved outpatient care and access to foster care placement. More recently, several studies have examined the average length of stay for pediatric AIDS hospitalizations, as well as the average per diem 12J D
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From page 105... ...
Using hospital discharge data bases maintained by the states of New York, California, and Florida on all hospitalizations in short-term general hospitals, they extracted all pediatric AIDS cases reported in the period 1983-1986. Surprisingly, they found that, for this four-year period, children with AIDS had an average length of hospital stay in both California and New York that was lower than that for adults.
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From page 106... ...
In New York City, for example, public hospitals provide ~ disproportionate share of services to children with AIDS: although they account for only 20 percent of all hospital beds in the city, they provide nearly 50 percent of all bed days for children with AIDS. Developing Early Medical Intervention Services for HIV-Infected Children The reliance on the public health care delivery and financing system noted above underscores the socioeconomic realities of pediatric HIV infection that make the development of early intervention services for children a demanding task Other factors that complicate the development of a successful early treatment program for HIV-infected children include difficulties in diagnosing infection in young infants, variability in the natural history of infection, the limited annamentarium of medical therapies, and the almost uniform economic privations that characterize the lives of HIV-infected women and their children.
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From page 107... ...
Total estimated early intervention treatment costs per child per year are $2,902 This estimate should be regarded only as a baseline figure, however, because it does not include hospitalizations. A richer picture of the economic burden of pediatric HIV disease would include not only hospital length~f-stay data but an assessment of the fiscal repercussions for the foster care system and other social service and housing providers.
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From page 108... ...
Poor pregnant women in particular are the population most likely to be insured through Medicaid as a result of changes in eligibility criteria. In all states, pregnant women are currently eligible for Medicaid if their family incomes are no higher than 133 percent of the federal poverty level, which is about $13,000 per year for a family of three.
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From page 109... ...
The expansion of EPSDT may offer the most logical source of financing for pediatric HIV-related care; however, several other programs may also provide some assistance. For example, the Title V Maternal and Child Health Block Grant program (which allocates funds directly to states for various services for pregnant women, infants, and children)
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From page 110... ...
Whether HIV screening of pregnant women and newborns constitutes an efficient, appropriate use of resources must be determined in light of other competing interests and programs, quite often in the absence of complete data. Once a screening program is in place, evaluation is necessary to determine its effectiveness.
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From page 111... ...
Consider other issues of concern to decision makers that lie outside the scope of the analysis. The application of this model to HIV screening and early intervention programs for pregnant women and newborns, although complex, offers some direction for the types of data required to conduct a cost-effectiveness analysis.
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From page 112... ...
In conducting a cost-effectiveness analysis of prenatal or newborn HIV screening assessment of the evidence of program effectiveness involves an examination of HIV diagnostic capacity in women and infants and consideration of the interventions that are possible for these populations. The HIV testing algorithm~omposed of the ELISA and Western Blot testsms highly sensitive and specific in adult populations, although the predictive value of a positive test (i.e., the probability that an individual with a positive test result is, indeed, infected)
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From page 113... ...
First, treatment of the pregnant woman may result in major gains in life expectancy and quality of life for her child, if chemoprophylalas were, indeed, successful in interrupting perinatal HIV transmission. Yet, as noted earlier, this is still only a theoretical possibility.
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From page 114... ...
What value or disvalue does one assign to an aborted fetus that would not have been infected? Sensitivity analyses provide a means to address the uncertainties inherent in a cost-effectiveness analysis of a prenatal or newborn HIV screening program.
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From page 115... ...
A Cost-Effectiveness Analysis of Prenatal HIV Screening Renata Kiefer and colleagues at the Center for AIDS Prevention Studies, University of California, San Francisco, have conducted a costeffectiveness analysis of voluntary (with informed consent) , confidential prenatal HIV screening, comparing maternal and infant outcomes and the COStS of alternative, prenatal HIV-antibody screening strategies.
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From page 116... ...
This is an important consideration if the goal of the screening program is ultimately to identity all infected pregnant women for the purpose of early intervention. As expected, the table shows that the cost per HIV-infected woman identified declines with increasing prevalence of infection.
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From page 117... ...
Hearst, and S Hulley, adapted from their study, accosts and Benefits of Prenatal HIV Screening, presented at the Sixth International Conference on AIDS, San Fr~ncisco, California, June 2~24, 1990.
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From page 118... ...
If counseling costs were to increase beyond the consecrative estimates used In this analysis, however, then all screening strategies would be more costly than under the current assumptions. Other outcomes of prenatal HIV screening that should be considered when selecting a particular screening strategy are the possibility of reduced maternal and infant morbidity as a result of early diagnosis and treatment, facilitation of health resources planning, potential reduction of vertical HIV transmission, and possible reduction of horizontal HIV transmission to partners (which will depend to some extent on the capacity of the program to identify and counsel infected women)
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From page 119... ...
Reaching women at increased risk for infection means that HIV testing services need to be available in settings where these women frequently receive care prenatal, family planning, and sexually transmitted disease clinics, as well as substance abuse treatment centers. As mentioned earlier, HIV screening confined to the prenatal care setting may miss a substantial proportion of at-risk pregnant women because those women who receive little or no prenatal care are often at greatest risk of infection.
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From page 120... ...
In developing prenatal HIV screening policy with the goal of early identification and treatment of infected women, this fact-and the implications it brings robust be taken into consideration. Screening polisher cannot be developed in a vacuum, that is, without reference to the populations it iS meant to serve.
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From page 121... ...
Pregnant women who have had experience with preventive or prenatal care are familiar with medical testing. Hey may not necessarily understand the specific details of such testing, but they believe the tests are being performed for the benefit of their unborn child.
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From page 122... ...
Prenatal HIV screening programs must find a way to identify women early in their pregnancy, which is not an easy taste In addition to the difficulties presented by early identification, some of these women will not enroll in prenatal care, some will discontinue care, and others, such as the substance abuser who is afraid that her child will be taken away from her, will only receive care in the emergency or delivery room. An HIV screening program must also facilitate and support the reproductive choices a woman makes after being informed she is HIVantibody positive.
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From page 123... ...
The other is that when funding requests are issue specific, a certain amount of money is allocated for that particular issue but other, interconnected problems are ignored. Advocates for women of color fully support HIV screening but not at the expense of other programs and only if it is part of a long-tenn process to provide pregnant women with services and support that will help improve their lives and the lives of their children.
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From page 125... ...
Many pregnant women believe that their baby's best interests are served by being born and nurtured, despite their own potential disability. In such cases, fundamental constitutional rights to privacy and reproductive choice make it difficult, both ethically and legally, to authorize the state to unduly influence a pregnant woman's decision either to continue or terminate the pregnancy.
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From page 126... ...
. An analysis of precedents in this area sheds some light on the degree to which these practices would be constitutionally permissible and judicially sanctioned for HIV-infected women.
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From page 127... ...
Recent legal trends lean toward ensuring benefit to the fetus and may require some women to act in a manner that they perceive as disadvantageous to them. Ways must be found to limit coercion and ensure protection of the rights of HIV-infected women as well as those of their infants.
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