7
ELEMENTS OF A PRENATAL HIV SCREENING PROGRAM

The translation of prenatal HIV screening policy into a specific screening program for pregnant women requires thoughtful consideration of the key elements of such a program. The general prerequisites of screening program design and implementation have been reviewed elsewhere (Lappé al., 1972; National Research Council, 1975; President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1983).1 Therefore, the following discussion does not provide an exhaustive review of screening program components but instead highlights those elements the committee judges to be of particular relevance and importance in prenatal HIV screening implementation.

Education and Counseling

Education and counseling before and after the administration of an HIV test should be regarded as essential components of a prenatal screening program,2 The pretest counseling session provides the foundation for an individual's informed consent, which, as noted earlier, should be secured in writing before testing is initiated. To facilitate informed decision making and to permit careful weighing of the risks and benefits associated with HIV testing, a range of information should be reviewed with the woman at this time. Topics to be addressed include the spectrum of HIV disease; modes of transmission; risk reduction behaviors; the purpose of an HIV-antibody test and the clinical meaning of a positive or negative test result; the importance of the woman knowing her HIV-

1  

 These publications focus specifically on genetic screening program development; however, the guidance they offer is generally applicable to prenatal HIV screening programs as well.

2  

 For a more detailed discussion of the key elements of prenatal HIV counseling, see Holman and colleagues (1989).



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HIV Screening of Pregnant Women and Newborns 7 ELEMENTS OF A PRENATAL HIV SCREENING PROGRAM The translation of prenatal HIV screening policy into a specific screening program for pregnant women requires thoughtful consideration of the key elements of such a program. The general prerequisites of screening program design and implementation have been reviewed elsewhere (Lappé al., 1972; National Research Council, 1975; President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1983).1 Therefore, the following discussion does not provide an exhaustive review of screening program components but instead highlights those elements the committee judges to be of particular relevance and importance in prenatal HIV screening implementation. Education and Counseling Education and counseling before and after the administration of an HIV test should be regarded as essential components of a prenatal screening program,2 The pretest counseling session provides the foundation for an individual's informed consent, which, as noted earlier, should be secured in writing before testing is initiated. To facilitate informed decision making and to permit careful weighing of the risks and benefits associated with HIV testing, a range of information should be reviewed with the woman at this time. Topics to be addressed include the spectrum of HIV disease; modes of transmission; risk reduction behaviors; the purpose of an HIV-antibody test and the clinical meaning of a positive or negative test result; the importance of the woman knowing her HIV- 1    These publications focus specifically on genetic screening program development; however, the guidance they offer is generally applicable to prenatal HIV screening programs as well. 2    For a more detailed discussion of the key elements of prenatal HIV counseling, see Holman and colleagues (1989).

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HIV Screening of Pregnant Women and Newborns antibody status for the effective medical management of her pregnancy and her own health care, as well as for the careful monitoring of her child's condition; the treatment options currently available to her and her infant; and the potential untoward social consequences that may result from being identified as HIV positive. In addition, the woman should be informed of the current availability of follow-up services and be forewarned of the possible barriers she may encounter in gaining access to them. (See the later discussion of the development of services for HIV-infected women and children.) A variety of approaches can be used to present the above material—for example, educational brochures, videotapes, face-to-face dialogue, or some combination of these methods. At a minimum, however, some individual face-to-face counseling should precede the test, in particular to assess the woman's emotional and psychological readiness to cope with a positive result and to answer any questions or concerns the woman may have about the test and its clinical and psychosocial implications. HIV test results should be communicated to the individual during a face-to-face discussion. This posttest encounter also permits whoever is performing the counseling to reinforce any HIV risk reduction and prevention messages presented earlier. The extent and length of such posttest counseling for seronegative pregnant women may be tailored to their risk status and emotional state. For instance, women at increased risk of infection may require more extensive counseling and educational reinforcement. At a minimum, however, seronegative women should receive a brief personal communication of their test results and additional written information (e.g., pamphlets and brochures) about HIV infection and its prevention (including risk-associated behaviors and ways of reducing the risk of becoming infected). Individual posttest counseling for a seropositive pregnant woman is crucial, not only to discuss her test results and their meaning but also to give her emotional and psychological support as she assimilates this information and faces potentially difficult reproductive decisions. During such counseling, the counselor has an opportunity to review the implications of HIV infection for her pregnancy, including the risks of transmitting the virus to her child and what is known about the possible effects of pregnancy on disease progression. Thorough examination of the reproductive options available to an HIV-infected pregnant woman is an important task of the posttest counseling session. Traditionally (i.e., in the context of genetic screening), counselors have assumed a nondirective or neutral posture toward reproductive counseling, and the committee found no compelling reason to recommend a change in this stance in the context of HIV screening. The committee affirms that reproductive counseling should validate the woman's right to make the reproductive choice that

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HIV Screening of Pregnant Women and Newborns conforms to her personal values, beliefs, and desires. Ultimately, the woman must decide whether to continue or terminate an existing pregnancy in the face of HIV infection. Regardless of her choice, she should be supported in her decision and receive or be referred for medical evaluation, follow-up care, and counseling as necessary. In particular, if she elects to continue her pregnancy, arrangements should be made for appropriate pediatric care. Partner Involvement A recurring and fundamentally important theme during the committee's deliberations centered on the involvement of male partners in the HIV education and counseling process associated with prenatal screening. Changes in heterosexual couples' sexual practices and, in particular, condom use ultimately require the assent and cooperation of the male partner. In some instances, if a woman insists on condom use or other modifications in sexual practices, she may risk physical abuse, ostracism, or even dissolution of the relationship (which may also mean loss of financial security, if the woman is dependent on her partner for support). For many women, the threat of personal violence or the potential destruction of a relationship present formidable barriers to the implementation of behavioral changes. Therefore, the committee believes that without the participation of male partners in the HIV education and counseling process, the likelihood of fostering behavioral change in women and their partners will be greatly diminished. Of course, such involvement of the partner cannot be initiated without the woman's permission. Women should be actively encouraged to invite their partner to participate in the information and counseling sessions. When they request it, male partners should also be referred for individual counseling and testing. Confidentiality Assurance of patient confidentiality should be a central feature of any HIV screening program, as should protection against unauthorized disclosure of test results. In the event that the result of a woman's test is to be documented in her medical record, she must be alerted to this fact before testing occurs. A woman should also be informed of those individuals in the medical setting who may have legitimate access to her records and thus become aware of her HIV infection status. (It should be noted, however, that providers may decide to keep test results separate from general medical records to safeguard confidentiality.) In at least one

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HIV Screening of Pregnant Women and Newborns instance, however, the committee recommends that a woman's HIV test result be shared-with her child's medical caregiver. This prospect should be discussed with the woman during the informed consent process. The diagnosis of HIV infection in a mother has important implications for the clinical management and appropriate medical follow-up of her child. The mother should be informed, during the pretest counseling session and in advance of any disclosure, of the importance of releasing her HIV test results to the pediatric caregiver, and she should be encouraged to do so to provide more effective medical management of her infant. Partner Notification The counseling session that follows testing offers an opportunity to discuss partner notification with the HIV-infected woman and advise her on informing her sexual or drug use partner(s) of her infected status. Some women may be reluctant, afraid, or embarrassed to share this information. In this case, health care providers should offer partner notification assistance by ensuring that the woman receives help from local public health officials in notifying her partner(s). Partner notification, as described by Toomey and Gates (1989), encompasses two approaches: patient referral and provider referral With the first approach, the infected individual is encouraged to inform her partner(s) directly, without the intervention of the provider. In the second approach, health department personnel (with the woman's consent) directly notify individuals who unknowingly have been exposed to infection or disease, so that they may be referred for medical evaluation and treatment. Notification is carried out without revealing the identity of the infected person, thereby preserving client confidentiality. This process is fundamentally voluntary in that it relies on infected individuals to divulge the names of their partners voluntarily.3 Although historically partner notification has been a useful public health tool for curtailing the spread of infectious disease, recently the 3    Another situation arises when the health care provider knows the identity of the infected woman's partner and is aware that she has refused to notify her partner, even after repeated counseling and offers of assistance. Considerable debate has centered on whether, in such a situation, a provider has a duty to warn third parties known to be at risk of exposure to infection. Currently, many states have chosen to leave the responsibility for the choice of whether such third parties are informed with the provider, without specifically indicating the basis on which this choice should be made (Edgar and Sandomire, 1990). As noted by Gostin (1989:1628), ''by giving the [provider] a power to exercise his or her discretion, instead of a duty, it shields the [provider] from liability and does not require breaches of confidence that would discourage testing and counseling.''

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HIV Screening of Pregnant Women and Newborns argument has been made that, in areas of highly concentrated HIV infection, the substantial staff and counseling resources needed for such programs could be used more effectively in other HIV education and prevention efforts. Despite these reservations, the committee recommends that a well-functioning, coordinated voluntary partner notification system be an integral part of a prenatal HIV screening program and, if not already established, be developed in parallel with screening. A major benefit to such a system is that it provides another avenue to engage male partners in counseling and educational efforts connected with prenatal screening, as well as an opportunity to refer them for HIV testing and diagnostic evaluation. Services for HIV-Infected Women and Children A central tenet of screening is that, before such a program is introduced, resources should be available for the medical evaluation, management, and treatment of affected individuals identified through screening. Because the early diagnosis and treatment of maternal HIV infection (and perhaps, ultimately, of pediatric infection) are considered the primary objectives of prenatal HIV screening, a question arises of whether it is ethical to implement screening if the full array of medical and social services for HIV-infected women and their children is not in place. Constructing such a network of coordinated, integrated, family-oriented medical and psychosocial support services can be a major challenge. To satisfy the myriad health and social needs of HIV-infected women and children requires a range of multidisciplinary medical care and social services: routine ambulatory care, such as immunologic surveillance and medical monitoring associated with antiretroviral therapy or prophylaxis against opportunistic infection; inpatient care; reproductive health care; day care; home care; substance abuse treatment; psychological support services; a variety of social services; and sometimes even housing and income support. These services are often provided at multiple sites of care and by numerous providers. Because the lives of HIV-infected women and their children are so often characterized by social chaos, poverty, substance abuse, and eventually deteriorating health, they generally need assistance in navigating this fragmented delivery system and in obtaining the necessary services. Moreover, they typically depend on the public sector for the provision and financing of their care. In many areas (particularly those with a high prevalence of HIV infection) the public health care system may already be overburdened and underfinanced, creating additional problems in ensuring that families affected by HIV disease receive appro-

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HIV Screening of Pregnant Women and Newborns priate care. In some cases, the full complement of services is available but not readily accessible, perhaps because of location or cost, a poorly coordinated and inefficient referral network, or the lack of adequate insurance coverage and consequent inability to pay for care. The committee decries the inherent inadequacies in the current health services delivery and financing system and recognizes that prenatal HIV screening may identify more women and children who need care than the system can currently accommodate. Nevertheless, it believes that the benefits of screening pregnant women for HIV infection in high-prevalence areas are sufficient to justify proceeding with program implementation, even though the present health and social services infrastructure may not be completely adequate. Some health officials suggest that screening can be used to reveal unmet need and create a demand for the necessary services, thereby forcing the development of an adequate system of follow-up care. The committee concludes, however, that in mounting a screening program, state public health authorities must be firmly committed to the construction and expansion of health and social services for all HIV-infected women and children in tandem with screening program implementation; otherwise the necessary system of follow-up services is unlikely to be developed. Yet before screening is initially introduced, some level of HIV-related treatment services for women and children should be in place. For example, resources (e.g., qualified laboratory facilities to perform CD4+ cell counts) should be adequate to provide further medical evaluation and monitoring of immunologic function in HIV-infected women identified through screening. Women should also have access to antiretroviral therapy or prophylaxis against opportunistic infection when medically indicated. Because HIV infection in women is so often inextricably tied to substance abuse, particular attention should be paid to resolving the current problems women, and particularly pregnant women, face in receiving substance abuse treatment.4 There should also be some mechanism, preferably one coordinated and integrated with maternal health care, for pediatric follow-up and medical surveillance of children born to HIV-infected mothers. As state public health authorities move to institute screening, they incur an obligation to build a coordinated, integrated system of care for women and children who are identified and to remedy the current impediments to access. Developing the network of integrated services that will ultimately be required to support prenatal HIV screening may involve 4    For example, one survey of drug treatment programs in New York City revealed that 54 percent of such programs categorically excluded pregnant women (Chavkin, 1990).

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HIV Screening of Pregnant Women and Newborns the regionalization of HIV-related services, the creation of appropriate referral linkages with other maternal and child health and social services programs, and the development of some mechanism (e.g., case management) to coordinate care and ensure that HIV-infected women and children have access to and receive appropriate follow-up services. The committee recognizes that prenatal HIV screening efforts constitute yet another compelling argument to ensure all individuals in this country access to needed health care. States that attempt to ensure adequate care for HIV-infected women, however, may find their efforts thwarted by the discrimination some of these women face in gaining access to needed services. In fact, this is one of the most troubling barriers to care. The committee was greatly disturbed by accounts of the systematic exclusion of HIV-infected women from care—in particular, from reproductive health care. For example, HIV-infected pregnant women who elect to terminate their pregnancies may discover that their access to abortion services is restricted. Some areas report outright exclusion of HIV-infected women by abortion clinics (New York City Commission on Human Rights, AIDS Discrimination Division, 1990). Such exclusion only serves to limit further the reproductive options available to HIV-infected pregnant women, as well as the opportunities for reducing perinatal transmission. It also compounds the stigmatization and isolation that many women confront in dealing with their own HIV infection. The committee deplores discrimination against HIV-infected women and children in the provision of health care services. State policymakers should assess the extent of such discrimination and develop a mechanism for expeditiously redressing any discriminatory actions. If HIV screening for pregnant women is to achieve its goals, there must be some assurance that identified women and their children will not be denied access to needed health care by virtue of their infected status. The committee concludes that health care providers who offer HIV testing to thew patients have an obligation to render appropriate treatment or to ensure that a referral is made and that such treatment is ultimately received. Additionally, it is imperative that when a woman seeks care and is offered an HIV test, the provision of needed health services must not be contingent on submission to testing; that is, if a pregnant woman refuses to be tested, she should still be eligible to receive care. Health Care Provider Education and Training The successful implementation of prenatal HIV screening policy as a standard of medical practice will require a well-organized, structured HIV

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HIV Screening of Pregnant Women and Newborns education and training component for health care providers. Education and training are needed not only to improve compliance but also to ensure that providers (particularly primary, obstetrical, and family care providers) are adequately prepared to counsel women about HIV infection and its attendant ramifications and to handle their medical care effectively. In some large medical centers or practices, it may be possible to engage specifically trained HIV counselors in the prenatal screening program. The committee recognizes the current shortage of trained counselors and therefore believes that efforts should be redoubled to recruit and train individuals to become HIV counselors. In many cases, however, the primary caregiver (e.g., the obstetrician, the family practitioner) will be responsible for securing a meaningful informed consent for testing and for offering supportive, sensitive counseling. To fulfill this responsibility, health care providers will need instruction and training in a variety of areas: the changing intricacies of HIV infection and the spectrum of disease, modes of transmission, risk behaviors, HIV serologic tests and the interpretation of test results, current therapy and treatment options (for women and children), and the special considerations that emerge when counseling HIV-infected women about their reproductive options. Admittedly, ignorance and a lack of understanding on the part of providers often reinforce feelings of discomfort and inadequacy in discussing some of the sensitive topics relating to HIV infection, such as sexual practices and illicit drug use. Specific training in this regard can alleviate the awkwardness many providers experience in broaching these subjects with their patients. The committee recommends that health care professional societies, training institutions, and public health authorities cooperate to institute comprehensive HIV education and training, as well as continuing education programs, for the health professions. Because such programs are likely to require substantial resources and technical expertise, public funding and technical assistance may be necessary to facilitate and support these training efforts. Laboratory Services The availability of high-quality laboratory facilities and qualified technicians to perform the HIV serologic test series on collected blood specimens is critical to a successful screening program. Standardized quality assurance in laboratory performance is particularly important to ensure testing accuracy, that is, to minimize false-positive and false-negative test results, as well as to resolve indeterminate test outcomes. Laboratory capacity should also be sufficient to accommodate the increased level of blood specimen testing that will be required once a screening

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HIV Screening of Pregnant Women and Newborns program is instituted. In addition, a well-orchestrated system is needed to obtain blood specimens from patients, label specimens, and transport them to accredited laboratories for swift processing. Timely and accurate reporting of test results to individual care providers, along with appropriate instruction for interpreting results, should also be ensured. The committee recommends, as part of any state-level screening effort, that states require laboratories to participate in a publicly sponsored (e.g., state or federal) quality assurance and performance evaluation program.5 States should also be responsible for informing providers of the recommended laboratories to which they should forward their HIV test specimens. States may wish to consider using their own or regional laboratory facilities (rather than smaller commercial laboratories) to process specimens collected through the prenatal screening program. The generally high HIV test volume in these labs is likely to minimize test costs. Program Evaluation A well-articulated, carefully designed evaluation plan is an essential component of any prenatal HIV screening program and must be an integral part of program planning. Such a plan requires that program goals be clearly specified prior to the program's inception. Provisions must also be made from the outset to monitor program performance and to identify flaws in design or implementation, as well as to evaluate the program's overall impact and detect any unanticipated consequences or adverse effects. A comprehensive evaluation process offers an opportunity to ascertain whether program goals have actually been achieved and whether they need to be modified. This ability to adjust program objectives and design is particularly important for HIV screening, given that diagnostic technology and medical therapy continue to evolve. A thorough review of program evaluation design and methodology is beyond the scope of this report6 Rather, the committee has chosen to highlight several aspects of evaluation and to identify the screening program elements that it deemed important to consider when planning and 5    States may seek guidance in monitoring laboratory quality assurance and performance from CDC's Model Performance Evaluation Program, which was developed to assess and improve the analytic quality of HIV-antibody testing. (See Valdiserri and colleagues [1990] for further details about the program.) 6    A more detailed discussion of process and outcome evaluation, as well as approaches and methodologies to evaluate AIDS intervention programs, is included in Coyle and colleagues (1991). Although this publication does not deal specifically with the evaluation of HIV screening programs, it offers information and guidance that may be useful in developing an evaluation plan.

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HIV Screening of Pregnant Women and Newborns performing an evaluation. There are two stages of evaluation (usually conducted periodically) that can take place once a program has been implemented. The first—process evaluation—assess whether the program was implemented as planned. For HIV screening programs, this type of evaluation determines whether the program infrastructure is in place and whether the services (e.g., counseling, screening, follow-up care) are being delivered as intended. Information gathered through such an assessment can be used to revise program objectives, modify implementation strategies, and, ultimately, improve program operation. The second stage—outcome evaluation—assesses the overall impact of the program, for example, whether program objectives have been achieved, whether there have been any unexpected negative (or positive) program effects, and its relative success or failure. The committee identified several elements or aspects of HIV screening programs it viewed as important to examine during the course of both process and outcome evaluations. These items are listed below. The number of women tested, the number of HIV-infected women identified, and the proportion of these women (and their children) who are receiving appropriate medical monitoring and treatment Seroprevalence data for childbearing women can provide an estimate of the number of infected women that are expected to be reached through screening. A comparison of these figures with the number of seropositive women identified through the program indicates the acceptance and use of the program by the population of interest (i.e., pregnant women, particularly those at risk). Examination of various aspects of pre-and posttest counseling. These could include an assessment of (1) the extent and quality of information presented during the pretest session, as well as the most appropriate or effective methods (e.g., pamphlets, videotapes, face-to-face dialogue) of delivering this information; (2) the adequacy of the informed consent process—for example, whether appropriate informed consent is elicited in advance of testing and whether excessive or inappropriate numbers of refusals of testing are occurring; (3) the overall effectiveness of pretest education and counseling—for instance, how well-informed women are with regard to HIV infection, risk behaviors, and the antibody test and its clinical and social implications; (4) the psychological and behavioral impacts of HIV testing and counseling (particularly posttest counseling), for example, whether knowledge of infection status influences

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HIV Screening of Pregnant Women and Newborns subsequent behavior,7 as well as the most appropriate and effective means of counseling seropositive women in the posttest context. Availability of needed follow-up services for HIV-infected women and children, including identification of gaps in the services delivery and financing system and unresolved barriers to access; also, the extent of HIV-related discrimination (e.g., the systematic exclusion of HIV-infected persons from care) in the health care system and its effect on women's ability to gain access to care. Possible adverse effects associated with therapeutic intervention for HIV-infected pregnant women and children—for example, evidence of fetal or neonatal harm or poor pregnancy outcomes as a result of maternal therapy. Assessment of reproductive outcomes among HIV-infected pregnant women (e.g., the frequency of pregnancy continuation or termination). Incidence of discrimination and stigmatization (e.g., loss of employment, housing, or insurance, and ostracism or violence by friends and family) as a result of screening, as well as unauthorized or unwarranted disclosures of infection status. For example, women who have been screened could be surveyed to determine whether they have suffered discrimination or whether their infection status has been disclosed without their consent. Effect of the screening program on the delivery of other health services or programs—for instance, whether funds to support screening have been reprogrammed or diverted from other needed service programs, producing a deleterious impact on them. Extent of health care provider compliance with the HIV screening standard of medical practice (i.e., prenatal HIV screening recommendations). For example, provider surveys could be conducted to discover how many caregivers are actually following the practice guidelines for screening pregnant women and to assess the adequacy of their knowledge and skills in counseling and treating HIV-infected women. Adequacy of laboratory capacity to process blood specimens collected through screening in a timely fashion, as well as the quality and accuracy of overall laboratory performance. 7    Although behavioral change is not a primary goal of prenatal HIV screening, it would still be important to assess whether screening has had an impact on women's behavior that might subsequently affect horizontal or vertical transmission of infection. There should also be an assessment of which methods of counseling and education are most effective in helping seronegative women adopt self-protective behaviors. (This could be accomplished through randomized field experiments, as described in Chapter 5 of Coyle and colleagues [1991].)

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HIV Screening of Pregnant Women and Newborns Although the prevalence of infection among childbearing women (and of perinatal infection) should continue to be monitored for epidemiological purposes, trends in seroprevalence should not be used as markers or indicators of screening program success or failure; in fact, these data may reveal very little about the overall impact of the program. Because reductions in vertical or horizontal transmission are not seen as currently achievable goals of prenatal HIV screening, measuring the relative success of the program by changes (or the lack thereof) in seroprevalence is inappropriate, particularly over the short term. Moreover, many factors influence seroprevalence (e.g., the prevalence of sexually transmitted diseases; substance abuse; seroprevalence among heterosexual men, particularly IV drug users; other HIV prevention efforts); any alteration observed in the prevalence of infection cannot necessarily be attributed to the screening program itself. The committee recognizes the considerable resources, talent, and effort that will be required to plan and conduct a thorough screening program evaluation. Because prenatal HIV screening programs have national relevance and importance, the committee concludes that federal support, in the form of additional funds specifically earmarked for evaluation, is needed to ensure careful monitoring and assessment of program effects. These funds, by definition, would be used only for evaluation and not for program operations.