A protocol for routine voluntary antepartum human immunodeficiency virus antibody screening

A protocol for routine voluntary antepartum human immunodeficiency virus antibody screening Michael K. Lindsay, MD, MPH Atlanta, Georgia Human immunodeficiency virus infection among both women of reproductive age and their infants is rapidly increasing. One strategy to address this increase involves the offering of routine voluntary antepartum human immunodeficiency virus antibody counseling and testing . The rationale for this policy is that all prenatal patients are educated about the major modes of viral transmission and encouraged to practice risk reduction behavior. Human immunodeficiency virus-infected women receive comprehensive prenatal care; they are referred for medical follow-up, and their infants are identified and targeted for pediatric infectious disease follow-up. During the past 4 years we have developed a protocol for antepartum human immunodeficiency virus screening in our institution. The protocol includes a self-reported human immunodeficiency virus risk behavior profile, pretest counseling conducted by trained human immunodeficiency virus counselors in small groups, written informed consent for human immunodeficiency virus antibody testing, posttest counseling, and education . By following this protocol we have identified and referred for follow-up > 350 human immunodeficiency virus-infected women . (AM J

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Key words: Protocol antepartum human immunodeficiency virus screening, human immunodeficiency virus counseling and testing, human immunodeficiency virus infection in pregnancy

As of June 1991 the number of acquired immunodeficiency syndrome (AIDS) cases among women in the United States reported to the Centers for Disease Control (CDC) exceeded 19,000, representing 11% of all reported cases in adults. I Women with human immunodeficiency virus (HIV) infection experience both increased morbidity" , and mortality' and account for an increasing number and percentage of adults with AIDS. 5 In addition, the CDC projects that by 1993 the cumulative total cases of AIDS as a result of perinatal transmission will more than double from the current level of approximately 1500 to approximately 4000. 6 HIV infection among women and children represents an emerging public health problem. One strategy to address the increase in infection involves offering routine voluntary antepartum HIV counseling and testing, a poli cy recently endorsed by the Institute of Medicine." The rationale for this policy is that all prenatal patients can be educated about the major routes of viral transmission and can be encouraged to avoid high-risk behavior. Those women found to be HIV infected can discuss pregnancy options and be encouraged to use

From the Department of G)'TUicology and Obstetrics, Emory University. Reprint requests: Michael K. Lindsay, MD, MPH, Department of Gynecology and Obstetrics, Emory University School of Medicine, P.O. Box 26158, Athwta, GA 30335. Copyright © 1993 Mosby-Year Book, In c. 0002-9378/93 $1 .00 + .20 611/39716

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contraception. Routine screening also provides the opportunity for long-term medical follow-up of HIV-infeeted women and their infants. This report presents a protocol for antepartum HIV antibody screening that has evolved over the past 48 months. It is hoped that our experience will offer valuable insight to those who anticipate establishing a prenatal antibody screening program in their institution in the near future. History of HIV antibody screening in pregnancy

The majority of HIV seroprevalence studies in pregnancy have been anonymous cord blood or newborn heel stick surveys."!" In 1987 , Landesman et a1.8 reported the HIV seroprevalence of 602 consecutive cord blood samples from an inner-city municipal hospital in New York City; 12 (2%) were HIV positive. Surprisingly, 5 of the 12 seropositive women had no identifiable risk factors for infection. As a result of their findings the authors" recommended consideration of broader HIV counseling and testing in pregnancy. In 1988 , Hoff et a1.9 from the Massachusetts Health Department introduced a new laboratory technique to detect HIV antibody in neonatal heel stick blood specimens routinely collected on absorbent paper for other purposes. The authors found a statewide seroprevalence of 2. I per 1000 with higher rates in urban than suburban areas. The authors concluded that this laboratory method would be useful in collectin g data needed to plan and evaluate HIV

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prevention strategies, to predict the health care resources needed to care for women and children with AlDS, and to conduct national surveillance of AIDS in women'; Since 1988, the CDC, in collaboration with 38 state health departments and the National Institute of Child Health and Human Development, has used the heel stick method to conduct a population-based seroprevalence survey of HIV infection among childbearing women. The highest seroprevalence was found in New York, New Jersey, and Florida. The nationwide seroprevalence was 1.5 per 1000 women delivered of live infants." The primary advantage of anonymous cord blood and heel stick HIV surveys is that they provide important epidemiologic data that can be used to help plan and evaluate HIV prevention strategies. The major disadvantage of such an approach is that neither the infected mother nor the potentially infected neonate is identified for important counseling and medical follOW-Up, In 1989, we reported the results of 6 months of routine voluntary antenatal HIV antibody screening among inner-city prenatal patients in Atlanta. The screening was preceded by the completion of a selfadministered HIV risk behavior profile and was conducted only after written informed consent was obtained. Ten of 3472 women (2.8/l000) registering for prenatal care were seropositive. Seven of the 10 seropositive women had no self-identified risk factors for infection and would not have been identified if screening had been performed according to CDC criteria. II Ninety-six percent of women consented to HIV testing. We concluded that routine voluntary antepartum HIV screening could be performed provided the appropriate multidisciplinary team was available for follow-up. 12 Rationale The primary goal for instituting routine voluntary antepartum HIV screening is to identify HIV-infected women. The identification of infected women will offer health care providers the opportunity to educate these women about the major modes of viral transmission, to encourage the practice of risk reduction strategies, to discuss pregnancy options, to provide contraceptives for the avoidance of future pregnancies, to provide gynecologic follow-up for screening of cervical dysplasia, and to refer for medical follow-up and monitoring of disease progression. Routine screening also affords the opportunity to encourage the HIV-infected woman to notify sexual and needle-sharing partners so that they can receive HIV counseling and testing. Finally, routine screening leads to the identification of infants who will require extensive pediatric infectious disease follow-up. Whether routine voluntary antepartum HIV screening will decrease the spread of either heterosex-

ual or perinatal HIV infection is unknown. However, it is clear that such a policy will provide an opportunity to offer early treatment to both women and their infants. Protocol for routine voluntary antepartum HIV screening Our protocol for routine voluntary antepartum HIV screening has evolved over 48 months, a period in which we have tested > 32,000 prenatal patients. Before an HIV testing program is established, it is essential that a well-coordinated clinical team providing comprehensive follow-up and a referral network involving both pediatric and adult infectious disease be in place. At their initial visit all prenatal patients undergo a comprehensive medical interview and numerous laboratory tests, including screening for antibody to HIV- 1. In our institution the majority of prenatal patients present for care in the early second trimester. Before antibody testing is requested, all patients are asked to complete a self-administered questionnaire ascertaining risk factors for infection. The information from the self-administered questionnaire is not used as a tool to assist a patient in deciding whether she should consent to HIV-l antibody testing. The risk behavior questionnaire instead provides a characterization of the risk profile of the prenatal population. This information will be incorporated into future risk reduction strategies. In addition, all patients are given an information sheet about AIDS. The information sheet provides answers to the following questions: What is AlDS? How does a person get the AlDS virus? How can I find out if I have the virus? What if I test positive for antibodies? What about pregnancy and AlDS? What can I do to keep from getting the virus and spreading it? The information sheet is written for individuals with seventh grade literacy skills. All patients also receive 25 to 30 minutes of HIV pretest counseling. They are counseled in small groups of five to seven individuals by health educators, who receive 2 days of instruction on HIV counseling and education conducted by the state Office of Infectious Disease. The pretest counseling session includes material appearing in the Georgia Department of Human Resources Division of Public Health, Office of Infectious Disease booklet, entitled Should You Be Tested?" The content of the booklet includes the rationale for HIV antibody testing, an explanation of the HIV antibody test, and a discussion of the major modes of viral transmission and the risk of perinatal transmission. Risk reduction strategies are presented and all patients are given a limited supply of condoms. Those patients desiring antibody testing are asked to complete a written informed consent statement, which certifies that the patient has received HIV counseling, has been in-

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formed of the advantages and disadvantages of testing, and has had the opportunity to ask questions. In addition, all patients are informed that they will not be denied medical services if they fail to consent to antibody testing. Blood specimens are screened for HIV-I antibody with a commercial solid-phase enzyme immunoassay (Abbott HTLV-IlI EIA; Abbott Laboratories, North Chicago) according to the manufacturer's assay protocol. Specimens that are repeatedly reactive by the assay are examined by the Western blot technique (Biotech Dupont HTLV-III Western blot kit, Dupont Pharmaceuticals, Wilmington, Del.). Specimens with reactivity to any antigen band in two of three viral gene product groups are considered HIV-I seropositive. During more than 48 months of routinely offered and encouraged antibody screening> 30,000 women have registered for prenatal care and approximately 95% have agreed to antibody testing. This patient population is predominantly black, young, single, and indigent. To date, we have not screened any women for HIV-2 antibody. HIV-infected patients are managed by a well-coordinated clinical team composed of a perinatal nurse specialist, an obstetrician, a psychiatrist, and a social worker. The perinatal nurse specialist is the backbone of our team. She maintains close liaison with the clinical laboratory. The names of all patients identified as HIV seropositive are forwarded to her. She then attempts to contact all these patients by either telephone, letter, or visiting nurse so they can return to the clinic for discussion of their laboratory results. Once contacted, these women are scheduled to see the obstetrician, who informs them of their positive antibody results. To date, the nurse specialist has been successful in having > 90% of seropositive women return to be informed of their HIV infection. Seronegative women are not scheduled for a special return visit to be informed of their serostatus. Instead, at their next clinic visit they receive a booklet, entitled What Do Your Test Results Meanr" This booklet explains the importance of negative antibody results and reinforces the importance of risk reduction behavior. The obstetrician, in the presence of the nurse specialist, informs the seropositive woman of her infection. During this 30- to 45-minute counseling and educational session the following essential points are discussed: the major modes of viral transmission, the lack of a risk of transmission by casual contact, the risk of perinatal transmission, and the distinction between asymptomatic HIV infection and AIDS. All patients seen before 24 weeks' gestation are offered the option of a pregnancy termination. During the 4-year screening period approximately 20% of those eligible have had pregnancy terminations performed. Seropositive patients are encouraged to be discreet about their test results and are warned of the potential adverse effects

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of indiscriminately divulging their serostatus. They are told to inform their sexual partner and to encourage him to undergo antibody testing. To date, approximately 50% of seropositive women have notified their sexual partners. We have not chosen to notify sexual partners of those women who refuse or fail to do so. However, if this protocol is followed, the potential for anonymous notification of sexual partners exists. Seropositive women are also told to encourage their sexual partners to use condoms and to avoid unintended pregnancies. In addition, those women who are active intravenous drug users are told to avoid sharing of intravenous needles and are referred for drug treatment. Seropositive women are encouraged to notify their needle-sharing partners and advise them to seek HIV counseling and testing. They are advised not to share implements that could be contaminated with blood (e.g., toothbrushes, razors). The importance of notifying other health care providers of their positive antibody status is emphasized. Finally, they are encouraged to seek independent confirmation of their serostatus by having repeat antibody testing in the county health department. The obstetrician concludes the session by completing a 5-minute interviewer-administered questionnaire ascertaining risk factors for infection. The information obtained from this questionnaire has been invaluable in helping to describe the epidemiologic characteristics of HIV-I infection on our service, because many seropositive women fail to selfreport risk factors for infection but later acknowledge risk behavior after being informed of their seropositive status. At the conclusion of the counseling session the perinatal nurse specialist supplies the patient with literature about HIV infection, introduces the patient to the social workers, coordinates referral for repeat antibody testing, and volunteers to help the patient inform her sexual partner. All seropositive women are then given a l-week follow-up appointment. To date, approximately 85% of women identified through prenatal screening have returned for obstetric follow-up and completed their 6-week postpartum visit. The psychiatrist is available on a referral basis to provide consultation for seropositive women having difficulty adjusting to news of their seropositivity. To date about 1% (3 of > 350) of seropositive women have required psychiatric hospitalization for acute anxiety reactions. The social worker is an invaluable member of our clinical team. We are able to provide comprehensive care primarily through her efforts of linking seropositive women to the appropriate social service agency. Many of these patients have limited financial resources and may require help in finding housing, obtaining food, and securing transportation to and from the prenatal clinic. All seropositive patients electing to continue tl: eir

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pregnancies are followed up in a special obstetric clinic. This clinic provides continuity of care and is staffed by the perinatal nurse specialist, the obstetrician, and the social worker. In the immediate postpartum period all seropositive women are visited by the perinatal nurse specialist, who coordinates postpartum follow-up, In addition, they are seen by both a family planning counselor and a pediatric infectious disease nurse. The family planning counselor reviews contraceptive options, including tubal ligation, oral contraceptives, levonorgestrel implants, barrier methods, and foam and condoms. All women are encouraged to choose a method before they are discharged. The pediatric infectious disease nurse reviews the risk of perinatal transmission, reinforces the importance of pediatric follow-up, and makes a follow-up appointment for the newborn. At the time of the 6-week postpartum visit all seropositive women undergo a complete physical examination; in addition, a CD4 lymphocyte count, baseline chest x-ray, film, and Papanicolaou smear are obtained. Finally, all seropositive women are referred to both the adult infectious disease clinic and the gynecology clinic for long-term follow-up. Our understanding of the long-term prognosis of HIV infection after pregnancy is limited. Thus there is an urgent need for research to clarify this important issue. This protocol has evolved to include HIV antibody testing among pregnant women who receive no prenatal care. Recent evidence suggests that these women are more likely to be HIV infected. Their increased risk of infection is associated with intravenous drug and "crack" cocaine use.": 16 These women appear at the labor and delivery suite in early or active labor; therefore two major modifications of the testing protocol are necessary. First, pretest counseling consists primarily of written information about HIV infection and HIV testing. Second, all women are seen in the immediate postpartum period and complete the self-administered questionnaire at that time. The confirmation of positive antibody status does not occur before patient discharge, so the major difficulty in conducting screening in this population is reaching women for posttest counseling. Because such counseling is important, we maximize our efforts by involving the perinatal nurse specialist, public health nurses, and outreach workers. During the screening period we have been able to contact and inform 75% of unregistered seropositive women of their serostatus.

Our protocol for routine voluntary antenatal HIV antibody screening is simple and effective. This protocol has allowed us to identify > 350 HIV-infected women. REFERENCES 1. Centers for Disease Control. HIV/AIDS surveillance report. Atlanta: Centers for Disease Control, 1991]uly: 1-18. 2. AIDS in women- United States. MMWR 1990;39:845-6. 3. Minkoff HF, Willoughby A, Mendez H, et al. Serious infections during pregnancy among women with advanced human immunodeficiency virus infection. AM ] OBsrET GYNECOL 1990;162:30-4. 4. Chu S, Buehler ], Berkleman R. Impact of the human immunodeficiency virus epidemic on mortality in women of reproductive age, United States. JAMA 1990;264:225-9. 5. Ellerbrock T, Bush T, Chamberland M, Oxtoby M. Epidemiology of women with AIDS in the United States, 1981 through 1990. JAMA 1991;265;2971-5. 6. Centers for Disease Control. HIV prevalence estimates and AIDS case projections for the United States: report based upon a workshop. MMWR 1990;39:1-31. 7. Committee on Prenatal and Newborn Screening for HIV Infection, Institute of Medicine. In: Hardy LM, ed. HIV screening of pregnant women and newborns. Washington: National Academy Press, 1991. 8. Landesman S, Minkoff H, HolmanS, et al. Serosurvey of human immunodeficiency virus infection in parturients: implications for human immunodeficiency virus testing programs of pregnant women. JAMA 1987;258:2701-3. 9. Hoff R, Berardi VP, Weiblen BJ, et al. Seroprevalence of human immunodeficiency virus among childbearing women: estimation by testing samples of blood from newborns. N EnglJ Med 1988;318:525-30. 10. Gwinn M, Pappaionou M, George R, et al. Prevalence of HIV infection in childbearing women in the United States. JAMA 1991;265:1704-8. 11. Recommendations for assisting in the prevention of perinatal transmission of human T-Iymphotropic virus type (III) lymphadenopathy associated virus and the acquired immunodeficiency syndrome. MMWR 1988;34:721-31. 12. Lindsay MK, Peterson HB, Feng TI, et al. Routine antepartum human immunodeficiency virus infection screening in an inner-city population. Obstet Gynecol 1989;74: 289-94. 13. Georgia Department of Human Resources Division of Public Health, Office of Infectious Diseases. Should you be tested? Atlanta: Georgia Department of Human Resources, 1988 July. 14. Georgia Department of Human Resources Division of Public Health, Office of Infectious Disease. What do your test results mean? Atlanta: Georgia Department of Human Resources, 1988 July. 15. Minkoff HL, McCalla S, Delke I, Stevens R, Salwen M, Feldman J. The relationship of cocaine use to syphilis and human immunodeficiency virus infections among inner city parturient women. AM J OBSTET GYNECOL 1990; 163: 521-6. 16. Lindsay MK, Feng TI, Peterson HB, et al. Routine human immunodeficiency virus infection screening in unregistered and registered inner-city parturients. Obstet GynecoI1991;77:599-603.