AIDS INFORMATION NEWSLETTER Michael Howe, MSLS, Editor AIDS Information Center VA Medical Center, San Francisco (415) 221-4810 ext 3305 November 4, 1994 Women and HIV Infection (Part XII) Women and AIDS: Mother and Child--The HIV Connection Most babies born to HIV-infected women escape the virus. According to the Surgeon General's 1993 report on HIV infection and AIDS, about 1 in 4 of these infants, however, does become infected before or during birth. Scientists have been trying for some time to discover what influences whether or not a child will be affected. "No one is certain when viral transmission occurs," says Janet Arrowsmith-Lowe, M.D., medical officer in FDA's division of antiviral drugs, Center for Drug Evaluation and Research. "It may be during childbirth when the placenta separates from the uterine wall and there may be some mixing of maternal and fetal blood, or as the child passes through the vaginal canal and is exposed to vaginal fluids. Or it may occur earlier in pregnancy when there may be mixing of blood or passage of the virus across the placental wall. In any case, all pregnant women--and especially those at risk of HIV--should seek early prenatal care." Apart from the timing of transmission, studies suggest that the likelihood of the child becoming infected may correlate with the mother's health during the pregnancy or birth. In the June 9, 1993, Journal of the American Medical Association, Michael E. St. Louis, M.D., and his colleagues reported that a baby is more likely to become infected if the mother is in the very earliest stage of infection (when the virus is thought to be abundant) or in an advanced stage of disease, or if the membrane surrounding the placenta is inflamed. A child can also become infected after birth through breast-feeding. By 1994, an estimated 7,500 children in the United States will have developed AIDS from infection before or during birth or through breast- feeding. Not surprisingly, experts predict that as more women of childbearing age become infected, the number of infected children will also rise. A disturbing prospect under any circumstances, the significance of this projection is most poignant for minorities in New York City, where AIDS is already the leading cause of death in Hispanic children 1 to 4 years of age and the second leading cause of death for African-American children of the same ages. And those children fortunate enough to escape infection do not escape hardship. "As painful as it is to consider," says Arrowsmith-Lowe, "the facts as we see them now are that an uninfected child born to an infected mother will lose his or her mother before the child becomes a teenager." According to the Surgeon General's report, in the next decade, 125,000 or more children may become orphans because of AIDS and will need to be cared for by family members or other responsible adults, or placed in foster care. (Marian Segal. FDA Consumer. October 1993) HIV Survey in Childbearing Women These are answers from the Centers for Disease Control and Prevention (CDC) to questions concerning the HIV Survey in Childbearing Women, which was done by testing newborn blood specimens collected on filter paper for maternal HIV antibody. 1. What is the HIV Survey in Childbearing Women? The HIV Survey in Childbearing Women is an ongoing, national serosurvey initiated in 1988. It is designed to measure the prevalence of HIV infection in women delivering infants in the United States and to monitor this rate over time. The survey is based on HIV testing of leftover blood specimens collected on filter paper for routine newborn metabolic screening, an existing public health program in all areas conducting the survey. 2. Where is the survey conducted? CDC is conducting the survey in collaboration with the health departments of 45 states, the District of Columbia, Puerto Rico, and the Virgin Islands. The 5 states not conducting the survey are Idaho, Nebraska, North Dakota, South Dakota, and Vermont. 3. How much does the survey cost? In fiscal year 1994 the survey cost approximately $10.5 million. 4. How are data collected? All personally identifying information is permanently separated from the specimen before it is tested for HIV antibody. Limited demographic data, including the month and county of birth, are abstracted from the metabolic screening form; in some states, the mother's age group and race/ ethnicity are also collected. State health departments maintain a database containing survey results; these data are also periodically transferred to CDC. 5. How is HIV antibody testing performed? Laboratory testing for the survey is conducted in state public health laboratories using standard enzyme immunoassay (EIA) and Western blot methods adapted to dried blood specimens collected on filter paper. All laboratories participate in a special quality assurance program maintained by CDC. 6. What does an HIV-positive test result mean? A positive test result reflects HIV infection in the mother, but not necessarily the infant, because antibodies cross the placenta during pregnancy. Test results are interpreted according to standard criteria established by the Association of State and Territorial Public Health Laboratory Directors (ASTPHLD) and CDC. 7. How are the data reported? State health departments periodically report results from the survey in health department newsletters or press releases. CDC recently published a summary of survey data in the National HIV Serosurveillance Summary, Results through 1992 (single copies available from the CDC National AIDS Clearinghouse, 1-800-458-5231). 8. What are the principal findings? In 1992 (the most recent year for which complete data are available), approximately 7,000 HIV-infected women delivered infants in the United States. The prevalence of HIV infection in women delivering infants was about 1.7 per 1,000, or about 1 in every 585 women delivering infants. The transmission rate of HIV from mother to infant is estimated to be between 20% and 30%. Therefore, between 1,400 and 2,100 HIV-infected infants were born in the United States in 1992. 9. What has been done for women with HIV as a result of the survey? Results from the survey have been used to estimate the needs for HIV services for women and children, to stimulate the development of HIV prevention programs, and to target resources. As an example, because of the high HIV seroprevalence among childbearing women found in New Jersey, in 1989 the New Jersey Commissioner of Health recommended that all pregnant women in New Jersey be offered HIV counseling and testing. Similar recommendations have been made or are under consideration in other areas. 10. Is informed consent obtained for the survey? CDC and the Office of Protection from Research Risks (OPRR) at the NIH have established that the survey: 1) Causes no collection of information or specimens that would not otherwise be obtained for routine medical purposes; and 2) Obtains no data which can be linked to identifiable individuals. Therefore, this is considered an unlinked survey that does not involve human subjects, and informed consent is not required. The survey protocol has been reviewed by CDC's institutional review board (IRB) and by many state IRBs as well. 11. Can women tested in the survey obtain their test results? Testing for HIV antibody is done only after all personal identifiers have been permanently removed. Therefore, HIV test results from this survey cannot be associated with individual women or infants, and it would be impossible to "unblind" the survey. 12. Can the survey be converted to a screening program in states choosing to do so? Since it is impossible to link HIV test results to individual women, the survey cannot serve as a screening program. The survey does not take the place of voluntary testing and counseling programs; states are encouraged to develop such programs, independent of the survey. 13. If a state chooses to unblind the survey and add mandatory HIV testing to the existing newborn screening program, will CDC funding to conduct the survey in that state be withdrawn? CDC will fund states to conduct the survey only as prescribed in the approved protocol. CDC funds for the survey may not be used for any other studies. However, states may choose to conduct screening programs independent of the survey with other funding. 14. What implications for the survey are there in the findings from the AIDS clinical trial (ACTG 076) on use of AZT to prevent perinatal HIV transmission? Results from ACTG 076 study demonstrate that AZT therapy administered during pregnancy and delivery and to the newborn could reduce the risk of perinatal HIV transmission by as much as two-thirds in some infected women and their infants. Because data from the survey are population-based, they provide a unique measure of the women and infants that could potentially benefit from intervention with AZT. 15. How may information from the HIV Survey in Childbearing Women be used to guide and evaluate programs for preventing perinatal HIV transmission? The survey provides very accurate data for states and health-care providers to use in focusing their efforts to provide HIV counseling and testing, prenatal care, and follow-up for women at greatest risk of HIV infection. Preventive services should be provided to women before they become infected. Ideally, women should have the opportunity to learn their serostatus before they become pregnant. Services offered to pregnant women with HIV infection should include education about the potential for AZT to reduce the risk of perinatal transmission. The results of ACTG 076 demonstrated benefit in women who began receiving AZT between 14 and 34 weeks of pregnancy; therefore, pregnant women with HIV should receive this information during prenatal care, not at the time of delivery. 16. Would unblinding the HIV Survey in Childbearing Women assist in preventing perinatal HIV transmission? No. HIV counseling and testing should be offered prior to or early in pregnancy so that AZT use can be considered during pregnancy (as early as the 14th week), and certainly before the birth of the child. Detection of HIV during pregnancy also allows better coordination with pediatric care for the infant than detection following birth. 17. What does CDC recommend regarding use of AZT in pregnancy? Based on the findings of ACTG 076, the Public Health Service published interim recommendations in the April 29, 1994, issue of the MMWR (Vol. 43, No. 16). The recommendations are as follows: 1) All health-care workers providing care to pregnant women and women of childbearing age should be informed of the results of ACTG 076; 2) HIV-infected pregnant women meeting the protocol eligibility criteria should be informed of the potential benefits but unknown long-term risks of AZT therapy as administered in the ACTG 076 protocol, and decisions to use AZT for prevention of perinatal transmission should be made in consultation with their health-care providers; 3) Health-care providers should inform their patients that this AZT regimen substantially reduced, but did not eliminate, the risk for HIV infection among the infants; and 4) Until the potential risk for teratogenicity and other complications from AZT therapy given in the first trimester can be assessed, AZT therapy only for the purpose of reducing the risk for perinatal transmission should not be instituted earlier than the 14th week of gestation. PHS is developing further recommendations for the uses of AZT for HIV-infected pregnant women whose clinical indications differ from the ACTG protocol 076 eligibility criteria and for counseling and HIV-antibody testing for women of childbearing age. 18. Legislation has been proposed in several states to mandate testing of pregnant women by testing their infants at delivery. What is CDC's position regarding mandatory testing of pregnant women in light of results from NIH's 076 trial? Mandatory HIV testing and screening have not been generally implemented in this country for civilian, noninstitutionalized populations, or populations at risk. Such programs have been rejected largely because of their unmanageability and expense and their powerful psychological and social impacts. The formulation of HIV screening policies through legislative or regulatory routes does not permit the flexibility and latitude required to respond to new developments in diagnostic technology and medical intervention. Mandatory HIV testing may discourage pregnant women from exercising their rights to participate in important reproductive decisionmaking, including seeking prenatal care. Recent ACTG 076 results indicate that early detection and medical intervention of HIV infection can benefit the unborn children of infected mothers. One of the main objectives of the HIV Survey in Childbearing Women and other HIV serosurveys is to provide data for health officials to direct HIV counseling and testing programs to the populations with the highest infection rates. High seroprevalence rates from the survey of childbearing women should be used by health departments as a basis for recommending routine voluntary HIV counseling and testing of some or all such women in a local areas or states and increasing prevention efforts for this population. While the protocol for the HIV Survey in Childbearing Women requires that this testing be unlinked, it does not prevent states from establishing additional voluntary testing programs through which to inform persons of their infection status. (Centers for Disease Control and Prevention. Training Bulletin. June 15, 1994.)