Date: Fri, 7 Jul 1995 16:17:09 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: 076 Questions and Answers F A C T S H E E T ************************************* PUBLIC HEALTH SERVICE Centers for Disease Control and Prevention July 1995 Questions and Answers on... PHS Guidelines for HIV Counseling and Voluntary Testing for Pregnant Women The Centers for Disease Control and Prevention (CDC) has published guidelines that call upon medical professionals to provide HIV counseling and voluntary testing for all pregnant women. This document provides summary information on commonly asked questions about the guidelines. More detailed information is available from the sources listed at the end of the document. Why did CDC develop these guidelines? HIV can be perinatally transmitted from mother to fetus during pregnancy, labor, and delivery, and from mother to infant during breastfeeding. In February 1994, the results of the National Institutes of Health (NIH) AIDS Clinical Trials Group Protocol 076 were announced, indicating that zidovudine (ZDV, or AZT) could reduce perinatal HIV transmission by as much as two-thirds in some infected women and their babies. The results were reported in the New England Journal of Medicine in November 1994. In August 1994, the Food and Drug Administration approved AZT use for pregnant women, and the U.S. Public Health Service issued guidelines on using AZT during pregnancy (MMWR 1994;43[RR-11]). For HIV-infected women and their infants to benefit optimally from AZT and other medical treatment, it is best for women to know if they are HIV infected early in pregnancy. CDCgs guidelines promote early HIV counseling and voluntary testing, helping women learn if they are infected. This will enable women to seek and receive the care they need for themselves and for reducing the chances of transmitting HIV to their infants. If women do not receive prenatal care, or if for any reason their HIV status is unknown, the guidelines recommend that HIV testing be offered to the mothers or their babies at or shortly after labor and delivery. How were the guidelines developed? In response to the recent advances in preventing perinatal HIV transmission, CDC worked with academic experts, clinical practitioners, community members, womengs organizations, public health officials and advocacy groups to develop these guidelines based on the best scientific information available. They were released in draft form in February and refined in response to input received during a 45-day public comment period. The "U.S. Public Health Service Recommendations for HIV Counseling and Voluntary Testing for Pregnant Women" guidelines, were published on July 7, 1995, in theMorbidity and Mortality Weekly Report (MMWR). Is this a big problem? In 1993 (the most recent year for which complete data are available), an estimated 7,000 HIV-infected women gave birth in the United States. The prevalence of HIV infection in women giving birth was about 1.6 per 1,000, or about 1 in every 625. Assuming an HIV transmission rate from mother to infant of about 15%-30%, about 1,000-2,000 HIV-infected infants were born in the United States in 1993. Whogs most affected? Rates of HIV infection and AIDS among all women are increasing. The numbers vary by region, but across the nation, the racial/ethnic disparities are striking. African American and Hispanic women account for 21% of all U.S. women, but they represent 75% of cumulative AIDS cases reported among U.S. women. What do you mean by counseling and voluntary testing? Health care providers should provide all pregnant women counseling about the ways they could be infected with HIV and what a positive HIV test means for their health and that of their baby. Voluntary testing means that after a woman receives appropriate counseling from her health care provider, she is able to make an informed decision about having a test for HIV. Research shows that when her health care provider talks with a pregnant woman about the test and what it means for her and her baby, most women choose to be tested and then to be treated as their doctor recommends. How do we know voluntary testing will work? The combined strategy of HIV counseling for all pregnant women and voluntary HIV testing is already proving effective in several communities, such as Los Angeles, Atlanta, and Baltimore. In addition, if women do not receive prenatal care, or for any reason their HIV status is unknown, the guidelines recommend that HIV testing be offered to the mothers or their babies shortly after labor and delivery. But in some places women dongt accept testing. How do you explain that? If a specific HIV counseling and voluntary testing program has a low rate of women choosing to be tested, the reasons they decline should be carefully examined. Important questions include: Is enough information about HIV and the test provided to the women? Is it provided in an understandable, credible, and supportive way? Do women understand their options and the risks and benefits of AZT therapy? Are appropriate medical services available in a timely manner? Complete counseling from a trusted health care provider and, equally important, access to medical care and other services can help increase the number of women who choose to be tested. For information on free, anonymous and/or confidential HIV testing, women can be referred to the National AIDS Hotline (1-800-342-AIDS). Wouldngt mandatory tests ensure everyone is tested and treated? Testing alone will not prevent perinatal transmission. Simply knowing shegs infected will not help a woman prevent transmitting HIV to her baby. To have a chance of doing that, she needs to have ongoing treatment and care. Policies must be developed that will create the best opportunity for infected women and babies to get the treatment and care they need. Offering all pregnant women counseling and voluntary HIV testing is an important first step in preventing perinatal transmission -- but it is only the first step. Mandatory testing risks putting women and their health care providers at odds, destroying the trusting relationship essential for discussions about care and treatment and ready access to needed services. It is important for a pregnant woman to understand why she should be tested and what a positive test might mean for her and her baby. If she is infected with HIV, she needs to understand the benefits and potential risks of AZT for herself and her infant. Moreover, faced with the certainty of mandatory HIV testing, many women might avoid medical care altogether, resulting in fewer women being tested and then receiving AZT and other prenatal care. What about mandatory newborn testing in the event the mother's HIV status is unknown? Again, testing is not the intervention. In order for infected infants to receive the care and treatment they need, policies must be developed that foster trust, thereby creating the best opportunity for compliance with complex medical procedures. How was the NIH study done? Last year, NIH announced the results of a study of AZT therapy for 409 pregnant women who were infected with HIV but did not yet have AIDS. Half received AZT orally starting between the 14th and 34th weeks of pregnancy and continued until they went into labor. The drug was given to these women intravenously during labor and delivery and orally to their infants for 6 weeks after birth. The other half of the women in the study received a placebo, a pill that has no effect, instead of AZT. Neither the pregnant women nor their doctors knew which therapy the women received. About 25.5% of HIV-infected women who received the placebo passed HIV to their babies, but only 8.3% of the women treated with AZT transmitted HIV. What did the NIH study show? The study showed a 67.5% reduction in HIV transmission. That is exciting and promising, and there were no serious short-term side effects in any mothers or babies. What dongt we know? Several questions remain to be answered. The trial included a select group of women in the early stages of disease, who had not previously taken AZT long-term, and who had access to prenatal care. The therapy may differ in effectiveness in women who differ from these characteristics. Researchers dongt know exactly how the therapy prevented transmission, so they dongt know why it didngt work 100% of the time, and they also dongt know the effect of any therapy variations -- such as using AZT only during labor or later in the pregnancy, or using it for a shorter time during pregnancy. Moreover, scientists dongt know about the long-term effects of AZT on both mothers and infants. Researchers continue to seek answers to these questions. NIH is continuing to monitor the mothers and babies in the trial. So why recommend AZT therapy? Although AZT therapy is not 100% effective and the long-term risks to both the mother and her child are not yet known, the dramatic reduction in HIV transmission in the trial dictates that every HIV-infected pregnant woman should certainly be offered AZT therapy to reduce the risk of transmitting the virus to her baby. Because of the uncertainties, a woman should make a personal decision about taking AZT only after she discusses the benefits and potential risks for herself and her child with her health care provider. Whatgs CDC doing to prevent HIV infection in women? CDC funds states and community-based organizations that target prevention programs to women and, particularly, minority women. To focus resources and prevention efforts toward those who most need them, CDC has implemented a new HIV prevention community planning process that will ensure that community prevention programs are targeted to those most affected by the epidemic. Members of HIV/AIDS-affected populations, including minority women, are part of 225 community planning groups nationwide. Where can people get more information? Printed copies of the guidelines and gRecommendations of the U.S. Public Health Service Task Force on the Use of Zidovudine to Reduce Perinatal Transmission of Human Immunodeficiency Virusg (MMWR 1994;43[RR-11]) which describes AZT therapy for HIV- infected pregnant women and their infants are available from the CDC National AIDS Clearinghouse (CDC NAC). Printed copies may be ordered by calling the CDC National AIDS Hotline (1-800-342-AIDS). The Hotline can also provide information about any AIDS-related issue. The guidelines are also available electronically through the CDC NAC On-line bulletin board , as well as through other HIV/AIDS bulletin boards, including the Internet. For specific information regarding the 076 Clinical Trial or any other HIV/AIDS clinical trial, call the AIDS Clinical Trial Information Service (ACTIS) at 1-800-TRIALS A. For information regarding treatment and care of persons with HIV infection and AIDS, including use of AZT in pregnant women, call the HIV/AIDS Treatment Information Service (ATIS) at 1-800-448-0440.