Date: Thu, 23 Feb 1995 16:33:48 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: US PHS Recommendations for HIV.... Part 1 of 2 NOT FOR PUBLICATION D R A F T February 23, 1995 U.S. Public Health Service Recommendations for HIV Counseling and Testing for Pregnant Women INTRODUCTION During the past decade, human immunodeficiency virus (HIV) infection has become a leading cause of morbidity and mortality among women and children in the United States, and research has focused on developing both biomedical and behavioral interventions to prevent infection and its subsequent morbidity. In the last several years, advances have been made in early interventions to improve survival and quality of life for HIV- infected persons, in strategies to reduce the risk of perinatal HIV transmission, and in management of HIV-infected pregnant women and perinatally exposed or infected children. Most recently, results from a randomized, placebo-controlled clinical trial have shown that the risk of perinatal HIV transmission can be significantly reduced by administering zidovudine (ZDV) to HIV-infected pregnant women and their newborns.1 To optimally benefit from these advances, HIV-infected women need to be diagnosed early in the course of their infection and prior to or early during pregnancy. Towards this goal the USPHS is recommending HIV counseling and voluntary testing of all pregnant women in the United States so that important interventions for the woman's health and that of her infant can be offered in the most timely and effective manner. This document contains information and recommendations concerning HIV counseling and testing of pregnant women and follow-up of infected women and their infants. These recommendations update previously published guidelines (2,3) designed to assist health-care providers and state and local health departments in developing programs for prevention and management of HIV infection in women and their infants. The information in this document complements other published guidelines for HIV counseling and testing of men and women,(4,5,6,7) management of HIV-infected adults and children,(8,9) and management of gynecologic conditions in HIV-infected women.10,11 These recommendations were developed to provide a framework for health care providers to 1) enable HIV-infected pregnant women to know their infection status; 2) advise infected women of ways to prevent perinatal, sexual, and other transmission of HIV; 3) facilitate appropriate follow up for HIV-infected women and their infants; and 4) assist uninfected pregnant women in reducing their risk of acquiring HIV infection. These recommendations are written for the United States and may not pertain to other countries. Increased availability and provision of HIV counseling, voluntary testing, and follow-up medical and support services are an integral part of the successful implementation of these recommendations. These services are optimally delivered through a readily available medical system with support services designed to retain patients in care. BACKGROUND HIV Infection and AIDS in Women and Children HIV infection is a major cause of illness and death among women of childbearing age and children. HIV infection was the fourth leading cause of death nationally in 1993 among women 25-44 years of age(12) and the seventh leading cause of death in 1992 among children ages 1 to 4 years.13 The most striking impact of mortality from AIDS has occurred among blacks and Hispanics. In 1993, HIV infection was the leading cause of death for young black women in this age group and the third leading cause of death among young Hispanic women.12 In 1991, HIV infection was the second leading cause of death among black children ages 1 to 4 years in New Jersey, Massachusetts, New York, and Florida and among Hispanic children in this same age group in New York (CDC unpublished data). Through June 1994, the Centers for Disease Control and Prevention (CDC) had received reports of more than 51,000 AIDS cases among adult and adolescent women and more than 5,000 cases among children who acquired HIV infection perinatally. Approximately half of all cases among women have been attributed to injecting drug use and one-third to heterosexual contact. Nearly 90% of cumulative AIDS cases reported among children and virtually all new HIV infections among children in the United States are attributed to perinatal transmission of HIV. An increasing proportion of perinatal AIDS cases have been reported among children whose mothers acquired HIV through heterosexual contact with an infected partner whose risk was not known by the mother. Data from the National Survey of Childbearing Women indicate that in 1992 the estimated national prevalence of HIV infection among childbearing women was 1.7 HIV-infected women per 1000 childbearing women.14 During 1989-1992, approximately 7000 HIV-infected women gave birth each year.15 Assuming a 15%-30% perinatal transmission rate, an estimated 1,000-2,000 HIV-infected infants were born annually during these years in the United States. Perinatal Transmission of HIV HIV can be transmitted from an infected woman to her fetus or newborn during pregnancy, during labor and delivery, and during the postpartum period through breastfeeding, although the proportion of infections transmitted during each of these intervals is not precisely known.16,17,18 While HIV transmission to a fetus can occur as early as 8 weeks gestation, (16) accumulating data suggest that at least half of perinatal transmissions in non-breastfeeding populations may occur close to or during the time of birth.19,20,21 Breastfeeding may increase the rate of transmission by 10%-20%.18,22,23 Perinatal transmission rates found in prospective studies have ranged from 13%-40%.24,25,26,27,28 Transmission rates may differ among studies depending on the prevalence of various factors that have been shown to influence the likelihood of transmission. Several maternal factors have been associated with an increased risk of transmission including low CD4+ counts, high maternal viral titer, advanced HIV disease, the presence of p24 antigen in maternal serum, placental membrane inflammation, intrapartum events resulting in increased exposure of the fetus to maternal blood, breastfeeding, premature rupture of membranes, and premature delivery.17,20,24,29,30,31 Cesarean section delivery, the presence of maternal neutralizing antibodies, and maternal zidovudine therapy have been associated with a decreased rate of transmission in some studies.20,32,33 Importance of HIV Counseling and Testing for Pregnant Women HIV counseling and testing during prenatal care offer important prevention opportunities for both uninfected and infected women and their infants. For uninfected women, such counseling is intended to 1) assist women in assessing their current or future risk for HIV infection; 2) initiate or reinforce HIV risk reduction behavior; and 3) allow for referral to other HIV prevention services (e.g., substance abuse treatment) when appropriate. For infected women, knowledge of their HIV infection status provides opportunities for 1) early diagnosis and treatment for themselves and their infants, 2) informed reproductive decisions, 3) methods to reduce the risk of perinatal transmission, 4) information to prevent HIV transmission to others, and 5) referral for psychological and social services as needed. Interventions designed to reduce morbidity in HIV-infected persons require early diagnosis of HIV infection so that treatment can be initiated prior to the onset of opportunistic infections and disease progression. However, studies indicate that many HIV-infected persons do not learn of their infection status until late in the course of their illness. A recent CDC- sponsored survey of men and women diagnosed with AIDS between January 1990 and December 1992 found that 57% of the 2,081 men and 62% of the 360 women in the survey were not tested for HIV infection until they became symptomatic, with 36% first tested within 2 months of their AIDS diagnosis (CDC unpublished data). The provision of HIV counseling and testing services in prenatal and other obstetrical settings provides an opportunity for early diagnosis for many infected women since they are likely to become pregnant at a young age and early during the course of their infection. When appropriately linked to ongoing care during and beyond pregnancy, infected women can be monitored for clinical and immunologic status and provided with preventive treatment and other medical care and services as needed. Important medical assessments for HIV-infected persons include monitoring of CD4+ T-lymphocyte levels to determine initiation of antiretroviral therapy and prophylaxis against Pneumocystis carinii pneumonia (PCP) and other opportunistic infections, assessment of tuberculosis infection and disease (followed by preventive therapy and treatment as indicated), and periodic examinations to identify potential oncologic and infectious manifestations of immunodeficiency.8 Diagnosis of HIV infection before or during pregnancy allows women to make informed decisions regarding prevention of transmission to their infants. Early in the epidemic, strategies to prevent perinatal HIV transmission among infected women were limited to options of avoiding or terminating pregnancy and avoidance of breastfeeding for women in countries with safe alternatives to breastmilk. More recent strategies to prevent perinatal HIV transmission have focused on efforts to interrupt intrapartum and in utero transmission. Foremost among these to date have been recommendations from the U.S. Public Health Service regarding administration of ZDV during pregnancy, during labor and delivery, and to the newborn.9 These recommendations followed results from a multicenter, placebo-controlled clinical trial, which showed that ZDV given to a select group of HIV- infected women during pregnancy, labor, and delivery, and to their newborns reduced the risk of perinatal transmission by approximately two thirds: 25.5% of infants born to mothers in the placebo group were infected, compared with 8.3% of those born to mothers in the ZDV group (Kaplan-Meier estimate at age 18 months; p=0.00006).1 The ZDV regimen was tolerated well by both the mothers and their infants, with the only adverse effect after 18 months of follow-up being mild anemia in the infants that resolved without therapy. The recommendations on ZDV therapy extend to HIV-infected pregnant women with clinical conditions different from those of the women in the clinical trial, but emphasize that the long-term effects of the ZDV regimen for both treated mothers and infants are unknown and that HIV-infected pregnant women must consider both the benefits and potential risks when making decisions to receive such therapy. Consistent with these recommendations, the Food and Drug Administration (FDA) has approved the use of ZDV for therapy to prevent perinatal HIV transmission. Several other strategies to reduce the risk of perinatal HIV transmission are under study or being planned.34 These include administration of HIV hyperimmune globulin to infected pregnant women and to infants, efforts to boost maternal and infant immune responses through vaccination, virucidal cleansing of the birth canal before and during labor and delivery, and cesarean section delivery. Recognition of HIV infection during pregnancy also allows for early identification of HIV-exposed infants, all of whom are recommended to have diagnostic testing, monitoring, and possible treatment.8 Early identification and close monitoring of HIV- infected children can be lifesaving and is essential for optimal medical management, particularly in infancy.8,35,36 In general, about 10%-20% of perinatally infected children develop rapidly progressive disease and die in their first few years of life.37,38 Pneumocystis carinii pneumonia is the most common opportunistic infection in children with AIDS and is often fatal. Because PCP occurs most commonly among perinatally infected children between the ages of 3 and 6 months, (39) effective prevention requires that children born to HIV-infected mothers be identified early, preferably prenatally, and that prophylactic therapy for the child, when indicated, begin as early as the second month of life. Careful follow-up of other potentially treatable conditions, such as severe bacterial infections, tuberculosis, and vaccine preventable diseases (e.g., influenza and pneumococcal pneumonia) may prevent morbidity and reduce hospitalizations.8 Infants born to HIV-infected women also require changes in their routine immunization regimens which begin as early as age 2 months.40 Administration of inactivated poliovirus vaccine rather than live, attenuated oral vaccine is recommended for the health of both the infants and their HIV- infected household members. Live, attenuated poliovirus can be transmitted to HIV-infected mothers and other infected household members and poses a theoretical risk of causing paralytic disease in persons with immune dysfunction. Despite the potential benefits of HIV counseling and testing to both women and their infants, concerns have been raised about the possible negative effects of widespread counseling and testing programs in prenatal and other settings. These concerns include the fear that such programs could be a deterrent to use of prenatal care services if testing is not clearly perceived as voluntary, and that women who have been tested but do not wish to learn their test results may be reluctant to return for further prenatal care. Concerns have also been expressed about other potential negative consequences following a diagnosis of HIV infection including loss of confidentiality, job or health-care related discrimination and stigmatization, loss of relationships, domestic violence, and adverse psychological reactions. While limited data indicate that serious adverse effects of HIV testing are infrequent, additional information is needed to document their extent.41,42 Provision of or referral to psychological, social, or legal services for infected women may help to minimize potential risks and enable women to benefit from the multiple health advantages of early HIV diagnosis. Counseling and Testing Strategies Guidelines published in 1985 (2) regarding HIV counseling and testing of pregnant women recommended a targeted approach aimed at women known to be at risk for HIV infection (e.g., injecting drug users, women whose sex partners were HIV-infected or at risk for infection). However, several studies have shown that counseling and testing strategies that offer testing only to those women who report risk factors fail to identify and offer services to many HIV-infected women (50%-70% in some studies).43,44,45 Women may be unaware of their risk for infection if they have unknowingly had sexual contact with an HIV-infected person.46 Others may refuse testing to avoid the stigma often associated with high-risk sexual and injecting drug use behaviors. With the advances made over the past 10 years in treatment and prevention of opportunistic infections for HIV-infected adults and children, several professional organizations,(10,47) and others (7) have recommended a more widespread approach of offering HIV counseling and testing for pregnant women. This approach can be applied nationally to all pregnant women in the United States or to women in limited geographic areas based on the prevalence of HIV infection among childbearing women in those areas.14 However, a counseling and testing recommendation based upon a prevalence threshold (e.g., 1 HIV-infected woman per 1000 childbearing women) could delay or discourage implementation of counseling and testing services in areas (e.g., states) where prevalence data is inadequate, outdated, or unavailable and would miss significant numbers of HIV-infected pregnant women in areas with lower seroprevalence rates but high numbers of births (e.g., California). A prevalence-based approach could also lead to potentially discriminating testing practices by singling out a geographic area or racial/ethnic group. A universal approach for HIV counseling and testing of all pregnant women, regardless of the prevalence of HIV in their community or their risk for infection, has the advantage of providing a uniform policy that will reach HIV-infected pregnant women in all populations and geographic areas of the United States. While this universal approach will necessitate increased resources for HIV counseling and testing services for pregnant women, effective implementation of these services and the ensuing medical interventions will reduce HIV-related morbidity in women and their infants and may ultimately reduce medical costs. Counseling and testing policies must also address issues related to provision of consent for testing. Results from several areas with universal, routine HIV counseling and voluntary testing programs indicate that high test acceptance levels can be achieved without mandating testing.48,49 Mandatory testing may increase the potential negative consequences of HIV testing noted earlier (see page 10) and result in some women avoiding prenatal care altogether. In addition, mandatory testing may adversely affect the patient-provider relationship by placing the provider in an enforcing rather than facilitating role which is needed to assist women in making decisions regarding HIV testing and zidovudine preventive therapy. Although few studies have addressed the issue of acceptance of HIV testing, results from several areas with universal, routine HIV counseling and voluntary testing programs indicate that most women will accept HIV testing if it is offered.49,50 Increased levels of test acceptance have been found in clinics where testing is voluntary but recommended by the health care provider compared with clinics which use a nondirective approach (i.e, patients are told the test is available, but are neither encouraged nor discouraged to be tested).50 Laboratory Testing Considerations Large-scale testing of populations with relatively low HIV prevalence, such as pregnant women, raises concerns about the accuracy of laboratory tests used. Incorrect HIV test results can have significant psychologic and medical consequences for women who are misdiagnosed. The HIV-1 testing algorithm recommended by the U.S. Public Health Service involves initial screening with an enzyme immunoassay (EIA) followed by confirmatory testing of repeatedly reactive EIAs with a supplemental test such as Western blot (WB) or immunofluorescence assay.3 While each of these tests is highly sensitive and specific, the use of both the EIA and supplementary tests further increases the accuracy of the results. Indeterminate Western blot results occur rarely, and can be due to either incomplete antibody response to HIV in sera from infected persons or to non-specific reactions in sera from uninfected persons.51,52,53 Persons recently infected with HIV who are in the process of seroconverting, those with end-stage disease, and perinatally exposed infants who are seroreverting can have incomplete antibody responses that produce negative or indeterminate results on Western blot. Non-specific reactions producing indeterminate results in uninfected persons have occurred more frequently in pregnant or parous women than in other groups with low HIV seroprevalence.52,53 No large scale studies to estimate the prevalence of indeterminate test results in pregnant women have been conducted. However, a survey testing more than 1 million neonatal dried-blood specimens for maternally acquired HIV-1 antibody found a relatively low rate of indeterminate Western blots (<1 in every 4,000 specimens tested by EIA; in all, 1,044,944 EIA tests and 2,845 Western blots were performed).53 False-positive Western blot results occur even less frequently. A study of more than 290,000 blood donors using a sensitive culture technique found no false-positive Western blots.54 A study of the frequency of false positive diagnoses among military applicants from a low prevalence population (<1.5 infections per 1,000 population) found 1 false positive among 135,187 persons tested.55 Incorrect HIV test results occur primarily because of specimen handling errors, laboratory errors, or failure to follow the recommended testing algorithm. However, patients may report incorrect test results because they misunderstood previous test results or misperceive that they are infected.56 While these occurrences are rare, increased testing of pregnant women will result in additional indeterminate, false-positive, and incorrect results. Because of the significance of a positive HIV test for the mother's health and reproductive decisions and because of the potential toxicity of HIV therapeutic drugs for both the pregnant woman and her infant, it is essential that test results are obtained and interpreted correctly. Correct interpretation often requires consideration of not only additional testing, but also the woman's clinical condition and epidemiologic characteristics, including history of possible exposure to HIV infection. RECOMMENDATIONS Recommendations for HIV Counseling and Testing of Pregnant Women and Their Newborns 1. Health care providers should ensure that all pregnant women are routinely counseled and encouraged to be tested for HIV infection to allow women to know their infection status both for their own health and for reducing the risk of HIV transmission to their infants and others. Pretest HIV counseling of pregnant women should be in accordance with previous guidance on HIV counseling (3,5,6) and should include information regarding the potential risk of HIV infection associated with sexual activity and injection drug use, ways to reduce her risk of becoming infected or transmitting HIV or other sexually transmitted diseases, the risk of transmission to her infant if she is infected, and the availability of therapy to reduce this risk. Pretest HIV counseling should be linguistically, culturally, and educationally appropriate for individual patients. 2. HIV testing of pregnant women and their infants should be voluntary. Consent for testing should be in accordance with legal requirements of the jurisdiction where testing is performed. Women who are found to be infected or who refuse testing must not be denied prenatal or other health-care services, reported to child protective service agencies because of refusal to be tested or because of their HIV status, or discriminated against in any other way. 3. Health care providers should counsel and offer HIV testing to women as early in pregnancy as possible so that informed therapeutic and reproductive decisions can be made in a timely manner. Ideally, women should know their HIV infection status before becoming pregnant. 4. Uninfected pregnant women who continue to be at high risk for infection (e.g., injecting drug users, women who continue to have unprotected sexual contact with an HIV- infected or high-risk partner, etc.) should be encouraged to avoid further HIV exposure and to be retested in the third trimester of pregnancy to rule out recently acquired HIV infection.6 5. The prevalence of HIV infection may be higher in women who have not received prenatal care.57 These women should receive rapid assessment for HIV infection and for consideration and use of intrapartum and postpartum ZDV to reduce the risk of perinatal HIV transmission. Such an assessment should include information regarding prior HIV testing, test results, and risk history. If the woman is known to be HIV-infected, she should be offered ZDV therapy according to published recommendations.9 If her HIV infection status is unknown, she should be counseled and encouraged to be tested for HIV as soon as the clinical situation permits. In some situations, however, management of obstetrical emergencies may preclude discussions of HIV testing before delivery. 6. Although prenatal HIV counseling and voluntary testing of women is recommended because it identifies both women and children in need of care and offers the opportunity to prevent perinatal transmission, some HIV-infected women do not receive prenatal care, may choose not to be tested for HIV, or may not retain custody of their newborns. If the mother refuses testing for herself, she should be informed of the importance of knowing her child's infection status for the child's health and encouraged to allow the child to be tested. For infants with unknown HIV infection status who have been placed in foster care, the authority legally able to provide consent should be encouraged to allow the infant to be tested, with the consent of the biologic mother when possible. The mother or other guardian responsible for providing consent for HIV testing of the infant should be informed that a positive antibody test in the infant is indicative of HIV infection in the biologic mother. 7. Pregnant women should be provided access to other HIV prevention and treatment services (e.g., drug treatment) as needed. --$----Novell--Attachment----$ X-NVL-Content-Type: TEXT X-NVL-Content-Charset: X-IBM-437 X-NVL-Content-Filename: attach X-NVL-Content-Modification-Date: 23-Feb-1995 16:04:00 -0500 FEDERAL REGISTER NOTICE ********************************** DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Availability of Draft U.S. Public Health Service Recommendations for HIV Counseling and Testing for Pregnant Women AGENCY: Centers for Disease Control and Prevention (CDC), Public Health Service (PHS), Department of Health and Human Services. ACTION: Notice of availability and request for comments. SUMMARY: This notice announces the availability for review and comment of a draft document entitled ``U.S. Public Health Service Recommendations for HIV Counseling and Testing for Pregnant Women.'' The document was prepared by CDC staff in collaboration with other internal PHS and external consultants. DATES: To ensure consideration, written comments on this draft document must be received on or before April 10, 1995. ADDRESSES: Requests for copies of the draft recommendations must be submitted to the CDC National AIDS Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003, telephone (800) 458-5231. Written comments on the draft document should be sent by mail or facsimile to the Technical Information Activity, Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Mailstop E-49, 1600 Clifton Road, NE., Atlanta, GA 30333, facsimile (404) 639-2007, for receipt by April 10, 1995. FOR FURTHER INFORMATION CONTACT: Technical Information Activity, Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Mailstop E-49, Atlanta, GA 30333. SUPPLEMENTARY INFORMATION: In February 1994, the National Institutes of Health announced interim results from AIDS Clinical Trial Group (ACTG) protocol 076 indicating that zidovudine (ZDV) therapy administered to a select group of HIV-infected pregnant women and their newborns reduced the risk of perinatal HIV transmission by approximately two thirds. In April 1994, provisional recommendations for the use of ZDV therapy in HIV-infected pregnant women and their newborns were published. In June 1994, representatives from Federal and nonfederal health agencies and other organizations attended a meeting in Bethesda, Maryland, to discuss development of U.S. Public Health Service recommendations to prevent perinatal HIV transmission and the implications of those recommendations for HIV treatment, counseling, and HIV testing. In August 1994, the U.S. Public Health Service published recommendations for ZDV therapy to reduce the risk of perinatal transmission of HIV (also available from the CDC National AIDS Clearinghouse, telephone (800) 458-5231). The draft recommendations for HIV counseling and voluntary testing for pregnant women have been developed to provide a framework to enable pregnant women to know their HIV infection status; advise HIV-infected pregnant women of ways to prevent perinatal, sexual, and other stdin:1000transmission of HIV; facilitate appropriate follow up for HIV-infected women and their infants; and assist uninfected pregnant women in identifying methods to reduce their risk of acquiring HIV infection. ============================================ Date: Thu, 23 Feb 1995 16:48:36 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: US PHS Recommendations for HIV..... Part 2 of 2 Interpretation of HIV Test Results 1. HIV antibody testing should be performed according to published recommendations which include the use of an enzyme immunoassay (EIA) for antibody to HIV and confirmatory testing with an additional, more specific assay (e.g., Western blot, immunofluorescence assay).3 All assays should be performed and conducted according to manufacturer's instructions. 2. HIV infection in a pregnant woman (as indicated by antibody to HIV) is defined as a repeatedly reactive EIA and a positive confirmatory supplemental test. Confirmation or exclusion of HIV infection in a pregnant woman with indeterminate test results should be made not only on the basis of her HIV antibody test results but with consideration of her medical and behavioral history, additional virologic and immunologic tests when performed, and clinical follow-up. Uncertainties regarding HIV infection status, including laboratory test results, should be resolved before final decisions are made about pregnancy termination, ZDV therapy to prevent perinatal transmission, or other interventions. 3. Pregnant women with repeatedly reactive EIA and indeterminate supplemental tests should be retested for HIV antibody immediately to distinguish between recent seroconversion and a negative test result. Women whose results remain indeterminate, especially those with behavioral risk factors for HIV, recent exposure to HIV, or clinical symptoms compatible with acute retroviral illness, may require additional tests such as viral culture or polymerase chain reaction to exclude HIV infection. 4. Women with negative or repeatedly reactive EIA but negative supplemental tests should be considered uninfected. Specific Recommendations for HIV-infected Pregnant Women 1. HIV-infected pregnant women should be evaluated to assess their need for antiretroviral therapy, antimicrobial prophylaxis, and treatment of other conditions for their own health according to published recommendations.8,58,59 Although medical management of HIV infection is essentially the same for pregnant and nonpregnant women, recommendations for treatment of tuberculosis have been modified for HIV-infected pregnant women because of potential teratogenic effects of specific medications (60) (e.g., use of either streptomycin or pyrazinamide during pregnancy is discouraged). HIV-infected pregnant women should be referred for psychological and social services as needed. 2. HIV-infected women should receive counseling as previously recommended.6 Such counseling should include a discussion of the interaction between pregnancy and HIV infection, (61) the risk of HIV transmission to their infants and ways to reduce this risk, the prognosis of HIV infection for their infants if they become infected, and the need to consider provision of future care for their children in the likely event that they, at some point, become unable to care for them. 3. HIV-infected pregnant women should be provided information on ZDV therapy to reduce the risk of perinatal HIV transmission, including the substantial benefit and short-term safety of ZDV, as well as the uncertainties regarding long-term risks of such therapy. Decisions about ZDV therapy should be made by the HIV-infected pregnant woman in a noncoercive atmosphere and based on a balance of the benefits and potential risks of the regimen to herself and and her child. For women who choose to receive the ZDV regimen, therapy should be offered according to published recommendations.9 4. HIV-infected pregnant women should receive information about all reproductive options. Counseling regarding reproductive options should be nondirective. Health care providers should be aware of the complex issues HIV-infected women face in making decisions about becoming pregnant or continuing a pregnancy and be supportive of the woman's choice. 5. To reduce the risk of HIV transmission to their infants, HIV-infected women in the United States should be advised to not breastfeed. Support services should be provided when necessary for use of appropriate breast milk substitutes for infant feeding. 6. To optimize medical management, positive and negative HIV test results should be available to a woman's health-care provider and, if possible, preferably be included on both her and her infant's confidential medical records. Maternal health care providers should notify the pediatric care providers of the impending birth of an HIV-exposed child and any anticipated complications. If HIV is first diagnosed in the child, the child's health care providers should obtain consent from the mother to notify her health care providers of her HIV infection. 7. Counseling for HIV-infected women should include an assessment of the potential for negative effects resulting from their HIV infection such as possible discrimination, domestic violence, and psychological difficulties. For women who anticipate or experience such difficulties, counseling should include 1) information on how to minimize these potential consequences, 2) assistance in identifying supportive persons within their own social network, and 3) referral for appropriate psychological, social, and legal services. 8. HIV-infected women should be encouraged to allow HIV testing of any of their children born after they became infected or after 1977 if they do not know when they became infected. Testing of older children should be done with informed consent or assent. Women should be informed that the lack of signs and symptoms suggestive of HIV infection in older children does not necessarily indicate a lack of HIV infection; some perinatally infected children can remain asymptomatic for many years. Recommendations for Follow-up of Infected Women and Perinatally Exposed Children 1. Following pregnancy, HIV-infected women should be referred for ongoing HIV-related medical care including monitoring of immune function, antiretroviral therapy, and prophylaxis for and treatment of opportunistic infections and other HIV- related conditions.8,58,59 HIV-infected women should receive gynecologic care including regular Pap smears, reproductive counseling and information on the use of latex condoms and other methods to prevent sexually transmitted diseases, and treatment of gynecologic conditions according to published recommendations.8,10,11,62 2. HIV-infected women or other guardians of children born to these women should be informed of the importance of careful follow-up of their children and referred for follow-up care to determine the child's infection status, to initiate prophylactic therapy to prevent PCP, to evaluate the need for antiretroviral therapy and prophylaxis for other infections, to promptly diagnose and treat HIV-related conditions, and to monitor disorders in growth and development, which often occur in the first two years of life.8,35,35,63 HIV-infected children and other children sharing households with HIV- infected persons should be immunized according to published recommendations for altered schedules.40 3. Because identification of an HIV-infected mother also identifies a family that is or will be in need of many medical and social services as the disease progresses, health-care providers should ensure that referrals to health-care and other services are provided for the family. REFERENCES 1. Conner EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med 1994;331:1173-80. 2. CDC. Recommendations for assisting in the prevention of the perinatal transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus and acquired immunodeficiency syndrome. MMWR 1985;34:721-6,731-2. 3. CDC. Public Health Service guidelines for counseling and antibody testing to prevent HIV infection and AIDS. MMWR 1987;36:509-15. 4. CDC. Additional recommendations to reduce sexual and drug abuse-related transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus. MMWR 1986;35:152-5. 5. CDC. Technical guidance on HIV counseling. MMWR 1993;42(RR- 2). 6. CDC. HIV counseling, testing and referral. Standards & guidelines. Atlanta: U.S. Department of Health & Human Services, Public Health Service, May 1994. 7. Hardy LM, ed. HIV screening of pregnant women and newborns. Washington, D.C.: National Academy Press, 1991. 8. El-Sadr W, Oleske JM, Agins BD, et al. Evaluation and Management of Early HIV Infection. Clinical Practice Guideline No. 7. AHCPR Publication No. 94-0572. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services, January 1994. 9. CDC. Recommendations of the U.S. Public Health Service Task Force on the use of zidovudine to reduce perinatal transmission of human immunodeficiency virus. MMWR 1994;43(RR-11). 10. ACOG Technical Bulletin. Human Immunodeficiency Virus Infections. June 1992;169. 11. CDC. 1993 Sexually transmitted diseases treatment guidelines. MMWR 1993;42(RR-14). 12. National Center for Health Statistics. Annual summary of births, marriages, divorces, and deaths: United States, 1993. Monthly Vital Statistics Report, Vol. 42, No. 13. Hyattsville, MD: Public Health Service. 1994. 13. 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