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Universal, Routine Screening of Pregnant Women for HIV Infection (I-01) Full Text

Introduction

Perinatal Transmission of HIV

Factors Associated with Perinatal Transmission of HIV
Dynamics of Transmission
Breastfeeding
Maternal Viral Load
Mode of Delivery

Current Barriers to Eliminating Perinatal Transmission in the United States
Epidemiology of HIV in Women
Adequacy of Prenatal Care

Universal, Routine Screening Versus Mandatory Screening

CDC Strategies to Reduce Perinatal HIV Transmission

Conclusions

Recommendations (Adopted AMA Policy)
References
Tables

Perinatal transmission of human immunodeficiency virus (HIV) from the HIV-infected mother to her infant is the principal cause of HIV infection in infants and children in the United States. Early in the HIV epidemic, it was proposed that mandatory screening of pregnant women for HIV infection might be appropriate to reduce the transmission rate. However, following the rapid and successful implementation of United States Public Health Service (USPHS) guidelines for universal counseling and voluntary HIV testing of pregnant women and the use of zidovudine to prevent perinatal transmission of HIV, the number of estimated pediatric acquired immunodeficiency syndrome (AIDS) cases diagnosed annually in the United States has declined steadily. Nevertheless, some barriers to eliminating perinatal HIV transmission in the United States still exist. This report reviews the recent literature on perinatal transmission of HIV and discusses the benefits of routine, universal HIV testing of all pregnant women, with patient notification of the right of refusal, as a routine component of prenatal care. It also examines the advantages of this approach over mandatory screening of all pregnant women for HIV infection.

Data Sources:  Literature searches conducted in the MEDLINE database for articles published between 1996 to 2001 using the search terms AIDS or HIV in combination with perinatal transmission or prenatal screening or pregnancy yielded a combined total of 1401 references. One hundred sixty-two English-language references, from 1998 to 2001, were examined further. Additional references were culled from the bibliographies of these references. Lexis/Nexis news databases were searched for current developments using the search term HIV and perinatal transmission. The World Wide Web was searched with several different search engines for information using the search words HIV or AIDS in combination with perinatal transmission or prenatal screening.

Perinatal Transmission of HIV

Perinatal transmission (also known as vertical transmission) of HIV is the most common cause of HIV infection in infants and children in the United States and is responsible for slightly more than 90% of pediatric AIDS cases and almost all new HIV infections in preadolescent children.¹ As of June 2001, adult women account for about 31% of US cases of new HIV infection and 25% of AIDS cases, and 78% of HIV-infected women are members of a racial or ethnic minority.² Through June 2001, women of childbearing age (aged 20 to 39 years) comprised 64% of AIDS cases in women.² Prevalence data suggest, and other studies of incidence of HIV in women show,³ that the rate of HIV infection in young women of childbearing age continues to increase in the United States. The HIV/AIDS epidemic in children strongly paralleled the growing epidemic in women until 1994, when antiretroviral prophylaxis was shown to reduce perinatal HIV transmission. Before 1994, it was estimated that 2000 US children were born annually with maternally transmitted HIV.^4,5 As of June 2001, a total of about 8,200 perinatally HIV-infected children had been born.² A disproportionate number (>84%) are African American or Hispanic.²

Reports on the worldwide frequency of transmission of HIV from mother to child range from 11% to more than 40% of children born to HIV-infected women, with transmission rates approximately doubled in breast-fed compared to formula-fed children.^6-8 These figures are derived from polymerase chain reaction and virus culture studies, as maternal antibodies are present in the newborn at birth^9-11 and may persist for up to 18 months.¹² In North America, in the absence of breastfeeding and antiretroviral intervention, the most widely quoted figures range from 15% to 25%.¹³ Variability in estimated transmission rates is likely due to a difference in prevalence of risk factors such as breastfeeding, premature birth, nutritional deficiencies, obstetrical practices, and maternal viral load.¹⁴ Thus, in countries in Africa, transmission rates can be as high as 40% or more.^15,16

In 1994, the landmark Pediatric AIDS Clinical Trial Group (PACTG) Protocol 076 demonstrated that a 3-part zidovudine regimen administered to selected women and their newborns reduced perinatal transmission from 25% to 8%.¹⁷ Consequently, the USPHS in 1994 released its first recommendation for the use of zidovudine to reduce perinatal transmission¹⁸ and in 1995 released its revised recommendations for HIV counseling for, and voluntary testing of, pregnant women.¹⁹ The USPHS recommended that "health care providers ensure that all pregnant women are counseled and encouraged to be tested for HIV…" and that the testing be voluntary and not mandatory.

Because of the rapid implementation of these guidelines and increased prenatal HIV counseling and testing, US perinatal HIV transmission rates decreased to as low as 5% with administration of zidovudine.²⁰ In 1996, combination therapy with protease inhibitors became available, resulting in increased use of combination antiretroviral therapy during pregnancy. In 1998, the USPHS released its prophylactic treatment guidelines for use of antiretroviral agents (including combination therapy) during pregnancy for maternal health and reduction of perinatal transmission.²¹ Such combination therapy led to reported transmission rates as low as 1.5% in 1999.^22-24 In 1999, it was also demonstrated that one dose of nevirapine given to the mother at labor and delivery and one dose given to the infant could reduce transmission 47% relative to a short regimen of intrapartum/one week neonatal zidovudine alone.²⁵ Studies on the use of nevirapine and other antiretroviral agents to reduce perinatal transmission are ongoing.^26-28 Finally, it has been shown that the use of scheduled cesarean section in the presence of zidovudine therapy can reduce the rate of perinatal HIV transmission to as low as 1%.^29,30

In February 2002, the USPHS released the latest version of its recommendations for use of antiretroviral drugs in pregnant HIV-1 infected women for maternal health and interventions to reduce perinatal HIV-1 transmission.²⁸ These recommendations reflect the availability of aggressive combination therapy to maximally suppress viral replication and state that while pregnancy may affect decisions of timing and choice of therapy, it is not a reason to defer standard treatment. However, it is stressed that using antiretroviral drugs during pregnancy requires unique considerations; data on short-term effects on the fetus, newborn, and mother are limited, and the potential long-term effects are unknown. Therefore, offering antiretroviral treatment to HIV-infected women should be accompanied by discussion of the known and unknown short- and long-term benefits and risks of such treatment for women and their infants. In addition to considering potential toxicity, distinction must be made between (1) the use of antiretrovirals for treatment of HIV infection in the woman; and (2) the use of antiretrovirals to reduce the risk of perinatal transmission. Thus, the recommendations for a treatment-experienced HIV-infected pregnant woman may differ from those for a treatment-naïve woman. It is highly recommended that health care professionals consult these USPHS recommendations, and/or seek consultation from HIV experts, when treating pregnant HIV-1-infected patients.

The most recent US surveillance data indicate the dramatic effects of the implementation of the USPHS guidelines for universal counseling and voluntary HIV testing of pregnant women and the use of zidovudine on the perinatal transmission of HIV in the United States. Besides the obvious decline in rates of perinatal transmission, estimated pediatric AIDS cases diagnosed each year have declined steadily since 1993. Between the first half of 1994, when the results of PACTG 076 were released, to the end of 1998, a 79% decline in the number of perinatal AIDS cases occurred.³¹ This decline coincides with the increased use of zidovudine, which rose from 13% in 1993 to 87% in 1998.³²

Although only 166 pediatric AIDS cases were reported in the United States between July 2000 and June 2001, perinatal transmission remains responsible for 86% of these cases.² Development of AIDS, however, is a late manifestation of perinatal HIV infection. As perinatal HIV infection is not yet reportable in all states, exact numbers are difficult to determine. However, the US Centers for Disease Control and Prevention (CDC) currently estimates that no more than 300 US infants a year acquire perinatal HIV infection.³³ Thus, current recommendations for universal counseling and voluntary HIV testing of pregnant women and the use of zidovudine in HIV-infected pregnant women have dramatically reduced perinatal HIV transmission, such that it is now possible to consider the elimination of perinatal HIV transmission in the United States.³⁴
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Factors Associated with Perinatal Transmission

Dynamics of Transmission: Perinatal transmission of HIV occurs primarily during pregnancy (in utero), during labor and delivery (intrapartum), and during breastfeeding (postpartum).^{6,13,14,28,31} In a nonbreastfeeding population, about 70% of perinatal transmissions occur at delivery and about 30% of transmissions occur in utero.^13,35 About 67% of in utero transmissions are thought to be due to virus transmitted during the last 14 days before delivery.^35,36

Infections occurring in utero are most likely the result of transplacental HIV transmission, either through breaks in the placental barrier (eg, development of chorioamnionitis), infection of placental cells leading to fetal infection, or transfer of cell-free virus across the placenta to the fetus (eg, through receptor-mediated endocytosis).^37,38 Evidence supporting the direct in utero transmission of HIV includes the discovery of HIV in aborted fetuses as early as 8 weeks into gestation,³⁹ and the isolation of HIV-1 from the peripheral blood of neonates at birth.⁴⁰

However, it is generally believed that intrapartum infection is responsible for the bulk of perinatal HIV transmissions.^41-43 Intrapartum HIV transmission occurs when infectious fluids from the mother directly contact the fetus during maternal-fetal microtransfusions of blood during uterine contractions; by ascending HIV infection through the cervix or vagina; or by the infant swallowing HIV present in maternal genital secretions during passage through the birth canal, with subsequent viral transmission by direct infection of gastrointestinal cells or indirect transfer of cell-free virus to lymphoid cells in the gastrointestinal mucosa.^37,38 Studies show that about 50% of HIV-infected infants born to HIV-positive mothers have undetectable virus levels at birth, but during the first week following delivery, HIV becomes detectable.⁴⁴ Other studies have demonstrated reduced HIV infection in infants born by cesarean section and increased transmission during prolonged rupture of membranes.^29,45 These data support the concept of infection of the newborn during labor and delivery.

Breastfeeding: Studies in Africa, where breastfeeding remains a common practice among HIV-infected mothers, reveal that as many as 50% of perinatal transmissions are due to breastfeeding following
birth.^6,46-48 HIV has been isolated from both cellular and cell-free extracts of human milk from HIV-infected women,^49-51 and rates of infection of the infant are higher when the mother seroconverts during breastfeeding, possibly associated with an increased maternal viral load.⁵² Little is known about when the greatest risk for transmission via breastfeeding occurs, but the highest risk probably exists during the first few months of life, and the risk declines thereafter.^46,47 An international multi-center meta-analysis identified the risk of transmission after the infant is 4 months of age as 3.2 cases per year per 100 breast-fed infants.⁵³

Data from a study in Kenya indicate that breastfeeding by HIV-1 infected women resulted in a maternal mortality rate that was higher than in HIV-infected women using formula. Additionally, there was an association between maternal death and subsequent infant death. Thus, breastfeeding by HIV-1 infected women might actually result in adverse outcomes for both mother and infant.⁵⁴ However, data from a study in South Africa did not reveal increased mortality in breastfeeding women, so this finding remains controversial and requires further research.⁵⁵

Maternal Viral Load: Many studies have now demonstrated the importance of maternal viral load in predicting the risk of perinatal transmission.^56,57 Two studies suggest that in pregnant women and their infants, maternal viral load was the best predictor of the risk, but not the timing, of perinatal transmission of HIV.^58,59 Elevated maternal viral load at the time of delivery may be particularly associated with increased transmission risk.^58,60 In women and infants receiving zidovudine therapy, antiretroviral treatment that reduced maternal viral load to <500 copies/mm³ eliminated the risk of perinatal transmission while improving the general health of the women.^58,59 Other reports indicate that perinatal transmission of HIV has occurred, even when viral load was undetectable, although the incidence is extremely rare.⁶¹ Increasing geometric mean levels of plasma HIV-1 RNA were generally associated with increasing rates of perinatal HIV transmission, with the highest rate of transmission among women whose HIV plasma level was >100,000 copies/mm.^3,59 Finally, in one study, there was no significant difference in the median levels of HIV RNA in mothers of infants with early infection and mothers of infants with late infection, and there was no relation between the rates of early or late transmission and maternal HIV levels measured throughout pregnancy.⁵⁹

Evidence also shows that antiretroviral therapy can help prevent perinatal transmission of HIV, even in women with maternal viral loads <1000 copies/mm.^3,62 Thus, antiretroviral treatment is recommended for all pregnant women regardless of their plasma HIV RNA levels.²⁸

That other factors play a role in perinatal transmission is suggested by the fact that some transmission of HIV occurs even when maternal viral levels are extremely low and because there is no upper threshold of viral load whereby transmission always occurs. Data also suggest that pre- and post-exposure prophylaxis of the infant is important in determining the perinatal transmission rate.⁶³ Premature birth, low birth weight, longer duration of membrane rupture (>4 hours before delivery), and obstetrical factors (eg, intrapartum use of fetal scalp electrodes or fetal scalp pH sampling) are also associated with increased rates of perinatal HIV transmission.^13,64,65

Mode of Delivery: Cesarean delivery before the onset of labor and the rupture of membranes has been shown to significantly reduce the incidence of perinatal HIV transmission, even in women receiving zidovudine.^29,30 Meta-analysis and other studies demonstrate an additive protection resulting from the combined use of zidovudine and scheduled cesarean delivery.⁶⁶ However, it is unknown whether scheduled cesarean delivery provides any benefit to either the mother or the child if the mother is on potent antiretroviral therapy that has lowered plasma viral loads to undetectable levels. Because there also is no threshold viral load below which no perinatal transmission can be guaranteed,²⁸ it remains controversial as to whether HIV-infected women on potent antiretroviral therapy with undetectable viral loads should deliver by scheduled cesarean. It is thought unlikely that scheduled cesarean would confer any further benefit to antiretroviral-treated women with low viral loads, as the perinatal transmission rates in this situation are already very low. Thus, the American College of Obstetricians and Gynecologists regards a maternal viral load of 1000 copies/mm³ as the threshold, above which it recommends consideration of scheduled cesarean delivery to prevent perinatal HIV transmission.⁶⁷

Cesarean delivery is associated with additional risks as compared with vaginal delivery. The risks may be similar for HIV-infected and noninfected women^30,68; however, several case-control studies have implied an increased risk in perioperative complications following cesarean delivery in HIV-infected women.^69-71 In several cases, increased complications were associated with a decreased CD4 T cell count^70,71; however, in a prospective study, increased complications were associated with more severe HIV disease but not necessarily with CD4 cell count.⁶⁹ Thus, HIV-infected women with low CD4 cell counts are more prone to complications from scheduled cesarean delivery but also stand to benefit most in terms of prevention of perinatal transmission. Consequently, HIV-infected women should be counseled about these increased risks associated with cesarean delivery.^{28
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Current Barriers to Eliminating Perinatal Transmission in the United States

Despite the remarkable success of perinatal transmission intervention programs, some perinatal HIV transmission still occurs in the United States. Thus, some barriers to eliminating perinatal HIV transmission continue to exist, the most important being the lack of timely HIV testing and treatment of pregnant women due to poor or absent prenatal care.^32,72

Epidemiology of HIV in Women: Before HIV can be transmitted to the infant, the woman must first become infected with the virus.^31,73 Unfortunately, the recent epidemiology of HIV in US women is disturbing. Through June 2001, 79% of HIV infections in women were in those aged 13 to 39 years, and there were more HIV infections in women aged 13 to 19 years than there were in similarly aged men.² Most of these women (90%) apparently acquired their infection through heterosexual contact.^2,31 An overwhelming proportion of these women belong to an ethnic minority. Data on HIV prevalence in out-of-school youth (aged 16 to 21 years) in the Job Corps indicate that HIV prevalence was higher in young women than young men, and higher among young African-American women than any other race or gender category.⁷⁴ Unfortunately, these young women at high risk of HIV infection are also at high risk for unintentional pregnancy.³¹ Unintended pregnancies also tend to occur frequently in young women infected with HIV.^75,76 "Street youth" are particularly vulnerable to unintended pregnancy and are also more likely to contract HIV because of high-risk behaviors.⁷⁷ To control perinatal transmission of HIV, prevention programs must target these youth and should be coupled with efforts to treat substance abuse and to reduce adolescent pregnancy.

Adequacy of Prenatal Care: HIV-infected women must be identified early in pregnancy for counseling and treatment to occur. Data from a national CDC study of HIV-infected women indicate that by 1996 all but an estimated 20% of HIV-infected pregnant women had received a diagnosis before delivery, demonstrating successful, albeit incomplete, implementation of the voluntary screening guidelines.⁷⁶ Of the women who received prenatal care, a large proportion was treated according to the regimens from PACTG 076. However, 14% of HIV-infected women received no or minimal prenatal care and another 19% did not initiate prenatal care until the third trimester.⁷⁶ Twenty-eight percent of HIV-infected women used illicit drugs during pregnancy and of these, 36% received no prenatal care. Of women who received HIV testing at or within 7 days of delivery, 71% had received no prenatal care and 67% had used drugs during pregnancy.

Among HIV-infected US women, those at the greatest risk of receiving no or minimal prenatal care are minority women, those living in urban settings, illicit drug users, women with shorter Medicaid enrollment during pregnancy, and those in whom HIV infection is not diagnosed until after delivery.^1,78 These women usually do not seek prenatal care for reasons such as fear of criminalization, social disruption, the stigmatization associated with illicit drug use, and a general lack of access to health care.^1,34

When a woman receives prenatal care, it is also important that she receive adequate counseling about HIV infection and the importance of testing for HIV. Surveys of US health care providers indicate that they are likely to offer HIV testing only to women they consider to be at risk for HIV infection, ⁷⁹ although providers in general agree that all pregnant women should be offered HIV testing.^79,80 Barriers reported by health care providers include a lack of provider time, the need for counseling and record keeping, and general embarrassment about discussing the issue with patients.^31,79

In 1999 the Institute of Medicine (IOM) called for universal, routine HIV testing of all pregnant women, with patient notification of the right of refusal (Table 1).^73,81 This recommendation was subsequently adopted by the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and, in November 2001, by the USPHS. For women receiving prenatal care, this new standard should increase the number of HIV-infected women receiving a proper diagnosis. When properly implemented (Table 2), the universal offer of HIV testing is not intrusive and is acceptable to pregnant women.⁸² When antiretroviral therapy is offered to HIV-infected women for prevention of perinatal transmission, it is rarely refused^32,72; data demonstrate that women with a diagnosis of HIV infection will act to reduce the risk of transmission of HIV to their infants.⁸³ However, following diagnosis, it is important to provide adequate counseling about HIV infection and proper advice on antiretroviral therapy for both treatment of the infection in the woman and reduction of perinatal transmission to the infant.²⁸ The IOM report also emphasized that without linkage to specialty care, the recommendation for universal, routine HIV testing would violate one of the most fundamental criteria for public health screening programs: that there should be adequate facilities for diagnosis and resources for treatment for all who are found to have the condition, as well as agreement as to who will treat them.

For HIV-infected women who do not receive prenatal care until late in pregnancy or during labor and delivery, reliable rapid HIV testing must be available. ^32,84 Short-course antiretroviral treatments for these women will also be important, as zidovudine and other antiretroviral treatments when administered in partial regimens can reduce perinatal HIV transmission.^63,85,86 Evidence that antiretroviral therapy administered to the mother at the onset of labor and to the newborn can also reduce the incidence of perinatal HIV transmission further supports the need for rapid HIV testing.^{25,63,85,87
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Universal, Routine Screening Versus Mandatory Screening

The controversy over HIV testing of pregnant women has subsided somewhat since the original debate in 1996. There are probably two major reasons: first, the tremendous success in reducing perinatal HIV transmission as a result of the implementation of voluntary HIV testing program as originally recommended by the USPHS, and second, the recommendation from the IOM for universal HIV testing, with patient notification of the right of refusal, as a routine component of prenatal care. In fact, numerous experts in the field of perinatal HIV transmission believe that with successful implementation of the IOM recommendation, the major hurdle to reducing perinatal transmission of HIV lies in increasing access to adequate prenatal care.^31-33,73

Past controversy about HIV screening of pregnant women was related less to the scientific aspects than to the social, ethical, and political implications of testing, particularly mandatory testing. HIV disease and the individuals infected with it have often been subjected to prejudice and discrimination, such that the potential for such effects is enough to separate HIV screening from screening for other maternal infectious diseases. Ironically, rigid legal requirements for informed consent for prenatal HIV testing, which exist in some US states,⁸⁸ actually hinder the implementation of universal HIV testing, with patient notification of the right of refusal, as a routine component of prenatal care.⁸⁸

It has been suggested that mandatory testing for HIV in pregnant women is rational because of the life-and-death issue at stake for the infant.⁸⁹ However, the failure of mandatory premarital HIV testing in the United States highlights the important shortcomings of such testing. When mandatory premarital HIV testing was implemented in Illinois, the number of marriage licenses issued greatly declined.⁹⁰ Thus, mandatory testing may actually reduce the number of pregnant women seeking prenatal care, especially those in high-risk populations.⁹¹

Mandatory testing also requires that persons who are identified as HIV-positive be provided medical care and social services follow-up. If pregnant women are required to be tested for HIV, states must be prepared to provide medication and social services when a positive diagnosis occurs. This will further tax already stressed state resources. Along these lines, ethical and legal questions will then arise concerning a state’s ability to force a woman to submit to antiretroviral therapy for the benefit of her infant even if she does not want such treatment. Antiretroviral therapy is extremely complex, especially during pregnancy, and requires the active participation of both the patient and her physician.²⁸ Finally, states would also have to consider the ethical and legal ramifications of whether or not to punish a woman who refuses HIV testing, antiretroviral therapy, or both.

On the other hand, the benefits of universal, routine screening, with patient notification of the right of refusal, are many. Studies indicate that universal screening is cost-effective,⁹² acceptable to pregnant women,⁸² and can achieve the benefits of prenatal HIV screening without violating women’s civil liberties.⁹³ Mandatory programs would have the greatest direct costs and place the greatest burden on women’s constitutional rights.⁹³ Finally, studies have also shown that given high levels of acceptance of voluntary HIV testing now coming to fruition in the United States with the new IOM recommendation, the benefits of mandatory testing are minimal and may lead to avoidance of prenatal care to elude mandatory testing.^{91
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Centers for Disease Control and Prevention Strategies to Further Reduce Perinatal HIV Transmission

The CDC’s current perinatal HIV prevention activities⁹⁴ address the barriers to reducing perinatal HIV transmission described above. Thus, the CDC is distributing funds to high-prevalence states (>90% of HIV-infected women live in 7 states^2,32) to enhance voluntary counseling and testing programs; is involved in the USPHS working group that updates the antiretroviral guidelines for pregnant women; has updated CDC guidelines for HIV screening of pregnant women to reflect the IOM’s recommendation⁹⁵; and is supporting research into rapid HIV testing and evaluating its possible use during labor and delivery. The CDC is improving its surveillance activities and expanding HIV reporting to all states. It will support additional operational research to improve implementation of interventions during the intrapartum period and will continue to educate health care providers regarding universal, routine HIV testing of pregnant women. The CDC will also advocate for and support HIV testing of pregnant women as a Health Employer Data and Information Set (HEDIS) measure and will promote model Medicaid-managed care contract language.

The CDC will direct primary prevention programs at youth and women of childbearing age and will continue to seek congressional funding to enhance voluntary counseling and testing programs and services to pregnant women. Studies are being planned to evaluate where opportunities to reduce perinatal HIV transmission are being missed and also to examine possible interventions when cases of perinatal AIDS do occur. As research demonstrates the value of rapid testing, the CDC will work to expand availability of such testing for women with unknown HIV status presenting in labor. Rapid HIV testing will also be useful in the prenatal setting, especially for testing women who might be unlikely to return for test results.⁷³ Finally, the CDC will develop approaches for long-term monitoring of infants who were exposed to antiretroviral therapy perinatally. Significantly, lessons learned in the United States will be important for global efforts to reduce perinatal HIV transmission.
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Conclusion

In light of the data presented in this report, the AMA’s House of Delegates adopted several policy statements (see Recommendations) at its 2001 Interim Meeting, including supporting the IOM’s recommendation for universal, routine HIV testing of all pregnant women, with patient notification of the right of refusal, as a routine component of prenatal care.

RECOMMENDATIONS (Adopted AMA Policy)

The following statements, recommended by the Council on Scientific Affairs, were adopted by the AMA House of Delegates as AMA policy at the 2001 AMA Interim Meeting:

1. Counseling and Testing of Pregnant Women for HIV. The AMA supports the position that there should be universal HIV testing of all pregnant women, with patient notification of the right of refusal, as a routine component of prenatal care, and that such testing should be accompanied by basic counseling and awareness of appropriate treatment, if necessary.
   
2. Maternal HIV Screening and Treatment to Reduce the Risk of Perinatal HIV Transmission. In view of the significance of the finding that treatment of HIV-infected pregnant women with appropriate antiretroviral therapy can reduce the risk of transmission of HIV to their infants, the AMA recommends the following statements: (a) Given the prevalence and distribution of HIV infection among women in the United States, the potential for effective early treatment of HIV infection in both women and their infants, and the significant reduction in perinatal HIV transmission with treatment of pregnant women with appropriate antiretroviral therapy, routine education about HIV infection and testing should be part of a comprehensive health care program for all women The ideal would be for all women to know their HIV status before considering pregnancy. (b) Universal HIV testing of all pregnant women, with patient notification of the right of refusal, should be a routine component of prenatal care. Basic counseling on HIV prevention and treatment should also be provided to the patient, consistent with the principles of informed consent. (c) The final decision about accepting HIV testing is the responsibility of the woman. The decision to consent to or refuse an HIV test should be voluntary. When the choice is to reject testing, the patient’s refusal should be recorded. Test results should be confidential within the limits of existing law and the need to provide appropriate medical care for the woman and her infant. (d) To assure that the intended results are being achieved, the proportion of pregnant women who have accepted or rejected testing and follow-up care should be monitored and reviewed periodically at the appropriate practice, program or institutional level. Programs in which the proportion of women accepting HIV testing is low should evaluate their methods to determine how they can achieve greater success. (e) Women who are not seen by a health care professional for prenatal care until late in pregnancy or after the onset of labor should be offered HIV testing at the earliest practical time, but not later than during the immediate postpartum period. (f) When HIV infection is documented in a pregnant woman, proper post-test counseling should be provided. The patient should be given an appropriate medical evaluation of the stage of infection and full information about the recommended management plan for her own health. Information should be provided about the potential for reducing the risk of perinatal transmission of HIV infection to her infant through the use of antiretroviral therapy, and about the potential but unknown long-term risks to herself and her infant from the treatment course. The final decision to accept or reject antiretroviral treatment recommended for herself and her infant is the right and responsibility of the woman. When the woman’s serostatus is either unknown or known to be positive, appropriate counseling should also be given regarding the risks associated with breast-feeding for both her own disease progression and disease transmission to the infant. (g) Appropriate medical treatment for HIV-infected pregnant women should be determined on an individual basis using the latest published Public Health Service (PHS) recommendations. The most appropriate care should be available regardless of the stage of HIV infection or the time during gestation at which the woman presents for prenatal or intrapartum care. (h) To facilitate optimal medical care for women and their infants, HIV test results (both positive and negative) and associated management information should be available to the physicians taking care of both mother and infant. Ideally, this information will be included in the confidential medical records. Physicians providing care for a woman or her infant should obtain the appropriate consent and should notify the other involved physicians of the HIV status of and management information about the mother and infant, consistent with applicable state law. (i) Continued research into new interventions is essential to further reduce the perinatal transmission of HIV, particularly the use of rapid HIV testing for women presenting in labor and for women presenting in the prenatal setting who may not return for test results. The long-term effects of antiretroviral therapy during pregnancy and the intrapartum period for both women and their infants also must be evaluated. For both infected and uninfected infants exposed to perinatal antiretroviral treatment, long-term follow-up studies are needed to assess potential complications such as organ system toxicity, neurodevelopmental problems, pubertal development problems, reproductive capacity, and development of neoplasms. (j) Health care professionals should be educated about the benefits of universal HIV testing, with patient notification of the right of refusal, as a routine component of prenatal care, and barriers that may prevent implementation of universal HIV testing as a routine component of prenatal care should be addressed and removed. Federal funding for efforts to prevent perinatal HIV transmission, including both prenatal testing and appropriate care of HIV-infected women, should be maintained.
   
3. Neonatal HIV Antibody Screening. The AMA: (a) Urges the US Public Health Service to rapidly pursue the implementation of confirmatory tests and procedures for more accurate demonstration of HIV infection in the newborn; (b) supports HIV antibody testing of the newborn in states with a high prevalence of HIV infection on a voluntary basis with maintenance of strict confidentiality; (c) favors giving consideration to rapid HIV testing of newborns, with maternal consent, when the maternal HIV status has not been determined during pregnancy or labor.
   
4. AMA Policy H-20.988 paragraph (2), Prevention and Control of AIDS, is amended to read:

Voluntary testing should be regularly provided for the following types of individuals who give an informed consent: (a) Patients at sexually transmissible disease clinics. (b) Patients at drug abuse clinics. (c) Individuals who are from areas with a high incidence of AIDS or who engage in high-risk behavior seeking family planning services. (d) Patients who are from areas with a high incidence of AIDS or who engage in high-risk behavior requiring surgical or other invasive procedures. In addition, universal HIV testing of all pregnant women, with patient notification of the right of refusal, should be a routine component of prenatal care.

The following statements, recommended by the Council on Scientific Affairs, were adopted by the AMA House of Delegates as AMA directives at the 2001 AMA Interim Meeting:

1. The AMA supports the recommendations of the Institute of Medicine’s report on perinatal HIV transmission, "Reducing the Odds: Preventing Perinatal Transmission of HIV in the United States."
2. The AMA’s Council on Scientific Affairs will prepare a policy consolidation report that will consolidate current AMA policy on HIV.

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References

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Table 2. Institute of Medicine Recommendations for Incorporating Universal, Routine HIV Testing into Prenatal Care

• Health departments, professional organizations, medical specialty boards, regional perinatal HIV centers, and health care plans should increase their emphasis on education of prenatal care providers about the value of universal HIV testing and about avenues of referral for patients who test positive.
• Because specific clinical policies and guidelines from professional organizations have great impact on physicians’ practices, professional organizations should update their clinical practice guidelines to facilitate universal, routine prenatal HIV testing, with patient notification of the right of refusal.
• Health care plans and providers should develop, adopt, and evaluate clinical policies to facilitate universal prenatal HIV testing.
• Health care providers should become aware of the complex reasons why some pregnant women will refuse testing; outreach and education programs should be developed to address pregnant women’s concerns about HIV testing and treatment.
• Interventions to prevent perinatal transmission of HIV include targeting illicit drug users and averting unintended pregnancy; preconception counseling should provide an opportunity to identify and assist HIV-infected women who are considering pregnancy.
• The proportion of women, especially drug users, who receive prenatal care must be increased, including activities to: (1) remove financial barriers to care; (2) ensure adequate basic system capacity; (3) improve prenatal services at the delivery site; and (4) increase public information and education about prenatal care.
• Labor and delivery represents the last opportunity to interrupt perinatal HIV transmission through administration of antiretroviral therapy and advice to avoid breastfeeding but is not the ideal time for securing consent for HIV testing and for counseling on the implications of a positive result. Any program seeking to implement rapid HIV testing at labor and delivery must consider these issues.
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