Revised Recommendations for HIV Screening of Pregnant Women
Perinatal Counseling and Guidelines Consultation
April 26–27, 1999
Deborah Allen, Sc.D.
Division of Children With Special Health Needs
Bureau of Family and Community Health
Massachusetts Department of Public Health
Arthur Ammann, M.D.
Global Strategies for HIV Prevention
San Rafael, California
National Association of People with AIDS
United Health Care
New York, New York
Guthrie Birkhead, M.D., M.P.H.
Council of State and Territorial Epidemiologists
Albany, New York
Mary Boland, M.S.N., F.A.A.N.
University of Medicine & Dentistry of New Jersey
Newark, New Jersey
Health Education Department
Panorama City, California
Ezra Davidson, Jr., M.D.
Charles R. Drew University of Medicine & Science
Los Angeles, California
Maria Isabel Fernandez, Ph.D.
Department of Psychiatry & Behavioral Sciences
University of Miami School of Medicine
Toni Frederick, Ph.D.
Pediatric Spectrum of Disease Study
Los Angeles County Department of Health Services
Los Angeles, California
Donna Futterman, M.D.
Adolescent AIDS Program, Montefiore Medical Center and
Albert Einstein College of Medicine
Bronx, New York
Children’s Hospital Pediatric Infectious
Division of Advocacy & Special Issues
Health Care Financing Administration
AIDS Policy Center for Children, Youth, & Families
Family Planning Council
Association of Maternal & Child Health Programs
Sisters Together & Reaching
Johns Hopkins OBGYN Department
Jeanette Ickovics, Ph.D.
Department of Epidemiology
Yale University School of Medicine
New Haven, Connecticut
Ann Koontz, Dr.PH.
Division of Perinatal Systems/Women’s Health
Maternal & Child Health Bureau
Marlene LaLota, M.P.H.
Bureau of HIV/AIDS, Department of Health
Zita Lazzarini, J.D., M.P.H.
Program in Medical Humanities, Health Law and Ethics
University of Connecticut Health Center
Robert Levine, M.D.
Professor of Medicine
Yale University School of Medicine
Michael Lindsay, M.D.
Department of OB-GYN
Katherine Luzuriaga, M.D.
University of Massachusetts Medical School
Miguelina Maldonado, M.S.W.
National Minority AIDS Council
James McNamara, M.D.
National Institutes of Health
Lynne Mofenson, M.D.
National Institutes of Health/NICHD
Angus Nicoll, F.R.C.P.H., F.F.P.H.M., F.R.C.P.
HIV and STD Division, PHLS Communicable Disease Surveillance Centre
Deborah Parham, Ph.D.
Health Resources and Services Administration
Sindy Paul, M.D.
Division of AIDS Prevention and Control
New Jersey Department of Health
Trenton, New Jersey
Jim Pearson, Dr.PH.
Virginia Department of Health
Laura Riley, M.D.
Massachusetts General Hospital
Gwendolyn B. Scott, M.D.
Division of Pediatric Infectious Diseases and Immunology, University of Miami
School of Medicine
Association of Women’s Health, Obstetric, and Neonatal Nurses
San Francisco, California
Children’s Diagnostic and Treatment Center
Christa-Marie Singleton, M.D., M.P.H.
Maternal and Child Health Policy
Association of State and Territorial Health Officers
The Children AIDS Fund
Pauline Thomas, M.D.
Office of AIDS Surveillance
New York City Department of Health
New York, New York
Kate Thomsen, M.D.
Planned Parenthood Federation of America
New York, New York
Deborah Von Zinkernagel
Office of HIV/AIDS Policy
Diane Wara, M.D.
University of California, San Francisco
San Francisco, California
Theresa Watkins-Bryant, M.D.
Division of Programs for Special Populations
Bureau of Primary Health Care
Catherine Wilfert, M.D.
Duke University Medical Center
Chapel Hill, North Carolina
Carmen Zorilla, M.D.
University of Puerto Rico
San Juan, Puerto Rico
The following CDC staff members prepared this report:
Martha F. Rogers, M.D.
Mary Glenn Fowler, M.D., M.P.H.
Mary Lou Lindegren, M.D.
Division of HIV/AIDS Prevention — Surveillance and
National Center for HIV, STD, and TB Prevention
These guidelines replace CDC's 1995 guidelines,
U.S. Public Health Service Recommendations for Human Immunodeficiency Virus Counseling
and Voluntary Testing for Pregnant Women, and are for public- and
private-sector service providers who provide health care for pregnant women. In 1998,
the Institute of Medicine (IOM) published a report that recommended
simple, routine, and voluntary human immunodeficiency virus (HIV) testing for
all pregnant women in antenatal settings, given the effective
interventions available to treat HIV-infected women and reduce risk for perinatal
HIV transmission. In 1999, CDC convened consultation groups to discuss
and comment on the IOM report. These guidelines are based on input from
these meetings, the IOM report, and public comment on draft guidelines published
in Fall 2000 in the Federal Register. These guidelines were also prompted
by scientific and programmatic advances in the prevention of perinatally
acquired HIV and care of HIV-infected women. These recommendations are
consistent with the Revised Guidelines for HIV Counseling, Testing, and
Major revisions from the 1995 guidelines include
- emphasizing HIV testing as a routine part of prenatal care
and strengthening the recommendation that all pregnant women be tested
- recommending simplification of the testing process so that
pretest counseling is not a barrier to testing;
- making the consent process more flexible to allow for various types
of informed consent;
- recommending that providers explore and address reasons for refusal
of testing; and
- emphasizing HIV testing and treatment at the time of labor and
delivery for women who have not received prenatal testing and
These guidelines recommend voluntary HIV testing to preserve a
woman's right to participate in decisions regarding testing to ensure a
provider-patient relationship conducive to optimal care for mothers and infants and to support
woman's right to refuse testing if she does not think it is in her best interest.
In 1994, after the announcement of the results of Pediatric AIDS Clinical
Trials Group (PACTG) protocol 076 (1), the Public Health Service (PHS) published
guidelines for zidovudine (ZDV) use to reduce perinatal human immunodeficiency virus
(HIV) transmission (2). In 1995, PHS issued guidelines recommending universal
counseling and voluntary HIV testing of all pregnant women and treatment for those infected
(3). Publication of these recommendations was followed by rapid implementation
by health-care providers, widespread acceptance of chemoprophylaxis by
HIV-infected women, and a steep and sustained decline in perinatal HIV transmission
(4,5). Observational studies have confirmed the effectiveness of ZDV in reducing the risk
for perinatal transmission (6--8). This reduction in transmission risk resulted in an
83% decline in perinatal acquired immunodeficiency syndrome (AIDS) cases diagnosed
in 1999, compared with the peak incidence of 907 cases in 1992
Despite this progress, children are still being infected perinatally. CDC
estimates that 280--370 infants are born with HIV infection each year in the United States
(CDC, unpublished data, 2000). These continued infections underscore the need for
improved strategies to ensure that all pregnant women are offered HIV testing and, if
positive, treatment to reduce their transmission risk and to safeguard their health and
the health of their infants.
Several lessons have been learned from evaluation of the 1995 PHS
guidelines. Many women, especially those who used illicit drugs, were not tested for HIV
during pregnancy because of lack of prenatal care
(8). In addition, many women refused testing because their health-care providers did not strongly recommend it.
Some women declined testing because of perceived low risk, and some providers failed
to offer testing because of perceived low risk, perceived difficulties and complexity
of required counseling, and misunderstanding of counseling requirements. The
logistics of testing, if too complex, also were considered a potential barrier to testing.
In December 1998, the Institute of Medicine (IOM) completed a
study commissioned by Congress to assess the impact of current approaches for
reducing perinatal HIV transmission, identify barriers to further reductions, and determine
ways to overcome these barriers (9). IOM concluded that continued perinatal
transmission was mainly caused by a lack of awareness of HIV status among some
pregnant women. This problem was attributed to some health-care providers not offering
HIV testing to all pregnant women because the providers believed they could predict
which women were most at risk and that standard HIV testing protocols, particularly
the requirement for extensive pretest counseling, were too burdensome to conduct for
all women. IOM concluded that HIV testing should be simplified and made routine.
They recommended that the United States adopt a national policy of universal HIV
testing, with patient notification, as a routine component of prenatal care. That is,
testing should be offered to all pregnant women as part of the standard battery of
prenatal tests, regardless of risk factors and the prevalence rates in the community. IOM
also recommended that women be informed when an HIV test is conducted and of
their right to refuse testing.
Since 1994--1995, major scientific advances in the prevention of
perinatal transmission and the care of HIV-infected persons have occurred. These
advances increased the benefit of knowing one's HIV status, especially during pregnancy.
More effective treatment has prolonged survival of HIV-infected persons and improved
their quality of life (10). Clinical trials proved the effectiveness of prophylactic therapy
for preventing perinatal transmission in women who are not treated until the time
of delivery (11). Studies have indicated that women with nondetectable viral load
rarely transmit HIV infection (12--14). Finally, new testing technologies (e.g., rapid
testing, urine sampling) offer new options for HIV screening.
To address the lessons learned, IOM findings, and scientific advances, as well
as the causes of continued HIV infection in children, PHS convened specialists in the
field in April 1999 and sought widespread public comment in revising the 1995
guidelines for HIV counseling and testing for pregnant women. Consultation groups
included researchers, professional health-care provider organizations (e.g., American
Academy of Pediatrics, American College of Obstetricians and Gynecologists), clinicians,
women living with HIV, and representatives from community organizations and PHS
agencies overseeing care of HIV-infected pregnant women.
The resulting guidelines are presented in this document. They differ from the
1995 guidelines in that they
- emphasize HIV testing as a routine part of prenatal care and strengthen
the recommendation that all pregnant women be tested for HIV,
- recommend simplifying the testing process so that pretest counseling is not
a barrier to testing,
- increase the flexibility of the consent process to allow for various types
of informed consent,
- recommend that providers explore and address reasons for refusal of
- emphasize HIV testing and treatment at the time of labor and delivery for
women who have not received prenatal testing and chemoprophylaxis.
These guidelines maintain a voluntary approach to HIV testing. This
voluntary approach preserves a woman's right to make decisions regarding testing and
supports a woman's right to refuse testing if she does not think it is in her best interest.
This document replaces the 1995 PHS guidelines
(3). These recommendations are primarily intended for providers of health care for women, with a focus on
HIV screening of pregnant women to reduce mother-to-child transmission of HIV.
This report does not address other concerns related to continued perinatal
transmission (e.g., lack of prenatal care). CDC programs targeted to states with the
highest incidence of perinatal HIV infection address these ongoing public health
problems (information on these programs is available on the Internet at
<http://www.cdc.gov/hiv/projects/perinatal/default.htm>). Other PHS guidelines address the importance
of prevention interventions, including testing in the general population (see
Revised Guidelines for HIV Counseling, Testing, and
Referral). This report applies only to the United States; different recommendations, especially on breast-feeding, will apply
in other countries.
HIV Infection and AIDS in Women and Children
Of the approximately 750,000 AIDS cases reported to CDC through the end
of 1999, approximately 129,000 were in women. Approximately 64,000 women
were living with AIDS in 1999, a 31% increase from 1996, reflecting improved survival
with new combination treatment regimens (15). However, women with AIDS
represent only a fraction of the number of HIV-infected women who need medical and
social services. An estimated 120,000--160,000 HIV-infected women reside in the
United States, 80% of whom are of childbearing age
Most women with HIV/AIDS in the United States reside in the Northeast and
the South. The highest numbers of cases were first observed in the Northeast, but
the South has reported the greatest increases in recent years. African-American
and Hispanic women are disproportionately affected by the epidemic and account for
80% of AIDS cases reported in U.S. women in 1999. Over time, the proportion of cases
in women attributable to injection-drug use has declined, whereas the proportion
of cases from heterosexual contact has increased, particularly among young women.
During 1985--1995, approximately 6,000--7,000 HIV-infected women gave birth
in the United States each year (7). During the early 1990s, before
perinatal chemoprophylaxis was available, an estimated 1,000--2,000 infants were born
with HIV infection annually. By June 2000, a total of 8,027 perinatally acquired AIDS
cases were recorded nationwide, most (85%) in African-American and Hispanic
children (7,15). Before the results of the PACTG 076 trial using prenatal, intrapartum,
and postpartum ZDV for perinatal prophylaxis, the risk for mother-to-child
transmission ranged from 16% to 25% in studies from North America and Europe
(17--19), up to 24% in Thailand (20), and 25--40% in Africa
(21,22). Worldwide, approximately 600,000 infants each year become infected through mother-to-child transmission
of the HIV virus.
In the United States, widespread implementation of the PHS guidelines
for universal counseling and testing and perinatal use of ZDV has sharply
reduced transmission risk and the number of perinatally acquired HIV infections
(7). By 1995, several cohort studies had documented transmission rates of
<11% (19,23). During 1996--2000, U.S. studies indicated that transmission rates had declined to
5%--6% (12,24) and <1% in women with nondetectable plasma viral loads
(12,14,25). During 2000--2001, perinatal transmission rates of
<2% have been achieved with combination antenatal antiretroviral drugs
(26) or with ZDV combined with cesarean section
(27--29). Analysis of U.S. perinatal AIDS surveillance data
(15) reported through June 2000 indicated a sharp decline in the number of perinatal AIDS cases; this decline
was temporally associated with increasing ZDV use among pregnant women aware of
their HIV status (7). To more accurately monitor trends in perinatal HIV transmission and
the implementation and impact of perinatal prevention programs (including HIV
counseling and testing recommendations), CDC, the Council of State and
Territorial Epidemiologists (CSTE), and the American Academy of Pediatrics (AAP)
recommended national reporting of perinatal HIV exposure and HIV infection to help identify
and target populations where prevention opportunities are missed
Despite the declines, cases of perinatal HIV transmission continue to occur,
largely because of missed opportunities for prevention, particularly among women who
lack prenatal care or who are not being offered voluntary HIV counseling and testing
during pregnancy. The estimated 280--370 infants born with HIV infection each
year represent populations in which prevention efforts are impeded by lack of timely
HIV testing and treatment of pregnant women
(7). Of 329 children with perinatally
acquired AIDS born during 1995--1996, a total of 112 (34%) were born to mothers not tested
for HIV before the child's birth and 67 (20%) to mothers for whom the time of testing
was not known.
Dynamics of Perinatal HIV Transmission
Perinatal transmission can occur during pregnancy (intrauterine), during labor
and delivery (intrapartum), or after delivery through breast-feeding (postpartum). In
the absence of breast-feeding, intrauterine transmission accounts for 25%--40%
of infection, and 60%--75% of transmission occurs during labor and delivery
(32). Among women who breast-feed, approximately 20%--25% of perinatal infections are
believed to be associated with intrauterine transmission, 60%--70% with
intrapartum transmission or very early breast-feeding, and 10%--15% with later
postpartum transmission through breast-feeding
(33). In a randomized trial of formula
feeding versus breast-feeding, approximately 44% of HIV infection was attributed to
breast-feeding (34). In breast-feeding populations, a shift toward an increasing proportion
of transmission related to breast-feeding is likely to occur as a consequence of
successful preventive interventions directed at late prenatal and intrapartum transmission.
Intrapartum transmission can occur during labor through maternal-fetal
exchange of blood or during delivery by contact of the infant's skin or mucous membranes
with infected blood or other maternal secretions
(32). Several studies have indicated that most infections transmitted through breast-feeding probably occurred during the
first few weeks to months of life (34--36). Risk factors during breast-feeding include
viral load in breast milk (37,38), subclinical or clinical mastitis
(37,39,40), breast abscesses (39,40), and maternal seroconversion during the lactation period
Several risk factors are associated with perinatal HIV transmission. Clinical
factors that increase the likelihood of transmission include immunologically or
clinically advanced HIV disease in the mother, high plasma viral load
(12,25,42), maternal injection-drug use during pregnancy, preterm delivery, nonreceipt of the PACTG
076 regimen, and breast-feeding (32). No link has been established between perinatal
HIV transmission and maternal age, race/ethnicity, or history of having a
previously infected child.
Obstetric factors also influence HIV transmission risk. The risk for perinatal
trans-mission increases per hour duration of membrane rupture after controlling for
other risk factors (43). Delivery >4 hours after the rupture of the fetal membranes
can double the risk for HIV transmission
(19,44). Maternal infection with another
sexually transmitted disease (STD) during pregnancy and certain obstetrical procedures
can also increase risk (45). Chorioamnionitis (i.e., uterine infection) has been
associated with an increased risk for HIV transmission
Most of these risk factors were identified before the recommended use of ZDV
to prevent perinatal HIV transmission. Their effects are unknown now that most
pregnant women infected with HIV are receiving ZDV chemoprophylaxis to prevent
child transmission, as well as combination therapy for their own health. Because of
the sharp reductions in perinatal HIV transmission associated with effective
antiretroviral interventions, factors that interfere with women or their infants receiving
ZDV treatment (e.g., barriers to prenatal care, lack of HIV testing for some
pregnant women) are increasingly important
Prevention of Perinatal Transmission
The birth of every perinatally HIV-infected infant is a sentinel health event
signaling either a missed prevention opportunity or, more rarely, a failure of prophylaxis.
An opportunity is missed whenever a woman of childbearing age is unaware of her
HIV status or her risk for HIV or when an HIV-infected pregnant woman a) does not
receive prenatal care, b) is not offered HIV testing, c) is unable to obtain HIV testing, d) is
not offered chemoprophylaxis, e) is unable to obtain chemoprophylaxis, or f) does
not complete the chemoprophylaxis regimen. Prophylaxis failures occur when an
infant becomes infected despite chemoprophylaxis and other preventive interventions
(9). Each of these missed opportunities or failures deserves attention from
service providers and prevention programs.
Early Prenatal Care
Maximum reduction of perinatal transmission depends on preventing HIV
infection in women or identifying HIV infection before pregnancy or as early as possible
during pregnancy. Diagnosis allows a woman to receive effective antiretroviral therapies
for her own health and preventive drugs (e.g., ZDV) to improve the chances that her
infant will be born free of infection. Early knowledge of maternal HIV status is also
important for decisions regarding obstetrical management. Achieving these goals
requires increased access to and use of prenatal care.
Four states that conducted enhanced HIV surveillance reported that during
1993--1996, approximately 15% of HIV-infected pregnant women in the United
States received no prenatal care, compared with only 2% of women in the general
population (5). HIV-infected women who used illicit drugs during pregnancy were at the
highest risk for not receiving prenatal care --- 35% compared with 6% for HIV-infected
women who were not drug users. During 1997--1998, the HIV transmission rate
among women in New York State was 17.5% (30/171) among those with no prenatal
care, 16.2% (23/142) among those with 1--2 prenatal visits, and 8.0% (90/1,124)
among those with >3 prenatal visits, indicating the importance of prenatal care in
providing services that prevent perinatal transmission
Offer and Acceptance of HIV Testing
Most women who have given birth since the 1995 PHS guidelines have
received information or counseling regarding HIV infection and have been offered testing.
This has occurred independently of state-to-state variations in application of
recommended practices, type of prenatal health-care provider, type of patient insurance, or
maternal demographic characteristics (9). A 14-state study of HIV counseling and testing
data for 1996--1997 reported that the proportion of pregnant women voluntarily tested
for HIV was 58%--81% (30). Women most likely to receive HIV counseling and
testing during pregnancy were those who were African-American, had less than a high
education, were aged <25 years, received care in public rather than private
health-care settings, and were Medicaid beneficiaries.
When offered, most women (approximately 70% in most settings) will accept
HIV testing. In a multicity study of prenatal clinic patients, 74%--95% of
participants accepted HIV testing (48). Reasons most commonly cited for acceptance were a)
belief that knowledge of positive HIV serostatus during pregnancy (and
subsequent chemoprophylaxis) can be beneficial to both mother and infant and b) strong
provider endorsement for prenatal HIV testing. The most common reasons for declining the
test were no perceived risk, administrative scheduling difficulties, history of
previous testing, and lack of provider endorsement.
Although most providers agreed that all women should be tested for HIV,
some offered testing only to women whom they considered at risk for infection
(49,50). Risk-based testing approaches identified fewer HIV-infected women than routine
voluntary testing of all pregnant women (3) and also decreases in effectiveness as more
women are infected through heterosexual contact without knowing their partner's HIV
Receipt of ZDV Chemoprophylaxis
The primary strategy to prevent perinatal transmission (in addition to avoidance
of breast-feeding) is antiretroviral chemoprophylaxis using ZDV, now often part of
a combined antiretroviral therapy regimen that reduces viral load as low as
possible near the time of delivery. In the PACTG 076 protocol, chemoprophylaxis consisted
of three components: ZDV administered orally to the mother during the second and
third trimesters of pregnancy, intravenous administration of ZDV to the mother during
labor and delivery, and administration of oral ZDV to the infant during the first 6 weeks of
Data from several sources demonstrated rapid implementation of
the recommendations for ZDV prophylaxis by health-care providers and use of ZDV
by HIV-infected pregnant women. One study analyzed approximately 6,800
perinatally exposed and infected children born during 1993--1998 in 32 states that reported
HIV infection (51). Among those whose mothers were tested for HIV before or at birth
of the infant, the percentage of infants receiving any component of the
recommended ZDV regimen increased from 37% in 1994 to approximately 85% during 1996--1998.
In a supplemental study of women diagnosed before delivery in four states,
the proportion offered prenatal ZDV increased from 27% in 1993 to 85% in 1996,
the proportion offered intrapartum ZDV increased from 5% to 75%, and the
proportion offered neonatal ZDV increased from 5% to 76%
(5). Fewer than 5% of women refused ZDV.
Abbreviated Antiretroviral Regimens
Given the complexity and cost of the PACTG 076 regimen, particularly for
the developing world, other effective strategies to reduce the risk for perinatal
HIV transmission have been identified. Results of randomized clinical trials in
developing countries and observational data from the United States indicated that
abbreviated perinatal antiretroviral regimens
(20,52--54), regimens that begin as late as the
onset of labor (11), and possibly antiretroviral chemoprophylaxis given only to the
newborn (47) are effective in reducing the risk for perinatal transmission.
Abbreviated antiretroviral regimens have also proved effective in reducing the
risk for transmission in resource-poor countries. In nonbreast-feeding women, a
short antepartum/intrapartum regimen of ZDV reduced transmission by 50%
(20); a similar regimen in breast-feeding populations was also effective, although efficacy was
lower (52--54). Two other intrapartum/postpartum antiretroviral regimens were effective
in reducing transmission in clinical trials among breast-feeding African women.
One regimen was nevirapine given as a single dose to the woman in labor and to the
infant at age 48 hours, and the other was ZDV plus lamivudine (3TC) given orally
intrapartum and to the infant and mother for 1 week postpartum
(11,36,55). Observational data and animal studies indicated that newborn prophylaxis alone offered some
protection (24,56). Updated recommendations for use of these regimens in the United
States, including for pregnant women who do not receive health care until near the time
of delivery are available at the HIV/AIDS Treatment Information Service (ATIS)
website at <http://www.hivatis.org>
Other Strategies to Prevent Perinatal Transmission
Reducing exposure of the infant to maternal blood and secretions during
the intrapartum period can prevent perinatal HIV transmission. Cesarean
delivery performed before onset of labor and membrane rupture lowers the risk for
HIV transmission compared with vaginal delivery in certain populations of
women. Cesarean delivery resulted in a 50% reduction in perinatal HIV transmission
overall among HIV-infected women who had cesarean deliveries compared with
women delivering vaginally (28). A randomized clinical trial in Europe
(27) demonstrated a benefit of elective cesarean section before onset of labor for both untreated
HIV-infected women and infected women on antiretroviral therapy. However,
cesarean delivery is associated with greater morbidity than vaginal delivery among both
HIV-infected and noninfected women (58). In 1999 and 2000, the American College
of Obstetricians and Gynecologists (ACOG) recommended offering scheduled
cesarean delivery at 38 weeks gestation to reduce the risk for vertical transmission of
HIV infection (57,59). Other intrapartum interventions alone (e.g., vaginal
disinfection during labor and cleansing of the newborn) have not proven effective
Follow-Up Care for Infected Women and Perinatally Exposed Infants
Providing mothers and their infants with ongoing HIV-related care can
maximize the benefits of prevention interventions. The medical care of HIV-infected women is
a complicated task requiring use of potent combinations of antiretroviral
drugs, monitoring of viral load and drug resistance, treatment and prophylaxis
of opportunistic infections, and monitoring of immune status. In addition to
conditions (e.g., Pneumocystis carinii pneumonia [PCP]) for which all immunocompromised
HIV-infected persons are at risk, women experience specific manifestations of HIV
disease (e.g., aggressive pelvic inflammatory disease and persistent and
difficult-to-treat vaginal yeast infections requiring frequent screening and treatment)
(61,62). HIV-infected women are also at increased risk for cervical dysplasia, which can result
in cancer (63). With early detection and appropriate treatment, many of
these complications can be prevented and treated. Improved health outcomes resulting
from advances in HIV management and treatment depend not only on access to
medical care but also on access to prevention and psychosocial support services. In the
States, most mothers and children with HIV/AIDS live in areas where poverty,
illicit drug use, poor housing, and limited access to and use of medical care and
social services add to the challenges of HIV disease
(4,9). Women with HIV infection often have difficulty gaining access to health care and frequently are responsible for
caring for children and other family members who might also be HIV-infected
(64). They often lack social support and face other challenges that could interfere with their ability
to gain access to and adhere to complicated treatment regimens. The complex
medical and social problems of families affected by HIV are best managed by
multidisciplinary case-management teams that integrate specialty medical care with
prevention, psychosocial, and other HIV-related services (see
Revised Guidelines for HIV Counseling, Testing, and
Postnatal evaluation of infants at risk for HIV infection that begins
immediately after birth is the key to early diagnosis and optimal medical management of
infected children. PCP is the most common opportunistic infection in children with AIDS and
is often fatal (65). Because PCP occurs most often in perinatally infected children at
ages 3--6 months (65), effective prevention requires that children born to
HIV-infected mothers be identified promptly, preferably through maternal testing, so that
PCP prophylactic therapy can be initiated at age 6 weeks. In 1995, CDC published
revised guidelines recommending PCP prophylaxis for all perinatally exposed infants at
ages 4--6 weeks until their infection status was determined
(66). Perinatal screening can identify HIV-exposed infants early, making it possible to follow infected children
closely and promptly diagnose other potentially treatable, HIV-related conditions (e.g.,
severe bacterial infections). This also allows antiretroviral treatment to be initiated as soon
as indicated to prevent morbidity, prolong survival, and reduce the need
for hospitalization (67).
Follow-up of infants, both infected and uninfected, who are exposed
to antiretroviral drugs is critical to identifying potential short- and long-term
toxicities. Data on the risks of antiretroviral drugs during pregnancy are summarized
and updated regularly (57).
Summary of IOM Recommendations
In 1996, Congress charged IOM with evaluating the extent to which state
efforts had been effective in reducing perinatal HIV transmission and analyzing barriers
to further reduction in such transmission. In 1999, IOM published its results,
which addressed ways to increase prenatal testing, improve therapy for HIV-infected
women and children, and generally reduce perinatal HIV infections
Despite sharp reductions in perinatally transmitted AIDS cases that resulted
from widespread implementation of the 1994 and 1995 PHS guidelines, IOM reported
that the number of children born with HIV infection exceeded achievable prevention
levels. Prenatal HIV testing was not universal, and many HIV-infected women
were inadequately treated because they did not seek prenatal care, were not tested for
HIV, or received treatment that did not reflect current standards. Even in settings
where most prenatal-care providers agreed that HIV tests should be offered to all
pregnant women, some reported that they did not offer the test to all women in their
practices, mainly because pretest counseling recommended by CDC and promulgated in
some state policies were too burdensome (9). Citing lack of time and skills for
providers based testing decisions on their own, often inaccurate, assessments
of maternal risk.
IOM recommended that the United States adopt a goal that all pregnant women
be tested for HIV and all infected women receive optimal treatment for themselves
and their children. To help meet this goal, IOM recommended that the United States
adopt a policy of universal HIV testing, with patient notification, as a routine component
of prenatal care (i.e., all pregnant women should be offered testing regardless of
their risk factors or the prevalence rates where they live). Early diagnosis of HIV
infection allows pregnant women to receive effective antiretroviral therapy for their own
health and reduce the risk for transmitting HIV to their infants. Universal testing
avoids stereotyping or stigmatizing any socioeconomic or ethnic group. Women should be
told they are being tested for HIV and told of their right to refuse testing. Patient
notification allows women to decline testing if they feel it is not in their best interest and
simplifies the testing process by eliminating the need for extensive pretest counseling.
IOM's recommendations prompted reconsideration of the focus,
implementation, and impact of PHS's guidelines for HIV screening of pregnant women. These
guidelines recommended counseling all pregnant women regarding the risk for HIV
infection, benefits of HIV testing, and voluntary testing. This approach was endorsed by
most professional organizations representing prenatal, obstetrical, and
perinatal-care providers. States quickly implemented the guidelines, but with substantial variability
in strategy (68). Most states responded with policies on HIV counseling and testing
of pregnant women; approximately 50% also enacted laws or regulations. Most
policies and statutes are directed at pregnant women rather than newborns and focus
on education, counseling, and consensual testing. New York and Connecticut are the
only states that mandate newborn testing. No evidence exists to indicate that any
legal approach is more successful than others in preventing perinatal transmission.
No states require mandatory testing of pregnant women. In considering adopting the
IOM guidelines, some states have implemented or are considering requiring some form
of pretest counseling, routine testing with right of refusal, or universal or
selective newborn screening. IOM's recommendation is for universal HIV testing with
patient notification. As states consider implementing the IOM recommendations,
other important considerations include availability of care and treatment for
HIV-infected mothers and their infants, provider training needs, and confidentiality laws to
protect positive test results reported to public health surveillance. States should consult
with public health officials, health-care providers, and representatives of
affected communities during this process.
For the individual woman, the substantial benefits of HIV testing must be
weighed against the possible risks. Potential negative consequences of a diagnosis of
HIV infection can include loss of confidentiality, job- or health-care--related
discrimination and stigmatization, loss of relationships, domestic violence, and adverse
psychological reactions (69). Providing HIV-infected women with or referring them to
psychological, social, and legal services could help minimize these risks and allow more women
to benefit from the health advantages of early HIV diagnosis without
adverse consequences. The Americans with Disabilities Act (ADA) of 1990 and other
federal, state, and local antidiscrimination provisions aim to protect persons with
against discrimination in the workplace, housing, public services, and
public accommodations (70). A 1998 U.S. Supreme Court decision provided
further antidiscrimination protection by ensuring that persons with asymptomatic HIV
disease are included under ADA and have access to nondiscriminatory and effective
health care (70).
Laboratory Testing Considerations
Testing of women before or during pregnancy is typically conducted according
to the standard protocol for detection of antibody to HIV
(71). For women with unknown HIV status during active labor, antiretroviral treatment can still be effective when
given during labor and delivery, followed by treatment of the newborn
(11). This expedited intervention requires the use of rapid diagnostic testing during labor or rapid return
of results from standard testing.
Standard Testing Protocol
The HIV testing algorithm recommended by PHS consists of initial screening
with an FDA-licensed enzyme immunoassay (EIA) followed by confirmatory testing
of repeatedly reactive EIAs with an FDA-licensed supplemental test (e.g., Western
blot). Although each test is highly sensitive and specific, using both increases the
accuracy of results.
Indeterminate Western blot results can be caused by either incomplete
antibody response to HIV in samples from infected persons or nonspecific reactions in
samples from uninfected persons (72--74). Incomplete antibody responses that
produce negative or indeterminate results on Western blot tests can occur among
persons recently infected with HIV who have low levels of detectable antibodies
(i.e., seroconversion), persons who have end-stage HIV disease, and perinatally
exposed but uninfected infants who are seroreverting (i.e., losing maternal
antibody). Nonspecific reactions producing indeterminate results in uninfected persons
have occurred more frequently among pregnant or parous women than among
other persons (73,74). No large-scale studies have been conducted to estimate
the prevalence of indeterminate test results in pregnant women. However, a survey
of 1,044,944 neonatal dried-blood specimens tested by EIA for maternally acquired
HIV-1 antibody indicated a relatively low rate of indeterminate Western blot results (<1
in 4,000 specimens tested by EIA) (74). Overall, 2,845 Western blots were performed.
False-positive Western blot results (especially those with a majority of bands)
are rare. For example, in a study that used a sensitive culture technique to
test approximately 290,000 blood donors , no false-positive Western blot results
were detected (75). In a study of the frequency of false-positive diagnoses among
military applicants from a low-prevalence population (i.e., <1.5 infections/1,000
population), one false-positive result was detected among 135,187 persons tested
An HIV test should be considered positive only after screening and
confirmatory tests are reactive. A confirmed positive test result indicates that a person has
been infected with HIV. False-positive results when both screening and confirmatory
tests are reactive are rare. However, the possibility of a mislabeled sample or
laboratory error must be considered, especially for a client with no identifiable risk for
HIV infection. HIV vaccine-induced antibodies may be detected by current tests and
may cause a false-positive result. Persons whose test results are HIV-positive and who
identified as vaccine trial participants should be encouraged to contact or return
to their trial site or an associated trial site for HIV counseling, testing, and referral
Incorrect HIV test results occur primarily because of specimen-handling
errors, laboratory errors, or failure to follow the recommended testing algorithm
(76). However, patients might report incorrect test results because they
misunderstood previous test results or misperceived that they were infected
(77). Although these occurrences are rare, increased testing of pregnant women will result in
additional indeterminate, false-positive, and incorrect results. Because of the significance of
an HIV-positive test result, its impact on a woman's reproductive decisions, and
the resulting need to consider HIV therapeutic drugs for both a pregnant woman and
her infant, previous guidelines have emphasized that HIV test results must be obtained
and interpreted correctly. In some circumstances, correct interpretation might
require consideration of not only additional testing but also the woman's clinical condition
and history of possible exposure to HIV.
Diagnosis of HIV Infection in Newborns
The standard antibody assays used for older children and adults are less useful
for diagnosis of infection in children aged <18 months. Nearly all infants born to
HIV-infected mothers passively acquire maternal antibody and, in some cases, will
test antibody positive until age 18 months regardless of whether they are
infected. Definitive diagnosis of HIV infection in early infancy requires other assays,
including nucleic acid amplification (e.g., polymerase chain reaction [PCR]) or viral culture.
HIV infection is diagnosed by two positive assays (PCR or viral culture) on two
separate specimens. Infant HIV testing should be done as soon after birth as possible
so appropriate treatment interventions can be implemented quickly
Rapid Tests for Expedited Screening
For certain HIV-infected pregnant women, the labor and delivery setting is the
first opportunity for HIV testing and interruption of mother-to-child transmission.
Although results of conventional EIAs and Western blots are typically not available for
1--2 weeks, rapid tests for detecting antibody to HIV can produce results in 10--60
minutes (78). The sensitivity and specificity of rapid assays are comparable with
EIAs. However, the predictive value of a single screening test varies with the prevalence
of HIV infection among the population tested. Because HIV prevalence is low in
most perinatal testing settings, the negative predictive value of a single rapid test (i.e.,
the probability that a negative test accurately indicates that the person tested
is uninfected) is high. A negative rapid test does not require further testing. In
contrast, the positive predictive value of a single test (i.e., the probability that a positive
test represents true infection) will be low among populations with low prevalence
(71). Therefore, a reactive rapid test must be confirmed by a supplemental test
(e.g., Western blot). However, necessary peripartum interventions to reduce the risk
for perinatal transmission might need to be based on the preliminary results of
rapid testing at labor and delivery. Decisions regarding use of antiretroviral drugs to
prevent perinatal transmission among women who are repeatedly reactive on a single
rapid HIV test require clinical judgment regarding initiation of prophylactic treatment
before results of a confirmatory test are available.
Only one FDA-approved rapid HIV test (Abbott Murex Single Use
Diagnostic System [SUDS] HIV-1 test, Abbott Laboratories, Inc., Abbott Park, Illinois)
is commercially available in the United States, although other rapid tests are
being considered for approval. This test can provide definitive negative and
preliminary positive test results at the time of testing and identify women who might
need antiretroviral treatment and whose infants might benefit from chemoprophylaxis.
A careful risk assessment could help make treatment decisions. The predictive value of
a reactive rapid test is higher among persons with risk for HIV infection, especially
in areas with high HIV prevalence (79). Use of a second screening test (either rapid
test or EIA) can also improve the positive predictive value of a single reactive rapid
HIV test. In studies conducted outside the United States, specific combinations of
>2 different screening assays provided results as reliable as those from the
conventional EIA/Western blot combination
Expedited EIA testing that produces results within a few hours can also
aid decisions regarding antiretroviral therapy. Although results from standard testing
are not likely to be available during labor and delivery, they could be available within
12 hours of an infant's birth. Because neonatal prophylaxis might be effective in
reducing risk for transmission (24), expedited application of the standard testing protocol
is another way to reduce mother-to-child infection.
Research and programmatic studies are underway to assess the feasibility
of offering voluntary HIV counseling and rapid testing at labor and delivery to women
of unknown serostatus in the United States. Implementation of rapid testing
and expedited EIA approaches should address several ethical and logistical
- acceptability of rapid HIV testing in the labor room,
- difficulty in obtaining informed consent for testing and treatment during labor
or soon after birth,
- acceptance of intrapartum and postpartum ZDV prophylaxis for the mother
- optimal timing of posttest counseling,
- logistical concerns for providers,
- implications of preliminary reactive test results, and
- comprehension of discussions regarding antiretroviral treatment by women
who are in labor (81,82).
A CDC-funded, multicenter initiative called Mother-Infant Rapid Intervention
at Delivery (MIRIAD) is underway to address these considerations among women
with inadequate prenatal care in communities with high HIV seroprevalence among
women of childbearing age (81). If successful, this initiative will offer crucial
peripartum interventions to reduce the risk for HIV transmission among HIV-infected women
first identified at labor and delivery.
The following revised recommendations for HIV screening of pregnant women
are based on scientific and clinical advances in preventing perinatally acquired HIV
and caring for HIV-infected women, recommendations from IOM, consultations
with specialists in the field, and public opinion. They reflect the need for universal
HIV testing of all pregnant women and simplification of the pretest process so
that operational procedures do not impede women from benefitting from proven
measures to prevent perinatal transmission and from other advances in the care and
treatment of HIV disease. Although universal testing is recommended, testing should remain
a voluntary decision by the pregnant woman.
Screening for HIV in Pregnant Women and Their Infants
- PHS recommends that all pregnant women in the United States be tested for
HIV infection. All health-care providers should recommend HIV testing to all of
their pregnant patients, pointing out the substantial benefit of knowledge of HIV
status for the health of women and their infants. HIV screening should be a routine
part of prenatal care for all women.
- HIV testing should be voluntary and free of coercion. Informed consent
before HIV testing is essential. Information regarding consent can be presented orally
or in writing and should use language the client understands. Accepting or
refusing testing must not have detrimental consequences to the quality of prenatal
care offered. Documentation of informed consent should be in writing, preferably
with the client's signature. State or local laws and regulations governing HIV
testing should be followed. HIV testing should be presented universally as part of
routine services to pregnant women, and confidential informed consent should
be maintained (see Revised Guidelines for HIV Counseling, Testing, and
- Although HIV testing is recommended, women should be allowed to
refuse testing. Women should not be tested without their knowledge. Women
who refuse testing should not be coerced into testing, denied care for themselves
or their infants, or threatened with loss of custody of their infants or other
negative consequences. Discussing and addressing reasons for refusal (e.g., lack
of awareness of risk or fear of the disease, partner violence, potential stigma,
or discrimination) could promote health education and trust-building and
allow some women to accept testing at a later date. Women who refuse
testing because of a previous history of a negative HIV test should be informed of
the importance of retesting during pregnancy. All logistical reasons for not
testing (e.g., scheduling) should be addressed as well. Health-care providers
should remember that some women who initially refuse testing might accept at a
later date, particularly if their concerns are discussed. Some women who
refuse confidential testing might be willing to obtain anonymous testing. However,
they should be informed that if they choose anonymous testing, no documentation
of the results will be recorded in the medical chart, and their providers might
have to retest them, potentially delaying provision of antiretoviral drugs for therapy
or perinatal prophylaxis. Some women will continue to refuse testing, and
their decisions should be respected.
- Before HIV testing, health-care providers should provide the following
minimum information. Although a face-to-face counseling session is ideal, other
methods can be used (e.g., brochure, pamphlet, or video) if they are culturally
and linguistically appropriate.
- HIV is the virus that causes AIDS. HIV is spread through unprotected
sexual contact and injection-drug use. Approximately 25% of HIV-infected
pregnant women who are not treated during pregnancy can transmit HIV to
their infants during pregnancy, during labor and delivery, or through
- A woman might be at risk for HIV infection and not know it, even if she has
had only one sex partner.
- Effective interventions (e.g., highly active combination antiretrovirals) for
HIV-infected pregnant women can protect their infants from acquiring HIV and
can prolong the survival and improve the health of these mothers and
- For these reasons, HIV testing is recommended for all pregnant women.
- Services are available to help women reduce their risk for HIV and to
provide medical care and other assistance to those who are infected.
- Women who decline testing will not be denied care for themselves or
- Health-care providers should perform HIV testing in consenting women as
early as possible during pregnancy to promote informed and timely
therapeutic decisions. Retesting in the third trimester, preferably before 36 weeks
of gestation, is recommended for women known to be at high risk for acquiring
HIV (e.g., those who have a history of sexually transmitted diseases [STDs],
who exchange sex for money or drugs, who have multiple sex partners
during pregnancy, who use illicit drugs, who have sex partner[s] known to be
HIV-positive or at high risk, and who have signs and symptoms of
seroconversion). Routine universal retesting in the third trimester may be considered in
health-care facilities with high HIV seroprevalence among women of childbearing
age. Retesting for syphilis during the third trimester and again at delivery also
is recommended for pregnant women at high risk
(83). Some states mandate syphilis screening at delivery for all pregnant women.
- Women admitted for labor and delivery with unknown or undocumented
HIV status should be assessed promptly for HIV infection to allow for
timely prophylactic treatment. Expedited testing by either rapid return of results
from standard testing or use of rapid testing (with confirmation by a second
licensed test when available) is recommended for these women. The goal is to
identify HIV-infected women or their infants as soon as possible because the efficacy
of prophylactic therapy is greatest if given during or as soon after exposure
as possible (i.e., within 12 hours of birth). Informed consent is essential for
women tested prenatally, and women in labor with unknown status should be allowed
to refuse testing without undue consequences. After delivery,
standard confirmatory testing should be done for women with positive rapid test results.
- Some women might not a) receive testing during labor and delivery, b) choose
to be tested for HIV, or c) retain custody of their infants. If the mother has not
been tested for HIV, she should be informed that knowing her infant's infection
status has benefits for the infant's health and that HIV testing is recommended for
her infant. Providers should ensure that the mother understands that a positive
HIV antibody test for her infant indicates infection in herself. For infants whose
HIV infection status is unknown and who are in foster care, the person
legally authorized to provide consent should be informed that HIV testing
is recommended for infants whose biological mothers have not been
tested. Testing should be performed in accordance with the policies of the
organization legally responsible for the child and with prevailing legal requirements for
HIV testing of children.
- Regulations, laws, and policies regarding HIV screening of pregnant women
and infants are not standardized throughout all states and U.S. territories.
Health-care providers should be familiar with and adhere to state/local
laws, regulations, and policies concerning HIV screening of pregnant women
Education and Prevention Counseling of Pregnant
Women Regarding HIV
When the pretest process is simplified to providing essential information, the
value of prevention counseling should not be lost. For some women, the prenatal care
period could be an ideal opportunity for HIV prevention and subsequent behavior change
to reduce risk for acquiring HIV infection. Thus, the following steps are recommended:
- Information regarding HIV and assessment of risks for HIV infection (i.e.,
risk screening) should be provided to all pregnant women as part of routine
health education. Reluctance to provide HIV prevention counseling should never be
a barrier to HIV testing. Similarly, a focus on increased HIV testing should not be
a barrier to providing effective HIV prevention counseling for persons
determined to be at increased risk for acquiring or transmitting HIV (see
Revised Guidelines for HIV Counseling, Testing, and
- Pregnant women found to have behaviors that place them at high risk
for acquiring HIV infection (e.g., multiple sex partners, current diagnosis or history
of STDs, exchange of sex for money or drugs, substance abuse) or who want
more intensive client-centered HIV prevention counseling should be provided with
or referred to HIV risk-reduction services (e.g., drug treatment, STD treatment,
HIV centers with personnel trained in HIV counseling).
Interpretation of HIV Test Results
- HIV antibody testing should be performed according to the
recommended algorithm, which includes an EIA to test for antibody to HIV and
confirmatory testing with a more specific assay (e.g., Western blot). All assays should
be performed according to manufacturers' instructions and state and
federal laboratory guidelines.
- HIV infection (as indicated by the presence of antibody to HIV) is defined as
a repeatedly reactive EIA and a positive confirmatory supplemental
test. Confirmation or exclusion of HIV infection in a person with indeterminate
test results should be based on HIV antibody test results, consideration of
the person's medical and behavioral history, results from additional virologic
and immunologic tests when performed, and clinical follow-up (see
Revised Guidelines for HIV Counseling, Testing, and
Referral). Whenever possible, uncertainties regarding HIV infection status, including laboratory test
results, should be resolved before final decisions are made regarding
reproductive options, antiretroviral therapy, cesarean delivery, or other interventions.
- Pregnant women who have repeatedly reactive EIAs and
indeterminate supplemental tests should be retested for HIV antibody to distinguish
between recent seroconversion and a negative test result. Almost all nonpregnant
HIV-infected persons with indeterminate Western Blot will develop detectable
HIV antibody within 1 month of exposure to the virus; relevant data are not
available for pregnant women. Although viral DNA/RNA assays can be helpful, they
are not FDA-approved for diagnostic use.
- Women who have negative EIA or rapid test results and those who
have repeatedly reactive EIAs but negative supplemental tests should be
considered uninfected unless they have had a recent HIV exposure. A negative test
result provides information regarding the woman's status, but does not ensure that
a sexual or needle-sharing partner is uninfected.
- As additional rapid assays become licensed and available in the United
States, specific combinations of >2 different rapid HIV tests for diagnosis of HIV
infection in women who do not receive health care until labor might be useful
because combinations of rapid tests have provided results as reliable as those from
the EIA/Western blot combination (78). Until other rapid assays are available,
some women who are reactive on a single rapid test might consider
prophylactic treatment until HIV infection is ruled out. Confirmatory standard testing
should be done after delivery for women with a positive rapid test result.
Recommendations for HIV-Infected Pregnant Women
- HIV-infected pregnant women should receive HIV prevention counseling
as recommended (see Revised Guidelines for HIV Counseling, Testing,
and Referral). This counseling should include discussion of the risk for perinatal
HIV transmission, ways to reduce this risk, and the prognosis for infants who
become infected. HIV-infected pregnant women should also be told the
clinical implications of a positive HIV antibody test result and the need for and benefit
of HIV-related medical and other early intervention services, including how
to access these services.
- HIV-infected pregnant women should be counseled regarding
antiretroviral therapy during pregnancy to improve their health
(84) and prevent perinatal transmission
(57). Medical care and management of HIV-infected
persons, especially pregnant women, can be complicated because of the need
for combination therapy with multiple drugs, management of common side
effects, careful monitoring of viral load and drug resistance, prophylaxis for
and treatment of opportunistic infections, and monitoring of immune status.
Health-care providers who are not experienced in the care of pregnant
HIV-infected women are encouraged to obtain referral for specialty care from providers
who are knowledgeable in this area.
Although pregnancy is not an adequate reason to defer therapy for HIV
infection, unique considerations exist regarding use of antiretroviral drugs during
pregnancy, including the potential need to alter dosing because of physiologic changes
associated with pregnancy, the potential for adverse short- or long-term effects on the fetus
and infant, and the effectiveness in reducing the risk for perinatal transmission
- Obstetric providers should adhere to best obstetric practices, including
offering scheduled cesarean section at 38 weeks to reduce risk for perinatal
HIV transmission (60,85).
- HIV-infected pregnant women should receive information regarding
all reproductive options. Reproductive counseling should be nondirective.
Health-care providers should be aware of the complex concerns that
HIV-infected women must consider when making decisions regarding their
reproductive options and should be supportive of any decision.
- To eliminate the risk for postnatal transmission, HIV-infected women in
the United States should not breast-feed. Support services for use of
appropriate breast milk substitutes should be provided when necessary. UNAIDS and
World Health Organization recommendations for HIV and breast-feeding should
be followed in international settings (86).
- To optimize medical management, positive and negative HIV test results
should be available to a woman's health-care provider and included on her
confidential medical records and those of her infant. After informing the mother,
maternal health-care providers should notify the pediatric-care providers of the
impending birth of an HIV-exposed infant and any anticipated complications. If HIV is
first diagnosed in the infant, health-care providers should discuss the implications
for the mother's health and help her obtain care. Women should also be
encouraged to have their other children tested for HIV. Children can be infected with HIV
for many years before complications occur. Providers are encouraged to
build supportive health-care relationships that promote discussion of pertinent
health information. Confidential HIV-related information should be disclosed or
shared only in accordance with prevailing legal requirements.
- After receiving their test results, HIV-infected pregnant women should
receive counseling, including assessment of the potential for negative effects
(e.g., discrimination, domestic violence, psychological difficulties). Counseling
should also include information on how to minimize these consequences, assistance
in identifying supportive persons in their own social networks, and referral
to appropriate psychological, social, and legal services. HIV-infected women
should be counseled regarding the risk for transmission to others and ways to
decrease this risk. They also should be told that discrimination based on HIV status or
AIDS in housing, employment, state programs, and public accommodations
(including physicians' offices and hospitals) is illegal.
- Health-care providers should thoroughly assess the prevention service needs
of HIV-infected women (e.g., substance abuse, STD treatment, partner referral,
or family planning services) and develop a plan to promote access to and use
of these services (see Revised Guidelines for HIV Counseling, Testing,
- Health-care providers should follow the Public Health Service Task
Force recommendations for using antiretroviral drugs to treat pregnant HIV-1
infected women and reduce perinatal HIV-1 transmission in the United States,
which address treating pregnant women who do not receive health care until near
the time of delivery. These recommendations are available at the
HIV/AIDS Treatment Information Service (ATIS) website at <http://www.hivatis.org>
Recommendations for Postpartum Follow-Up of
Infected Women and Perinatally Exposed Children
- HIV-infected women should receive ongoing HIV-related medical care,
including immune-function monitoring, recommended therapy, and prophylaxis for
and treatment of opportunistic infections and other HIV-related conditions
(84,87). HIV-infected women should receive gynecologic care, including regular
Pap smears, reproductive counseling, information on how to prevent sexual
and drug-related transmission of HIV, and treatment of gynecologic
conditions according to published recommendations
(87). Obstetrical providers should ensure that HIV-infected women are introduced or referred to another
provider to continue their care after pregnancy.
- HIV-infected women (or their children's guardians) should be informed of
the importance of follow-up for their children. Children whose HIV infection status
is unknown require early diagnostic testing and prophylactic therapy to
prevent PCP pending determination of their status.
- Infected children require follow-up care to determine the need for
prophylactic therapy and antiretroviral treatment and to monitor disorders in growth
and development that often occur before age 24 months.
- Uninfected children who are exposed to antiretroviral therapy should
be assessed for potential short- and long-term side effects.
- Identification of an HIV-infected mother indicates that her family needs or
will need medical and social services as her disease progresses. Thus,
health-care providers should ensure that referrals to services address the needs of
the entire family.
Because of recent advances in both antiretroviral and obstetrical
interventions, pregnant women infected with HIV who know their status prenatally can reduce
their risk for transmitting HIV to their infants to
<2%. The guidelines in this report are intended to reduce barriers to voluntary HIV testing for all pregnant women in
the United States and to make the voluntary counseling and testing process simple
and routine in prenatal settings. The recommendations underscore the importance of
HIV-infected pregnant women (and their health-care providers) knowing their status
to protect their own health and reduce the risk for transmitting HIV to their infants.
We are grateful for the contributions of Ida Onorato, M.D., CDC.
- Connor EM, Sealing RS, Gelber R, et al. Reduction of maternal-infant transmission
of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J
- CDC. Recommendations of the U.S. Public Health Service Task Force on use
of zidovudine to reduce perinatal transmission of human immunodeficiency
virus. MMWR 1994;43(No. RR-11):1--21.
- CDC. US Public Health Service recommendations for human immunodeficiency
virus counseling and voluntary testing for pregnant women. MMWR 1995;44(No.
- CDC. Update: perinatally acquired HIV/AIDS---United States, 1997. MMWR
- CDC. Success in implementing Public Health Service guidelines to reduce
perinatal transmission of HIV---Louisiana, Michigan, New Jersey, and South Carolina, 1993,
1995, and 1996. MMWR 1998;47:688--91.
- Fiscus SA, Adimora AA, Schoenback VJ, et al. Trends in human
immunodeficiency virus (HIV) counseling, testing, and antiretroviral treatment of HIV-infected women
and perinatal transmission in North Carolina. J Infect Dis 1999;180:99--105.
- Lindegren ML, Byers RH, Thomas P, et al. Trends in perinatal transmission of
HIV/AIDS in the United States. JAMA 1999;282:531--8.
- Cooper ER, Nugent RP, Diaz C, et al. After AIDS clinical trial 076: the changing pattern
of zidovudine use during pregnancy, and the subsequent reduction in the
vertical transmission of human immunodeficiency virus in a cohort of infected women
and their infants. J Infect Dis 1996;174:1207--11.
- Institute of Medicine, National Research Council. Reducing the odds:
preventing perinatal transmission of HIV in the United States. Washington, DC: National
Academy Press, 1999.
- Moore RD, Chaisson RE. Natural history of HIV infection in the era of
combination antiretroviral therapy. AIDS 1999;13:1933--42.
- Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose
nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1
in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 1999;354:795--802.
- Mofenson LM, Lambert JS, Stiehm ER, et al. Risk factors for perinatal transmission
of human immunodeficiency virus type 1 in women treated with zidovudine. N Engl
J Med 1999;341:385--93.
- Mock PA, Shaffer N, Bhadrakom C, et al. Maternal viral load and timing of
mother-to-child HIV transmission, Bangkok, Thailand. AIDS 1999;13:407--14.
- Ioannidis JPA, Abrams EJ, Ammann A, et al. Perinatal transmission of
human immunodeficiency virus type 1 by pregnant women with RNA virus loads <1000
copies/ml. J Infect Dis 2001;183:539--45.
- CDC. U.S. HIV and AIDS cases reported through June 2000: midyear edition.
HIVAIDS surveillance report 2000;12(No.1):1--41.
- Karon JM, Rosenberg PS, McQuillan G, Khare M, Gwinn M, Petersen LR. Prevalence
of HIV infection in the United States, 1984 to 1992. JAMA 1996;276:126--31.
- Dunn DT, Peckham CS, Semprini AE, Pardi G. Vertical transmission of HIV-1:
maternal immune status and obstetric factors. The European Collaborative Study.
- Pitt J, Brambilla D, Reichelderfer P, et al. Maternal and immunologic and virologic
risk factors for infant human immunodeficiency virus type 1 infection: Findings from
the Women and Infants Transmission Study. J Infect Dis 1997;175:567--75.
- Simonds RJ, Steketee R, Nesheim S, et al. Impact of zidovudine use on risk and
risk factors for perinatal transmission of HIV. Perinatal AIDS Collaborative
Transmission Studies. AIDS 1998;12:301--8.
- Shaffer N, Chuachoowong R, Mock PA, et al. Short-course zidovudine for perinatal
HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. Lancet
- Dabis F, Msellati P, Dunn D, et al. Estimating the rate of mother-to-child transmission
of HIV. Report of a workshop on methodological issues: Ghent (Belgium), 17--20
February 1992. AIDS 1993;7:1139--48.
- De Cock KM, Fowler MG, Mercier E, et al. Prevention of mother-to-child
HIV transmission in resource-poor countries: translating research into policy and
practice. JAMA 2000;283;1175--82.
- Van Dyke RB, Korber BT, Popek E, et al. The Ariel project: a prospective cohort study
of maternal-child transmission of human immunodeficiency virus type 1 in the era
of maternal antiretroviral therapy. J Infect Dis 1999;179:319--28.
- Wade NA, Birkhead GS, Warren BL, et al. Abbreviated regimens of
zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N
Engl J Med 1998;339:1409--14.
- Garcia PM, Kalish LA, Pitt J, et al. Maternal levels of plasma human
immunodeficiency virus type 1 RNA and the risk of perinatal transmission. N Engl J Med
- Dorenbaum A for the PACTG 316 Study Team. Report of results of PACTG 316:
an international phase III trial of standard antiretroviral (ARV) prophylaxis plus
nevirpine (NVP) for prevention of perinatal HIV transmission [Abstract LB7]. In: Programs
and abstracts of the 8th Conference on Retroviruses and Opportunistic
Infections. Alexandria, VA: Foundation for Retrovirology annd Human Health, 2001:277.
- The European Mode of Delivery Collaboration. Elective caesarean-section
versus vaginal delivery in prevention of vertical HIV-1 transmission: a randomised clinical
trial. Lancet 1999;353:1035--9.
- The International Perinatal HIV Group. The mode of delivery and the risk of
vertical transmission of human immunodeficiency virus type 1. N Engl J Med 1999;340:977--87.
- Mandelbrot L, Le Chenadec J, Berrebi A, et al, for the French Perinatal Cohort.
Perintal HIV-1 transmission: interaction between zidovudine prophylaxis and mode of
delivery in the French perinatal cohort. JAMA 1998;280:55--60.
- CDC. Prenatal discussion of HIV testing and maternal HIV testing---14 states,
1996--1997. MMWR 1999;48:401--4.
- Anonymous. Surveillance of pediatric HIV infection. American Academy of
Pediatrics. Pediatrics 1998;101:315--9.
- Fowler MG, Simonds RJ, Roongpisuthipong A. Update on perinatal HIV
transmission. Pediatr Clin North Am 2000;47:21--38.
- Bertolli J, St Louis ME, Simonds RJ, et al. Estimating the timing of
mother-to-child transmission of human immunodeficiency virus in a breast-feeding population
in Kinshasa, Zaire. J Infect Dis 1996;174:722--6.
- Nduati R, John G, Mbori-Ngacha D, et al. Effect of breastfeeding and formula
feeding on transmission of HIV-1: a randomized clinical trial. JAMA 2000;283:1167--74.
- Miotti PG, Taha TE, Kumwenda NI, et al. HIV transmission through breastfeeding:
a study in Malawi. JAMA 1999;282:744--9.
- Moodley D. The SAINT trial: nevirapine (NVP) versus zidovudine
(ZDV)+lamivudine (3TC) in prevention of peripartum HIV transmission [Abstract LB0r10]. In: Program
and abstracts of the XIIIth International AIDS Conference. Durban, South
Africa: International AIDS Society, 2000.
- Semba RD, Kumwenda N, Hoover DR, et al. Human immunodeficiency virus load
in breast milk, mastitis, and mother-to-child transmission of human
immunodeficiency virus type 1. J Infect Dis 1999;180:93--8.
- Pillay K, Coutsoudis A, York D, Kuhn L, Coovadia HM. Cell-free virus in breast milk of
HIV-1--seropositive women. J Acquir Immune Defic Syndr 2000;24:350--6.
- Embree JE, Njenga S, Datta P, et al. Risk factors for postnatal
mother-child transmission of HIV-1. AIDS 2000;14:2535--41.
- John GC, Nduati RW, Mbori-Ngacha DA, et al. Correlates of mother-to-child
human immunodeficiency virus type 1 (HIV-1) transmission: association with maternal
plasma HIV-1 RNA load, genital HIV-1 DNA shedding, and breast infections. J Infect
- Dunn DT, Newell ML, Ades AE, Peckham CS. Risk of human immunodeficiency
virus type 1 transmission through breast feeding. Lancet 1992;340:585--8.
- Shaffer N, Roongpisuthipong A, Siriwasin W, et al. Maternal virus load and
perinatal human immunodeficiency virus type 1 subtype E transmission, Thailand. J Infect
- The International Perinatal HIV Group. Duration of ruptured membranes and
vertical transmission of HIV-1: a meta-analysis from 15 prospective cohort studies.
- Landesman SH, Kalish LA, Burns DN, et al. Obstetrical factors and the transmission
of human immunodeficiency virus type 1 from mother to child. N Engl J Med
- Mandelbrot L, Mayaux M-J, Bongain A, et al, and The French Pediatric HIV
Infection Study Group. Obstetric factors and mother-to-child transmission of
human immunodeficiency virus type 1: the French perinatal cohorts. Am J Obstet
- St. Louis ME, Kamenga M, Brown C, et al. Risk for perinatal HIV-1
transmission according to maternal immunologic, virologic, and placental factors.
- Wade N, Birkhead G, Gourlay-Doyle M, et al. Perinatal HIV transmission rates
among HIV-infected pregnant women in New York State (NYS) [Abstract 708]. In: Program
and abstracts of the 7th Conference on Retroviruses and Opportunistic
Infections. Alexandria, VA: Foundation for Retrovirology annd Human Health, 2000.
- Fernandez MI, Wilson TE, Ethier KA, Walter EB, Gay CL, Moore J, for the
Perinatal Guidelines Evaluation Project. Acceptance of HIV testing during prenatal care.
Public Health Rep 2000;15:460--8.
- Royce RA, Walter EB, Fernandez MI, Wilson TE, Ickovics JR, Simonds RJ, for
the Perinatal Guidelines Evaluation Project. Barriers to universal prenatal HIV testing in
4 US locations in 1997. Am J Public Health 2001;91:727--33.
- Mills WA, Martin DL, Bertrand JR, Belongia EA. Physicians' practices and
opinions regarding prenatal screening for human immunodeficiency virus and other
sexually transmitted diseases. Sex Transm Dis 1998;25:169--75.
- Lindegren ML, Steinberg S, Byers RH. Epidemiology of HIV/AIDS in children.
Pediatr Clin North Am 2000;47:1--20.
- Wiktor SZ, Ekpini E, Karon JM, et al. Short-course oral zidovudine for prevention
of mother-to-child transmission of HIV-1 in Abidjan, Côte d'Ivoire: a randomised
trial. Lancet 1999;353:781--5.
- Dabis F, Msellati P, Meda N, et al, for the DITRAME Study Group. 6-month
efficacy, tolerance, and acceptability of a short regimen of oral zidovudine to reduce
vertical transmission of HIV in breastfed children in Côte d'Ivoire and Burkina Faso: a
double-blind placebo-controlled multicentre trial. Lancet 1999;353:786--92.
- Wiktor SZ, Leroy V, Ekpini ER, et al. 24-month efficacy of short-course
maternal zidovudine for the prevention of mother-to-child HIV-1 transmission in a breast
feeding population: a pooled analysis of two randomized clinical trials in West Africa
[Abstract TuOrB3542]. In: Program and abstracts of the XIII International AIDS
Conference. Durban, South Africa: International AIDS Society, 2000:329.
- Gray G. The PETRA study: early and late efficacy of three short ZDV/3TC
combination regimens to prevent mother-to-child transmission of HIV-1. In: Programme
supplement of the XIII International AIDS Conference. Durban, South Africa: International
AIDS Society, 2000:17.
- Thomas P, Bornschlegel K. Short courses of zidovudine and perinatal transmission
of HIV. [Letter]. N Engl J Med 1999;340:1041.
- Public Health Service Task Force recommendations for the use of antiretroviral
drugs in pregnant women infected with HIV-1 for maternal health and for reducing
perinatal HIV-1 transmission in the United States. HIV/AIDS Treatment Information Service
(ATIS) website at <http://www.hivatis.org>. Accessed August 2, 2001.
- Watts DH, Lambert JS, Stiehm ER, et al, for the Pediatric AIDS Clinical Trials
Study Group 185 Team. Complications according to mode of delivery among
human immunodeficiency virus-infected women with CD4 lymphocyte counts of
<500/µL. Am J Obstet Gynecol 2000;183:100--7.
- American College of Obstetricians and Gynecologists. Committee opinion:
scheduled cesarean delivery and the prevention of vertical transmission of HIV infection. No.
234, May 2000.
- Biggar RJ, Miotti PG, Taha TE, et al. Perinatal intervention trial in Africa: effect of a
birth canal cleansing intervention to prevent HIV transmission. Lancet 1996;347:1647--50.
- Irwin KL, Moorman AC, O'Sullivan MJ, et al, for the PID-HIV Infection Study
Group. Influence of human immunodeficiency virus infection in pelvic inflammatory
disease. Obstet Gynecol 2000;95:525--34.
- Duerr A, Sierra MF, Feldman J, Clarke SM, Ehrlich I, DeHovitz J. Immune
compromise and prevalence of Candida vulvovaginitis in human immunodeficiency
virus-infected women. Obstet Gynecol 1997;90:252--6.
- Ellerbrock TV, Chiasson MA, Bush TJ, et al. Incidence of cervical
squamous intraepithelial lesions in HIV-infected women. JAMA 2000;283:1031--7.
- Schable B, Diaz T, Chu SY, et al. Who are the primary caretakers of children born to
HIV-infected mothers? Results from a multisite surveillance project. Pediatric
- Simonds RJ, Oxtoby MJ, Caldwell MB, Gwinn ML, Rogers MF.
Pneumocystis carinii pneumonia among US children with perinatally acquired HIV infection. JAMA
- CDC. 1995 revised guidelines for prophylaxis against
Pneumocystis carinii pneumonia for children infected with or perinatally exposed to human immunodeficiency
virus. MMWR 1995;44(No. RR-4):1--11.
- Guidelines for the use of antiretroviral agents in pediatric HIV infection.
HIV/AIDS Treatment Information Service (ATIS) website at <http://www.hivatis.org>.
Accessed August 2, 2001.
- Lazzarini Z, Gostin LO, Ward JW, Fleming PL, Nesland V. State efforts to
reduce perinatal HIV transmission [Abstract 44105]. In: Program and abstracts of the
12th World AIDS Conference. Geneva, Switzerland, 1998:959.
- Koenig LJ, Moore J. Women, violence, and HIV: a critical evaluation with
implications for HIV services. Matern Child Health J 2000;4:103--9.
- Americans with Disabilities Act. 42 USC section 12101 et seq. Available at
<http://www.usdoj.gov/crt/ada/adahom1.htm>. Accessed August 2, 2001.
- George JR, Schochetman G. Detection of HIV infection using serologic techniques.
In: Schochetman G, George JR, eds. AIDS testing: a comprehensive guide to
technical, medical, social, legal, and management issues. 2 ed. New York, NY:
- Celum CL, Coombs RW, Lafferty W, et al. Indeterminate human immunodeficiency
virus type 1 Western blots: seroconversion risk, specificity of supplemental tests, and
an algorithm for evaluation. J Infect Dis 1991;164;656--64.
- Celum CL, Coombs RW, Jones M, et al. Risk factors for repeatedly reactive HIV-1
EIA and indeterminate Western blots: a population-based case-control study. Arch
Intern Med 1994;154:1129--37.
- Gwinn M, Redus MA, Granade TC, Hannon WH, George JR. HIV-1 serologic test
results for one million newborn dried-blood specimens: assay performance and
implications for screening. J Acquir Immune Defic Syndr 1992;5:505--12.
- MacDonald KL, Jackson JB, Bowman RJ, et al. Performance characteristics of
serologic tests for human immunodeficiency virus type 1 (HIV-1) antibody among
Minnesota blood donors: public health and clinical implications. Ann Intern Med 1989;110:617--21.
- Burke DS, Brundage JF, Redfield RR, et al. Measurement of the false positive rate in
a screening program for human immunodeficiency virus infections. N Engl J
- Sheon AR, Fox HE, Alexander G, et al. Misdiagnosed HIV infection in pregnant
women: implications for clinical care. Public Health Rep 1994;109:694--9.
- Branson BM. Rapid tests for HIV antibody. AIDS Rev 2000;2:76--83.
- Irwin K, Olivo N, Schable CA, Weber T, Janssen R, Ernst J, and the
CDC-Bronx-Lebanon HIV Serosurvey Team. Performance characteristics of a rapid HIV antibody assay in
a hospital with a high prevalence of HIV infection. Ann Intern Med 1996;125:471--5.
- Stetler HC, Granade TC, Nunez CA, et al. Field evaluation of rapid HIV serologic tests
for screening and confirming HIV-1 infection in Honduras. AIDS 1997;11:369--75.
- Bulterys M, Fowler MG. Prevention of HIV infection in children. Pediatr Clin North
- Minkoff H, O'Sullivan MJ. The case for rapid HIV testing during labor. JAMA
- CDC. 1998 guidelines for treatment of sexually transmitted diseases.
MMWR 1998;47(No. RR-1):1--118.
- Guidelines for the use of antiretroviral agents in HIV-infected adults and
adolescents. January 2000. HIV/AIDS Treatment Information Service (ATIS) website
at <www.hivatis.org>. Accessed August 10, 2001.
- American College of Obstetricians and Gynecologists. Human immunodeficiency
virus screening. Joint statement of the American Academy of Pediatrics and the
American College of Obstetricians an Gynecologists. Pediatrics 1999;104:128.
- WHO Technical Consultation on Behalf of the UNFPA/UNICEF/WHO/UNAIDS
Inter-Agency Task Team on Mother-to-Child Transmission of HIV. New data on
the prevention of mother-to-child transmission of HIV and their policy
implications. October 2000. Available at <http://www.unaids.org/publications/documents/mtct/index.html>. Accessed August 16, 2001.
- CDC. 1999 USPHS/IDSA guidelines for the prevention of opportunistic infections
in persons infected with human immunodeficiency virus. MMWR 1999;48(No.
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