Since the first pediatric case of HIV infection was documented in 1984,
tremendous medical and public health achievements have been made in
preventing mother-to-child transmission of HIV. A key step toward
ensuring that the perinatal HIV interventions offered are effective is
to make sure that care providers know the HIV status of the pregnant
women in their care. When a woman is identified as HIV infected during
pregnancy, antiretroviral and obstetrical interventions can reduce the
risk of having an infected baby to <2%. When preventive
anti-retroviral treatment is not initiated until labor or birth of the
newborn, the risk of for transmission is 9% to 13%.1-3
Without intervention, the risk for transmission is approximately 25% in
the United States.4
Maximal reduction of perinatal HIV transmission in the United States
depends on ensuring
- Pregnant women receive prenatal care
- Routine HIV screening of all pregnant women
- Recommended antiretroviral regimens are used during the prenatal,
intrapartum and postpartum periods for HIV-infected women and their
infants, as well as obstetrical interventions for women during labor
- Routine screening of women during labor and delivery or of the
newborn when the motherís HIV status has not been determined
Approximately 6,000 to 7,000 HIV-infected women gave birth in the
United States in 2000, resulting in an estimated 280 to 370 HIV-infected
infants. In about 40% of the perinatal transmissions, health care
providers were unaware of the motherís HIV status before delivery.
Additionally, in the November 15, 2002, issue of the Morbidity and
Mortality Weekly Report, CDC published information on the most
recently available prenatal HIV testing rates for the United States and
Canada.6 The report includes a comparison of the HIV prenatal testing
rates associated with different testing approaches. In opt-out,
pregnant women are notified that an HIV test will be included in the
standard battery of prenatal tests and procedures and that they may
decline testing. In the more commonly used opt-in approach,
pregnant women are given pretest counseling and must specifically
consent, usually in writing, to an HIV test.
Among states using the opt-in approach and in which data were
collected from medical records during 1998-1999, testing rates ranged
from 25% to 69%. Population-based data from Canada showed testing rates
in three opt-in provinces of 54% to 83%. In contrast, medical record
data from Tennessee, which uses the opt-out approach, revealed a testing
rate of 85%. Data from Canadian provinces using opt-out approaches
showed a 98% testing rate in Alberta and a 94% testing rate in
Newfoundland and Labrador. At the University of Alabamaís 8 prenatal
clinics, HIV testing rates rose from 75% to 88% after the opt-out
approach was implemented.7
In an April 22, 2003 Dear Colleague letter to health departments,
community-based organizations, and health care providers, CDC
recommended that clinicians routinely screen all pregnant women for HIV
infection, using an opt-out approach, and that jurisdictions with
statutory barriers to such routine prenatal screening consider revising
them.8 For women whose HIV status is unknown when labor begins, CDC
recommended routine rapid testing.9 CDC also encouraged clinicians to
test any newborn for HIV whose motherís HIV status is unknown.
The purpose of this document is to provide guidance for state health
departments to achieve
- Universal routine prenatal HIV testing in order to minimize
perinatal HIV transmission in the United States
- Routine rapid HIV testing during labor and delivery for women
whose HIV status is still unknown
- Rapid HIV testing post partum for women of unknown HIV status or
their neonates, when rapid testing at labor and delivery is not
possible or has been previously declined
- Appropriate antiretroviral treatment and comprehensive follow-up
care for HIV-infected pregnant women and their infants
During prenatal care
- Health departments in collaboration with the AIDS Education and
Training Centers (AETC) of the Health Resources and Services
Administrationís (HRSA), medical organizations, and other
partners, should facilitate the training of prenatal care providers
in use of the opt-out approach, including documenting in a womanís
medical chart her HIV test results or that she declined testing.
- Training should include the following key elements of the opt-out
- At the first prenatal visit, women should be given
information, which can be written (such as a brochure or
pamphlet) or shown in a video, about perinatal HIV transmission,
testing, and prevention.
- Women should be told that HIV testing will be included in the
standard battery of prenatal tests and procedures. This
information may be included in a consent form that women sign
for all prenatal care and services. Specific procedures
regarding consent will depend on state and local laws,
regulations, and policies.
- Women should be told that they have the right to decline
- HIV test results or the refusal to be tested should be
documented in the womanís medical chart.
- Health departments should distribute materials, which are being or
have been developed by the American College of Obstetricians and
Gynecologists (ACOG), including a fact sheet on HIV testing for
providers, an information sheet for women on HIV and other prenatal
tests, and forms for documenting HIV test results or decline of
- Health departments should encourage prenatal care providers who
work in areas of high HIV prevalence to rescreen women for HIV
during the third trimester.
- For pregnant women who test positive for HIV, health departments
should facilitate access to appropriate obstetric, medical, and
social services for prevention, care, and treatment.
During labor and delivery
Health departments should work with AETCs, medical organizations and
other partners to provide training to hospital staffs on procedures for
offering rapid testing during labor and delivery to pregnant women whose
HIV status is unknown. Training should emphasize the need to document
test results or refusals. The following are additional key points:
- Women in labor whose HIV status is unknown should be informed that
rapid HIV testing will be done routinely to help protect her
babyís health unless she declines testing.
- Women should be informed that a negative rapid test result means
that she is not HIV infected; a preliminary positive rapid test
result means that she probably is HIV infected.
- If a woman tests positive, she should be informed that medicines
can be given to her during labor and to her newborn based on the
preliminary test result to reduce the chance that the baby will
become HIV infected.
- Confirmatory testing will need to be done if she has a positive
rapid HIV test result.
Health departments should work with medical organizations and other
partners to train hospital staff to screen the mother or the infant or
both with a rapid HIV test as soon as possible if the motherís HIV
status remains unknown. Some states mandate newborn screening in this
Working with Partners and Integration into Existing Services
- State AIDS directors should arrange training in the opt-out
approach and in rapid testing with
- State and local medical organizations
- Maternal and child health (MCH) programs
- AIDS Education and Training Centers
- Hospitals offering obstetrical services
- Other venues such as family planning clinics and drug treatment
centers serving pregnant women.
They should ensure that training is provided in prenatal clinics
funded by MCH programs.
- Working with ACOG and other partners, CDC has developed a model
protocol for implementing rapid HIV testing in labor and delivery
settings. The protocol should be disseminated to providers of
- Implementing the opt-out approach into HIV screening of pregnant
women may require changes in state laws to streamline pretest
counseling and consent requirements and documentation of test
results or decline of testing.
- State health departments should provide information about the
expected public health benefits of the opt-out approach to local
representatives of national health care provider organizations,
community groups that focus on maternal and child health issues, and
state and local government officials.
In 1995, the state of Texas passed a law to permit the opt-out approach
to prenatal HIV testing. Prenatal care providers in Texas distribute to
pregnant women brochures obtained from the state health department
describing prenatal tests, including those for HIV. Most providers
obtain a general written consent for the standard battery of prenatal
tests, which includes a test for HIV. Refusal of the HIV test must be
documented in the medical record.
CDC grantees receiving HIV prevention funds will be required to
routinely report the following indicators to monitor their HIV testing
of pregnant women.
CDCís HIV Prevention Program Performance Indicators*:
- Proportion of women who receive an HIV test during pregnancy (D.1)
- Proportion of HIV-infected pregnant women who receive appropriate
interventions to prevent perinatal transmission (D.2)
- Proportion of HIV-infected pregnant women whose infants are
perinatally infected (D.3)
Other program measures:
- Statewide perinatal testing rates, possibly using PRAMS data (see
Resources for the PRAMS website)
- Hospital specific perinatal testing rates
- States with low prevalence of HIV among women of childbearing age
or who have low cumulative numbers of perinatal HIV infection, and
who adopt the chart review method to obtain this indicator, may
choose to sample only among hospital(s) with the largest proportion
of deliveries in the state
- Description of state laws related to perinatal HIV testing,
including prenatal HIV testing and documentation, testing at labor
and delivery, testing of the newborn and the use of rapid HIV
- Description of state efforts to monitor perinatal HIV testing
- Description of state efforts to promote routine prenatal HIV
testing, including, for example:
- Number and location of provider trainings.
- Number and occupation of participants attending provider
- Topics covered during training (e.g., the number, type, and
destination of materials distributed)
* The CDC Technical Assistance Guidelines for Health Department HIV
Prevention Program Performance Indicators provides information on
setting baseline, target, and indicator specification including
appropriate data sources, calculations and reporting issues. Note:
Performance indicators may have been modified to reflect specific
population or setting characteristics.
- Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn
nevirapine and standard antiretroviral therapy to reduce perinatal
HIV transmission: A randomized trial. JAMA 2002;288:189-198.
- 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.
- Wade NA, Birkhead GS, Warren BL et al. Abbreviated regimen of
zidovudine prophylaxis and perinatal transmission of the human
immunodeficiency virus. N Engl J Med 1998;339:1409-1414.
- Connor EM, Sperling RS, Gelber R, et al. Reduction of
maternal-infant transmission of human immunodeficiency virus type 1
with zidovudine treatment. N Engl J Med 1994; 331:1173-1180.
- Centers for Disease Control and Prevention (CDC).
recommendations for HIV screening of pregnant women. MMWR 2001; 50
(RR 19: 50-86).
HIV testing among pregnant women Ė United States and
Canada, 1998-2001. MMWR 2003;51:1013-1016.
- Stringer EM, Stringer JS, Cliver SP, Goldenberg RL, Goepfert AR.
Evaluation of a new testing policy for human immunodeficiency virus
to improve screening rates. Obstetrics & Gynecology
- CDC. Dear Colleague letter.
April 22, 2003.
- Cohen M et al., Rapid point-of-care testing for HIV-1 in labor and
delivery: Chicago, 2002. In preparation for MMWR.
AIDS Education and Training Centers
CDC perinatal HIV prevention website
CDC. Technical Assistance Guidelines for CDCís HIV Prevention Program