                   AIDS INFORMATION NEWSLETTER
                   Michael Howe, MSLS, Editor
                     AIDS Information Center
                VA Medical Center, San Francisco
                     (415) 221-4810 ext 3305
                        November 4, 1994

               Women and HIV Infection (Part XII)

      Women and AIDS: Mother and Child--The HIV Connection

     Most babies born to HIV-infected women escape the virus.
According to the Surgeon General's 1993 report on HIV infection and
AIDS, about 1 in 4 of these infants, however, does become infected
before or during birth. Scientists have been trying for some time
to discover what influences whether or not a child will be
affected.
     "No one is certain when viral transmission occurs," says Janet
Arrowsmith-Lowe, M.D., medical officer in FDA's division of
antiviral drugs, Center for Drug Evaluation and Research. "It may
be during childbirth when the placenta separates from the uterine
wall and there may be some mixing of maternal and fetal blood, or
as the child passes through the vaginal canal and is exposed to
vaginal fluids. Or it may occur earlier in pregnancy when there may
be mixing of blood or passage of the virus across the placental
wall. In any case, all pregnant women--and especially those at risk
of HIV--should seek early prenatal care."
     Apart from the timing of transmission, studies suggest that
the likelihood of the child becoming infected may correlate with
the mother's health during the pregnancy or birth. In the June 9,
1993, Journal of the American Medical Association, Michael E. St.
Louis, M.D., and his colleagues reported that a baby is more likely
to become infected if the mother is in the very earliest stage of
infection (when the virus is thought to be abundant) or in an
advanced stage of disease, or if the membrane surrounding the
placenta is inflamed.  A child can also become infected after birth
through breast-feeding.  
     By 1994, an estimated 7,500 children in the United States will
have developed AIDS from infection before or during birth or
through breast- feeding. Not surprisingly, experts predict that as
more women of childbearing age become infected, the number of
infected children will also rise. A disturbing prospect under any
circumstances, the significance of this projection is most poignant
for minorities in New York City, where AIDS is already the leading
cause of death in Hispanic children 1 to 4 years of age and the
second leading cause of death for African-American children of the
same ages.  And those children fortunate enough to escape infection
do not escape hardship.
     "As painful as it is to consider," says Arrowsmith-Lowe, "the
facts as we see them now are that an uninfected child born to an
infected mother will lose his or her mother before the child
becomes a teenager."
     According to the Surgeon General's report, in the next decade,
125,000 or more children may become orphans because of AIDS and
will need to be cared for by family members or other responsible
adults, or placed in foster care. (Marian Segal. FDA Consumer.
October 1993)

                HIV Survey in Childbearing Women

These are answers from the Centers for Disease Control and
Prevention (CDC) to questions concerning the HIV Survey in
Childbearing Women, which was done by testing newborn blood
specimens collected on filter paper for maternal HIV antibody.

1.   What is the HIV Survey in Childbearing Women?

     The HIV Survey in Childbearing Women is an ongoing, national
     serosurvey initiated in 1988.  It is designed to measure the
     prevalence of HIV infection in women delivering infants in the
     United States and to monitor this rate over time.  The survey
     is based on HIV testing of leftover blood specimens collected
     on filter paper for routine newborn metabolic screening, an
     existing public health program in all areas conducting the
     survey.   

2.   Where is the survey conducted?

     CDC is conducting the survey in collaboration with the health
     departments of 45 states, the District of Columbia, Puerto
     Rico, and the Virgin Islands.  The 5 states not conducting the
     survey are Idaho, Nebraska, North Dakota, South Dakota, and
     Vermont.  

3.   How much does the survey cost?

     In fiscal year 1994 the survey cost approximately $10.5
     million. 

4.   How are data collected? 

     All personally identifying information is permanently
     separated from the specimen before it is tested for HIV
     antibody.  Limited demographic data, including the month and
     county of birth, are abstracted from the metabolic screening
     form; in some states, the mother's age group and race/
     ethnicity are also collected.  State health departments
     maintain a database containing survey results; these data are
     also periodically transferred to CDC. 
 
5.   How is HIV antibody testing performed?

     Laboratory testing for the survey is conducted in state public
     health laboratories using standard enzyme immunoassay (EIA)
     and Western blot methods adapted to dried blood specimens
     collected on filter paper.  All laboratories participate in
     a special quality assurance program maintained by CDC.

6.   What does an HIV-positive test result mean?

     A positive test result reflects HIV infection in the mother,
     but not necessarily the infant, because antibodies cross the
     placenta during pregnancy.  Test results are interpreted
     according to standard criteria established by the Association
     of State and Territorial Public Health Laboratory Directors
     (ASTPHLD) and CDC.

7.   How are the data reported?

     State health departments periodically report results from the
     survey in health department newsletters or press releases. 
     CDC recently published a summary of survey data in the
     National HIV Serosurveillance Summary, Results through 1992
     (single copies available from the CDC National AIDS
     Clearinghouse, 1-800-458-5231).

8.   What are the principal findings?

     In 1992 (the most recent year for which complete data are
     available), approximately 7,000 HIV-infected women delivered
     infants in the United States.  The prevalence of HIV infection
     in women delivering infants was about 1.7 per 1,000, or about
     1 in every 585 women delivering infants. The transmission rate
     of HIV from mother to infant is estimated to be between 20%
     and 30%.  Therefore, between 1,400 and 2,100 HIV-infected
     infants were born in the United States in 1992.

9.   What has been done for women with HIV as a result of the
     survey?

     Results from the survey have been used to estimate the needs
     for HIV services for women and children, to stimulate the
     development of HIV prevention programs, and to target
     resources.  As an example, because of the high HIV
     seroprevalence among childbearing women found in New Jersey,
     in 1989 the New Jersey Commissioner of Health recommended that
     all pregnant women in New Jersey be offered HIV counseling and
     testing.  Similar recommendations have been made or are under
     consideration in other areas. 

10.  Is informed consent obtained for the survey?

     CDC and the Office of Protection from Research Risks (OPRR)
     at the NIH have established that the survey:

     1)   Causes no collection of information or specimens that
          would not otherwise be obtained for routine medical
          purposes; and
     2)   Obtains no data which can be linked to identifiable
          individuals.

     Therefore, this is considered an unlinked survey that does not
     involve human subjects, and informed consent is not required. 
     The survey protocol has been reviewed by CDC's institutional
     review board (IRB) and by many state IRBs as well.

11.  Can women tested in the survey obtain their test results?  

     Testing for HIV antibody is done only after all personal
     identifiers have been permanently removed.  Therefore, HIV
     test results from this survey cannot be associated with
     individual women or infants, and it would be impossible to
     "unblind" the survey.

12.  Can the survey be converted to a screening program in states
     choosing to do so?

     Since it is impossible to link HIV test results to individual
     women, the survey cannot serve as a screening program.  The
     survey does not take the place of voluntary testing and
     counseling programs; states are encouraged to develop such
     programs, independent of the survey.

13.  If a state chooses to unblind the survey and add mandatory HIV
     testing to the existing newborn screening program, will CDC
     funding to conduct the survey in that state be withdrawn?

     CDC will fund states to conduct the survey only as prescribed
     in the approved protocol.  CDC funds for the survey may not
     be used for any other studies.  However, states may choose to
     conduct screening programs independent of the survey with
     other funding.

14.  What implications for the survey are there in the findings
     from the AIDS clinical trial (ACTG 076) on use of AZT to
     prevent perinatal HIV transmission?

     Results from ACTG 076 study demonstrate that AZT therapy
     administered during pregnancy and delivery and to the newborn
     could reduce the risk of perinatal HIV transmission by as much
     as two-thirds in some infected women and their infants. 
     Because data from the survey are population-based, they
     provide a unique measure of the women and infants that could
     potentially benefit from intervention with AZT.

15.  How may information from the HIV Survey in Childbearing Women
     be used to guide and evaluate programs for preventing
     perinatal HIV transmission?

     The survey provides very accurate data for states and
     health-care providers to use in focusing their efforts to
     provide HIV counseling and testing, prenatal care, and
     follow-up for women at greatest risk of HIV infection. 
     Preventive services should be provided to women before they
     become infected.  Ideally, women should have the opportunity
     to learn their serostatus before they become pregnant.
     Services offered to pregnant women with HIV infection should
     include education about the potential for AZT to reduce the
     risk of perinatal transmission.  The results of ACTG 076
     demonstrated benefit in women who began receiving AZT between
     14 and 34 weeks of pregnancy; therefore, pregnant women with
     HIV should receive this information during prenatal care, not
     at the time of delivery.

16.  Would unblinding the HIV Survey in Childbearing Women assist
     in preventing perinatal HIV transmission?

     No.  HIV counseling and testing should be offered prior to or
     early in pregnancy so that AZT use can be considered during
     pregnancy (as early as the 14th week), and certainly before
     the birth of the child.  Detection of HIV during pregnancy
     also allows better coordination with pediatric care for the
     infant than detection following birth. 

17.  What does CDC recommend regarding use of AZT in pregnancy?

     Based on the findings of ACTG 076, the Public Health Service
     published interim recommendations in the April 29, 1994, issue
     of the MMWR (Vol. 43, No. 16).  The recommendations are as
     follows: 

     1)   All health-care workers providing care to pregnant women
          and women of childbearing age should be informed of the
          results of ACTG 076;

     2)   HIV-infected pregnant women meeting the protocol
          eligibility criteria should be informed of the potential
          benefits but unknown long-term risks of AZT therapy as
          administered in the ACTG 076 protocol, and decisions to
          use AZT for prevention of perinatal transmission should
          be made in consultation with their health-care providers;
          
     3)   Health-care providers should inform their patients that
          this AZT regimen substantially reduced, but did not
          eliminate, the risk for HIV infection among the infants;
          and

     4)   Until the potential risk for teratogenicity and other
          complications from AZT therapy given in the first
          trimester can be assessed, AZT therapy only for the
          purpose of reducing the risk for perinatal transmission
          should not be instituted earlier than the 14th week of
          gestation.

     PHS is developing further recommendations for the uses of AZT
     for HIV-infected pregnant women whose clinical indications
     differ from the ACTG protocol 076 eligibility criteria and for
     counseling and HIV-antibody testing for women of childbearing
     age.

18.  Legislation has been proposed in several states to mandate
     testing of pregnant women by testing their infants at
     delivery.  What is CDC's position regarding mandatory testing
     of pregnant women in light of results from NIH's 076 trial?

     Mandatory HIV testing and screening have not been generally
     implemented in this country for civilian, noninstitutionalized
     populations, or populations at risk.  Such programs have been
     rejected largely because of their unmanageability and expense
     and their powerful psychological and social impacts.  The
     formulation of HIV screening policies through legislative or
     regulatory routes does not permit the flexibility and latitude
     required to respond to new developments in diagnostic
     technology and medical intervention.  Mandatory HIV testing
     may discourage pregnant women from exercising their rights to
     participate in important reproductive decisionmaking,
     including seeking prenatal care.

     Recent ACTG 076 results indicate that early detection and
     medical intervention of HIV infection can benefit the unborn
     children of infected mothers.  One of the main objectives of
     the HIV Survey in Childbearing Women and other HIV serosurveys
     is to provide data for health officials to direct HIV
     counseling and testing programs to the populations with the
     highest infection rates.  High seroprevalence rates from the
     survey of childbearing women should be used by health
     departments as a basis for recommending routine voluntary HIV
     counseling and testing of some or all such women in a local
     areas or states and increasing prevention efforts for this
     population.  While the protocol for the HIV Survey in
     Childbearing Women requires that this testing be unlinked, it
     does not prevent states from establishing additional voluntary
     testing programs through which to inform persons of their
     infection status. 

(Centers for Disease Control and Prevention. Training Bulletin.
June 15, 1994.)
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