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III.
Key Elements of a Model Protocol for Rapid Testing during Labor and
Delivery
A. Determining Eligibility for Rapid HIV Testing
The prenatal records of all women presenting to the labor and delivery
unit should be reviewed for documentation of an HIV test result during
the current pregnancy. Any woman without documentation of an HIV
test result during
the current pregnancy should be routinely screened for HIV by the
use of a rapid HIV test and an opt-out approach (see section III.
C). Including a standing
order (e.g., “provide routine rapid HIV testing if there is no documentation
of prenatal HIV test results unless the woman declines”) as part of
the admission orders for women in labor may also save valuable time.
Clinicians may use an opt-out approach to rapid HIV testing to re-screen
women with documented
negative HIV test results during the current pregnancy if there are
indications that the woman is at continued risk for HIV infection
(e.g., a history of
sexually transmitted diseases [STDs], exchange of sex for money or
drugs, multiple sex partners during the current pregnancy, use of
illicit drugs,
sex partner[s] known to be HIV-positive or at high risk, or signs
and symptoms of seroconversion). This approach is similar to that
used for syphilis screening,
in which retesting for syphilis during the third trimester and again
at delivery is recommended for pregnant women at high risk.13Some
states mandate syphilis
screening at delivery for all pregnant women. Routine universal retesting
for HIV by the use of an opt-out approach should be considered in
health care facilities in areas with high HIV seroprevalence among
women of childbearing
age.14
B.
Ensuring Confidentiality of Pregnant Women
Protecting the confidentiality of the pregnant woman who receives
HIV testing during labor is required both by ethical standards
and legal requirements. However, in the busy and complex labor
and delivery unit,
maintaining confidentiality requires that staff members be
knowledgeable and vigilant. The following are practical tips
to help protect the confidentiality
of women who receive rapid HIV testing during labor and delivery:
- Discuss
HIV testing when the woman is alone and feels safe
to answer honestly: spouses, partners, and other family
members may not know her sexual, reproductive or HIV
testing history and this information should not be
disclosed to them.
- Set
up services as part of the rapid testing protocol to
make available a professional interpreter,
rather than family members, to protect the confidentiality
of women who do not speak English.
- Ask
the woman in labor ahead of time whom, if anyone, she
would like present when the results of
the HIV test are provided. Confidentiality should be
maintained when giving results, and only the persons
the woman has indicated should be present when the test
results are provided.
- Ensure
confidentiality when discussing ARV prophylaxis if
the test result is positive.
- Label
intravenous ARV medications in a way that protects
confidentiality.
- Develop
and implement procedures to ensure the confidentiality
of HIV test results received in the
labor and delivery unit. Some hospitals maintain a logbook
in which to record the following information: the patient’s
medical record number, date and time that the HIV test
is done in the unit or sent to the laboratory, date and
time the test results are received, and notation that
the test results have been documented in the chart or
communicated to the postpartum unit if the patient has
given birth and been transferred. The system should both
maintain confidentiality and ensure that results are
communicated promptly to clinical staff.
C. Suggested Approaches to Routine Rapid HIV Testing during
Labor and Delivery for Women of Unknown HIV Status: Considerations
in Implementing the Opt-out Approach
CDC recommends routine rapid HIV testing for women in labor whose
HIV status is unknown (women with no documentation of a prenatal
HIV test in their medical records) unless they decline testing,
that is, unless they
opt out (Appendix A, CDC,
Dear Colleague Letter, April 22,
2003).
CDC also
recognizes that regulations, laws, and policies regarding the HIV
screening of pregnant women and neonates are not standardized throughout
US states
and territories. Health care providers and other hospital staff
developing a rapid testing protocol for their facility should be
familiar with, and
adhere to, state and local laws, regulations, and policies concerning
the HIV screening of pregnant women and neonates. They should document
in the
medical chart the results of all tests, both the rapid and the
confirmatory. If a woman in labor and of unknown HIV status refuses
rapid HIV screening,
her refusal should likewise be noted in the medical chart.
The
following information should be given to a woman in
labor whose HIV status is unknown so that she has sufficient
information to make an informed decision about screening:
- She should
be informed that the HIV virus can be transmitted from
a mother to her infant during pregnancy, during labor
and delivery,
and through breastfeeding and that effective interventions
during labor and after birth can substantially reduce
the risk that her baby will become infected.
- She
should be informed that rapid HIV testing will be done
routinely
to help protect her infant’s
health unless she declines testing.
- She
should be informed that a negative rapid HIV test result
means that she is most probably not HIV infected,
but that the test cannot detect very recent infection
or recent exposure. A positive rapid test result is preliminary
and a confirmatory test will need to be done.
- She
will be offered medicines right away for both her and
her baby to reduce the chance that her baby will
become infected. If the confirmatory test is also positive,
she will be offered medical care for her own health
All efforts should be made to determine a mother’s
HIV status as soon as
possible during labor. If the mother’s HIV status remains unknown at delivery,
she or the infant or both should have rapid HIV testing as soon as possible postpartum.
Some states mandate HIV screening of the neonate in this circumstance; however
no states mandate screening of mothers. Providing
information about HIV infection to women in labor whose HIV status is unknown
and routinely conducting rapid HIV testing are challenging, but
the obstacles can generally be overcome with a thoughtful and systematic
approach.
CDC recommends routine rapid HIV testing by the use of an opt-out
approach, in which women are informed that HIV testing will be routinely
done if her
HIV status is unknown during labor and delivery but that she may decline
testing (Appendix A,CDC,
Dear Colleague Letter,
April 22, 2003).
(For an example of a script for an opt-out approach, see Appendix B.) Recognizing
that some
jurisdictions may still require written, signed informed consent for HIV
testing, a sample written informed consent document (opt-in; also included
in Appendix
B) may be useful during the transition to routine HIV testing during labor
and delivery.
The François-Xavier Bagnoud Center (FXBC), of the University
of Medicine and Dentistry of New Jersey is an internationally-recognized
organization
dedicated to improving the lives families infected and affected by HIV infection.
FXBC
has developed a formula for offering routine rapid testing. (For an adaption
of this forumla, see Appendix C, which incorporates both the content that
must be covered and the process still required by some state laws.).
D. Currently Approved Rapid HIV Test Kits
Two
of the 4 rapid HIV antibody tests currently approved by the FDA are available
for clinical use:
the OraQuick Rapid HIV-1 Antibody Test and the Reveal HIV-1
Antibody Test. The UniGold Recombigen HIV Test is expected to become available
shortly. The availability of rapid HIV tests will change as new devices
are developed and approved by the FDA and marketed by manufacturers. Information
on the availability of rapid HIV tests is routinely updated on the CDC
Web
site, at http://www.cdc.gov/hiv/rapid_testing/ and
is also available on the FDA Web site, at http://www.fda.gov/cber/products/testkits.htm.
The
manufacturer’s
instructions for rapid HIV tests should be strictly followed.15,16
E. Interpreting Preliminary and Confirmatory Testing
Results
Test results from rapid HIV tests are interpreted the same as
other HIV screening
test results.
- A negative result
from a single test is considered negative. However, if the person
being tested may have been exposed to HIV within the past
3 months, a repeat test at a later time is recommended because the
rapid antibody test may not show very recent infection.
- A positive (or
reactive) result from a rapid HIV test is considered a preliminary
positive and must be followed up with a confirmatory
test, either a Western blot or an immunofluorescence assay (IFA). Confirmatory
testing should be done as soon as possible.
- When the results
of a rapid test and a confirmatory test are discrepant, both the
rapid and confirmatory test should be repeated,
and consultation with an infectious disease specialist is recommended.
F. Providing Results
When the rapid HIV test is discussed, the woman should be
told how soon to expect the results. Usually, test results
will be available before
delivery and are given to the woman during labor, at which time
she is asked to consent to antiretroviral prophylaxis if the
preliminary result is positive. A woman may state that she doesn’t
want to be told the result of the rapid HIV test until after
the baby’s birth. In such an instance, consent for the initiation
of prophylaxis should be obtained when testing is discussed.
If possible, the clinician who discussed the HIV test should
give the results. Privacy during the discussion of test results
is essential to ensure confidentiality. The woman’s
physical comfort should be assessed and monitored while she is
being given test results.
Providing NEGATIVE rapid HIV test results
If the rapid test result is negative, no further medical intervention
is necessary. The woman should be told that that she is most
likely not infected with HIV but that the test may not show recent
infection. The clinician should ask whether she is concerned
about any recent specific risk of exposure; if she is concerned,
the clinician should recommend retesting after 3 months if indicated.
More extensive HIV counseling should be set up for her during
the postpartum period, and she should be told of these arrangements.
Providing POSITIVE rapid HIV test results
If the rapid HIV test result is positive, the clinician should tell the woman
that she is likely to have HIV infection and that the baby may be exposed to
HIV. She should be assured that a second test is being done right away to confirm
the rapid test result but that the results will not likely be available before
delivery. The clinician should explain that the rapid test result is preliminary
and that false-positive results are possible but that it would be best to start
ARV prophylaxis as soon as possible to reduce the risk of HIV transmission
to the baby. The medication regimen that will be offered to the woman and her
baby should be explained, including the known effects and possible adverse
effects, and she should be given the opportunity to ask questions before accepting
it. She should also be told to postpone breastfeeding until the confirmatory
results are available because she should not breastfeed if she is HIV infected.
The clinician should explain that all ARV prophylaxis will be stopped if the
confirmatory test result is negative.
Preliminary results may not be available before delivery if labor is rapid or
the woman is admitted to the unit late in labor. If the preliminary HIV test
result is positive, ARV prophylaxis for the neonate should be initiated as soon
as possible. (See Section G, for information on peripartum clinical management,
scenario 4.)
If the confirmatory HIV test result is positive, antiretroviral
prophylaxis
for
the infant, to help prevent perinatal transmission, will be continued.
If the rapid HIV test result is positive, complicated and sensitive information
needs to be explained privately to the woman during labor, a very vulnerable
time. The clinician should allow time for questions and assure her that with
her permission, every measure will be taken to reduce the infant’s risk of acquiring
HIV. She should also be reassured that effective treatment is available to help
keep her healthy while she is raising her child.
In some settings, the results of the confirmatory Western blot or IFA will be
available after the mother and her infant are discharged from the hospital. As
part of discharge planning, the woman should be informed of the importance of
returning to discuss her confirmatory test result so that both she and her infant
can receive appropriate medical care. A system for contacting women who miss
appointments to receive their confirmatory test results is important, especially
for women who did not receive prenatal care. Involving family members or other
support persons in discharge planning can be helpful if the woman agrees to their
participation and has disclosed her rapid HIV test results to them.
G. Peripartum Clinical Management of Women with Positive Rapid HIV Test
Results
The US Public Health Service Perinatal HIV Guidelines Working Group publishes
Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1–Infected
Women for Maternal Health and to Reduce Perinatal HIV-1 Transmission in the
United States. The recommendations are available as a living document (frequently
updated) at
www.aidsinfo.nih.gov/guidelines/. Given
the potential complexity of the clinical management decisions, it is strongly
encouraged that local
protocols for peripartum intervention for women whose HIV infection is diagnosed
during labor be developed in consultation with HIV/infectious disease experts.
The current recommendations (version dated November 26, 2003) present 4 clinical
scenarios and ARV treatment recommendations to reduce perinatal transmission.
Scenarios 3 and 4 (summarized in the following sections) apply to women who
arrive in a labor and delivery with undocumented HIV status and who have positive
rapid HIV test results. In initiating rapid HIV testing and treatment protocols,
hospital staff should access
www.aidsinfo.nih.gov/guidelines/ to
ensure that they follow the most recently updated recommendations. When hospital
policy
is being developed, input from clinicians with expertise in perinatal HIV management
is encouraged.
HIV-infected women in labor with no prior treatment
(The following is a summary of scenario 3 from the USPHS guidelines.)
Several effective ARV treatment regimens are available, including (1) zidovudine
(ZDV) monotherapy, (2) ZDV plus lamivudine (3TC), (3) nevirapine (NVP) monotherapy,
and (4) ZDV plus NVP. Dosing is described in Table 3.
Table 3. Antiretroviral regimens for HIV-infected women
in labor with no prior therapy.
Medication(s) |
Woman |
Neonate |
ZDV |
Intrapartum
IV ZDV (loading dose [2 mg/kg] for 1 hour, followed
by continuous infusion [1mg/kg/hr] until delivery) |
ZDV
syrup (2 mg/kg) orally every 6 hours for 6 weeks,
beginning 8–12 hours after birtha |
ZDV
+ 3TC |
ZDV
(600mg) po and 3TC
(150 mg) orally at onset of labor, followed by ZDV
(300 mg) orally every 3 hours and 3TC
(150 mg) orally every 12 hours until delivery |
ZDV
syrup (4 mg/kg) and 3TC (2 mg/kg)
orally every 12 hours for 7 days |
NVP |
Single
dose of NVP (200 mg) orally at onset of laborb |
Single
dose of NVP 2 mg/kg 48–72 hours after
birth |
NVP+ZDV |
Intrapartum
IV ZDV (loading dose [2 mg/kg] for 1 hour, followed
by [1 mg/kg/hr.] until delivery) and single
dose of NVP (200 mg) orally at onset of laborb |
ZDV
syrup (2 mg/kg) orally every 6 hours for 6 weeks,
beginning 8–12 hrs after birth and single
dose of NVP (2 mg/kg) orally 48–72 hours after birth |
Note.
IV, intravenous; ZDV, zidovudine; 3TC, lamivudine; NVP, nevirapine.
aZDV
dosing for infants of <35 weeks gestation at birth is 1.5
mg/kg/dose orally, every 12 hours, increasing to every 8 hours at
2 weeks of age if >30 weeks gestation at birth or at 4 weeks of
age if <30 weeks gestation at birth.17
bIf the mother received
NVP less than 1 hour before delivery, the neonate should be given
2 mg/kg of oral NVP
as soon as possible after
birth and again at 48–72 hours.
During the immediate postpartum period, the woman
should have appropriate assessments (e.g., CD4+ count and HIV-1
RNA copy number)
to determine whether ARV treatment is recommended for her own health.
A description of recommended intrapartum and postpartum
treatment regimens for women identified in labor (USPHS guidelines,
scenario
3) is available at www.aidsinfo.nih.gov/guidelines/ and
includes data on transmission and the advantages and disadvantages
of each
regimen. The selection of a specific abbreviated ARV prophylaxis
regimen may be based on the resources of the institution or the
facility and an individualized clinical assessment of the patient.
Clinicians should also weigh the potential for future NVP resistance
when considering treatment options.
Infants
born to mothers who have received no antiretroviral therapy
during pregnancy or intrapartum (Summary of scenario 4
of the USPHS guidelines)
-
The 6-week neonatal ZDV component of the ZDV chemoprophylactic
regimen should be discussed with the mother and recommended for
the neonate.
- ZDV for
the neonate should be initiated as soon as possible after
birth?preferably within 6–12
hours.
- Some clinicians
may choose to use ZDV in combination with other antiretroviral
drugs, particularly if the mother
is known or suspected to have ZDV-resistant virus. However,
the efficacy of this approach for the prevention of transmission
is unknown, and appropriate dosages for neonates are incompletely
defined.
- During
the immediate postpartum period, the woman should undergo
appropriate assessments (e.g., CD4+ count and
HIV-1 RNA copy number) to determine whether ARV treatment is
required for her health. The neonate should undergo early diagnostic
testing so that if the neonate is HIV infected, treatment can
be initiated as soon as possible.
Note: Discussion of treatment options and recommendations
should not be coercive, and the final decision about the use
of ARV prophylaxis is the mother’s.
The selection of a specific, abbreviated course of ARV prophylaxis
may be based on the resources and policies of the institution
or the facility, as well as an individualized clinical assessment
of the patient.
Intrapartum care
If labor progresses and membranes are intact, artificial rupture
of membranes and invasive monitoring should be avoided. Labor
should be managed with spontaneous rupture of membranes (SROM).
Episiotomy should be avoided
if clinically appropriate. Breastfeeding should also be avoided.
Cesarean section
Women diagnosed with HIV infection through rapid testing at the
time of presentation for delivery will frequently present in
active labor and/or with ruptured membranes. In such circumstances,
information regarding maternal viral load will likely not be
available to guide the management of delivery. Data are insufficient
to indicate whether cesarean section (C-section) will add any
benefit in reducing the risk of MTCT.18In the only
published randomized controlled trial of C-section in HIV-infected
women,
rates of perinatal HIV transmission between mother-infant pairs
with emergency C-section (after active labor or rupture of membranes)
and mother-infant pairs with vaginal delivery did not differ.19
However, for women whose HIV infection was diagnosed late in
pregnancy and who have no evidence of labor or rupture of membranes
but who have clinical indications for delivery (e.g., preeclampsia,
vaginal bleeding, fetal heart rate abnormalities, intrauterine
growth retardation, oligohydramnios), C-section may help to prevent
HIV transmission. Management in such circumstances should be
individualized, and accepted principles should be taken into
consideration:
- The greatest benefit
in preventing transmission is associated with cesarean
delivery performed before the rupture of membranes
or to the onset of labor in conjunction with the administration
of ARV prophylaxis.
- ARV prophylaxis
should be administered to the woman before cesarean delivery
whenever possible (ideally, 2 –4 hours).
A more comprehensive
discussion of the role of C-section in the prevention of perinatal
HIV transmission
is available in the U.S. Public Health Service
Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant
HIV-1–Infected
Women for Maternal Health and Interventions to Reduce Perinatal HIV-1
Transmission in the United States (www.aidsinfo.nih.gov/guidelines/).
Neonatal
care
- The neonate should
be bathed promptly after birth and before injections (e.g.,
vaccines or vitamin K).
- A baseline complete
blood count (CBC) with differential AND serum chemistries
should be performed before initiating
ARV prophylaxis. A CBC should be repeated at 6 and 12 weeks
of age.
- Polymerase chain
reaction (PCR) testing for HIV-1 should be done at birth
(before 48 hours
of age) and repeated at
ages 1–2
months and 3–6 months. Additional testing at 14 days of age
might allow the early detection of infection.20
*HIV-exposed infants should
be evaluated by, or in consultation with, a specialist in HIV infection
in pediatric patients. Regular updates of the
Guidelines for the Use of Antiretroviral Agents in Pediatric HIV
Infection are available at www.aidsinfo.nih.gov/guidelines/. H.
Communication with Pediatricians
It is crucial that the obstetric provider communicate with the
pediatric provider when a neonate has been exposed to HIV.
The medical care of an HIV-exposed infant is different than
that of an infant who
has not been exposed to HIV. In some states, regulations ensure
that the obstetric provider’s communication of the mother’s
HIV status to the pediatric provider is not considered a breach
of confidentiality.
I. Referral for Follow-up
of HIV-infected Mother and HIV-exposed Infant
Both mother and infant need to be referred for ongoing care to
providers with experience and expertise in HIV care. Services
for families affected by HIV infection are available in many
communities through Title
IV or Title III of the Ryan White CARE Act. HIV-infected mothers
who are just learning their HIV status or who have not been in
care need a thorough
evaluation of their immune and clinical status and assessment
of their need for ARV treatment or other care. Infants need diagnostic
testing
and clinical monitoring to determine their HIV status. All
infants exposed to HIV should be placed on an antibiotic for
prophylaxis against Pneumocystis
carinii pneumonia (PCP) at 6 weeks of age, and should continue
to receive it until it has been confirmed that they are not infected
with HIV.20
Families need access to case management and psychosocial support
services, ideally through a comprehensive, family-centered HIV
program. In some
communities, a case manager from the family HIV care program
will visit the mother in the hospital if notified of the referral.
Before discharge, the mother
should be educated about the ARV prophylaxis and why it is important
that the infant complete the full course of medication.
Teaching should emphasize that (1) the infant must complete the
ARV prophylaxis, (2) the infant should begin taking antibiotic
prophylaxis for PCP at 6 weeks
of age, (3) the infant will need further testing during the first
few months of life to determine HIV status, and (4) the mother
should return to receive
confirmatory HIV test results (if not received before discharge).
If the mother has disclosed her HIV status to a family member
or other support
person, it is beneficial to involve the support person in instructions
about the necessary follow-up care of both mother and infant.
J. Reporting
HIV/AIDS
If Western blot or IFA test results confirm HIV infection, the
facility must follow all applicable local and state requirements
regarding the reporting of HIV infection or AIDS. If personnel
are uncertain about
the HIV/AIDS reporting requirements in their area, they should
contact their state health department HIV/AIDS surveillance unit.
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