It’s the Law

HIV Testing in Pregnancy in

New Jersey

François-Xavier Bagnoud Center

University of Medicine & Dentistry of New Jersey

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 Objectives
 Describe missed opportunities for
preventing perinatal HIV infection in NJ.
 Describe components of prenatal HIV
testing as required by NJ P.L. 2007.c.218.
 Discuss current CDC recommendations and
rationale for HIV testing, for adults as well
as pregnant women.
 Identify current recommendations for
prevention of perinatal HIV transmission.

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 Objectives
 Identify strategies for routine prenatal HIV
testing, 3rd trimester retesting and rapid
HIV testing in L & D or for the newborn.
 Identify specific state/community resources
for referral & follow-up of pregnant women
and infants with positive HIV test results.
 Discuss training strategies for educating
staff on requirements of the law and best
practices for preventing perinatal HIV
transmission.
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 Where are we in 2008?
Preventing Perinatal HIV Transmission

 Without antiretroviral (ARV) drugs during

pregnancy, risk of transmission from mother
to infant was 1 in 4
 Today, risk of perinatal transmission can be
less than 2% (1 in 50) with:
– highly effective ARV therapy
– elective cesarean section (C/S) as appropriate
– formula feeding

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 Epidemic in the US Among
Women and Children
 AIDS in women has risen from 7% in 1985 to
26% of adult cases in 2006
 191,714 AIDS cases in women reported through
December 2006
 HIV-infected infants born each year has decreased
from ~ 1750 (mid ‘90’s) to ~142 in 2006
 In 2006, in 25 states with name-based reporting, 65
infants were diagnosed with HIV infection and 13
with AIDS

CDC Surveillance Report, 2006 5

 HIV/AIDS in Women in New Jersey
Reported 1/07-12/07*
 628 HIV/AIDS cases were reported in women
 31% of cumulative HIV/AIDS cases are women
 Nearly 7 of 10 females living with HIV/AIDS are currently
20–49 years old
 53% of HIV/AIDS cases in youth 13-19 are girls
 Exposure categories for women
– IVDU = 10%
– Heterosexual contact
• Partner(s) of unknown risk = 45%
• Partner is HIV-infected = 20%
• Partner is injection drug user = 4%

* NJ HIV/AIDS Report, Dec. 31, 2007 6

Pediatric HIV/AIDS Cases in New Jersey

 Perinatal transmission has been reduced to

less than 2%
 Of 792 cases of children living with HIV/AIDS,
72% are >13 years of age

NJ HIV/AIDS Report, Dec. 31, 2007

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 <5 30
Perinatally 6
<5 <5
HIV Infected 137
52
Children Born <5 <5 19
in N.J. 18
25
12
1993-2007
As of 12/31/ 07 9
<5
12
<5
<5 6
5
Thanks to Linda Dimasi,
<5 Epidemiologic Services, Div.
of HIV/AIDS, NJDHSS
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 Missed Opportunities:
Children Infected as of 12/31/06
 7 new infections during 2004-2006
 6/7 mothers had no known or inadequate
prenatal care
 Only 1/7 received ZDV during pregnancy
 6/7 mother’s HIV status unknown to delivery
team

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 Other Missed Opportunities
(some perinatal “details”)
 32 weeks, mom IVDU, tested HIV + at
delivery, vaginal delivery, no ZDV prenatal
or intrapartum, infant received ZDV
 Full term, good prenatal care, mother not
tested — “I’m negative”— infant diagnosed in
PICU with PCP (and AIDS) at 4 months
 38 weeks, mom had no prenatal care, tested
positive at delivery, non-elective C/S, no ZDV
intrapartum, infant ZDV on day 2
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What have we learned about
perinatal HIV transmission?

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 Timing of Perinatal
HIV Transmission
 Intrauterine - 25%–40% of cases
 Intrapartum - 60%–75% of cases
 Breastfeeding – increases risk 14-29%
 Most transmission occurs close to or
during labor and delivery (L&D)

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 Factors Influencing
Perinatal Transmission

 Maternal Factors
– HIV-1 RNA levels (viral load [VL])
– Low CD4+ lymphocyte count (“T-cells”)
– Co-infections: Hepatitis C, CMV, BV
– Maternal injection drug use
– No antiretroviral therapy or prophylaxis

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 Factors Influencing
Perinatal Transmission
 Obstetrical Factors
– Length of ruptured membranes and/or
chorioamnionitis
– Vaginal delivery ( if VL >1000)
– Invasive procedures
 Infant Factors
– Prematurity
– Breastfeeding

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 Breastfeeding and HIV Infection

 Women with HIV infection in the US should

not breastfeed

 Women considering breastfeeding should

know their HIV status

 Cultural norms should be considered in

supporting the non-breastfeeding woman
with HIV infection

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 PACTG 076
A phase III randomized placebo-controlled trial of
ZDV for preventing maternal-fetal HIV transmission.
Treatment Regimen
 Antepartum: 100 mg ZDV po 5x day, started at
14–34 weeks gestation
 Intrapartum: During labor, 1-hour initial dose 2 mg/kg
IV followed by continuous infusion of 1 mg/kg until
delivery
 Postpartum/Infant: 2 mg/kg po q 6 hr for 6 weeks,
start 8–12 hours after birth

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 Results of ACTG 076

30 Intervention led to a 66%

Transmission Rate (%)

reduction in risk for transmission

22.6%
(P= <0.001).
20
Efficacy was observed in all
subgroups.
10 7.6%

Placebo ZDV Group

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Reducing HIV Transmission with
Partial ZDV Regimens (NY cohort)

26.6
Transmission Rate

30%
25%
20%
15% 9.3
6.1 10
10%
5%
0%

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 Mechanisms to Reduce Perinatal
HIV Transmission
 Antiretroviral drugs
– Lower maternal antepartum viral load
– Provide pre- and post-exposure prophylaxis
for the infant
 Prophylaxis is recommended
– Antepartum
– Intrapartum
– Neonatal

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 HIV Testing in Pregnancy
National and New Jersey

Routine and Rapid HIV Testing

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 National Recommendations for
HIV Testing of Pregnant Women
(CDC and ACOG) and Rationale
 Prenatal: routine, universal HIV screening with
the right to decline
 Effective treatment for HIV infection
 Treatment for preventing perinatal HIV transmission
 Risk-based testing does not work
 3rd trimester: repeat if at risk, in area of high
prevalence, or previous refusal
 Seroconverting in pregnancy = high risk for
transmitting to infant
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 National Recommendations for
HIV Testing of Pregnant Women
(continued)

 L&D: routine rapid testing for women with

unknown HIV status
 It’s not too late - ARVs can still reduce transmission
 Postnatal: rapid testing for infants whose
mother’s status is unknown
 Post exposure prophylaxis for the infant

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 Prenatal Rapid HIV Testing
for Some Pregnant Women?

 An opportunity for HIV testing for women

─ who are hard to reach/not in prenatal care
─ who present late in the pregnancy
─ who are unlikely to return for HIV results
 Priority referral for care/treatment for woman
and to reduce transmission to baby

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 HIV Testing in Pregnancy in
New Jersey: NJ P.L.2007.c.218
 HIV testing should be part of routine prenatal
care for all pregnant women.
 Timing of testing: as early in the pregnancy
as possible and again in the 3rd trimester.
 The physician or health care provider shall
advise the woman that HIV testing is
recommended early in pregnancy and again
in the 3rd trimester; it will be included with
routine prenatal tests unless she declines.
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 NJ P.L.2007.c.218 (continued)
 A physician or health care provider shall
provide the woman with information (orally or
in writing) about HIV/AIDS:
– Explanation about HIV infection
– Meaning of positive and negative results
– Benefits of testing as early as possible during
pregnancy and again in 3rd trimester
– Treatment available if diagnosed early
– Reduced rate of perinatal transmission if treated
– Interventions available to reduce risk of mother-to-
child transmission
– Opportunity to ask questions
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 NJ P.L.2007.c.218 (continued)
 The healthcare provider shall document
decline of testing in the medical record.
 A woman shall not be denied care if she
declines testing; or denied testing on the basis
of economic status.
 Testing shall be voluntary & free of coercion.
 A woman in L & D who has not been tested
will be given information and tested as soon
as medically appropriate, unless she declines.
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 NJ P.L.2007.c.218 (continued)
 If the mother’s HIV status is unknown, newborn
HIV testing is required.
 The newborn will be tested unless the parents
object in writing that the testing conflicts with
their religious beliefs and practices.
 Commissioner will establish a comprehensive
program for follow-up of infant and mother:
testing, maternal counseling, disclosure of
NB’s status, infant tracking, facility compliance,
educational activities related to testing.
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 Specific Issues

Education, “Opting Out”

Giving Results, Confidentiality,
Documentation, Communication

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 Education about HIV Testing
 Staff and OB providers
– What will change in practice?
• Prenatal clinics, FQHCs, private OB practice
– Pretest counseling/written separate consent not
required
– Oral or written information about HIV and testing
for every pregnant woman
 Pregnant women
– Routine for everyone unless declined
– Required by law - early and repeat in 3rd trimester

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 Opting-out
 HIV testing is routine - included with other
prenatal tests
 How will you inform a woman she can decline
HIV testing?
 Written information on HIV and testing in
pregnancy – what is available?

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 Confidentiality
 HIV test results are confidential and
reportable by law
 Specific consent is needed to share results
with other providers/agencies except OB with
the pediatrician
 Issues of disclosure and partner testing
– HIV stigma and discrimination still exist
– Maintain confidentiality while assuring appropriate care
– Support and referral for disclosure/ partner testing

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 Counseling a Pregnant Woman with
Negative Prenatal HIV Test Results

 Meaning of a negative test: “Your HIV test

was negative…You’re not infected with HIV…
the test may not detect recent infection.”
 Refer women at risk for HIV infection for
counseling and risk reduction interventions
 Repeat HIV testing in 3rd trimester

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 Counseling a Pregnant Woman
with a Positive HIV Test

 Meaning of a positive test result:

“Your HIV test was positive. This means you
have HIV infection.”
 “What you need to know right now is that there
is effective treatment for HIV and to reduce the
risk to your baby.”
 Focus on client’s feelings, immediate support
system
“Do you have someone you can talk to about
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this?”
 Positive HIV Results (continued)
 Referral for HIV care/consult with HIV/OB
expert
– Evaluation for ARV treatment
– ARV for preventing perinatal transmission
 Referral for post-test counseling
 Referral to a Family Treatment Program
 Reinforce that there is treatment for her and
for reducing the risk for her baby

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 Documentation & Communication
 Document test results in prenatal record
– Declined testing
– Initial prenatal test
– 3rd trimester repeat test
 Ensure prenatal record with HIV results
gets to L & D in timely fashion
 Document mother’s prenatal HIV test results (or
rapid test) in L & D and newborn record
 Communicating test results
– To L & D
– Mom’s positive results with nursery/pediatrician

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 Rapid HIV Testing
in Labor and Delivery

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 Which Pregnant Women in New Jersey
Will Need Rapid HIV Testing in Labor?

Women
– with no or limited prenatal care
– whose results are unavailable
– who declined testing previously
– who have not had a repeat test in
3rd trimester

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 Rapid HIV Tests

 6 tests FDA approved for blood/serum

 4 point-of-care tests (CLIA waived)
 1 test available for oral fluid
 All are highly specific and sensitive

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 Rapid HIV Testing in Labor
What a woman needs to know
 No record of an HIV test result (or a 3rd trimester
test) is on her chart
 By law in New Jersey, if a woman had not had an
HIV test this pregnancy, a rapid HIV test is routine
in labor and delivery
– HIV rapid test gives us results quickly.
– The rapid test is a screening test; we always do a 2nd
test if the screening test is positive
– If a woman is positive, she can lower her baby’s risk of
getting HIV and get treatment for herself
– She can decline the test and won’t be denied care
– By law, if a mother’s HIV status is unknown, her baby
will be tested after birth
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 Giving Negative Rapid HIV
Results in Labor
 Meaning of a negative test:
“Your HIV test was negative…You’re not infected with
HIV…the test may not detect recent infection.”
 Follow-up in postpartum:
– Assess for ongoing risk
– Discuss risk reduction strategies and safer sex
practices to help keep her HIV negative
– Refer women at high risk for further counseling
and interventions
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 Giving Positive Rapid
HIV Results in Labor
 “Your preliminary HIV test was positive…this means
that you may have HIV infection. We always do
another test to confirm a positive rapid test.”
 “It is best that we start medicine to reduce the risk to
your baby, while we wait for the confirmatory results.”
– Treatment to reduce transmission to her baby
– Need to postpone breastfeeding until results of
confirmatory test
 Psychosocial support during labor and follow-up for
mom and baby in postpartum
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 Confirmatory Results
 A preliminary positive rapid HIV test must
always be confirmed
 Rapid test should be confirmed with a
Western Blot or IFA
 Note that “Rapid HIV Test was positive” on
confirmatory test request slip.
 A EIA (Elisa) is not necessary

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Treatment of HIV+ Women
During Pregnancy

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 Goals of ARV Therapy

 Suppress HIV to below the limits of detection or

as low as possible, for as long as possible

 Prolong life and improve quality of life
 Preserve or restore immune function
 Reduce risk of perinatal transmission

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 Care Guidelines for All Pregnant
Women with HIV Infection
 Evaluate HIV disease, degree of
immunodeficiency (CD4+ count) and need for
ARV treatment
 Monitor viral load for treatment and to plan for
method of delivery
 Develop strategy for long-term follow-up and
management of mother and infant

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 Labor and Delivery

Treatment to Prevent Perinatal

HIV Transmission

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 HIV-Infected Women Currently
on ARV Treatment
 Continue ARVs orally during labor
 Start IV ZDV immediately (3 hrs prior to
scheduled C-section)
 Discontinue d4T during labor (ZDV
antagonist)
 C-section if appropriate

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 Elective Cesarean Section
 May reduce risk of HIV transmission during labor and
delivery for women with VL >1000 or with unknown
VL and not on ARV

 Scheduled at 38 weeks before labor and rupture

of membranes

 Complications of C/S slightly more frequent in women

with HIV infection

 Discuss potential risks and benefits of scheduled C/S

 Respect patient’s decision about method of delivery

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 Vaginal Delivery

 Vaginal delivery if viral load <1000

– Minimize duration of ruptured membranes
– Educate women not to delay when labor
starts
– Avoid use of scalp electrodes, other
invasive procedures

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 HIV-infected Woman in Labor
With No Prior Treatment
 Discuss benefits of treatment during labor and
for infant for 6 weeks.
 Begin IV ZDV loading dose and continue until
delivery
 Consult with HIV/OB expert about the use of
additional ARVs
 Refer to Guidelines for Use of ARVs in
Pregnancy pocket cards
 Give newborn oral ZDV for 6 weeks

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 Intrapartum Management
 If possible, administer IV ZDV 4 hours prior
to delivery
 Avoid ROM > 4 hours
 Avoid invasive monitoring unless obstetrically
indicated
 If vaginal delivery, avoid instruments, forceps or
vacuum extraction if possible
 Do not use methergine for uterine atony with
postpartum hemorrhage in women on protease
inhibitors
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 Postpartum Care of the Women with
a Positive Rapid HIV Test

 Postpone breastfeeding with symptom support

until after negative confirmatory results
 Primary and HIV specialty care
– Counseling support
– Refer while in the hospital
– Follow-up for confirmatory test results
– Assess ARV treatment needs (e.g., CD4+, VL)

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 Future Needs of the HIV
Positive Woman
 Ob/GYN and family planning services
 Care coordination and support through case
management for the woman and her family
 Evaluation for current ARV needs
 Mental health and substance abuse treatment
 Adherence support
 Assistance around disclosure

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 Clinical Management of the Perinatally
HIV-Exposed Infant
 Administration of neonatal ZDV
– Oral - 2mg/kg/dose q 6 hours for 6 weeks
– Give first dose within 6 –12 hours
of delivery (preferably within 4 – 6 hours)
– IV dose for full term infant is 1.5 mg/kg
q 6 hours
– Dose is adjusted for preterm infants

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 The HIV Exposed Infant:
Neonatal ZDV Discharge Tips
 Teach mom to give the dose (<1 ml – use TB
syringe)
 If at all possible, send mom home with the oral
ZDV for her newborn
 Ensure that the family's community pharmacy
has ZDV syrup in stock
 Contact local pediatric/family HIV program for
assistance
 Ask mom to sign medical record release for
baby
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 Evaluation and Follow Up
of HIV-Exposed Infants
 Support for ZDV prophylaxis for 6 weeks
 Diagnostic testing to establish or rule out HIV
infection as early as possible
 Referral to a pediatric HIV specialist
 PCP prophylaxis initiated at 6 weeks of age
until HIV presumptively excluded
 Long-term follow up of HIV and ARV-exposed
infants
 Support services for the family 56
Perinatal Hotline--National Perinatal HIV
Consultation and Referral Service
…offers around-the-clock advise on testing and
care of HIV-infected pregnant women and
their infants
…provides referral to HIV specialists and
regional resources

1-888-448-8765
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 Clinical Guidelines for Antiretroviral
Treatment
– Adults and Adolescents
– Pediatrics
– Perinatal/Mother-to-Child Transmission
 Offering information on AIDS treatment,
prevention and research
 www.aidsinfo.nih.gov

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 Resources and Follow-up for the Family
 The NJ Statewide Family Centered HIV Care Network
 François-Xavier Bagnoud Center(FXB), UMDNJ, Newark
• OB referral: University OB/GYN
 Jersey City Medical Center Regional Family HIV Treatment Center
 Jersey Shore Medical Center Family HIV Program, Neptune
 The Family Treatment Center at Newark Beth Israel Medical Center
 Robert Wood Johnson AIDS Program (RWJAP), New Brunswick
 Southern NJ Regional Family HIV Treatment Center, Cooper
University Hospital, Camden
 St. Joseph’s Hospital and Medical Center Comprehensive Care
Center, Paterson

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 François-Xavier Bagnoud Center
National Resource Center
University of Medicine & Dentistry of New Jersey

 Capacity building, training and technical

assistance
 Information dissemination of clinical and
training resources
 Development of patient education and
clinician support materials for routine HIV
testing

www.fxbcenter.org www. aids-etc.org

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Case Studies and Best Practices

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