It’s the Law
HIV Testing in Pregnancy in
New Jersey
François-Xavier Bagnoud Center
University of Medicine & Dentistry of New Jersey
1
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.
2
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.
3
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
–
4
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
7
<5
Perinatally
HIV Infected
Children Born
in N.J.
1993-2007
30
<5
137
19
<5
<5
18
12
As of 12/31/ 07
<5
12
<5
6
<5
<5
52
25
9
6
5
<5
Thanks to Linda Dimasi,
Epidemiologic Services, Div.
of HIV/AIDS, NJDHSS
8
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
9
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
10
What have we learned about
perinatal HIV transmission?
11
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)
12
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
13
Factors Influencing
Perinatal Transmission

Obstetrical Factors
– Length of ruptured membranes and/or
chorioamnionitis
– Vaginal delivery ( if VL >1000)
– Invasive procedures

Infant Factors
– Prematurity
– Breastfeeding
14
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
15
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
16
Results of ACTG 076
30
22.6%
20
Intervention led to a 66%
reduction in risk for transmission
(P= <0.001).
Efficacy was observed in all
subgroups.
7.6%
10
Placebo
ZDV Group
17
Transmission Rate
Reducing HIV Transmission with
Partial ZDV Regimens (NY cohort)
26.6
30%
25%
20%
15%
10%
5%
0%
6.1
9.3
Co
m
10
In
t
In
No
fa
ne
nt
pl
ete
rtu
Re
m
/n
gim
eo
en
na
ta
l
ra
pa
18
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
19
HIV Testing in Pregnancy
National and New Jersey
Routine and Rapid HIV Testing
20
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
21
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
22
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
23
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.
24
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-tochild transmission
– Opportunity to ask questions
25
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.
26
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.
27
Specific Issues
Education, “Opting Out”
Giving Results, Confidentiality,
Documentation, Communication
28
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
29
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?
30
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
31
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
32
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 this?”
33
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
34
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
35
Rapid HIV Testing
in Labor and Delivery
36
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
37
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
38
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
39
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
40
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
41
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
42
Treatment of HIV+ Women
During Pregnancy
43
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
44
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
45
Labor and Delivery
Treatment to Prevent Perinatal
HIV Transmission
46
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
47
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
48
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
49
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

50
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
51
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)
52
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
53
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
54
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
55
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
57

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
58
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
59
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
60
Case Studies and Best Practices
61