It

1
Its the LawHIV Testing in Pregnancy in New
Jersey
François-Xavier Bagnoud Center University of
Medicine Dentistry of New Jersey
2
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.

3
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.

4

• 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

5

• 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 90s) 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
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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 2049 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
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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 gt13 years of age

NJ HIV/AIDS Report, Dec. 31, 2007
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lt5
30
Perinatally HIV Infected Children Born in
N.J. 1993-2007 As of 12/31/ 07
6
lt5
lt5
137
52
19
lt5
lt5
18
25
12
9
lt5
12
lt5
lt5
6
5
Thanks to Linda Dimasi, Epidemiologic Services,
Div. of HIV/AIDS, NJDHSS
lt5
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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 mothers 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
  Im 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 - 2540 of cases
• Intrapartum - 6075 of cases
• Breastfeeding increases risk 14-29
• Most transmission occurs close to or during
  labor and delivery (LD)

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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 gt1000)
• 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
  1434 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 812 hours after birth

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Results of ACTG 076
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Intervention led to a 66 reduction in risk for
transmission (P lt0.001). Efficacy was observed
in all subgroups.
22.6
20
Transmission Rate ()
7.6
10
ZDV Group
Placebo
18
Reducing HIV Transmission with Partial ZDV
Regimens (NY cohort)
26.6
Transmission Rate
9.3
6.1
10
19
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 PregnancyNational 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)

• LD routine rapid testing for women with unknown
  HIV status
• Its not too late - ARVs can still reduce
  transmission
• Postnatal rapid testing for infants whose
  mothers 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 mothers 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 NBs
  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
  negativeYoure not infected with HIVthe 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 clients feelings, immediate support
  system Do you have someone you can talk to
  about this?

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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 mothers prenatal HIV test results (or
  rapid test) in L D and newborn record
• Communicating test results
• To L D
• Moms 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 LaborWhat 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 babys
  risk of getting HIV and get treatment for herself
• She can decline the test and wont be denied care
• By law, if a mothers 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
  negativeYoure not infected with HIVthe 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 positivethis
  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

46
Labor and Delivery

• Treatment to Prevent Perinatal HIV Transmission

47
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 gt1000 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 patients decision about method of
  delivery

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Vaginal Delivery

• Vaginal delivery if viral load lt1000
• Minimize duration of ruptured membranes
• Educate women not to delay when labor starts
• Avoid use of scalp electrodes, other invasive
  procedures

50

• HIV-infected Woman in Labor With No Prior
  Treatment

• Discuss benefits of treatment during labor
  andfor 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 gt 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 (lt1 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

57
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. Josephs Hospital and Medical Center
  Comprehensive Care Center, Paterson

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François-Xavier Bagnoud CenterNational Resource
CenterUniversity 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