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It

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Title: 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
6
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
7
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
8
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
9
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

10
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

11
What have we learned about perinatal HIV
transmission?
12
  • 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)

13
  • 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

14
Factors Influencing Perinatal Transmission
  • Obstetrical Factors
  • Length of ruptured membranes and/or
    chorioamnionitis
  • Vaginal delivery ( if VL gt1000)
  • Invasive procedures
  • Infant Factors
  • Prematurity
  • Breastfeeding

15
  • 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

16
  • 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

17
Results of ACTG 076
30
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

20
HIV Testing in PregnancyNational and New Jersey
  • Routine and Rapid HIV Testing

21
  • 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

22
  • 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

23
  • 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

24
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.

25
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

26
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.

27
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.

28
Specific Issues
  • Education, Opting Out
  • Giving Results, Confidentiality, Documentation,
    Communication

29
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

30
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?

31
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

32
  • 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

33
  • 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?

34
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

35
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

36
Rapid HIV Testing in Labor and Delivery
37
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

38
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

39
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

40
  • 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

41
  • 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

42
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

43
Treatment of HIV Women During Pregnancy
44
  • 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

45
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

48
  • 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

49
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

51
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

52
  • 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)

53
  • 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

54
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

55
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

56
  • 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
58
  • 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

59
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

60
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

61
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