1 It’s the Law HIV 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 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 ,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

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 20–49 years old 53% of HIV/AIDS cases in youth 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 >13 years of age NJ HIV/AIDS Report, Dec. 31, 2007

8 6 6 < <5 52 < < <5 19 <5 137 Perinatally HIV Infected Children Born in N.J As of 12/31/ 07 Thanks to Linda Dimasi, Epidemiologic Services, Div. of HIV/AIDS, NJDHSS

9 Missed Opportunities: Children Infected as of 12/31/06 7 new infections during /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

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 — “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

11 What have we learned about perinatal HIV transmission?

12 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)

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 >1000) – 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 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

17 Results of ACTG 076 ZDV GroupPlacebo % 22.6% 7.6% Transmission Rate (%) Intervention led to a 66% reduction in risk for transmission (P= <0.001). Efficacy was observed in all subgroups.

18 Reducing HIV Transmission with Partial ZDV Regimens (NY cohort) Transmission Rate

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 Pregnancy National 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) 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

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 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.

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 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

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 client’s 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 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

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 3 rd 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 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

40 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

41 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

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 >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

49 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

50 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

51 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

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 (<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

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

58 Clinical Guidelines for Antiretroviral Treatment – Adults and Adolescents – Pediatrics – Perinatal/Mother-to-Child Transmission Offering information on AIDS treatment, prevention and research

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. Joseph’s Hospital and Medical Center Comprehensive Care Center, Paterson

60 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. aids-etc.org

61 Case Studies and Best Practices