It’s the Law HIV Testing in Pregnancy in New Jersey

1. It’s 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. 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 Epidemic in the US Among Women and Children 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 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 >13 years of age NJ HIV/AIDS Report, Dec. 31, 2007

8. <5 30 Perinatally HIV Infected Children Born in N.J. 1993-2007 As of 12/31/ 07 6 <5 <5 137 52 19 <5 <5 18 25 12 9 <5 12 <5 <5 6 5 Thanks to Linda Dimasi, Epidemiologic Services, Div. of HIV/AIDS, NJDHSS <5

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 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. 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 PACTG 076

17. Results of ACTG 076 30 Intervention led to a 66% reduction in risk for transmission (P= <0.001). Efficacy was observed in all subgroups. 22.6% 20 Transmission Rate (%) 7.6% 10 Placebo ZDV Group

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:repeatif 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. 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?” Counseling a Pregnant Woman with a Positive HIV Test

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 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 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. 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 Giving Negative Rapid HIV Results in Labor

41. “Your preliminary HIV test was positive…this means that you mayhave 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 Giving Positive Rapid HIV Results in Labor

42. ConfirmatoryResults • 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. 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 Elective Cesarean Section

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. 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 HIV-infected Woman in Labor With No Prior Treatment