1. HIV Counseling and Rapid Testing in Labor

2. 11/03 2 Acknowledgements  Original slide set developed by Elaine Gross and Carolyn Burr, François-Xavier Bagnoud Center at UMDNJ (FXB Center) with funding from the NJ Department of Health & Senior Services  Material adapted for AETC use by representatives from Midwest AIDS Training and Education Center, New England AETC, the FXB Center, the National Clinicians’ Consultation Center, and AETC National Resource Center

3. 11/03 3 Learning Objectives This presentation will assist you to:  Describe national recommendations for HIV testing in pregnancy  Examine barriers to universal HIV counseling and testing  Discuss research findings and clinical strategies for preventing perinatal HIV transmission  Describe unique issues related to HIV counseling and rapid testing of women in labor with no prenatal care or unknown HIV status  Discuss strategies for managing the HIV positive woman in labor including rapid testing and short-course antiretroviral therapy

4. 11/03 4 Components of the Slide Set  National recommendations for HIV counseling and testing in pregnancy  Overview of HIV in pregnancy and prevention of perinatal HIV transmission  Rapid HIV testing during labor  Short course antiretroviral therapy  Case studies

5. 11/03 5 Chain of events leading to an HIV-infected child The proportion of women...  Who are HIV-infected  Who become pregnant  Who do not seek prenatal care  Who are not offered HIV testing  Who refuse testing  Who are not offered ARV prophylaxis  Who refuse ARV prophylaxis  Who do not complete the ARV prophylaxis  Whose child is infected despite treatment IOM, 1998

6. 11/03 6 Scope of the Epidemic Among Women and Children  152,060 AIDS cases in women reported through December 2002  AIDS in women has risen from 7% early in the epidemic to 26% of adult/adolescent cases in 2002  158 new AIDS cases reported in children in 2002  10,000 – 20,000 estimated children living with HIV infection  280 – 370 babies continue to be born with HIV infection each year in the U.S.

7. 11/03 7 Scope of the Epidemic Among Women and Children in Your State  NJ is 5 th in the U.S. in AIDS cases — 49,000  Women are 28% — highest proportion in U.S.  91% of pregnant women know their HIV status  ART use in pregnant women rose from 7% in 1993 to 70% in 1999  Perinatal transmission fell from 21% in ’93 to 5.0% in ‘99  But... 25% of HIV+ pregnant women have no prenatal care

8. 11/03 8 National Recommendations for HIV Testing of Pregnant Women  Regulations, laws, & policies about HIV screening of pregnant women vary state to state  Institute of Medicine in 1998 recommended universal HIV testing of pregnant women  American College of Obstetrics & Gynecology and the American Academy of Pediatrics in 1999 supported IOM and encourage counseling but not as a barrier to testing

9. 11/03 9 National Recommendations for HIV Testing of Pregnant Women  CDC (USPHS) recommendations for HIV screening of pregnant women (4-22-03)  Prenatal: routine HIV screening for all pregnant women using the “opt out” approach  Women will be notified that they will be tested unless they decline  Labor and delivery: Routine rapid testing for women whose HIV status is unknown  Postnatal: Rapid testing for all infants whose mother’s status is unknown.

10. 11/03 10 (Add local laws/regulations)

11. 11/03 11 “Opt-Out” HIV Testing in Pregnancy  Advantages  Easier and quicker for the provider  Greater percentage of women likely to be tested means fewer infected infants  “Normalizes” HIV testing

12. 11/03 12 “Opt-Out” HIV Testing in Pregnancy  Disadvantages  Risk of no pretest counseling  Patient education may be inadequate  Provider may not be prepared to give positive results

13. 11/03 13 Opt-Out as a “Consenting Process”  Minimum information  An HIV test is part of the routine pregnancy screening tests  You have the right to refuse the test  The HIV test is important. We strongly recommend that all pregnant women be tested because a woman can pass HIV to her baby  If a woman has HIV, she will be offered medicines for her health and to reduce the risk of passing HIV to her baby  Services are available for her and her family

14. 11/03 14 Barriers and Supports to Universal Prenatal HIV Testing  Provider’s recommendation about testing  92.8% were tested if strongly recommended  42% if clinician had not recommended  Private insurance associated with not being tested  Reasons for not being tested  Not perceiving herself at risk (55.3%)  Having been tested recently (39%)  Test not offered or recommended (11%)  Adverse consequences rarely mentioned

15. What We Know About Perinatal HIV Transmission

16. 11/03 16 Perinatal Transmission of HIV  Without antiretroviral prophylaxis, 16%–25% mother- to-child transmission in North America and Europe  21% transmission rate in the U.S. in 1994 before the standard recommendation of zidovudine (ZDV) in pregnancy  With the change in practice, transmission was 11% in 1995  Today, risk of perinatal transmission can be < 2% with highly active antiretroviral therapy (HAART), elective C/S as appropriate and formula feeding

17. 11/03 17 Timing of Perinatal HIV Transmission  Cases documented intrauterine, intrapartum, and postpartum by breastfeeding  In utero 25%–40% of cases  Intrapartum60%–75% of cases  Additional risk with breastfeeding  14%  risk with established infection  29%  risk with primary infection  Current evidence suggests most transmission occurs during the intrapartum period

18. 11/03 18 Breastfeeding and HIV Infection  Women with HIV infection in the U.S. should not breastfeed  Women considering breastfeeding should know their HIV status

19. 11/03 19 Influences on Perinatal Transmission: Maternal Factors  HIV-1 RNA levels (viral load)  Low CD4 lymphocyte count  Other infections, Hepatitis C, CMV, bacterial vaginosis  Maternal injection drug use  Lack of ZDV during pregnancy

20. 11/03 20 Influences on Perinatal Transmission: Obstetric and Infant Factors  Obstetrical Factors  Length of ruptured membranes/ chorioamnionitis  Vaginal delivery  Invasive procedures  Infant Factors  Prematurity

21. 11/03 21 Maternal Viral Load (VL), ZDV Treatment and the Risk of Perinatal HIV Transmission  Correlation between high maternal VL and transmission  Transmission observed at every VL level, including undetectable levels  No HIV RNA threshold below which there was no risk of transmission  ZDV decreases transmission regardless of HIV RNA level  Recommendation: Initiate maternal ZDV regardless of plasma HIV RNA or CD4 counts

22. What have we learned? Interrupting Perinatal HIV Transmission: Study Results

23. 11/03 23 PACTG 076 A phase III randomized placebo-controlled trial of zidovudine (ZDV) for the prevention of 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 Regimen 2 mg/kg po q 6 hr for 6 weeks, to start 8 – 12 hours after birth

24. 11/03 24 Results of PACTG 076 ZDV groupPlacebo 22.6% 7.6 % 30 20 10 Transmission Rate (%) This represents a 66% reduction in risk for transmission (P = <0.001) Efficacy was observed in all subgroups

25. 11/03 25 Follow-up of Uninfected Infants and of Mothers in PACTG 076  No significant differences in infant growth, development, or immune function in placebo v. ZDV.  No other safety abnormalities have been identified in infants  Follow-up of infants with exposure to nucleoside analogues is ongoing due to the potential for mitochondrial toxicity  In the U.S. no cases of mitochondrial toxicity have been identified  For mothers, no substantial differences in CD4 count, time to progression to AIDS, or death in women who received ZDV compared to those who received placebo

26. 11/03 26 Reducing Intrapartum HIV Transmission: Studies of Short Course Therapy  Oral ZDV in a non-breastfeeding population (Thailand) from 36 weeks and during labor  Transmission rate: 9.4 % ZDV vs 18.9 % placebo  Petra study – intrapartum/postpartum oral ZDV/3TC in a breast-feeding population (Uganda, S. Africa, Tanzania)  Transmission rate: 10% ZDV/3TC vs 17% placebo  HIVNet 012 – intrapartum/postpartum/neonatal nevirapine (NVP) vs short course/neonatal ZDV in a breast-feeding population (Uganda)  Transmission rate: 12% NVP vs 21% ZDV

27. 11/03 27 Reducing Intrapartum HIV Transmission: Studies of Short Course ARV Therapy Placebo ZDV Placebo ZDV/3TC NVP

28. 11/03 28 Reducing HIV Transmission with Suboptimal Regimens: The New York Cohort

29. Treating Women with HIV Infection in Pregnancy

30. 11/03 30 Goals of Antiretroviral Therapy  To prolong life and improve quality of life  To suppress HIV to below the limits of detection or as low as possible, for as long as possible  To preserve or restore immune function

31. 11/03 31 Perinatal Guidelines  USPHS Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant HIV-1 Infected Women for Maternal Health and to Reduce Perinatal HIV-1 Transmission in the United States  Developed in 1994 in response to ACTG 076  Working Group reconvened in December 1999 and meets monthly  Updated recommendations available online at HIV/AIDS Treatment Information Service web site (www.aidsinfo.nih.gov)

32. 11/03 32 Guidelines for Antiretroviral Drugs During Pregnancy  Use optimal ARV for the woman’s health  Add ZDV regimen for reducing perinatal HIV transmission  Discuss preventable risk factors for perinatal transmission  Counsel on cesarean delivery  Support decision-making by woman following discussion of known and unknown benefits and risks  Acceptance or refusal of ARV or ZDV should not result in denial of care or punitive action

33. 11/03 33  Recommend:  Standard combination therapy for women with high viral load, low CD4 count  Combination therapy for women with viral load  1,000 regardless of clinical or immunologic status  3-part ZDV regimen to reduce perinatal transmission for all HIV-infected pregnant women, regardless of antenatal VL  Consider delaying therapy until completion of first trimester  Offer scheduled cesarean delivery for women with viral loads >1000 (based on most recent VL results) Clinical Scenario 1 : Women without prior antiretroviral therapy

34. 11/03 34 Clinical Scenario 2: Women currently on antiretroviral therapy  Discuss benefits and potential risks of her current regimen during pregnancy  Add or substitute ZDV at  14 weeks  Recommend intrapartum and neonatal ZDV  Discontinue teratogenic drugs  Consider continuing or stopping current therapy based on gestational age (<14 weeks)  If therapy is stopped, stop and restart all ARV simultaneously  Resistance testing for suboptimal viral suppression or failure

35. 11/03 35 Clinical Scenario 3: Women with HIV infection who present in labor with no previous treatment  Discuss benefits of treatment during intrapartum and neonatal period  Four treatment options  Intrapartum IV ZDV followed by six weeks ZDV for the newborn  Oral ZDV/3TC for mother during labor followed by one week oral ZDV/3TC to the newborn  Single dose nevirapine for mother at onset of labor followed by single dose of nevirapine for the newborn at age 48–72 hrs  The two-dose nevirapine regimen as above combined with intrapartum IV ZDV and six week ZDV for the newborn

36. 11/03 36 Cesarean Section to Reduce Perinatal HIV Transmission  Scheduled C/S offers potential benefit to reduce perinatal transmission for women with VL  1000  Unknown whether scheduled C/S offers any benefit to women on HAART with low or undetectable VL given the low transmission rate  Complications of C/S similar to HIV uninfected women  Patient’s decision should be respected and honored  No known benefit of C/S if labor has begun

37. The Woman who Presents in Labor with Unknown HIV Status

38. 11/03 38 Counseling During Labor  Not a great time but it is possible!  Other opportunities: ER visits for false labor, antenatal admissions, premature labor  Materials for patient education/informed consent  Policy and procedure in place with a counseling “script” for providers

39. 11/03 39 Which pregnant women will need rapid HIV testing in labor?  Women with no or limited prenatal care  Women who were not offered testing  Women whose results are unavailable  Women who declined testing previously

40. 11/03 40 Formula for HIV Counseling and Testing in Labor* Confidentiality Comfort Consent Reasons to test Results Rx to decrease risk R3R3 C3C3 * Concept developed by Carolyn Burr and Elaine Gross, FXB Center

41. 11/03 41 Confidentiality  Who is in the room with the patient?  How can you assure confidentiality during  History taking  Giving test results  Giving medication for treatment?

42. 11/03 42 Comfort  What is her level of discomfort?  How is her pain being managed?  Is she anxious?

43. 11/03 43 HIV Counseling and Testing During Labor: Case Studies Lucy is admitted with contractions 7 minutes apart. She is 17, scared and asking to be given something to stop the pain. This is her first baby. Her parents are with her. She recently moved back home, and had only one visit with her present OB. You don’t have a prenatal chart for Lucy.

44. 11/03 44 HIV Counseling and Testing During Labor: Case Studies Ms. R is admitted from the ER fully dilated and pushing. This is her third baby and, according to her chart, she had two prenatal visits for care. Her history leads you to believe she is at risk for HIV.

45. 11/03 45 Informed Consent  Who is responsible for obtaining informed consent?  How much information is “informed?”  HIV is the virus that causes AIDS  A woman could be at risk for HIV and not know it  Effective interventions can protect the infant from HIV and improve mother’s health  HIV testing is recommended for all pregnant women  Services are available to help women reduce their HIV risk and provide medical care to women with HIV  Women who decline testing won’t be denied care Centers for Disease Control & Prevention, Nov. 2001

46. 11/03 46 HIV Counseling and Testing During Labor: Case Studies Ms. G. has just been admitted to L&D. No HIV test results are on her chart. A partner/ husband and her mother are with her. The family only speaks a little English. You need to take an admission history including asking about HIV testing in labor.

47. 11/03 47 HIV Counseling and Testing During Labor: Case Studies Ms. B. was just admitted in active labor. She has no record of prenatal care and no information about her HIV status. She “might have had an HIV test” in the past but isn’t sure if it was during this pregnancy. This is the OB resident’s first week.

48. 11/03 48 Reasons for HIV Testing During Labor  HIV— the virus that causes AIDS — is spread by unprotected sexual intercourse  Therefore, all pregnant women may be at risk for HIV infection  A pregnant woman with HIV has a 1 in 4 chance of passing HIV to her baby if she is not treated  If a woman with HIV takes antiretroviral medicine during labor and delivery and her baby takes the medicine after birth, only 1 in 10 babies will get HIV

49. 11/03 49 HIV Counseling and Testing During Labor: Case Studies You begin to explain to Ms. Q that her prenatal record does not indicate that she has had an HIV test during this pregnancy and that it is recommended for every pregnant woman. Ms. Q becomes angry and says “What kind of woman do you think I am?”

50. 11/03 50 Giving Results of Rapid Testing in Labor  When and how should results be given?  Post-test counseling for positive results  What does a preliminary positive test mean?  What do you say?  Post-test counseling for negative results  What treatment is available if the preliminary test is positive  Consent for prophylactic treatment based on preliminary test results

51. 11/03 51 Results of a Rapid Test During Labor The results of Ms. L’s rapid HIV test are positive. Her labor is progressing and she is at 7 cm. Her family is in the room with her. The L & D nurse accompanies the Obstetrician to the room to tell Ms. L the results. When the doctor leaves, Ms. L asks for clarification of what she’s been told.  What are the issues?  What do you tell her?

52. 11/03 52 HIV Counseling and Testing During Labor: Case Studies Ms. M was not offered an HIV test during her prenatal care. She consented to have a rapid test during labor. The result of the test is negative. She asks the nurse if she can be certain that she doesn’t have HIV.

53. 11/03 53 The Postpartum Woman with a Negative HIV Test  Counseling regarding risk reduction  Assessment of on-going risk  Referral for intensive counseling if high risk

54. 11/03 54 Rx: Treatment to Reduce Perinatal HIV Transmission  Antiretroviral treatment to mother during labor and delivery and to the baby after birth decrease the risk of transmission to 1 in 10  National guidelines offer 4 choices of treatment  Woman with a preliminary positive HIV test should delay breastfeeding until the results of the confirmatory test are known

55. 11/03 55 HIV Counseling and Testing During Labor Case Studies  Ms. P is in early labor. She refused testing during prenatal care. After consenting to the test, the preliminary result is positive. The physician and nurse explain to her the treatment options they recommend and the follow-up that will occur.  What are the treatment options for Ms P — for her baby?  What follow-up should be done?

56. 11/03 56 Clinical Scenario 4: Infant whose mother did not receive prenatal or intrapartum ZDV Offer the six-week neonatal ZDV component Initiate therapy as soon as possible after maternal consent (preferably within 6 – 12 hours of birth) Begin diagnostic testing of the infant Refer to pediatric HIV specialist for long-term care

57. 11/03 57 Rapid HIV-1 Antibody Tests  OraQuick  One step test that uses whole blood (finger stick)  Can be done in the laboratory or at the point of care  Very high sensitivity (99.6%) and specificity (100%)  Reveal  Multi-step process that uses serum or plasma  High sensitivity (98.6), specificity (99.1%) in plasma  Rapid tests should be confirmed with WB

58. 11/03 58 Labor & Delivery Versus the Laboratory: Where to Do Rapid Testing  Factors to consider:  Logistics in the L & D unit  Availability of trained staff  Training and continuing supervision  Lab – can it consistently give STAT results (in <60 minutes), 24 hours a day?

59. 11/03 59 Point of Care Testing  Requirements  Quality control  Clear concise procedures  Training and education of personnel  Verification of personnel competence  Proper performance of quality control procedures  Record keeping

60. 11/03 60 Resources and Follow-up for the Family  Add your local resources