1. "Eliminating HIV Mother to Baby Transmission: A Status Report on Perinatal HIV in Florida " Ana M. Puga, MD- Medical Director Comprehensive Family AIDS Program Ryan White Part D Program- Broward County Childrens Diagnostic & Treatment Center

2. Objectives Participants will know the impact of Perinatal HIV in Florida Participants will learn ways to reduce HIV transmissions from mothers to babies in their communities Participants will understand the risks of HIV acquisition for women and infants. Participants will know necessary management of HIV pregnant women in order to prevent perinatal transmission.

3. Hi, Im Marta Married to first and only boyfriend for the past 2 years Excited about starting a family now As soon as she missed a period, she went to the doctor for prenatal care Along with the ultrasound, she was told that her HIV test came back positive!

4. AIDS in the U.S. In the U.S. HIV/AIDS is the #2 cause of death in #2 cause of death in African Americans aged 25-44. In Florida, it is #1 ~An average 56,300 new HIV infections in the US per year. 530,757 AIDS DEATHS ~1.039 – 1.185 million people living with HIV in the US** ~25% new HIV infections in people under 25. In 13 to 19-year-olds, male-to-female ratio = 1:1. ~125,000 people living with HIV in Florida.*** Florida is #2 in the US for new cases in women and children. women and children.

5. Scope of the Epidemic in the United States among Women and Children AIDS in women has risen from 7% early in the epidemic to 24% - 26% of adult cases today 73 new HIV/AIDS cases reported in children in 2007 181,802 AIDS cases in women reported through 2005 10,000–20,000 estimated children/youth living with HIV infection (8797 under the age of 13) 100- 270 babies continue to be born each year with HIV infection

6. Florida HIV Rates 1 in 208 Floridians are known to be currently living with HIV infection. 1 in 415 Whites are known to be infected 1 in 67 Blacks are known to be infected 1 in 230 Hispanics are known to be infected

7. Impact of Perinatal HIV in Florida Florida has 114,057 people with AIDS and 43,814 people living with HIV Statewide rate is 31.1 per 100,000 All counties but 1 had at least 1 HIV case in 2009 10 counties had >100 cases of HIV in 2009 Broward, Duval, Hillsborough, Lee, Miami-Dade, Orange, Palm Beach, Pinellas, Polk, and Volusia 77% of all cases in first 9 counties above 50% of cases in SE Florida

8. Impact of Perinatal HIV in Florida Cases have shifted from 23% white to 34% white from 2002 to 2009 and from 62% black to 46% black Black women 15 X higher than white women Hispanic women 2.5 X higher than white women 47% of cases occurred in 20 – 40 year old Transmission risk for women: 90% heterosexual contact

9. Impact of Perinatal HIV in Florida Florida ranks 2 nd in Pediatric cases Infected cases declined 96% from 201 in 1992 to 8 in 2008 601 babies were born to HIV positive women in Florida in 2008 (8- 1.3% were infected) 7 of 8 new status before pregnancy 5-63% had PNC only 3 of these had adequate PNC 4-50% received ART during pregnancy 4-50% received AZT at delivery 7-87% received AZT for baby

10. Of the 136 Infected babies born in Florida from 2000- 2005: 27% of all mothers that delivered an infected infant did not know they were positive prior to delivery. 20% of all mothers that delivered an infected infants contracted HIV during the pregnancy. The trend continues Of the four infected infants born in 2010, one was born to a mother who had two negative HIV tests (1 st and 3 rd trimester) and 17 prenatal care visits during her pregnancy. FL DOH Perinatal Prevent Project Surveillance Data, 2011 Impact of Perinatal HIV in Florida

11. HIV Cases Reported by County of Residence* Florida, 2008 N= 7,111 Based on 2008 statewide population estimates, the 2008 state rate is 47.1 per 100,000 population. *County totals exclude Department of Corrections cases (N=477). This map does not reflect HIV incidence. Numbers on counties are cases reported. 0 0.1 to 15.0 15.1 to 30.0 > 30.0 Case Rate per 100,000

12. HIV/AIDS Pediatric Cases By Expanded Modes of Exposure Born in and Reported in 2000-2008 South Florida Counties (N=85), Florida Mom IDUMom-Sex RiskMoms Risk-Other/Unkn. Miami-Dade (N=41)Broward (N=29)Palm Beach (N=15)

13. <1 year1 year2+ years HIV/AIDS Pediatric Cases By Age at First Diagnosis Born in and Reported in 2000-2008 South Florida Counties (N=85), Florida Palm Beach (N=15)Miami-Dade (N=41)Broward (N=29)

14. Pediatric AIDS Cases by Age Group and Year of Diagnosis, Florida, 1990-2008* These data represent a 81% decline in pediatric AIDS cases diagnosed from 1992 (N=178) to 2008 (N=34). *Due to reporting lags, 2008 data are provisional. Data as of 08/25/09 N=1,430

15. Hi, Im Tom I am 17 and have my first serious girlfriend We just graduated high school and decided it was ok to have sex now. Since it was the first time for both of us, we didnt use protection- she was on the pill. Later that month, I find out I was born with the AIDS virus

16. Perinatally Acquired HIV (not AIDS) Cases by Age at Diagnosis (N=618) Florida, Born through 2008 Number of Cases Age in MonthsAge in Years *34% (N=210) were <6 mos. and 50% (N=308) were <2 yrs.. Furthermore, 24 (4%) were diagnosed after the age of 12, data as of 09/30/09. < 2 yrs of age

17. Perinatally Acquired AIDS Cases by Age at Diagnosis (N=1,684) Florida, Born through 2008 Number of Cases Age in Months Age in Years < 2 yrs of age *21% (N=359) were <6 mos. and 52% (N=868) were <2 yrs.. Furthermore, 220 (13%) were diagnosed after the age of 12, data as of 09/30/09.

18. Living Perinatal AIDS or HIV (not AIDS) Born through 2008, by County of Diagnosis Florida, (N=1,446) N=1,446 Living HIV/AIDS Cases 0 1 - 10 11 - 25 26 - 50 over 50 Florida reported 1,446 pediatric (<13 years) AIDS or HIV cases through 2008, with the majority (62%) of these cases reported from Miami-Dade (N=401), Broward (N=243) Palm Beach (N=151) and Hillsborough (N=99) counties. Data as of 09/30/09

19. Participants will learn ways to reduce HIV transmissions from mothers to babies in their communities

20. Maternal to Child Transmission

22. Perinatal HIV/AIDS Cases by Year of Birth Reported in Florida*, 1977-2008** (N=2,306) Note: These data represent a 96% decline in HIV-perinatally infected births from 1992 (N=204) to 2008 (N=9) *Includes all perinatal HIV/AIDS cases diagnosed in Florida, regardless of place of birth. **HIV Infection Reporting began July, 2007. 2008 data are provisional. Data as of 09/30/09.

24. Prenatal HIV Testing Among Women Delivering a Live Birth, Florida, 1996-2007 = 95% C.I. Comment: Floridas percentage of childbearing women tested perinatally for HIV is the highest in the U.S., which has probably contributed to the continued decline in pediatric HIV/AIDS cases. Source: Florida Pregnancy Risk Assessment Monitoring System (PRAMS),(2006 or 2008 not available, 2007 had half of normal sample size). http://www.doh.state.fl.us/disease_ctrl/epi/Chronic_Disease/PRAMS/Data_Books.htm

25. HIV Testing Who should get tested? CDC recommends routine testing of EVERYONE 13-64 years of age regardless of risk factor one time then annually based on risk.

26. HIV Testing Laws in Florida Mandatory Offering of HIV test at initiation of Prenatal Care and at 28-32 weeks if initial test is negative Mandatory Offering at Delivery or of newborn if no test available Reporting of all HIV positive tests and exposed newborn testing < 18 months whether positive or negative Super-confidential HIV considered STD in Florida Statutes- youth > 12 years of age can seek testing and care on own

27. Types of HIV Tests Antibody Tests- HIV ELISA/EIA and Western Blot Blood or Oral Standard or Rapid Anonymous or Confidential Viral Tests- HIV RNA-PCR, DNA-PCR, bDNA, Culture, p24 antigen Blood Quantitative and qualitative

28. New Perinatal Cases Failed MTCT intervention opportunities Late presenters/No Prenatal care Non-adherent women Substance using Mental illness Missed early childhood cases Unexplained failures

29. FIMR is a Community Cycle of Improvement Data Collection Case Review Community Action Improved Maternal & Child Health

30. Case Definition HIV exposed infant/fetus > 24 weeks gestation and < 24 months of age at the time of review Prioritized for each community, not randomly selected Cases are selected based on key indicators of missed HIV prevention or treatment opportunities. ( late maternal HIV diagnosis during prenatal period, lack of maternal hiv treatment or poor viral suppression during pregnancy) Case Review Process

31. FIMR/HIV by Ethnicity When examining the cases reviewed by mothers ethnicity, the largest number of cases reviewed were African American, followed by Haitian.

32. FIMR/HIV by Zip Code Zip Code# of Participants 33313 5 330233 33311 2 33025 1 33441 1 33068 1 33060 1 33319 1 33314 1 33304 1 33064 1

33. FIMR/HIV Cases and Time of Diagnosis More than half of the sample of mothers, were diagnosed HIV positive at this pregnancy.

34. FIMR/HIV by Entry to Prenatal Care Only 22% of the mothers entered prenatal care in the first trimester.

35. FIMR/HIV by Mothers Age

36. FIMR/HIV Contributing Factors Contributing FactorPercentage of Occurrence Maternal STD infection other than HIV66% Substance Abuse33% Physical Abuse33% Sexual Abuse28% No Prenatal Care11% Mothers who received a Healthy Start screen 67% Mothers who were not known to Healthy Start 17% History of incarceration33% History of alcohol use17% Mental Health Issues33%

37. Healthy Start data details 12 of the 18 mothers received a Healthy Start screen 2 out of the 12 declined Healthy Start services. 3 mothers were not referred for service. 7 mothers were referred but were unable to be found.

38. FIMR/HIV Identified Gaps Lack of preconception care No prenatal care Inappropriate HIV Care during pregnancy Services not linking: between incarceration, parole, and medical services among community providers in maternal/child health and HIV services No resources for mental health care for HIV + women especially if they are pregnant Poor knowledge of and ability to access care Inconsistent Healthy Start referrals Patients of private OB and pediatric providers not receiving appropriate follow up and management of HIV Care

39. FIMR/HIV Identified Gaps Labor and Delivery – Timeliness of HIV medication delivery Incomplete bilateral tubal ligation requests Lack of screening for substance or alcohol abuse upon admission Lack of substance abuse referrals on those with history of positive screen Lack of psychiatry/psychology consults ordered for patients with mental health issues No follow up on mental health referrals made Lack of documentation of HIV medical follow up Overall gaps between labor and delivery and post partum

40. Time of Maternal HIV Testing Among Perinatal HIV/AIDS Cases Born in and Reported in Florida, 2000-2008 (N=170) Note: 124 (73%) of the 170 moms knew they were infected prior to birth. *2008 data are provisional.

41. Percent of Pregnant Women Giving Birth To a Child Diagnosed with HIV in Florida and Were Known to be HIV Positive Prior to Delivery By Year of Birth 2000-2008* (124 of 170 births (73%)) *2008 data are not complete due to reporting lag.

42. Mothers of Perinatally HIV-Infected Cases According to Receipt of Prenatal Care and/or Prenatal ART* Born in and Reported in Florida, 2000-2008** And Moms HIV status was known prior to delivery (N=170) *ART – Antiretroviral Therapy Adequate Prenatal Care Began by 4 th month with 5+ visits Any Prenatal ART AZT and/or antiretrovirals YesNo **2008 data are provisional.

43. Mothers of Perinatally HIV-Infected Cases According to Receipt of Caesarean Delivery and/or ART at Delivery Born in and Reported in Florida, 2000-2008** And Moms HIV status was known prior to delivery (N=170) *ART – Antiretroviral Therapy Caesarean Delivery YesNo **2008 data are provisional. ART during Labor AZT and/or antiretrovirals

44. Abused DrugsHad an STD Percent of Mothers of Perinatally HIV-Infected Cases Who Abused Drugs or Had an STD During Pregnancy Born in and Reported in Florida, 2000-2008 (N=170) A total of 21 (12%) of the moms had both abused drugs and had an STD during pregnancy. *2008 data are not complete due to reporting lag.

45. Received any Neonatal Drugs Breastfed Perinatally HIV-Infected Cases Status of Receiving Neonatal Drugs and Breastfeeding Born in and Reported in Florida, 2000-2008 (N=170) *2008 data are provisional.

46. WHAT GAPS EXIST IN YOUR COMMUNITY?

47. Gaps identified by Comprehensive Family AIDS Program Lack of HIV providers willing to serve HIV + pregnant women OB providers unable to keep up with frequent changes in HIV management of pregnant women Women avoiding care due to denial or stigma Lack of education among women regarding HIV care during pregnancy Co-morbidities affecting womans ability to adhere to prenatal care or HIV treatment

48. CFAP Referral Manager CFAP Medical Director Ob/Gyn Offices Prenatal Care Centers Pediatricians Birthing Hospitals Case Managers Peer Advocates

49. CFAP Perinatal Enhanced Service Program Initiated in 2002 to further reduce perinatal transmission Average transmission rate from 1996-2001 was 6.4% After enhanced services initiated- transmission dropped significantly from 4.5% to 1.5% in first year Average transmission rate from 2002-2009 was 1.8% (Transmission Rate for those linked to CFAP during these years = 0.2%) Transmission in 2010 was ZERO!

50. CFAP Perinatal Program CFAP Numbers 20022003200420052006 Total # of positive women served 11461209125712901288 # of Pregnancies 131183155162144 # of Babies delivered 129134110114106 # of Positive babies 21232 All transmission rate per year(%) 1.55.751.82.61.9 CFAP Transmission rate per year (%) 0.0 0.9*0.0 * Mother referred 21 days prior to delivery

51. CFAP Perinatal Program CFAP Numbers 20062007200820092010 Total # of positive women served 1288110511161132896 # of Pregnancies 144132118113115 # of Babies delivered 1069910910689 # of Positive babies 22220 All transmission rate per year (%) 1.92.01.81.90 CFAP transmission rate per year(%) 0.0 0.9*0.0 *Mother did not adhere to medications

52. Steps to Prevention Success

53. Care Coordination Co-morbidity Management Close monitored follow up

54. Participants will understand the risks of HIV acquisition for women and infants.

55. Hi, I am Veronica I have been married for 3 years Were both very excited about our expected baby boy My HIV tests was negative and the ultrasound shows a healthy baby I havent missed a single visit to prenatal care The doctor says I need another HIV test This time its positive How can that be- I havent had sex with anyone else?

56. Women and HIV Who is at risk? Pregnant women Women with frequent yeast infections Women with other vaginal infections Women who have sex without a condom Women who share needles Women who had blood transfusion before 1986 Women from other countries where universal precautions are not practiced Women whose partners have unprotected sex with them and others

57. Pediatric and Adolescent HIV Who is at risk? Infants, children and youth born to a positive mother Infants exposed to pre-mastication Breastfeeding from positive mom Children and youth who have been sexually abused Youth who have unprotected sex or share needles

58. June 201058www.aidsetc.org Preconception Counseling & Care Recommendations for Women of Childbearing Age Contraception counseling to avoid unintended pregnancy is an essential part of care Counsel on safe sexual practices, eliminating alcohol, illicit drug use, and smoking Evaluation of HIV-infected woman includes assessment of HIV disease status and need for ARV therapy For women on ART, review regimen in terms of potential pregnancy; avoid EFV Attain a stable maximally suppressed VL prior to conception

59. Removing Perinatal Transmission Risks in HIV Positive Pregnant Women You can help!

60. Possible Missed Opportunities to Prevent Perinatal Transmission of HIV Among HIV/AIDS Cases Born in and Reported in Florida, 2000-2008**** (N=170)

61. Ways you can help! Incorporate HIV education into all your cases Learn what women should expect during pregnancy care if positive and educate them to make sure gaps are avoided Emphasize protection for women who test negative at the beginning of pregnancy Remove stigma and discrimination by normalizing HIV as a disease that can affect any woman in pregnancy.

62. Participants will know the necessary management of HIV pregnant women in order to prevent perinatal transmission.

63. Basic HIV education HIV is the virus that causes Acquired Immuno-Deficiency Syndrome(AIDS) If you get medical care & take treatment, you can expect essentially a normal life expectancy Transmission is through exchange of body fluids/blood- anyone who has unprotected sex is at risk. This means ALL PREGNANT WOMEN Rates are very high in Florida and you cannot tell by looking at someone that they have HIV

64. Basic HIV education With medications and prenatal care you can have an HIV negative healthy baby You can receive care and treatment even if you have no insurance or even if you are not here legally You cannot pass HIV to others by everyday casual contact Your test results are super confidential- no one but the doctor and health department need to know

65. Antepartum Care

66. June 201066www.aidsetc.org Pregnancy Counseling and Care Recommendations Assessment of HIV disease status Resistance testing Recommendations regarding initiating ART or altering the current ARV regimen- Use ZDV in 3 drug regimen when feasible ARV prophylaxis for ALL pregnant HIV- infected women, regardless of VL or CD4 count (AI) Discuss known benefits and potential risks of ARVs during pregnancy (AIII)

67. 67www.aidsetc.org Current ARV Medications NRTI Abacavir (ABC) Didanosine (ddI) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4T) Tenofovir (TDF) Zidovudine (AZT, ZDV) NNRTI Efavirenz (EFV) Etravirine (ETV) Nevirapine (NVP) Rilpivirine (RPV) PI Atazanavir (ATV) Darunavir (DRV) Fosamprenavir (FPV) Indinavir (IDV) Lopinavir + Ritonavir (LPV/r) Nelfinavir (NFV) Ritonavir (RTV) Saquinavir (SQV) Tipranavir (TPV) Entry Inhibitor Enfuvirtide (ENF, T-20) Maraviroc (MVC) Integrase Inhibitor Raltegravir (RAL)

68. June 2010 68 www.aidsetc.org Types of ARV Regimens for Pregnant Women NNRTI based (1 NNRTI + 2 NRTI backbone) PI based (1 or 2 PIs + 2 NRTI backbone)

69. June 2010 69 www.aidsetc.org Lab Monitoring Check CD4 cell count at initial visit (AI) Monitor CD4 at least every 3 months thereafter (BIII) Monitor plasma HIV RNA levels Offer C- section at 38 weeks, if viral load not below 1000 c/ml at 36 weeks/near delivery

70. Intrapartum Care

71. Intrapartum Management IV ZDV recommended for all HIV-infected women during labor Scheduled Cesarean delivery recommended for women on ART who have suboptimal Viral Load suppression >1000c/ml Avoid Artificial ROM, Invasive monitoring and/or Forceps or vacuum assistance

72. June 201072www.aidsetc.org Intrapartum ARV Prophylaxis For women with unknown HIV status who present in labor, perform rapid HIV antibody testing (AII) If first test result is positive Start IV ZDV immediately (without waiting for confirmatory test result) Perform confirmatory test (AII) If confirmatory test is positive, give infant 6 weeks of ZDV (AI) If confirmatory test is negative, infant ZDV is stopped

73. June 201073www.aidsetc.org Intrapartum ARV Prophylaxis If mother received no antepartum ARVs, start IV ZDV during labor and give 6 weeks of infant ZDV (AII) Few data on benefit of adding other ARVs to intrapartum/ newborn ZDV regimen Some experts combine IV intrapartum/6- week newborn ZDV with single-dose NVP (CIII) If single-dose NVP is given, cover with ARV tail to reduce NVP resistance (AII)

74. Postpartum Care

75. June 201075www.aidsetc.org Postpartum Follow-Up Immediate postpartum period poses unique challenges for adherence (AII) New or continued supportive services arranged before discharge Breastfeeding not recommended in US due to the risk of transmission of HIV via breast milk (AI)

76. June 201076www.aidsetc.org Postpartum Follow-Up Contraceptive counseling/information includes: Condom use to prevent HIV and STD transmission Unintended pregnancy rate is high with condom use alone Safety and efficacy of intrauterine devices (IUDs) and hormonal methods for HIV-infected women Drug interactions between oral contraceptives and many PIs and NNRTIs Interactions do not rule out use of hormonal contraceptive

77. Comprehensive Care of Women Postpartum Primary and HIV specialty care Ob/GYN and family planning services Mental health and substance abuse treatment as needed Coordination of care through case management for the woman and her family Support services for the family

78. Neonatal Postnatal Care

79. June 201079www.aidsetc.org Diagnosis of HIV in the HIV-Exposed Neonate Use DNA-PCR to diagnose HIV infection in infants <18 months of age Maternal HIV antibody crosses the placenta and is detectable in the exposed infant up to age 18 months Perform at a minimum at: Age 14-21 days (some perform at birth), 1-2 months, 4-6 months If positive, confirm with a second virologic test on a different specimen 2 positive tests constitute a diagnosis of HIV

80. June 2010 80 www.aidsetc.org Diagnosis of HIV in the HIV-Exposed Neonate Presumptive exclusion of HIV: 2 negative tests (one at 14 days, another at 1 month of age) Definitive exclusion of HIV in nonbreastfed infants: 2 negative virologic tests at 1 month and 4 months of age Many experts confirm negative status with HIV antibody at age 12-18 months

81. June 201081www.aidsetc.org Infants Born to Mothers with Unknown HIV Infection Status Rapid HIV antibody testing of mother and/or infant recommended as soon as possible after birth If either mothers or infants HIV antibody test is positive: Start infant ARV prophylaxis immediately (AII) Perform confirmatory test (e.g., Western blot) (AIII) If confirmatory test is positive, obtain HIV DNA PCR for infant (AIII) If positive: discontinue ARV prophylaxis for newborn and refer to pediatric HIV specialist for confirmation of diagnosis and for treatment (AI) If negative: Discontinue ARV prophylaxis

82. June 201082www.aidsetc.org Infant ARV Prophylaxis 6-week ZDV chemoprophylaxis advised for all HIV-exposed neonates (AI) Start as close to the time of birth as possible (within 6-12 hours of delivery) (AII) Adjust dose for premature infants Start regardless of maternal ZDV resistance history (BIII) ARV drugs other than ZDV not recommended in premature infants (BIII)

83. June 2010 83 www.aidsetc.org Infant PCP Prophylaxis Start oral TMP-SMX at 4-6 wks for all HIV-infected infants and exposed infants if does not have 2 negative tests (one at greater than 4 weeks of age)

84. June 2010 84 www.aidsetc.org Breastfeeding HIV may be transmitted via breast milk Breastfeeding is not recommended for HIV-infected women (including those on ART) (AII) This recommendation applies to the United States, where safe infant feeding alternatives are available

85. Premastication A newly identified mode of transmission for infants 4 cases reported in the US EpiAIDS study by CDC confirmed practice Common practice in low income families and in certain racial/ethnic cultures

86. June 201086www.aidsetc.org Monitoring of the HIV-Exposed Neonate Laboratory monitoring CBC and differential as baseline (BIII) Schedule of hematologic monitoring depends on baseline results and clinical factors (CIII) Consult pediatric HIV specialist if hematologic abnormalities identified (CIII) For infants exposed to ART, some experts recommend more intensive monitoring of CBC, serum chemistry, and LFTs (CIII) Routine serum lactate not recommended Consider if infant has severe clinical symptoms (CIII)

87. Long Term Follow-up of HIV Exposed Infants Long term effects of HIV exposure Adverse effects of medications Potential premastication exposure Increased risk of acquisition during adolescence

88. Challenges in HIV care of Women Stigma/ discrimination Poverty History of childhood sexual abuse Mental illness Substance use Single heads of households Child care Lack of insurance Lack of transportation Denial

89. HIV Prevention Education Dont make assumptions Offer test to anyone who has had unprotected sex Use negative results to reinforce safer sex practices Know that being aware of status reduces transmission and improves survival There are effective treatments and they are tolerated better if started early

90. Challenges that remain in 2011 Prevention is KEY! HIV testing of all pregnant women Prenatal care for all women More intervention with substance using women Eliminating any missed opportunities for perinatal prevention Education on breastfeeding and premastication Better tracking of infants through 18 months of age Testing of all children of positive woman

91. Further Information 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: Updated recommendations available online at AIDSInfo website (www.aidsinfo.nih.gov)www.aidsinfo.nih.gov Florida Caribbean AIDS Education & Training Center (www.faetc.org) Call CDTC for consultation: 954-728-1036 (Nadia Graham) Ana M. Puga, MD- cell:954-548-0859 office 954-728-8080 ext 1017

92. Questions? Thank you!