Perinatal HIV and Addressing Missed Opportunities through the Texas Consortium for Peirnatal HIV Prevention

1. Perinatal HIV in Texas &
Addressing Missed
Opportunities through the
Texas Consortium for Perinatal
HIV Prevention (TCPHP)
Presenters:
Elvia Ledezma, MPH
Leslie Conley, L.M.S.W.-I.P.R.
Janak Patel, M.D.
Judy Levison, M.D.

2. Perinatal HIV in Texas
Elvia Ledezma, Epidemiologist
HIV/STD Epidemiology and Surveillance
Texas Department of State Health Services
[email protected]
512-533-3045

3. Outline
ƒOverview of perinatal HIV
ƒSteps to prevention of perinatal HIV
ƒPreventative factors

4. General Definitions
ƒPerinatal Exposure
-Any child born to an HIV
infected woman
•Infected
-Any child born to an HIV infected woman and
determined to be HIV positive
•Uninfected
Any child born to an HIV infected woman and
determined to be HIV negative
•Indeterminate
-Any child born to an HIV infected woman
with insufficient test history to determine his/her HIV
status.

5. HIV Positive Women in Texas
2008 ƒ13,751 HIV+ women living in Texas
•8,201 (60%) are women of childbearing age (15-44 years)
•361 (4%) of women gave birth to an infant
2000-2008 ƒ9% increase in the number of HIV+ women of
childbearing age from 2000 to 2008
•57% decrease in proportion of infected infants from 2000
to 2008

6. Race/Ethnicity, Texas
41%
60%
32%
22% 22%
12%
5% 6%
0
10
20
30
40
50
60
70
HIV+ Women Delivering an
Exposed Infant, 2008
HIV+ Women Delivering an
Infected Infant, 2005-2008
Percent (%) by Race/Ethnicity
Black
Hispanic
White
Other/Unknown
n=361n=41

7. Prenatal Care*, Texas
ƒ96% of women delivering an infant in Texas
received prenatal care, 2008**
ƒ92% of HIV positive women delivering an
infant received prenatal care, 2008
•55% (5/9) of HIV positive women delivering an
infected infant received no
prenatal care, 2008
*Excluding women with unknown receipt of prenatal care
**Based on provisional vital stat istics birth data for year 2008

8. Perinatal HIV in Texas, 2008
ƒ361 HIV+ women delivered 364 infants
•Uninfected: 122
•Indeterminate: 233
•Infected: 9

9. Perinatally Exposed and Infected
Children, Texas, 1999-2008
0
50
100
150
200
250
300
350
400
450
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Year of Birth
No. of Perinatal Exposures
0
1
2
3
4
5
6
7
8
Percent Infected
Exposures
Infected
n=7
n=13
n=12
n=9
n=21
n=21
n=22
n=20
n=13
n=8

10. No. Exposed=3,593
% of Total Births=
Numerator: No. of
HIV Exposed
Births by County
Denominator: No.
of HIV Exposed
Births for the State

11. No. Exposed=3,593
No. Infected=146
% of Total Births=
Numerator: No. of
HIV Exposed
Births by County
Denominator: No.
of HIV Exposed
Births for the State

12. Steps to Prevention Success
ƒWoman receives prenatal care
ƒTested for HIV
ƒDiagnosed before delivery
ƒReceives ARV therapy at all three recommended timings
ƒPregnancy
ƒLabor and delivery
ƒNeonatally

13. Prevention of Perinatal HIV Transmission, TX, 2005-2008, cont.
Prenatal Care (N=1461)
HIV Diagnosis Before Delivery
(N=1276)
Prenatal Antiretroviral (ARV)
Therapy (N=1211)
Any ARV Therapy Regimens
(N=1185)
Step 1: Missed
Opportunity
Infected=10
(9%)
No
n=113 (8%)
Yes
n=1276 (87%)
Unknown
n=72 (5%)
Step 2: Missed
Opportunity
Infected=6
(10%)
Step 3: Missed
Opportunity
Infected=6
(9%)
No (None or IP
and/or
Neonatal, yes):
n=65 (5%)
Yes
n=1124 (93%)
Unknown
n=22 (2%)
No Infected
Infants
No Infected
Infants
No Infected
Infants
No
n=61 (5%)
Yes
n=1211 (95%)
Unknown
n=4 (<1%)
No. of Women=1,461
No. of Infected Infants=41

14. Prevention of Perinatal HIV Transmission, TX, 2005-2008, cont.
Among deliveries with prenatal care,
HIV diagnosis before delivery,
and any ARV regimens
N=1185
Incomplete
Prevention
Infected=7
(7%)
1-2 arm ARV
n=103 (9%)
3 arm ARV
n=1082 (91%)
Unknown
n=0 (0%)
No Infected
Infants
No. of Women=1,461
No. of Infected Infants=41
Infected
n=18 (2%)
Uninfected
n=615 (57%)
Indeterminate
n=449 (41%)
56% (23/41) had at least one missed opportunity
45% (18/41) had no missed opportunities

15. Prevention of Perinatal HIV
Transmission
ƒReceipt of prenatal care
ƒTiming of HIV diagnosis ƒReceipt of antiretroviral therapy (ARV)

16. n=28
n=307
18%
1%
0
50
100
150
200
250
300
350
Any Prenatal Care No Prenatal Care
No. of HIV+ Women Delivering
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
% of Children Infected
Women
Infected Children (n=9)
Prenatal Care among HIV+ Women Delivering*
and Proportion of Infected Children, Texas, 2008
*Excluding women with unknown receipt of prenatal care
Infected: 56%
(5/9) received
no prenatal
care

17. n=24
n=105
n=229
3%
0%
13%
0
50
100
150
200
250
Prior to Pregnancy During Pregnancy At Delivery
No. of HIV+ Women Delivering
0%
2%
4%
6%
8%
10%
12%
14%
% of Children Infected
Women
Infected Children (n=9)
Timing of HIV Diagnosis among HIV+ Women
Delivering* and Proportion of Infected Children,
Texas, 2008
*Excluding women with unknown timing of diagnosis
Infected: 33%
(3/9) diagnosed at
delivery

18. n=67
n=286
1%
10%
0
50
100
150
200
250
300
350
All 3 Intervals None or 1-2 Intervals
No. of HIV+ Women Delivering
0%
2%
4%
6%
8%
10%
12%
% of Children Infected
Births
Infected Children (n=9)
Receipt of ARV* among HIV+ Women Delivering**
and Proportion of Infected Children, Texas,
2008
*ARV-Antiretroviral Therapy **Excluding women with unknown receipt of ARV
Infected: 78%
(7/9) received
incomplete ARV

19. Summary
ƒDecrease in proportion of perinatal HIV
transmission from 2000 to 2008
ƒAmong HIV+ women delivering an infectedinfant:
•Hispanic and White women were disproportionately
affected (2005-2008)
•Women predominantly received no prenatal care and
received incomplete ARV therapy (2008)
ƒPerinatally HIV infected and exposed children are
distributed throughout Texas (2005-2008)

20. Summary
ƒMissed opportunities continue to occur (2005-2008)
ƒEarlier encounters with HIV positive pregnant
women decreases the likelihood of perinatally
infected children
•Early diagnosis of HIV
•Ensure ARV therapy intake
•Counseling on breastfeeding practices

21. Addressing Missed Opportunities
through the Texas Consortium for
Perinatal HIV Prevention
(TCPHP)
Leslie Conley, L.M.S.W.-I.P.R.
Janak Patel, M.D.
Judy Levison, M.D.

22. Examples of Perinatally HIV
Infected Cases
Leslie Conley, L.M.S.W.-I.P.R.
Case Manager/Inpatient Liaison
Parkland Health and Hospital System

23. Case #1
• 20yo BF, G1P0
• Chlamydia positive, HIV negative in April 2009
• Presented to ER in July 2009
(27 w EGA)
– Abdominal pain
– No previous prenatal care
– HIV positive diagnosis
• Presented for prenatal care in August 2009
(34 w EGA)
– Late entry into prenatal care
– Refused HAART
*** 1
st
*** 2
nd

24. Case #1 Continued
• Presented to private OB (August-October 2009)
–No HIV test
• Presented to rural hospital in October 2009
– 39 w EGA, C-section
– HIV diagnosis not disclosed
– No HIV results at delivery (send out test)
– Breastfeeding
– HIV positive results not known until after discharge
Baby’s initial PCR—HIV+, VL on 2/4/10 = 4,300,000 copies/ml
Baby is INFECTED with HIV.
*** 3
rd
*** 4
th
*** 5
th

25. Case #2
• HIV negative in July 2005 • Presented for OB care in August 2006 (14 w EGA)
– Positive trichomonas, chlamydia, and HIV
– Referred to UTMB Maternal-Child HIV Clinic
• Presented to hospital in Galveston County in Sept
2006
– Miscarriage
– No subsequent HIV care

26. Case #2 Continued
• Presented to same hospital in February 2008
– Active labor
– HIV diagnosis not disclosed, but seen in medical record from previous
visit
– No prenatal care or HAART during pregnancy
– No IV zidovudine in stock for mother
– No oral zidovudine in stock for baby until > 24 hrs of age
– Delay in obtaining zidovudine for discharge
Baby’s initial VL at 10 days = 1,569 copies/ml, confirmed with
repeat tests. Baby is INFECTED with HIV.
*** 1
st
*** 2
nd
*** 4
th
*** 3
rd
*** 5
th

27. Overview of the TCPHP
Janak Patel, M.D.
Professor, Department of Pediatrics
Director, Pediatric Infectious Disease and Immunology
University of Texas Medical Branch

28. 28
What is the purpose of the TCPHP? ƒReduce or prevent perinatal HIV transmission
in Texas through the collaborative efforts of
Perinatal HIV champions

29. Who makes up the TCPHP?
ƒHospitals/Clinics
•Maternal and pediatric HIV providers
•Administrators and case managers
ƒDSHS departments
•Office of Title V and Family Health
•Mental Health and Substance Abuse Services
•HIV/STD Comprehensive Services Branch
•TB/HIV/STD Epidemiology and Surveillance Branch
ƒHIV education/outreach/prevention agencies
•AIDS Education and Training Center
•Houston Regional HIV/AIDS Resource Group
•International AIDS Empowerment
ƒLocal health departments
•Surveillance staff

30. 30
Project Components/Work Groups
ƒLeadership
ƒStandards of Care
ƒEducation
ƒOutreach

31. 31
Project Components/Work Groups
ƒLeadership
•List of perinatal experts
•Identified gaps in membership
ƒStandards of Care
•Guidelines for care for HIV+ pregnant women
ƒEducation
•In progress
ƒOutreach
•In progress

32. Standards of Care
Component Products

33. Goal 1: Objective and Product
ƒGoal 1: To improve access to necessary components
for perinatal HIV prevention
•Objective: Identify labor and delivery hospitals with access
to ARV therapy for mother and child
•Rational:
–11% of women received no ARV at L&D (2005-2007)
–1% of infants received no ARV at birth (2005-2007)
•Product: Developed a survey instrument for pharmacy staff
–76 hospitals surveyed
–15-20% do not stock IV AZT or oral AZT

34. 34
Goal 2: Objectives
ƒGoal 2: Improve SOC through enhanced
communication, knowledge, and cultural
competency among statewide stakeholders to
prevent perinatal HIV transmission
•Objective 1: Developed guidelines for care
•Objective 2: Develop prenatal HIV testing
recommendations to harmonize with national
testing guidelines

35. 35
Obj. 1: Product (Guidelines for
Care)
ƒPre-conceptual counseling
•Counseling/education
ƒAntepartum, intrapartum, and neonatal postnatal care
•Recommendations for ARV drugs during pregnancy,
labor & delivery and neonatallyby the child
ƒBreastfeeding practices
•Refrain from breastfeeding

36. Obj. 1: Product (Guidelines for
Care)
ƒMode of delivery
•Recommendations based on RNA levels
ƒPostnatal care
•Referral to an HIV specialist
ƒAccess to HIV medication
•Familiarity with medication resources
•Stock IV AZT and liquid AZT
•6 week course of AZT for the infant

37. 37
Obj. 2: Product (Testing
Recommendations)
ƒUniversal opt-out screening of all pregnant
women
ƒTiming of tests for pregnant women and infant
•1
st
test at first health care visit
•2
nd
test at 32-36 weeks gestation
•At labor and delivery (if no documentation of 2
nd
test)
•Infant testing (if mother’s HIV status is unknown)
ƒResults available within 6 hours of collection

38. New Law-Amendments to 81.090
(Effective January 1, 2010)
ƒSecond test in third trimester
ƒSample of woman’s blood orother appropriate
specimen
ƒTest at labor and delivery if no documentation of test
in 3
rd
trimester
•Make results available within 6 hours of collection
ƒTest infant if no documenta tion of maternal test in 3
rd
trimester or not tested prior to delivery •Test infant w/in 2 hours after birth and results made
available w/in 6 hours of collection

39. Doing the Right Thing…The
Process
Judy Levison, M.D.
Associate Professor, Department of Obstetrics and Gynecology;
Department of Family and Community Medicine
Baylor College of Medicine

40. How wegotstarted

41. Texas Law until 1/1/2010
ƒOffer HIV testing to all pregnant women early in
pregnancy and in Labor and Delivery
ƒSo, all of us have been doing that but most
clinicians and institutions have been using the
standard ELISA
ƒWorks great for those who get prenatal care; with
treatment, HIV transmission drops from 25% to
<1%
ƒYet we are left with missed opportunities: those
women with no prenatal care AND those who
seroconvert during pregnancy

42. True Scenario
ƒA woman presented to a local hospital in labor
and had had no prenatal care.
ƒRoutine HIV testing (ELISA=enzyme-linked
immunosorbentassay) was done. Results tend
to return in 24-48 hours and many labs do not
report the results before a confirmatory
Western blot is done, which may take 2-5
days.

43. True Scenario, cont.
ƒThe pediatricians were notified of this
woman’s positive ELISA and WB 5 days after
the baby was born, after the mother—who was
breastfeeding—was sent home.

44. A Missed Opportunity…
ƒThe majority of HIV transmission occurs at the
time of labor and delivery.
ƒThis baby had a 25% chance of being infected
with HIV. This mother’s risk of transmitting
HIV to her baby--if diagnosed as late as labor--
could have been reduced to 10% or less.

45. Some History
ƒ2007 Texas Department of State Health Services
funded the TRIAD project
ƒTRIAD = Texas Rapid-testing Implementation At
Delivery
ƒGoal was to educate physicians; midwives; labor
and delivery nurses; hospital labs, pharmacies,
risk management about their role in the
prevention of mother to child transmission of
HIV—with a focus on rapid HIV testing in Labor
& Delivery

46. Why rapid testing?
ƒIf a woman has HIV, the rapid test is more likely to
be positive than the ELISA (higher sensitivity)
ƒIf a woman does not have HIV, the rapid test is more
likely to be negative than the ELISA (higher
specificity)
ƒResults are available immediately(20 minutes on
site/60 minutes in our lab)
ƒAlthough confirmation is needed (Western blot), the
results are accurate enough to warrant action, i.e.
treating mother and baby

47. Why rapid testing? (cont.)
ƒ2006 CDC updated recommendations state:
•“A second HIV test during the third trimester,
preferably <36 weeks of gestation, is cost-effective
even in areas of low HIV prevalence”
ƒWouldn’t it make sense to maximize obtaining
test results during pregnancy and use rapid tests
for those who did not get a third trimester test?

48. So how do you change a law?
ƒStart early…the Texas legislature meets from
January until June every two years
ƒFind a sponsor…in this case Senator Rodney
Ellis of Houston had proposed a number of
bills related to routine HIV testing
ƒWork with sponsor’s office

49. Changing Laws
ƒWatch where the bill is in the process of review…
Senate bill proposal filed and sent to appropriate
committee for review, witnesses on each side
testify, financial impact is reviewed, and
suggested improvements are made
ƒIf passed in the Senate, then the bill is sent to the
House where similar process occurs; if decision is
made to attach the bill to another bill, then the
two must be relevant to one another
ƒWe watched “our”bill come to life and die
several times

50. House Bill 1795
ƒPart 1: “Greyson’sLaw”
•Expands newborn screening for enzyme
deficiencies as recommended by the American
College of Medical Genetics in 2005

51. House Bill 1795
ƒPart 2: Perinatal HIV screening
•Test at first prenatal visit for syphilis, HIV, and
hepatitis B (as before)
•Perform the second test for HIV in the third
trimester (a change)
•Do expedited testing for HIV in Labor and
Delivery (results available within 6 hours) IF no
third trimester results available (a change)
•Test baby within 2 hours after birth if mother did
not get tested (a change)

52. Where are we now?
ƒOn June 1, 2009, the last day of the 2009
official legislative session, the Texas
legislature voted to change Texas law related
to HIV screening in pregnancy
ƒAmends Section 81.090 of the Texas Health
and Safety Code

53. What does this mean to health care
providers?
ƒTest twice in pregnancy—as we had been doing
ƒDo second test at 32-36 weeks, e.g. when you do
GBS testing at 35 weeks. If positive, you have
time to start treatment and make decisions about
the most appropriate mode of delivery
ƒIf a woman presents in labor before the second
test has been done, then do rapid testing in Labor
and Delivery

54. What now?
ƒEducate physicians, office staff, and hospital staff about
new law
ƒCorrect misconceptions
ƒLectures to groups vs. computer modules available to
all providers/institutions
ƒMake proper prenatal HIV testing a quality indicator
ƒResearch the factors that contributed/barriers that
existed for the mothers whose babies were born HIV+
in last 5 years, e.g. why no prenatal care, why incorrect
test ordered in L&D, why + test in L&D not acted on

57. Questions/Suggestions

58. Perinatal HIV Interest Group
Session
When: Wednesday, May 26
th
Time: 5 to 7pm
Where: Frio
58