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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.
Perinatal HIV in Texas



       Elvia Ledezma, Epidemiologist
  HIV/STD Epidemiology and Surveillance
  Texas Department of State Health Services
       elvia.ledezma@dshs.state.tx.us
                512-533-3045
Outline
Overview of perinatal HIV
Steps to prevention of perinatal HIV
Preventative factors
General Definitions
Perinatal 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.
HIV Positive Women in Texas
2008
  13,751 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
  9% 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
Race/Ethnicity, Texas
                                                        Black   Hispanic     White   Other/Unknown
                                70
Percent (%) by Race/Ethnicity




                                      60%
                                60

                                50
                                                                       41%
                                40
                                                                               32%
                                30
                                            22%                                      22%
                                20
                                                  12%
                                10                      6%                                 5%

                                 0

                                     HIV+ Women Delivering an        HIV+ Women Delivering an
                                        Exposed Infant, 2008          Infected Infant, 2005-2008
                                              n=361                              n=41
Prenatal Care*, Texas
96% of women delivering an infant in Texas
received prenatal care, 2008**
92% 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 statistics birth data for year 2008
Perinatal HIV in Texas, 2008

361 HIV+ women delivered 364 infants
• Uninfected: 122
• Indeterminate: 233
• Infected: 9
Perinatally Exposed and Infected
  Children, Texas, 1999-2008
                             450                                                                            8
                                                                                 Exposures    Infected
                             400                                                                            7
No. of Perinatal Exposures




                             350   n=21                                                                     6
                                          n=21 n=22




                                                                                                                Percent Infected
                             300
                                                                                                            5
                             250                        n=20
                                                                                      n=13                  4
                             200                                                             n=12
                                                               n=13                                         3
                             150
                                                                                                    n=9     2
                             100                                      n=8
                                                                               n=7
                              50                                                                            1

                               0                                                                            0
                                   1999   2000   2001   2002   2003 2004       2005   2006   2007    2008
                                                               Year of Birth
No. Exposed=3,593




                % of Total Births=
                Numerator: No. of
                HIV Exposed
                Births by County
                Denominator: No.
                of HIV Exposed
                Births for the State
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
Steps to Prevention Success
Woman receives prenatal care
  Tested for HIV
    Diagnosed before delivery
       Receives ARV therapy at all three recommended timings
           Pregnancy
           Labor and delivery
           Neonatally
Prevention of Perinatal HIV Transmission, TX, 2005-2008, cont.

                                                                        No. of Women=1,461

Step 1: Missed                     Prenatal Care (N=1461)               No. of Infected Infants=41
 Opportunity
 Infected=10         No                     Yes             Unknown          No Infected
    (9%)         n=113 (8%)             n=1276 (87%)        n=72 (5%)         Infants

                             HIV Diagnosis Before Delivery
Step 2: Missed                        (N=1276)
 Opportunity
 Infected=6          No                     Yes             Unknown          No Infected
   (10%)          n=61 (5%)             n=1211 (95%)        n=4 (<1%)         Infants

                             Prenatal Antiretroviral (ARV)
Step 3: Missed                    Therapy (N=1211)
 Opportunity
 Infected=6      No (None or IP                                              No Infected
    (9%)             and/or                 Yes             Unknown           Infants
                 Neonatal, yes):        n=1124 (93%)        n=22 (2%)
                  n=65 (5%)


                             Any ARV Therapy Regimens
                                    (N=1185)
Prevention of Perinatal HIV Transmission, TX, 2005-2008, cont.
                  Among deliveries with prenatal care,
                    HIV diagnosis before delivery,
                       and any ARV regimens
                                                                No. of Women=1,461
                               N=1185
                                                                No. of Infected Infants=41




Incomplete
Prevention
              1-2 arm ARV       3 arm ARV         Unknown            No Infected
Infected=7     n=103 (9%)      n=1082 (91%)       n=0 (0%)            Infants
   (7%)




                Infected         Uninfected     Indeterminate
               n=18 (2%)        n=615 (57%)      n=449 (41%)




             56% (23/41) had at least one missed opportunity
                45% (18/41) had no missed opportunities
Prevention of Perinatal HIV
           Transmission

Receipt of prenatal care
Timing of HIV diagnosis
Receipt of antiretroviral therapy (ARV)
Prenatal Care among HIV+ Women Delivering*
and Proportion of Infected Children, Texas, 2008

                               350                                                                          20%
                                          n=307
No. of HIV+ Women Delivering




                                                                                   18%                      18%
                               300
                                                                                                            16%




                                                                                                                       % of Children Infected
                               250                                            Infected: 56%                 14%
                                                                              (5/9) received                12%
                               200                                            no prenatal
                                                                              care                          10%
                               150                                                                          8%
                               100                                                                          6%
                                                                                                            4%
                               50                                             n=28
                                           1%                                                               2%
                                0                                                                           0%
                                     Any Prenatal Care                 No Prenatal Care

                                                Women    Infected Children (n=9)

                                                              *Excluding women with unknown receipt of prenatal care
Timing of HIV Diagnosis among HIV+ Women
Delivering* and Proportion of Infected Children,
                 Texas, 2008
                               250        n=229                                                                      14%
No. of HIV+ Women Delivering




                                                                                                    13%
                                                                                                                     12%




                                                                                                                           % of Children Infected
                               200
                                                                                           Infected: 33%
                                                                                                                     10%
                               150                                                         (3/9) diagnosed at
                                                                                           delivery
                                                                                                                     8%
                                                                 n=105
                               100                                                                                   6%

                                            3%                                                                       4%
                               50                                                               n=24                 2%
                                                                   0%
                                0                                                                                    0%
                                     Prior to Pregnancy      During Pregnancy                At Delivery

                                                     Women       Infected Children (n=9)
                                                                      *Excluding women with unknown timing of diagnosis
Receipt of ARV* among HIV+ Women Delivering**
              and Proportion of Infected Children, Texas,
                                 2008
                               350                                                                                 12%
No. of HIV+ Women Delivering




                               300      n=286
                                                                                            10%                    10%




                                                                                                                           % of Children Infected
                               250
                                                                                     Infected: 78%                 8%
                                                                                     (7/9) received
                               200                                                   incomplete ARV
                                                                                                                   6%
                               150
                                                                                                                   4%
                               100                                                     n=67
                               50         1%                                                                       2%

                                0                                                                                  0%
                                     All 3 Intervals                           None or 1-2 Intervals
                                                 Births          Infected Children (n=9)
                                                       *ARV-Antiretroviral Therapy **Excluding women with unknown receipt of ARV
Summary
Decrease in proportion of perinatal HIV
transmission from 2000 to 2008
Among HIV+ women delivering an infected infant:
 • Hispanic and White women were disproportionately
   affected (2005-2008)
 • Women predominantly received no prenatal care and
   received incomplete ARV therapy (2008)
Perinatally HIV infected and exposed children are
distributed throughout Texas (2005-2008)
Summary
Missed opportunities continue to occur (2005-2008)
Earlier 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
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.
Examples of Perinatally HIV
     Infected Cases


       Leslie Conley, L.M.S.W.-I.P.R.
       Case Manager/Inpatient Liaison
     Parkland Health and Hospital System
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        *** 1st
   – Refused HAART                *** 2nd
Case #1 Continued
• Presented to private OB (August-October 2009)
   – No HIV test            *** 3rd
• Presented to rural hospital in October 2009
   – 39 w EGA, C-section
   – HIV diagnosis not disclosed           *** 4th
   – No HIV results at delivery (send out test)         *** 5th
   – 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.
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
Case #2 Continued
• Presented to same hospital in February 2008
   – Active labor
   – HIV diagnosis not disclosed, but seen in medical record from previous
     visit            *** 1st
   – No prenatal care or HAART during pregnancy                 *** 2nd
   – No IV zidovudine in stock for mother               *** 3rd
   – No oral zidovudine in stock for baby until > 24 hrs of age         *** 4th
   – Delay in obtaining zidovudine for discharge              *** 5th

Baby’s initial VL at 10 days = 1,569 copies/ml, confirmed with
repeat tests. Baby is INFECTED with HIV.
Overview of the TCPHP



                   Janak Patel, M.D.
          Professor, Department of Pediatrics
Director, Pediatric Infectious Disease and Immunology
          University of Texas Medical Branch
What is the purpose of the TCPHP?
 Reduce or prevent perinatal HIV transmission
 in Texas through the collaborative efforts of
 Perinatal HIV champions




                                                 28
Who makes up the TCPHP?
Hospitals/Clinics
• Maternal and pediatric HIV providers
• Administrators and case managers
DSHS 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
HIV education/outreach/prevention agencies
• AIDS Education and Training Center
• Houston Regional HIV/AIDS Resource Group
• International AIDS Empowerment
Local health departments
• Surveillance staff
Project Components/Work Groups
Leadership
Standards of Care
Education
Outreach




                             30
Project Components/Work Groups
Leadership
• List of perinatal experts
• Identified gaps in membership
Standards of Care
• Guidelines for care for HIV+ pregnant women
Education
• In progress
Outreach
• In progress
                                                31
Standards of Care
Component Products
Goal 1: Objective and Product
Goal 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
Goal 2: Objectives
Goal 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


                                               34
Obj. 1: Product (Guidelines for
             Care)
Pre-conceptual counseling
• Counseling/education
Antepartum, intrapartum, and neonatal postnatal care
• Recommendations for ARV drugs during pregnancy,
  labor & delivery and neonatally by the child
Breastfeeding practices
• Refrain from breastfeeding




                                                   35
Obj. 1: Product (Guidelines for
             Care)
Mode of delivery
• Recommendations based on RNA levels
Postnatal care
• Referral to an HIV specialist
Access to HIV medication
• Familiarity with medication resources
• Stock IV AZT and liquid AZT
• 6 week course of AZT for the infant
Obj. 2: Product (Testing
             Recommendations)
Universal opt-out screening of all pregnant
women
Timing of tests for pregnant women and infant
•   1st test at first health care visit
•   2nd test at 32-36 weeks gestation
•   At labor and delivery (if no documentation of 2nd test)
•   Infant testing (if mother’s HIV status is unknown)
Results available within 6 hours of collection


                                                              37
New Law-Amendments to 81.090
   (Effective January 1, 2010)
Second test in third trimester
Sample of woman’s blood or other appropriate
specimen
Test at labor and delivery if no documentation of test
in 3rd trimester
• Make results available within 6 hours of collection
Test infant if no documentation of maternal test in 3rd
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
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
How we got started
Texas Law until 1/1/2010
Offer HIV testing to all pregnant women early in
pregnancy and in Labor and Delivery
So, all of us have been doing that but most
clinicians and institutions have been using the
standard ELISA
Works great for those who get prenatal care; with
treatment, HIV transmission drops from 25% to
<1%
Yet we are left with missed opportunities: those
women with no prenatal care AND those who
seroconvert during pregnancy
True Scenario
A woman presented to a local hospital in labor
and had had no prenatal care.
Routine HIV testing (ELISA=enzyme-linked
immunosorbent assay) 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.
True Scenario, cont.
The 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.
A Missed Opportunity…
The majority of HIV transmission occurs at the
time of labor and delivery.
This 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.
Some History
2007 Texas Department of State Health Services
funded the TRIAD project
TRIAD = Texas Rapid-testing Implementation At
Delivery
Goal 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
Why rapid testing?
If a woman has HIV, the rapid test is more likely to
be positive than the ELISA (higher sensitivity)
If a woman does not have HIV, the rapid test is more
likely to be negative than the ELISA (higher
specificity)
Results are available immediately (20 minutes on
site/60 minutes in our lab)
Although confirmation is needed (Western blot), the
results are accurate enough to warrant action, i.e.
treating mother and baby
Why rapid testing? (cont.)
2006 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”
Wouldn’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?
So how do you change a law?
Start early… the Texas legislature meets from
January until June every two years
Find a sponsor… in this case Senator Rodney
Ellis of Houston had proposed a number of
bills related to routine HIV testing
Work with sponsor’s office
Changing Laws
Watch 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
If 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
We watched “our” bill come to life and die
several times
House Bill 1795
Part 1: “Greyson’s Law”
• Expands newborn screening for enzyme
  deficiencies as recommended by the American
  College of Medical Genetics in 2005
House Bill 1795
Part 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)
Where are we now?
On 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
Amends Section 81.090 of the Texas Health
and Safety Code
What does this mean to health care
           providers?
Test twice in pregnancy—as we had been doing
Do 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
If a woman presents in labor before the second
test has been done, then do rapid testing in Labor
and Delivery
What now?
Educate physicians, office staff, and hospital staff about
new law
Correct misconceptions
Lectures to groups vs. computer modules available to
all providers/institutions
Make proper prenatal HIV testing a quality indicator
Research 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
Questions/Suggestions
Perinatal HIV Interest Group
               Session
When: Wednesday, May 26th
Time: 5 to 7pm
Where: Frio




                                   58

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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 elvia.ledezma@dshs.state.tx.us 512-533-3045
  • 3. Outline Overview of perinatal HIV Steps to prevention of perinatal HIV Preventative factors
  • 4. General Definitions Perinatal 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 13,751 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 9% 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 Black Hispanic White Other/Unknown 70 Percent (%) by Race/Ethnicity 60% 60 50 41% 40 32% 30 22% 22% 20 12% 10 6% 5% 0 HIV+ Women Delivering an HIV+ Women Delivering an Exposed Infant, 2008 Infected Infant, 2005-2008 n=361 n=41
  • 7. Prenatal Care*, Texas 96% of women delivering an infant in Texas received prenatal care, 2008** 92% 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 statistics birth data for year 2008
  • 8. Perinatal HIV in Texas, 2008 361 HIV+ women delivered 364 infants • Uninfected: 122 • Indeterminate: 233 • Infected: 9
  • 9. Perinatally Exposed and Infected Children, Texas, 1999-2008 450 8 Exposures Infected 400 7 No. of Perinatal Exposures 350 n=21 6 n=21 n=22 Percent Infected 300 5 250 n=20 n=13 4 200 n=12 n=13 3 150 n=9 2 100 n=8 n=7 50 1 0 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Year of Birth
  • 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 Woman receives prenatal care Tested for HIV Diagnosed before delivery Receives ARV therapy at all three recommended timings Pregnancy Labor and delivery Neonatally
  • 13. Prevention of Perinatal HIV Transmission, TX, 2005-2008, cont. No. of Women=1,461 Step 1: Missed Prenatal Care (N=1461) No. of Infected Infants=41 Opportunity Infected=10 No Yes Unknown No Infected (9%) n=113 (8%) n=1276 (87%) n=72 (5%) Infants HIV Diagnosis Before Delivery Step 2: Missed (N=1276) Opportunity Infected=6 No Yes Unknown No Infected (10%) n=61 (5%) n=1211 (95%) n=4 (<1%) Infants Prenatal Antiretroviral (ARV) Step 3: Missed Therapy (N=1211) Opportunity Infected=6 No (None or IP No Infected (9%) and/or Yes Unknown Infants Neonatal, yes): n=1124 (93%) n=22 (2%) n=65 (5%) Any ARV Therapy Regimens (N=1185)
  • 14. Prevention of Perinatal HIV Transmission, TX, 2005-2008, cont. Among deliveries with prenatal care, HIV diagnosis before delivery, and any ARV regimens No. of Women=1,461 N=1185 No. of Infected Infants=41 Incomplete Prevention 1-2 arm ARV 3 arm ARV Unknown No Infected Infected=7 n=103 (9%) n=1082 (91%) n=0 (0%) Infants (7%) Infected Uninfected Indeterminate n=18 (2%) n=615 (57%) 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 Receipt of prenatal care Timing of HIV diagnosis Receipt of antiretroviral therapy (ARV)
  • 16. Prenatal Care among HIV+ Women Delivering* and Proportion of Infected Children, Texas, 2008 350 20% n=307 No. of HIV+ Women Delivering 18% 18% 300 16% % of Children Infected 250 Infected: 56% 14% (5/9) received 12% 200 no prenatal care 10% 150 8% 100 6% 4% 50 n=28 1% 2% 0 0% Any Prenatal Care No Prenatal Care Women Infected Children (n=9) *Excluding women with unknown receipt of prenatal care
  • 17. Timing of HIV Diagnosis among HIV+ Women Delivering* and Proportion of Infected Children, Texas, 2008 250 n=229 14% No. of HIV+ Women Delivering 13% 12% % of Children Infected 200 Infected: 33% 10% 150 (3/9) diagnosed at delivery 8% n=105 100 6% 3% 4% 50 n=24 2% 0% 0 0% Prior to Pregnancy During Pregnancy At Delivery Women Infected Children (n=9) *Excluding women with unknown timing of diagnosis
  • 18. Receipt of ARV* among HIV+ Women Delivering** and Proportion of Infected Children, Texas, 2008 350 12% No. of HIV+ Women Delivering 300 n=286 10% 10% % of Children Infected 250 Infected: 78% 8% (7/9) received 200 incomplete ARV 6% 150 4% 100 n=67 50 1% 2% 0 0% All 3 Intervals None or 1-2 Intervals Births Infected Children (n=9) *ARV-Antiretroviral Therapy **Excluding women with unknown receipt of ARV
  • 19. Summary Decrease in proportion of perinatal HIV transmission from 2000 to 2008 Among HIV+ women delivering an infected infant: • Hispanic and White women were disproportionately affected (2005-2008) • Women predominantly received no prenatal care and received incomplete ARV therapy (2008) Perinatally HIV infected and exposed children are distributed throughout Texas (2005-2008)
  • 20. Summary Missed opportunities continue to occur (2005-2008) Earlier 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 *** 1st – Refused HAART *** 2nd
  • 24. Case #1 Continued • Presented to private OB (August-October 2009) – No HIV test *** 3rd • Presented to rural hospital in October 2009 – 39 w EGA, C-section – HIV diagnosis not disclosed *** 4th – No HIV results at delivery (send out test) *** 5th – 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.
  • 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 *** 1st – No prenatal care or HAART during pregnancy *** 2nd – No IV zidovudine in stock for mother *** 3rd – No oral zidovudine in stock for baby until > 24 hrs of age *** 4th – Delay in obtaining zidovudine for discharge *** 5th Baby’s initial VL at 10 days = 1,569 copies/ml, confirmed with repeat tests. Baby is INFECTED with HIV.
  • 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. What is the purpose of the TCPHP? Reduce or prevent perinatal HIV transmission in Texas through the collaborative efforts of Perinatal HIV champions 28
  • 29. Who makes up the TCPHP? Hospitals/Clinics • Maternal and pediatric HIV providers • Administrators and case managers DSHS 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 HIV education/outreach/prevention agencies • AIDS Education and Training Center • Houston Regional HIV/AIDS Resource Group • International AIDS Empowerment Local health departments • Surveillance staff
  • 31. Project Components/Work Groups Leadership • List of perinatal experts • Identified gaps in membership Standards of Care • Guidelines for care for HIV+ pregnant women Education • In progress Outreach • In progress 31
  • 33. Goal 1: Objective and Product Goal 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. Goal 2: Objectives Goal 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 34
  • 35. Obj. 1: Product (Guidelines for Care) Pre-conceptual counseling • Counseling/education Antepartum, intrapartum, and neonatal postnatal care • Recommendations for ARV drugs during pregnancy, labor & delivery and neonatally by the child Breastfeeding practices • Refrain from breastfeeding 35
  • 36. Obj. 1: Product (Guidelines for Care) Mode of delivery • Recommendations based on RNA levels Postnatal care • Referral to an HIV specialist Access to HIV medication • Familiarity with medication resources • Stock IV AZT and liquid AZT • 6 week course of AZT for the infant
  • 37. Obj. 2: Product (Testing Recommendations) Universal opt-out screening of all pregnant women Timing of tests for pregnant women and infant • 1st test at first health care visit • 2nd test at 32-36 weeks gestation • At labor and delivery (if no documentation of 2nd test) • Infant testing (if mother’s HIV status is unknown) Results available within 6 hours of collection 37
  • 38. New Law-Amendments to 81.090 (Effective January 1, 2010) Second test in third trimester Sample of woman’s blood or other appropriate specimen Test at labor and delivery if no documentation of test in 3rd trimester • Make results available within 6 hours of collection Test infant if no documentation of maternal test in 3rd 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 we got started
  • 41. Texas Law until 1/1/2010 Offer HIV testing to all pregnant women early in pregnancy and in Labor and Delivery So, all of us have been doing that but most clinicians and institutions have been using the standard ELISA Works great for those who get prenatal care; with treatment, HIV transmission drops from 25% to <1% Yet we are left with missed opportunities: those women with no prenatal care AND those who seroconvert during pregnancy
  • 42. True Scenario A woman presented to a local hospital in labor and had had no prenatal care. Routine HIV testing (ELISA=enzyme-linked immunosorbent assay) 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. The 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… The majority of HIV transmission occurs at the time of labor and delivery. This 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 2007 Texas Department of State Health Services funded the TRIAD project TRIAD = Texas Rapid-testing Implementation At Delivery Goal 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? If a woman has HIV, the rapid test is more likely to be positive than the ELISA (higher sensitivity) If a woman does not have HIV, the rapid test is more likely to be negative than the ELISA (higher specificity) Results are available immediately (20 minutes on site/60 minutes in our lab) Although confirmation is needed (Western blot), the results are accurate enough to warrant action, i.e. treating mother and baby
  • 47. Why rapid testing? (cont.) 2006 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” Wouldn’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? Start early… the Texas legislature meets from January until June every two years Find a sponsor… in this case Senator Rodney Ellis of Houston had proposed a number of bills related to routine HIV testing Work with sponsor’s office
  • 49. Changing Laws Watch 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 If 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 We watched “our” bill come to life and die several times
  • 50. House Bill 1795 Part 1: “Greyson’s Law” • Expands newborn screening for enzyme deficiencies as recommended by the American College of Medical Genetics in 2005
  • 51. House Bill 1795 Part 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? On 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 Amends Section 81.090 of the Texas Health and Safety Code
  • 53. What does this mean to health care providers? Test twice in pregnancy—as we had been doing Do 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 If a woman presents in labor before the second test has been done, then do rapid testing in Labor and Delivery
  • 54. What now? Educate physicians, office staff, and hospital staff about new law Correct misconceptions Lectures to groups vs. computer modules available to all providers/institutions Make proper prenatal HIV testing a quality indicator Research 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
  • 55.
  • 56.
  • 58. Perinatal HIV Interest Group Session When: Wednesday, May 26th Time: 5 to 7pm Where: Frio 58