Handouts

1. Perinatal HIV in Texas &
Addressing Missed Perinatal HIV in Texas
Opportunities through the
Texas Consortium for Perinatal
HIV Prevention (TCPHP)
Elvia Ledezma, Epidemiologist
Presenters: HIV/STD Epidemiology and Surveillance
Elvia Ledezma, MPH Texas Department of State Health Services
Leslie Conley, L.M.S.W.-I.P.R.
elvia.ledezma@dshs.state.tx.us
Janak Patel, M.D.
Judy Levison, M.D. 512-533-3045
Outline General Definitions
Overview of perinatal HIV Perinatal Exposure-Any child born to an HIV
infected woman
Steps to prevention of perinatal HIV
• Infected-Any child born to an HIV infected woman and
Preventative factors 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 Race/Ethnicity, Texas
2008 Black Hispanic White Other/Unknown
70
Percent (%) by Race/Ethnicity
13,751 HIV+ women living in Texas 60%
60
• 8,201 (60%) are women of childbearing age (15-44 years)
50
• 361 (4%) of women gave birth to an infant 41%
40
32%
2000-2008 30
22% 22%
9% increase in the number of HIV+ women of 20
12%
childbearing age from 2000 to 2008 10 6% 5%
• 57% decrease in proportion of infected infants from 2000 0
to 2008 HIV+ Women Delivering an HIV+ Women Delivering an
Exposed Infant, 2008 Infected Infant, 2005-2008
n=361 n=41

2. Prenatal Care*, Texas Perinatal HIV in Texas, 2008
96% of women delivering an infant in Texas
received prenatal care, 2008** 361 HIV+ women delivered 364 infants
• Uninfected: 122
92% of HIV positive women delivering an
• Indeterminate: 233
infant received prenatal care, 2008
• Infected: 9
• 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
Perinatally Exposed and Infected
Children, Texas, 1999-2008 No. Exposed=3,593
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 % of Total Births=
50 1 Numerator: No. of
HIV Exposed
0 0 Births by County
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Denominator: No.
of HIV Exposed
Year of Birth Births for the State
Steps to Prevention Success
No. Exposed=3,593
No. Infected=146
Woman receives prenatal care
Tested for HIV
Diagnosed before delivery
Receives ARV therapy at all three recommended timings
Pregnancy
Labor and delivery
Neonatally
% of Total Births=
Numerator: No. of
HIV Exposed
Births by County
Denominator: No.
of HIV Exposed
Births for the State

3. Prevention of Perinatal HIV Transmission, TX, 2005-2008, cont. Prevention of Perinatal HIV Transmission, TX, 2005-2008, cont.
Among deliveries with prenatal care,
No. of Women=1,461
Prenatal Care (N=1461) HIV diagnosis before delivery,
Step 1: Missed No. of Infected Infants=41
Opportunity
and any ARV regimens
No. of Women=1,461
N=1185
Infected=10 No Yes Unknown No Infected No. of Infected Infants=41
(9%) n=113 (8%) n=1276 (87%) n=72 (5%) Infants
HIV Diagnosis Before Delivery Incomplete
Step 2: Missed (N=1276) Prevention
1-2 arm ARV 3 arm ARV Unknown No Infected
Opportunity n=103 (9%) n=1082 (91%) n=0 (0%)
Infected=7 Infants
Infected=6 (7%)
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 Uninfected Indeterminate
n=18 (2%) n=615 (57%) n=449 (41%)
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%)
56% (23/41) had at least one missed opportunity
Any ARV Therapy Regimens 45% (18/41) had no missed opportunities
(N=1185)
Prevention of Perinatal HIV Prenatal Care among HIV+ Women Delivering*
and Proportion of Infected Children, Texas, 2008
Transmission
350 20%
n=307
No. of HIV+ Women Delivering
Receipt of prenatal care 300
18% 18%
16%
% of Children Infected
Timing of HIV diagnosis 250 Infected: 56% 14%
(5/9) received 12%
200
Receipt of antiretroviral therapy (ARV) 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 Receipt of ARV* among HIV+ Women Delivering**
Delivering* and Proportion of Infected Children, and Proportion of Infected Children, Texas,
Texas, 2008 2008
250 14% 350 12%
n=229
No. of HIV+ Women Delivering
13%
No. of HIV+ Women Delivering
300 n=286
12% 10% 10%
% of Children Infected
% of Children Infected
200
10% 250
Infected: 33% Infected: 78% 8%
150 (3/9) diagnosed at (7/9) received
delivery
8% 200 incomplete ARV
n=105 6%
100 6% 150
4%
3% 4% 100 n=67
50 n=24 2% 50 1% 2%
0%
0 0%
Prior to Pregnancy During Pregnancy At Delivery
0 0%
All 3 Intervals None or 1-2 Intervals
Women Infected Children (n=9) Births Infected Children (n=9)
*Excluding women with unknown timing of diagnosis *ARV-Antiretroviral Therapy **Excluding women with unknown receipt of ARV

4. Summary Summary
Decrease in proportion of perinatal HIV Missed opportunities continue to occur (2005-2008)
transmission from 2000 to 2008 Earlier encounters with HIV positive pregnant
Among HIV+ women delivering an infected infant: women decreases the likelihood of perinatally
• Hispanic and White women were disproportionately infected children
affected (2005-2008) • Early diagnosis of HIV
• Women predominantly received no prenatal care and • Ensure ARV therapy intake
received incomplete ARV therapy (2008) • Counseling on breastfeeding practices
Perinatally HIV infected and exposed children are
distributed throughout Texas (2005-2008)
Addressing Missed Opportunities
through the Texas Consortium for Examples of Perinatally HIV
Perinatal HIV Prevention Infected Cases
(TCPHP)
Leslie Conley, L.M.S.W.-I.P.R. Leslie Conley, L.M.S.W.-I.P.R.
Janak Patel, M.D. Case Manager/Inpatient Liaison
Judy Levison, M.D. Parkland Health and Hospital System
Case #1 Case #1 Continued
• 20yo BF, G1P0 • Presented to private OB (August-October 2009)
• Chlamydia positive, HIV negative in April 2009 – No HIV test *** 3rd
• Presented to rural hospital in October 2009
• Presented to ER in July 2009 (27 w EGA)
– 39 w EGA, C-section
– Abdominal pain – HIV diagnosis not disclosed *** 4th
– No previous prenatal care – No HIV results at delivery (send out test) *** 5th
– HIV positive diagnosis – Breastfeeding
– HIV positive results not known until after discharge
• Presented for prenatal care in August 2009 (34 w EGA)
– Late entry into prenatal care *** 1st Baby’s initial PCR—HIV+, VL on 2/4/10 = 4,300,000 copies/ml
– Refused HAART *** 2nd Baby is INFECTED with HIV.

5. Case #2 Case #2 Continued
• HIV negative in July 2005 • Presented to same hospital in February 2008
– Active labor
• Presented for OB care in August 2006 (14 w EGA)
– HIV diagnosis not disclosed, but seen in medical record from previous
– Positive trichomonas, chlamydia, and HIV visit *** 1st
– Referred to UTMB Maternal-Child HIV Clinic – No prenatal care or HAART during pregnancy *** 2nd
– No IV zidovudine in stock for mother *** 3 rd
• Presented to hospital in Galveston County in Sept
– No oral zidovudine in stock for baby until > 24 hrs of age *** 4th
2006 – Delay in obtaining zidovudine for discharge *** 5th
– Miscarriage
– No subsequent HIV care Baby’s initial VL at 10 days = 1,569 copies/ml, confirmed with
repeat tests. Baby is INFECTED with HIV.
What is the purpose of the TCPHP?
Overview of the TCPHP Reduce or prevent perinatal HIV transmission
in Texas through the collaborative efforts of
Perinatal HIV champions
Janak Patel, M.D.
Professor, Department of Pediatrics
Director, Pediatric Infectious Disease and Immunology
University of Texas Medical Branch
28
Who makes up the TCPHP? Project Components/Work Groups
Hospitals/Clinics
• Maternal and pediatric HIV providers Leadership
• Administrators and case managers
DSHS departments
Standards of Care
• Office of Title V and Family Health
• Mental Health and Substance Abuse Services
Education
• HIV/STD Comprehensive Services Branch Outreach
• 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
30

6. Project Components/Work Groups
Leadership
• List of perinatal experts
Standards of Care
• Identified gaps in membership Component Products
Standards of Care
• Guidelines for care for HIV+ pregnant women
Education
• In progress
Outreach
• In progress
31
Goal 1: Objective and Product Goal 2: Objectives
Goal 1: To improve access to necessary components Goal 2: Improve SOC through enhanced
for perinatal HIV prevention communication, knowledge, and cultural
• Objective: Identify labor and delivery hospitals with access competency among statewide stakeholders to
to ARV therapy for mother and child
• Rational:
prevent perinatal HIV transmission
– 11% of women received no ARV at L&D (2005-2007) • Objective 1: Developed guidelines for care
– 1% of infants received no ARV at birth (2005-2007)
• Objective 2: Develop prenatal HIV testing
• Product: Developed a survey instrument for pharmacy staff recommendations to harmonize with national
– 76 hospitals surveyed
testing guidelines
– 15-20% do not stock IV AZT or oral AZT
34
Obj. 1: Product (Guidelines for Obj. 1: Product (Guidelines for
Care) Care)
Pre-conceptual counseling Mode of delivery
• Counseling/education • Recommendations based on RNA levels
Antepartum, intrapartum, and neonatal postnatal care Postnatal care
• Recommendations for ARV drugs during pregnancy, • Referral to an HIV specialist
labor & delivery and neonatally by the child Access to HIV medication
Breastfeeding practices • Familiarity with medication resources
• Refrain from breastfeeding • Stock IV AZT and liquid AZT
• 6 week course of AZT for the infant
35

7. Obj. 2: Product (Testing New Law-Amendments to 81.090
Recommendations) (Effective January 1, 2010)
Universal opt-out screening of all pregnant Second test in third trimester
women Sample of woman’s blood or other appropriate
Timing of tests for pregnant women and infant specimen
• 1st test at first health care visit Test at labor and delivery if no documentation of test
• 2nd test at 32-36 weeks gestation in 3rd trimester
• At labor and delivery (if no documentation of 2nd test) • Make results available within 6 hours of collection
• Infant testing (if mother’s HIV status is unknown) Test infant if no documentation of maternal test in 3rd
Results available within 6 hours of collection 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
37
How we got started
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
Texas Law until 1/1/2010 True Scenario
Offer HIV testing to all pregnant women early in A woman presented to a local hospital in labor
pregnancy and in Labor and Delivery and had had no prenatal care.
So, all of us have been doing that but most
clinicians and institutions have been using the Routine HIV testing (ELISA=enzyme-linked
standard ELISA immunosorbent assay) was done. Results tend
Works great for those who get prenatal care; with to return in 24-48 hours and many labs do not
treatment, HIV transmission drops from 25% to report the results before a confirmatory
<1% Western blot is done, which may take 2-5
Yet we are left with missed opportunities: those days.
women with no prenatal care AND those who
seroconvert during pregnancy

8. True Scenario, cont. A Missed Opportunity…
The pediatricians were notified of this The majority of HIV transmission occurs at the
woman’s positive ELISA and WB 5 days after time of labor and delivery.
the baby was born, after the mother—who was This baby had a 25% chance of being infected
breastfeeding—was sent home. 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 Why rapid testing?
2007 Texas Department of State Health Services If a woman has HIV, the rapid test is more likely to
funded the TRIAD project be positive than the ELISA (higher sensitivity)
TRIAD = Texas Rapid-testing Implementation At If a woman does not have HIV, the rapid test is more
Delivery likely to be negative than the ELISA (higher
specificity)
Goal was to educate physicians; midwives; labor
and delivery nurses; hospital labs, pharmacies, Results are available immediately (20 minutes on
site/60 minutes in our lab)
risk management about their role in the
prevention of mother to child transmission of Although confirmation is needed (Western blot), the
HIV—with a focus on rapid HIV testing in Labor results are accurate enough to warrant action, i.e.
treating mother and baby
& Delivery
Why rapid testing? (cont.) So how do you change a law?
2006 CDC updated recommendations state: Start early… the Texas legislature meets from
• “A second HIV test during the third trimester, January until June every two years
preferably <36 weeks of gestation, is cost-effective
Find a sponsor… in this case Senator Rodney
even in areas of low HIV prevalence”
Ellis of Houston had proposed a number of
Wouldn’t it make sense to maximize obtaining
bills related to routine HIV testing
test results during pregnancy and use rapid tests
for those who did not get a third trimester test? Work with sponsor’s office

9. Changing Laws House Bill 1795
Watch where the bill is in the process of review… Part 1: “Greyson’s Law”
Senate bill proposal filed and sent to appropriate • Expands newborn screening for enzyme
committee for review, witnesses on each side
deficiencies as recommended by the American
testify, financial impact is reviewed, and
College of Medical Genetics in 2005
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 Where are we now?
Part 2: Perinatal HIV screening On June 1, 2009, the last day of the 2009
• Test at first prenatal visit for syphilis, HIV, and official legislative session, the Texas
hepatitis B (as before) legislature voted to change Texas law related
• Perform the second test for HIV in the third to HIV screening in pregnancy
trimester (a change)
• Do expedited testing for HIV in Labor and Amends Section 81.090 of the Texas Health
Delivery (results available within 6 hours) IF no and Safety Code
third trimester results available (a change)
• Test baby within 2 hours after birth if mother did
not get tested (a change)
What does this mean to health care
What now?
providers?
Test twice in pregnancy—as we had been doing Educate physicians, office staff, and hospital staff about
new law
Do second test at 32-36 weeks, e.g. when you do
Correct misconceptions
GBS testing at 35 weeks. If positive, you have
Lectures to groups vs. computer modules available to
time to start treatment and make decisions about all providers/institutions
the most appropriate mode of delivery Make proper prenatal HIV testing a quality indicator
If a woman presents in labor before the second Research the factors that contributed/barriers that
test has been done, then do rapid testing in Labor existed for the mothers whose babies were born HIV+
and Delivery 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

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