Perinatal HIV in Texas &Addressing Missed

Opportunities through the Texas Consortium for Perinatal

HIV Prevention (TCPHP)Presenters:

Elvia Ledezma, MPHLeslie Conley, L.M.S.W.-I.P.R.

Janak Patel, M.D.Judy Levison, M.D.

Perinatal HIV in Texas

Elvia Ledezma, EpidemiologistHIV/STD Epidemiology and SurveillanceTexas Department of State Health Services

elvia.ledezma@dshs.state.tx.us512-533-3045

Outline

Overview of perinatal HIVSteps to prevention of perinatal HIVPreventative 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

200813,751 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

2000-20089% 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

41%

60%

32%

22% 22%

12%5%6%

0

10

20

30

40

50

60

70

HIV+ Women Delivering anExposed Infant, 2008

HIV+ Women Delivering anInfected Infant, 2005-2008

Perc

ent (

%) b

y R

ace/

Eth

nici

ty

Black Hispanic White Other/Unknown

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

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 P

erin

atal

Exp

osur

es

0

1

2

3

4

5

6

7

8

Perc

ent I

nfec

ted

Exposures Infected

n=7

n=13 n=12

n=9

n=21n=21 n=22

n=20

n=13

n=8

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 careTested for HIV

Diagnosed before deliveryReceives ARV therapy at all three recommended timings

PregnancyLabor and deliveryNeonatally

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%)

Non=113 (8%)

Yesn=1276 (87%)

Unknownn=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%)

Yesn=1124 (93%)

Unknownn=22 (2%)

No Infected Infants

No Infected Infants

No Infected Infants

Non=61 (5%)

Yesn=1211 (95%)

Unknownn=4 (<1%)

No. of Women=1,461

No. of Infected Infants=41

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 ARVn=103 (9%)

3 arm ARVn=1082 (91%)

Unknownn=0 (0%)

No Infected Infants

No. of Women=1,461

No. of Infected Infants=41

Infectedn=18 (2%)

Uninfectedn=615 (57%)

Indeterminaten=449 (41%)

56% (23/41) had at least one missed opportunity45% (18/41) had no missed opportunities

Prevention of Perinatal HIV Transmission

Receipt of prenatal careTiming of HIV diagnosisReceipt of antiretroviral therapy (ARV)

n=28

n=307 18%

1%

0

50

100

150

200

250

300

350

Any Prenatal Care No Prenatal Care

No.

of H

IV+

Wom

en D

eliv

erin

g

0%2%4%6%8%10%12%14%16%18%20%

% o

f Chi

ldre

n In

fect

ed

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

n=24

n=105

n=229

3%

0%

13%

0

50

100

150

200

250

Prior to Pregnancy During Pregnancy At Delivery

No.

of H

IV+

Wom

en D

eliv

erin

g

0%

2%

4%

6%

8%

10%

12%

14%

% o

f Chi

ldre

n In

fect

ed

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

n=67

n=286

1%

10%

0

50

100

150

200

250

300

350

All 3 Intervals None or 1-2 Intervals

No.

of H

IV+

Wom

en D

eliv

erin

g

0%

2%

4%

6%

8%

10%

12%

% o

f Chi

ldre

n In

fect

ed

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

SummaryDecrease in proportion of perinatal HIV transmission from 2000 to 2008Among 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)

SummaryMissed 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– Refused HAART

*** 1st

*** 2nd

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/mlBaby is INFECTED with HIV.

*** 3rd

*** 4th

*** 5th

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– 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 withrepeat tests. Baby is INFECTED with HIV.

*** 1st*** 2nd

*** 4th*** 3rd

*** 5th

Overview of the TCPHP

Janak Patel, M.D.Professor, Department of Pediatrics

Director, Pediatric Infectious Disease and ImmunologyUniversity of Texas Medical Branch

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

Who makes up the TCPHP? Hospitals/Clinics• Maternal and pediatric HIV providers• Administrators and case managersDSHS 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 EmpowermentLocal health departments• Surveillance staff

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Project Components/Work GroupsLeadershipStandards of CareEducationOutreach

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Project Components/Work GroupsLeadership• List of perinatal experts• Identified gaps in membershipStandards of Care• Guidelines for care for HIV+ pregnant womenEducation• In progressOutreach • In progress

Standards of Care Component Products

Goal 1: Objective and ProductGoal 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: ObjectivesGoal 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

Obj. 1: Product (Guidelines for Care)

Pre-conceptual counseling• Counseling/educationAntepartum, intrapartum, and neonatal postnatal care • Recommendations for ARV drugs during pregnancy,

labor & delivery and neonatally by the childBreastfeeding practices• Refrain from breastfeeding

Obj. 1: Product (Guidelines for Care)

Mode of delivery• Recommendations based on RNA levelsPostnatal 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

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Obj. 2: Product (Testing Recommendations)

Universal opt-out screening of all pregnant womenTiming 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

New Law-Amendments to 81.090 (Effective January 1, 2010)

Second test in third trimesterSample of woman’s blood or other appropriate specimenTest 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 MedicineBaylor College of Medicine

How we got started

Texas Law until 1/1/2010Offer HIV testing to all pregnant women early in pregnancy and in Labor and DeliverySo, all of us have been doing that but most clinicians and institutions have been using the standard ELISAWorks 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 projectTRIAD = Texas Rapid-testing Implementation At DeliveryGoal 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 testingWork 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 madeIf 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 anotherWe 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 pregnancyAmends 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 doingDo 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 deliveryIf 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 lawCorrect misconceptions Lectures to groups vs. computer modules available to all providers/institutionsMake proper prenatal HIV testing a quality indicatorResearch 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 7pmWhere: Frio

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