Perinatal Hiv Ledezma Addressing Missed Opp Patel Final Handouts


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Perinatal Hiv Ledezma Addressing Missed Opp Patel Final Handouts

  1. 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. 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 1
  2. 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 2
  3. 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 ART 3 arm ART 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 Any Prenatal Antiretroviral Step 3: Missed (ARV) 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 3
  4. 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. 4
  5. 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 Texas City in Sept 2006 – No oral zidovudine in stock for baby until > 24 hrs of age *** 4th – Miscarriage – Delay in obtaining zidovudine for discharge *** 5th – 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 5
  6. 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 6
  7. 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 7
  8. 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 8
  9. 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 9
  10. 10. Questions/Suggestions 10