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Prevention of Perinatal HIV Transmission: The Role of Epidemiology in Health Care Policy

Prevention of Perinatal HIV Transmission: The Role of Epidemiology in Health Care Policy. Sindy M. Paul, M.D., M.P.H. March 7, 2005. Epidemiology of HIV Disease in New Jersey: 12/31/04. 5th in US Cumulative reported AIDS Cases Highest proportion of women (32%)

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Prevention of Perinatal HIV Transmission: The Role of Epidemiology in Health Care Policy

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  1. Prevention of Perinatal HIV Transmission: The Role of Epidemiology in Health Care Policy Sindy M. Paul, M.D., M.P.H. March 7, 2005

  2. Epidemiology of HIV Disease in New Jersey: 12/31/04 • 5th in US Cumulative reported AIDS Cases • Highest proportion of women (32%) • 3rd US Cumulative reported pediatric AIDS cases • 1,204/1,287 (94%) pediatric HIV/AIDS perinatal transmission

  3. Timing of Perinatal HIV Transmission • Cases documented intrauterine, intrapartum, and postpartum by breastfeeding* • In utero 25%–40% of cases • Intrapartum 60%–75% of cases • Addition risk (14-29%) with breastfeeding • Evidence suggests most transmission occurs during the intrapartum period * Fowler, MG, Ped. Clinics of N. America 2000.

  4. Prevention of Perinatal HIV Transmission • The Risk Of Transmission Can Be Reduced • Prenatal Care • Mandatory Counseling/Voluntary Testing • Know Serostatus As Early As Possible! • Antiretroviral Therapy & OB Procedures • PACTG 076: AZT Decreases Transmission From 25% to 8% • Recommend Against Breast Feeding

  5. Evaluation of Implementation • Access to Prenatal Care • Counseling and Testing: Provider & Patient • AZT and other Antiretroviral Agent Use • Impact on Transmission • Missed Opportunities • Potential Toxicities • Potential Adverse Outcomes

  6. Access to Prenatal Care 1993, 1995, 1996 • 25% of HIV Infected Pregnant Women Had No Known Prenatal Care • In 2000: 14% No Known Prenatal Care & 6% 1-2 Prenatal Visits • A Major Gap In Prevention Of Perinatal HIV Transmission In New Jersey • An Opportunity For Intervention

  7. Implementation Of Counseling And Testing Recommendations • 1995: NJ Law Mandatory Counseling, Voluntary Testing • Surveillance Data: 91% HIV Infected Pregnant Women Know Serostatus Prior to Delivery & 4% Tested at Delivery • Statewide Assessment Diffusion of Counseling And Testing OBGYN • Interview Study Of Pregnant Women

  8. Provider Survey: Results • 160/351 (51%) Completed Survey • 94% Offer HIV Testing • 90% Discuss Benefits of HIV Testing • 77% Counsel • 59% Offer All 3 Components

  9. Respondents More Likely To Offer Counseling • Fit Into Office Routine p<0.0001 • Better Medical Outcome p=0.0261 • Easy p=0.0016 • Confident in Counseling p<0.0001 • Patient Appreciation p=0.0001 • Standard of Care p=0.0002 • Actively Promoted p=0.0012 • Discuss with Colleague p=0.0171

  10. Conclusion • Doing Well, but Room for Improvement • Missed Opportunities • Improved Diffusion and Implementation of HIV Counseling and Testing among OBGN Could be Accomplished through Peer Education

  11. Interview Study: Pregnant Women • Convenience sample - 170 Pregnant Women • Objective: To Ascertain How Pregnant Women Perceive AZT as a Possible Option to Prevent Perinatal HIV Transmission by Examining Their Knowledge, Attitudes, Beliefs, and Intentions Surrounding AZT Use.

  12. Demographic Profile • African-American 53% • Hispanic/Latina 29% • Ages 18-34 84% • Unemployed 63%

  13. HIV Counseling and Testing History • 74% Reported Being Told About Benefits of HIV Testing • 90% Tested for HIV • 10% Not Tested Yet • 13/17 (76%) Intended to Be Tested • 4/17 (24%) Did Not Intend to Be Tested

  14. Intention to Use AZT • 57% Would Use AZT • 41% Unsure • 2% Would Not Take AZT

  15. Factors Associated With Intention To Use AZT • Positive Beliefs About AZT p<0.0001 • Recommended by Dr. or Nurse p=0.0023 • Access to AZT at Clinic or Dr. p=0.0076 • Enough Information p<0.0001 • Conspiracy Theories NOT ASSOCIATED

  16. Conclusion • Pregnant Women Are Willing to Consider AZT Use if They Are Given Adequate, Accurate Information.

  17. Implementation of PHS Recommendations in New Jersey • ART use: increased from 8.3% in 1993 to 84.2% known in 2003 • Decrease in perinatal transmission from 21% in 1993 to 3.0% in 2003 • Room for improvement recent studies show vertical transmission can be as low as 1-2% • What are the missed opportunities?

  18. New JerseyPediatric HIV/AIDS Cases & ExposuresBorn 1993-2004 By CategoryAs of December 31, 2004

  19. Missed Opportunities: Children Who Became Infected • 7 children infected 1999, 1 infected 2000 (preliminary data reports through 12/31/00) • 5 of the 8 (63%) no known or inadequate prenatal care • 7/8 (88%) HIV status unknown to the delivery team

  20. Missed Opportunities: Children Who Became Infected Continued • 1 of the 8 (13%) had prenatal care starting in 3rd trimester with antiretroviral agents in pregnancy, labor/delivery, and neonatal period and a vaginal delivery • Major gap: women presenting in labor with unknown HIV serostatus to the provider • Contributing factor: lack of or inadequate prenatal care

  21. Prevention of Perinatal HIV Transmission: ? Serostatus • Rapid Test for Unknown Serostatus • Short Course Therapy Options: - 1 dose NVP labor onset & 1 dose NVP for the newborn at age 48 hours - ZDV+3TC in labor &1 week ZDV+3TC for the newborn -Intrapartum ZDV+6 weeks ZDV newborn -2 dose NVP regimen + 6 weeks ZDV

  22. Hospital Survey:Management Labor Unknown Serostatus • Questionnaire telephone survey of 12 hospitals Essex, Hudson, Union counties • IRB approval • 12 licensed acute care general hospitals • 9/12 (75%) responded • 6/9 (67%) provide obstetrical care • 1/9 (10%) rapid test capability

  23. Hospital Survey: Management Labor Unknown Serostatus • 1/6 (17%) always offers CTS in labor • 2/6 (33%) almost always offer CTS in labor • 2/6 (33%) rarely or never offer CTS in labor • 0 policy for rapid test/short course therapy • 5/6 (83%) use standard EIA + Western Blot • 1/6 (17%) use HIV DNA PCR • Problem: obtaining results in 72 hrs to treat infant with ZDV

  24. Plan of Action: A Statewide Policy for Unknown Serostatus • Identify & involve providers & other stakeholders • Education • Development of a statewide policy for use by hospitals • Dissemination of information • Implementation of the policy • Evaluation

  25. Intent of the Standard of Care • Provide HIV counseling and voluntary rapid or expedited testing of mothers or newborns if unknown HIV status or mother reports HIV infection with no documentation on the medical record • Offer maternal &/or newborn ART if HIV +, mother reports being HIV +, or mother previously documented to be HIV +

  26. Intent of the Standard of Care • To decrease the risk of vertical transmission in every HIV exposed baby born in a New Jersey hospital to the best practice standards

  27. Standard of Care:Women in Labor with ? HIV Status • Provide counseling (pre- and posttest) • Voluntary rapid or expedited HIV test • If HIV positive provide preliminary lab results (CDC & ASTPHLD) • If HIV positive offer short course therapy • DO NOT DELAY RX pending confirmatory lab results • Refer mother & child for follow-up care

  28. Rapid Tests • SUDS • OraQuick • Reveal • Unigold • Multispot

  29. Rapid Tests: Oraquick • Fingerstick, purple top tube, or OMT specimen • FDA approved 11/02 CLIA waived 1/03 except OMT (FDA approved 3/04) • Not CLIA waived in NJ (lab regs) - Need a lab licensed by NJDHSS to perform diagnostic immunology (HIV testing) - Need to comply with CLIA ‘88 regs • ? Point of Service Testing

  30. Rapid Tests: Reveal • FDA approved 4/17/03 • Not CLIA waived • Moderate complexity test • Most be done in licensed lab • Batched - minimum 8 specimens/batch

  31. Rapid Tests: Unigold • FDA approved 12/03 • Whole blood, serum, plasma • CLIA waived • 10 minutes

  32. Multispot HIV1/HIV2 Test • FDA approved • Moderately complex • Not CLIA waived • Fresh or frozen plasma • 10 minutes

  33. How do other Rapid Tests Perform Compared to SUDS?

  34. Current Clinical Response to Rapid Testing Preliminary Positive Results • Occupational Exposure • Women in labor with unknown HV status • Why? Because tested person benefits - PEP reduces risk of occupational transmission - Short course therapy reduces risk of mother-to-child HIV transmission

  35. Clinical Trial Data Supporting Short Course Therapy • International studies show not as effective as PACTG 076 regimen (66% decrease) • Thailand Study Short Course AZT - Non-breastfeeding population - From 36 weeks through labor - Did not include infant prophylaxis - 50% decrease transmission (9.4% AZT vs 18.9% placebo)

  36. Clinical Trial Data Supporting Short Course Therapy - Petra • Petra Study (Uganda, S. Africa, Tan.) - Breastfeeding population - Oral AZT/3TC from 36 weeks and during labor& delivery - Oral AZT/3TC to woman and infant q 12 hours for 7 days postpartum - Reduced transmission by 38% (10% AZT/3TC vs. 17% placebo)

  37. Clinical Trial Data Short Course Therapy HIVNet 012 Uganda • Breastfeeding population • Intrapartum/postpartum/neonatal NVP vs. short course neonatal AZT • 200 mg po NVP at labor onset; 2mg po NVP to infant within 3 days • 600 mg AZT labor onset; 300 mg AZT q 3 hr in labor; 4mg/kg AZT infant bid 7 d - Transmission rate 12% NVP vs. 21% AZT

  38. Goals of Treatment of HIV Infected Pregnant Women • Treatment of mother’s HIV disease • Reducing the risk of vertical HIV transmission • Health of the mother and the child

  39. CDC: What if a Woman Presents in Labor with Unknown Status? • Counseling • Opt out option possible (check state regs) • CDC Mother-Infant Rapid Intervention at Delivery (MIRIAD) counseling feasible in labor • Template developed based on NJ • Counselors should be trained

  40. CDC Recommendations for Women in Labor with ? HIV • Rapid testing • POCT shorter turn around time • Short course therapy • Referral for care and treatment

  41. CDC: Eligibility for Counseling & Offering Rapid Testing in Labor • Undocumented HIV status • Addition re-screen continued risk • Approach similar to syphilis retesting in 3rd trimester and at delivery for high risk • H/O STD, sex for $ or drugs, multiple sex partners during pregnancy, illicit drug use, HIV + or high risk partner, signs and symptoms of seroconversion

  42. Concerns with Counseling Women in Labor • How to present HIV counseling and offer testing during labor? • Development of model counseling session - Review of Lit & Discussion with CDC • Meetings teaching & non-teaching hospital staff • Focus group postpartum women • Statewide TOT with MCH consortia

  43. Counseling During Labor • Not a great time, but possible! • Policy and procedure in place with a counseling “script” • Materials for patient education/informed consent • Culturally and linguistically appropriate • Done for other OB procedures i.e. C-section

  44. C3 Confidentiality Comfort Consent R3 Reasons toTest Results Rx to decrease risk Formula for HIV Counseling and Testing in Labor: C3R3

  45. Confidentiality • Who is in the room with the patient? • How can you assure confidentiality during - History taking - Giving test results - Giving medication for treatment • Be creative - counseling part of admission process, visitors get coffee, in bathroom

  46. Comfort • What is her level of discomfort/anxiety? • How is her pain being managed? • Tell the woman she should signal you when a contraction is happening, so you can pause until it is over. • Important to show empathy:body language &/or touch. • Pause to verify understanding.

  47. How Much Information is “Informed” Consent? • HIV is the virus that causes AIDS • A woman can be at risk and not know it • Effective intervention can prevent transmission to the baby and improve mother’s health • Testing recommended all pregnant women • Women who decline testing won’t be denied care

  48. Reasons for HIV Testing During Labor • HIV the virus that causes AIDS is spread by unprotected sexual intercourse • Therefore, all pregnant women may be at risk for HIV infection • Pregnant woman has a 1 in 4 chance of passing HIV to baby if she is not treated • ART in labor/delivery & neonatal period: 1 in 10 babies will get infected

  49. Giving the Results: Preliminary Positive Results • May be infected with HIV • Confirm with a 2nd test (no test =perfect) • May be best to start ART for you & baby • Wait for confirmatory results before breastfeeding (Can start only if neg.) • If confirmatory test neg. stop medication • If confirmatory test + cont. meds, referral for care, follow-up testing baby

  50. Giving the Results: Preliminary Negative Results • Not infected with HIV • Emphasize risk reduction plan to prevent transmission • Referral for intensive counseling if high risk • Note: a negative rapid test is negative and does not need confirmation that it is negative

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