Prevention of Perinatal HIV Transmission

1
Prevention of Perinatal HIV Transmission

• Sindy M. Paul, M.D., M.P.H.
• March 5, 2008

2
Is HIV Disease Reportable in New Jersey and Why?

• HIV, AIDS and perinatal exposure reportable to
  NJDHSS
• Data used for
• Resource allocation
• Trend analysis
• Targeting prevention programs
• Identifying changes in organism

3
Epidemiology of HIV Disease in New Jersey
12/31/06

• 5th in US Cumulative reported AIDS Cases
• Highest proportion of women (32)
• 3rd US Cumulative reported pediatric AIDS cases
• 1,248/1,335 (94) pediatric HIV/AIDS perinatal
  transmission

4

• Timing of Perinatal HIV Transmission

• Cases documented intrauterine, intrapartum, and
  postpartum by breastfeeding
• In utero 2540 of cases
• Intrapartum 6075 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.
5

Pediatric HIV/AIDS Cases Exposures1993-2006 By
CategoryAs of December 31, 2006
6
New Jersey Reported Perinatally HIV Exposed
Children Born in New Jersey 1993-2006 As of
December 31, 2006
12
307
83
7
45
1305
424
239
14
40
193
143
213
33
58
135
17
37
112
76
28
28 Born Out-of-state
7
New Jersey Perinatally Exposed HIV Infected
Children Born in New Jersey 1993-2006 As of
December 31, 2006
lt5
31
6
lt5
lt5
136
52
19
lt5
lt5
18
24
12
lt5
9
12
lt5
lt5
6
5
lt5
8
New JerseyTop 10 Hospitals of BirthPerinatally
HIV Exposed ChildrenBorn 1993-2006 - As of
December 31, 2006
9
New JerseyTop 10 Hospitals of BirthPerinatally
HIV Exposed ChildrenBorn 2001-2006 - As of
December 31, 2006
10
Perinatally Exposed HIV ChildrenPrevalence By
MunicipalityBorn 1993-2006As of December 31,
2006
11
Perinatally Exposed HIV ChildrenPrevalence By
MunicipalityBorn 2001-2006As of December 31,
2006
12
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

13
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

14
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

15
Implementation Of Counseling And Testing
Recommendations

• 1995 NJ Law Mandatory Counseling, Voluntary
  Testing (Changing 6/08)
• 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

16
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

17
Respondents More Likely To Offer Counseling

• Fit Into Office Routine plt0.0001
• Better Medical Outcome p0.0261
• Easy p0.0016
• Confident in Counseling plt0.0001
• Patient Appreciation p0.0001
• Standard of Care p0.0002
• Actively Promoted p0.0012
• Discuss with Colleague p0.0171

18
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

19
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.

20
Demographic Profile

• African-American 53
• Hispanic/Latina 29
• Ages 18-34 84
• Unemployed 63

21
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
  

22
Intention to Use AZT

• 57 Would Use AZT
• 41 Unsure
• 2 Would Not Take AZT

23
Factors Associated With Intention To Use AZT

• Positive Beliefs About AZT plt0.0001
• Recommended by Dr. or Nurse p0.0023
• Access to AZT at Clinic or Dr. p0.0076
• Enough Information plt0.0001
• Conspiracy Theories NOT ASSOCIATED

24
Conclusion

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

25
Implementation of PHS Recommendations in New
Jersey

• ART use increased from 8.3 in 1993 to 97.0
  known in 2006
• Decrease in perinatal transmission from 21 in
  1993 to 2 in 2006
• Room for improvement recent studies show vertical
  transmission can be as low as 1-2
• What are the missed opportunities?

26
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

27
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

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Prevention of Perinatal HIV Transmission ?
Serostatus

• Rapid Test for Unknown Serostatus
• Short course therapy options
  
• Intrapartum IV ZDV 6 weeks ZDV for newborn
• ZDV3TC in labor 1 week ZDV3TC for newborn
• 1 dose NVP labor onset 1 dose NVP for newborn
  at 48 hours of age
• Single dose maternal/newborn NVP regimen
  intrapartum IV ZDV 6 weeks infant ZDV
• If NVP used alone or incombination with ZDV,
  consider maternal ZDV/3TC intrapartum and
  continue 3 7 days postpartum to reduce NPV

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Hospital SurveyManagement 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

30
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

31
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

32
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

33
Standard of CareWomen 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

34
CDC Recommendations Woman Presents in Labor with
? Status

• CDC recommendations similar to NJ
• Counseling
• Template training based on NJ
• Opt out option (Regs preclude in NJ)
• POCT RT short course therapy
• Retest in NJ 3rd Trimester
• Referral for care and treatment

35
Prevalence of Diseases Screened for in Newborns

• Tyrosemia 1 in gt
  300,000
• Maple-syrup urine disease 1 in 175,000
• Homocystinuria 1 in 100,000
• Galactosemia 1 in 60,000
• Phenylketonuria 1 in 14,000
• Hypothyroidism 1 in 4,000
• Perinatal HIV (US) 1 in 1,500

36
9/06 CDC Revised RecommendationsPregnant Women -
I

• Universal opt-out HIV screening
• Include HIV in routine panel of prenatal
  screening tests
• Consent for prenatal care includes HIV testing
• Notification and option to decline
• Note NJ Law/Regulations signed consent or
  declination changing 6/08!

37
9/06 CDC Revised RecommendationsPregnant Women -
II

• Second test in 3rd trimester for pregnant women
• Known to be at risk for HIV
• In jurisdictions with elevated HIV incidence
  including NJ
• In high HIV prevalence health care facilities

38
9/06 CDC Revised RecommendationsPregnant Women -
III

• Opt-out rapid testing with option to decline for
  women with undocumented HIV status in LD
• Initiate ARV prophylaxis on basis of rapid test
  result
• Note NJ Law Consent or Declination Required
  Changing 6/08
• Rapid testing of newborn recommended if mothers
  status unknown at delivery
• Initiate ARV prophylaxis within 12 hours of birth
  on basis of rapid test result

39
2008 Legislation Pregnant Women and Newborns

• Effective 6/08
• Follow current CDC recommendations
• Give information
• Opt-out HIV Testing 1st 3rd Trimesters
• Opt-out Rapid HIV Testing LD
• All newborns if mothers status unknown unless
  written parental religious objection

40
FDA Approved, Currently Available Rapid Tests

• OraQuick Advance HIV1/HIV2
• Reveal
• Unigold Recombigen
• Multispot HIV1/HIV2
• Sure Chek(Complete), Stat Pak HIV1/HIV2
• Confirmation with Western Blot or IFA
• Rapid testing recommended by CDC

41
Requirements for Rapid HIV Testing

• Have an adequate quality assurance program
• Assurance that operators will receive and use
  instructional materials
• Compliance with OSHA/PEOSH blood-borne pathogens
  regulations

42
The Need for Training

• Blood body fluid precautions
• Obtaining the specimen (finger stick or blood
  draw)
• Performing the test
• Providing test results and counseling
• Quality assurance
• OSHA/PEOSH requirements

43
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

44
Summary of Recent Perinatal Infections 2003-2004

• 7 cases
• Only 1 received appropriate care and prevention
  medications
• 2 Mom tested after birth
• 2 No PNC, no meds
• 1 neonate start ZDV day 3
• 1 neonate no ZDV
• 2 c/s (1 non-elective, 1 unknown)

45
Summary of Recent Perinatal Infections
2003-2004 Continued

• 3 Mom diagnosed before pregnancy
• - 3 No PNC, no meds
• - 1 neonate no ZDV, 1 unknown, 1 ZDV
• - 2 vaginal deliveries (1 home delivery)
• - 1 c/s 34 weeks type unknown
• 1 Mom diagnosed before pregnancy
• - PNC starting 7 months, non-adherent meds
• -elective c/s 38 weeks, ZDV LD, neonate day1

46
2005 Hospital Survey

• Collaborative effort NJHA UMDNJ
• Purpose evaluate implementation of standard of
  care
• Goal RT Short course therapy for women in
  labor all hospitals
• Self-administered survey
• Data collection June September 2005

47
2005 Hospital Survey Preliminary Data

• All 59 hospitals responded
• 56 (94.9) have a policy for documenting HIV
  status in labor and delivery (LD)
• 34 (57.6) have a policy for counseling women
  with unknown HIV status in LD
• 39 (66.1) have a policy for HIV testing

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2005 Hospital Survey Preliminary Data Continued

• 56 (94.9) of responding hospitals have HIV
  testing available in LD
• 45 (76.3) do point-of-care testing in LD
• 40 (67.8) provide antiretroviral agents to the
  mother in labor and to the newborn

49
Major Missed Opportunities 2005

• Potentially preventable cases persist
• Lack of or inadequate prenatal care
• Lack of availability of counseling, rapid testing
  and short course therapy at some New Jersey
  hospitals that provide OB care
• For maximal reduction need RT Short course
  therapy at all OB hospitals

50
Efforts to Decrease Missed Opportunities

• Target Population
• - Women in labor with ? HIV status
• - Women not in PNC
• Approach
• - Provider education
• - Facility TA

51
Pregnant.
Are You HIV?
Find Out.
YOU CAN HELP Prevent HIV In Your Baby.
Call The NJ AIDS Hotline [phone].
Free HIV Test And Care During Pregnancy.
52
Potential Adverse Outcomes

• Birth Defects
  - Match HARS To Birth Defects
  Registry - No Evidence Of Increased Incidence
  
• Cancer
  -Match HARS To Cancer Registry
  -No Evidence Of Increased Incidence
• Current Studies Population-Based Approach
  Through Registry Matching

53
Potential Toxicities Mitochondrial Disease

• Primate Studies
• French Cohort
  - 8/3,000 Children
• US, Europe, Thailand, Africa
  - 0/27,000 Children
• Current Studies in New Jersey
  - None Detected

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Summary

• Perinatal transmission decreased from 21 to 2
• Major missed opportunity NJ present in labor
  HIV status unknown
• Counseling, RT, short course Rx in labor
• Continue to use epidemiology to evaluate the
  implementation and effectiveness of
  recommendations
• Goal maximal decrease vertical HIV transmission