Transcript Prevention of Perinatal HIV Transmission

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%)
• 3rd US Cumulative reported pediatric AIDS
cases
• 1,204/1,287 (94%) pediatric HIV/AIDS
perinatal transmission
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.
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
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
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
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
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
Respondents More Likely To
Offer Counseling
•
•
•
•
•
•
•
•
Fit Into Office Routine
Better Medical Outcome
Easy
Confident in Counseling
Patient Appreciation
Standard of Care
Actively Promoted
Discuss with Colleague
p<0.0001
p=0.0261
p=0.0016
p<0.0001
p=0.0001
p=0.0002
p=0.0012
p=0.0171
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
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.
Demographic Profile
•
•
•
•
African-American
Hispanic/Latina
Ages 18-34
Unemployed
53%
29%
84%
63%
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
Intention to Use AZT
• 57% Would Use AZT
• 41% Unsure
• 2% Would Not Take AZT
Factors Associated With Intention
To Use AZT
•
•
•
•
Positive Beliefs About AZT
Recommended by Dr. or Nurse
Access to AZT at Clinic or Dr.
Enough Information
p<0.0001
p=0.0023
p=0.0076
p<0.0001
• Conspiracy Theories NOT ASSOCIATED
Conclusion
• Pregnant Women Are Willing to Consider
AZT Use if They Are Given Adequate,
Accurate Information.
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?
New Jersey
Pediatric HIV/AIDS Cases & Exposures
Born 1993-2004 By Category
As of December 31, 2004
Birth
Year
Infected
#
Indeterminate
%
#
%
Seroreverter
#
Total
Reported
%
1993
75
21
82
23
194
55
351
1994
55
17
103
32
162
51
317
1995
50
16
81
26
185
59
316
1996
39
13
76
26
180
61
295
1997
32
11
86
30
164
58
282
1998
23
7
94
31
191
62
308
1999
15
6
76
30
159
64
250
2000
13
5
73
27
182
68
268
2001
7
3
76
35
136
62
219
2002
4
2
78
36
134
62
216
2003
5
3
69
38
110
60
184
2004*
3
2
118
75
36
23
157
Total
326
12
1,012
31 1,833
58
3,163
1998
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
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
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
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
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
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
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 +
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
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
Rapid Tests
•
•
•
•
•
SUDS
OraQuick
Reveal
Unigold
Multispot
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
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
Rapid Tests: Unigold
•
•
•
•
FDA approved 12/03
Whole blood, serum, plasma
CLIA waived
10 minutes
Multispot HIV1/HIV2 Test
•
•
•
•
•
FDA approved
Moderately complex
Not CLIA waived
Fresh or frozen plasma
10 minutes
How do other Rapid Tests
Perform Compared to SUDS?
False
Negative
Determine
Reveal
MultiSpot
OraQuick
OraQuick Oral
Unigold
SUDS
0/37
5/67
0/45
0/73
0/72
4/45
1/72
Sensitivity
False
Positive Specificity
100% 2/1649
93.1% 16/1581
100% 0/769
100% 2/1639
100% 18/1569
91.1% 2/915
98.6% 6/1641
1649 Clients at Testing Site / STD Clinics
99.9%
99.0%
100%
99.9%
98.9%
99.8%
99.6%
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
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)
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)
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
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
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
CDC Recommendations for
Women in Labor with ? HIV
• Rapid testing
– POCT shorter turn around time
• Short course therapy
• Referral for care and treatment
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
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
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
Formula for HIV Counseling and
Testing in Labor: C3R3
•
•
•
•
C3
Confidentiality
Comfort
Consent
• R3
• Reasons to Test
• Results
• Rx to decrease risk
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
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.
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
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
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
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
RX: Treatment to Reduce
Perinatal Transmission
• ART in labor/delivery and to the baby after
birth decreases risk of transmission to 1 in
10
• National guidelines: 4 RX options
• Referral of mother and child to provider
with experience and expertise RX HIV
• Let pediatric provider know the child is
HIV exposed (NJ has a law for this)
Other Potential Barriers and How
to Overcome Them: Lab
• Cost: NJ law - mandatory counseling &
voluntary testing substituting 1 test for
another
• Volume of testing required:
- unknown serostatus not all 120,000
- Estimated 1,100-1,200 women (1% based
on electronic birth certificate data) women
with no prenatal care annually statewide
Potential Lab Barriers Continued
• Releasing preliminary positive lab results
- Recommended by CDC & ASTPHLD
- Lab alert
- CME article in NJ Medicine, AIDSLine
• PPV for SUDS
- Better tests now available & on the
horizon
Dissemination of the Standard of
Care
• Development & dissemination of a template
counseling session for pregnant women
• Hospital mailing with a Laboratory Alert
• Continuing education programs
• Web-based CME www.acadmed.org
• Hospital TA
• Articles for Publication: medical & lab
Dissemination - Continued
• Collaboration with NJDHSS hospital
licensure staff
• Collaboration with the Board of Medical
Examiners
- License physicians and nurse midwives
• Collaboration with OB Society & ACOG
Evaluation of Implementation &
Effectiveness
• Repeat questionnaire survey
• Surveillance data for women presenting
with unknown serostatus
- # positive rapid tests
- # short course therapy
- # children who serorevert
- # children infected
• Retrospective medical record review
How are we Doing? Repeat
Hospital Survey Spring 2003
• 24/59 (41%) OB hospitals responded
• 23/24 (96%) aware standard of care
• 19/23 (83%) always or almost always offer
counseling in labor
• 19/22 (86%) offer testing in labor
• 16/24 (67%) rapid or expedited testing
• 4/4 (100%) without rapid testing plan within
6 months
How are we Doing? Repeat
Hospital Survey Spring 2003
• 17/19 (89%) offer short course therapy if
rapid or expedited HIV test during labor is a
preliminary HIV positive result
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)
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 L&D, neonate day1
Efforts to Decrease Missed
Opportunities
• Target Population
- Women in labor with ? HIV status
- Women not in PNC
• Approach:
- Provider education
- Outreach to women
- Information on barriers – repeat hospital survey
- Missed opportunities work group
Pregnant.
Are You HIV+?
Find Out.
YOU CAN HELP Prevent HIV In Your Baby.
Call The NJ AIDS Hotline 1-800-624-2377.
Free HIV Test And Care During Pregnancy.
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
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
Controversies In Reducing
Perinatal HIV Transmission
• Mandatory Counseling, Voluntary Testing
- New Jersey Law
• Mandatory Testing of Pregnant Women
• Mandatory Testing of Newborns
- Currently required in New York
- Ryan White Legislation 2000
- Representative Coburn Letter
Controversies In Reducing
Perinatal HIV Transmission
• Universal Screening With Opt Out Option
- IOM Report & Supported by ACOG
• CDC Revised Recommendation
- HIV screening = routine part prenatal care
- Provide info e.g. brochure, pamphlet,
video before testing
- Written or verbal consent
- opt out for women in labor
Summary
• Epidemiology used to develop policy
• Perinatal HIV transmission decreased from
21% to 3%
• Continue to use epidemiology to evaluate
the implementation and effectiveness of
recommendations
• Trying to achieve maximal reduction of
perinatal HIV transmission