hiv counseling and rapid testing in labor. 11/03 2 acknowledgements original slide set developed by...
TRANSCRIPT
11/032
Acknowledgements
Original slide set developed by Elaine Gross and Carolyn Burr, François-Xavier Bagnoud Center at UMDNJ (FXB Center) with funding from the NJ Department of Health & Senior Services
Material adapted for AETC use by representatives from Midwest AIDS Training and Education Center, New England AETC, the FXB Center, the National Clinicians’ Consultation Center, and AETC National Resource Center
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Learning Objectives
This presentation will assist you to: Describe national recommendations for HIV testing
in pregnancy Examine barriers to universal HIV counseling and testing Discuss research findings and clinical strategies for
preventing perinatal HIV transmission Describe unique issues related to HIV counseling and rapid
testing of women in labor with no prenatal care or unknown HIV status
Discuss strategies for managing the HIV positive woman in labor including rapid testing and short-course antiretroviral therapy
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Components of the Slide Set
National recommendations for HIV counseling and testing in pregnancy
Overview of HIV in pregnancy and prevention of perinatal HIV transmission
Rapid HIV testing during labor
Short course antiretroviral therapy
Case studies
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Chain of events leading to an HIV-infected child
The proportion of women . . . Who are HIV-infected Who become pregnant Who do not seek prenatal care Who are not offered HIV testing Who refuse testing Who are not offered ARV prophylaxis Who refuse ARV prophylaxis Who do not complete the ARV prophylaxis Whose child is infected despite treatment
IOM, 1998
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Scope of the Epidemic Among Women and Children
152,060 AIDS cases in women reported through December 2002
AIDS in women has risen from 7% early in the epidemic to 26% of adult/adolescent cases in 2002
158 new AIDS cases reported in children in 2002 10,000 – 20,000 estimated children living with HIV
infection 280 – 370 babies continue to be born with HIV
infection each year in the U.S.
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Scope of the Epidemic Among Women and Children in Your State
NJ is 5th in the U.S. in AIDS cases — 49,000 Women are 28% — highest proportion in U.S. 91% of pregnant women know their HIV status ART use in pregnant women rose from 7% in 1993
to 70% in 1999 Perinatal transmission fell from 21% in ’93 to 5.0%
in ‘99 But . . . 25% of HIV+ pregnant women have no
prenatal care
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National Recommendations for HIV Testing of Pregnant Women
Regulations, laws, & policies about HIV screening of pregnant women vary state to state
Institute of Medicine in 1998 recommended universal HIV testing of pregnant women
American College of Obstetrics & Gynecology and the American Academy of Pediatrics in 1999 supported IOM and encourage counseling but not as a barrier to testing
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National Recommendations for HIV Testing of Pregnant Women
CDC (USPHS) recommendations for HIV screening of pregnant women (4-22-03)
Prenatal: routine HIV screening for all pregnant women using the “opt out” approach
Women will be notified that they will be tested unless they decline
Labor and delivery: Routine rapid testing for women whose HIV status is unknown
Postnatal: Rapid testing for all infants whose mother’s status is unknown.
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“Opt-Out” HIV Testing in Pregnancy
Advantages
Easier and quicker for the provider
Greater percentage of women likely to be tested means fewer infected infants
“Normalizes” HIV testing
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“Opt-Out” HIV Testing in Pregnancy
Disadvantages Risk of no pretest counseling
Patient education may be inadequate
Provider may not be prepared to give positive
results
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Opt-Out as a “Consenting Process” Minimum information
An HIV test is part of the routine pregnancy screening tests
You have the right to refuse the test The HIV test is important. We strongly recommend
that all pregnant women be tested because a woman can pass HIV to her baby
If a woman has HIV, she will be offered medicines for her health and to reduce the risk of passing HIV to her baby
Services are available for her and her family
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Barriers and Supports to Universal Prenatal HIV Testing
Provider’s recommendation about testing 92.8% were tested if strongly recommended 42% if clinician had not recommended
Private insurance associated with not being tested
Reasons for not being tested Not perceiving herself at risk (55.3%) Having been tested recently (39%) Test not offered or recommended (11%) Adverse consequences rarely mentioned
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Perinatal Transmission of HIV
Without antiretroviral prophylaxis, 16%–25% mother-to-child transmission in North America and Europe
21% transmission rate in the U.S. in 1994 before the standard recommendation of zidovudine (ZDV) in pregnancy
With the change in practice, transmission was 11% in 1995
Today, risk of perinatal transmission can be < 2% with highly active antiretroviral therapy (HAART), elective C/S as appropriate and formula feeding
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Timing of Perinatal HIV Transmission
Cases documented intrauterine, intrapartum, and postpartum by breastfeeding In utero 25%–40% of cases
Intrapartum 60%–75% of cases Additional risk with breastfeeding
14% risk with established infection 29% risk with primary infection
Current evidence suggests most transmission occurs during the intrapartum period
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Breastfeeding and HIV Infection
Women with HIV infection in the U.S. should not breastfeed
Women considering breastfeeding should know their HIV status
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Influences on Perinatal Transmission: Maternal Factors
HIV-1 RNA levels (viral load)
Low CD4 lymphocyte count
Other infections, Hepatitis C, CMV, bacterial vaginosis
Maternal injection drug use
Lack of ZDV during pregnancy
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Influences on Perinatal Transmission: Obstetric and Infant Factors
Obstetrical Factors Length of ruptured membranes/
chorioamnionitis Vaginal delivery Invasive procedures
Infant Factors Prematurity
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Maternal Viral Load (VL), ZDV Treatment and the Risk of Perinatal HIV Transmission
Correlation between high maternal VL and transmission
Transmission observed at every VL level, including undetectable levels
No HIV RNA threshold below which there was no risk of transmission
ZDV decreases transmission regardless of HIV RNA level
Recommendation: Initiate maternal ZDV regardless of plasma HIV RNA or CD4 counts
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PACTG 076A phase III randomized placebo-controlled trial of zidovudine (ZDV) for the prevention of maternal-fetal HIV transmission Treatment Regimen
Antepartum 100 mg ZDV po 5x day, started at 14 – 34 weeks gestation
IntrapartumDuring labor, 1- hour initial dose 2 mg/kg IV followed by continuous infusion of 1 mg/kg until delivery
Postpartum/Infant Regimen2 mg/kg po q 6 hr for 6 weeks, to start 8 – 12 hours after birth
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Results of PACTG 076
ZDV groupPlacebo
22.6%
7.6%
30
20
10
Transm
ission Rate (%
)
This represents a 66% reduction in risk for transmission (P = <0.001)
Efficacy was observed in all subgroups
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Follow-up of Uninfected Infants and of Mothers in PACTG 076
No significant differences in infant growth, development, or immune function in placebo v. ZDV.
No other safety abnormalities have been identified in infants
Follow-up of infants with exposure to nucleoside analogues is ongoing due to the potential for mitochondrial toxicity
In the U.S. no cases of mitochondrial toxicity have been identified
For mothers, no substantial differences in CD4 count, time to progression to AIDS, or death in women who received ZDV compared to those who received placebo
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Reducing Intrapartum HIV Transmission: Studies of Short
Course Therapy Oral ZDV in a non-breastfeeding population (Thailand)
from 36 weeks and during laborTransmission rate: 9.4 % ZDV vs 18.9 % placebo
Petra study – intrapartum/postpartum oral ZDV/3TC in a breast-feeding population (Uganda, S. Africa, Tanzania)
Transmission rate: 10% ZDV/3TC vs 17% placebo
HIVNet 012 – intrapartum/postpartum/neonatal nevirapine (NVP) vs short course/neonatal ZDV in a breast-feeding population (Uganda)
Transmission rate: 12% NVP vs 21% ZDV
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Reducing Intrapartum HIV Transmission:
Studies of Short Course ARV Therapy
0
5
10
15
20
25
Thai shortcourse
Petra HIV 012
Placebo ZDV ZDV/ 3TC NVP
Placeb
o
ZDV
ZDV
Placeb
o
ZDV/3
TCNVP
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Reducing HIV Transmission with Suboptimal Regimens:
The New York Cohort
6.1
10 9.3
26.6
0
5
10
15
20
25
30
Prenatal/ Intrapart./ Infant ZDV
Only intrapartumZDV
Infant ZDV only by48 hrs.
No ZDV
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Goals of Antiretroviral Therapy
To prolong life and improve quality of life
To suppress HIV to below the limits of detection or as low as possible, for as long as possible
To preserve or restore immune function
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Perinatal Guidelines USPHS Task Force Recommendations for the
Use of Antiretroviral Drugs in Pregnant HIV-1 Infected Women for Maternal Health and to Reduce Perinatal HIV-1 Transmission in the United States
Developed in 1994 in response to ACTG 076
Working Group reconvened in December 1999 and meets monthly
Updated recommendations available online at HIV/AIDS Treatment Information Service web site (www.aidsinfo.nih.gov)
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Guidelines for Antiretroviral Drugs During Pregnancy
Use optimal ARV for the woman’s health Add ZDV regimen for reducing perinatal HIV
transmission Discuss preventable risk factors for perinatal
transmission Counsel on cesarean delivery Support decision-making by woman following
discussion of known and unknown benefits and risks Acceptance or refusal of ARV or ZDV should not
result in denial of care or punitive action
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Recommend: Standard combination therapy for women with high viral
load, low CD4 countCombination therapy for women with viral load 1,000
regardless of clinical or immunologic status 3-part ZDV regimen to reduce perinatal transmission
for all HIV-infected pregnant women, regardless of antenatal VL
Consider delaying therapy until completion of first trimester
Offer scheduled cesarean delivery for women with viral loads >1000 (based on most recent VL results)
Clinical Scenario 1: Women without prior antiretroviral therapy
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Clinical Scenario 2: Women currently on antiretroviral therapy
Discuss benefits and potential risks of her current regimen during pregnancy
Add or substitute ZDV at 14 weeks Recommend intrapartum and neonatal ZDV Discontinue teratogenic drugs Consider continuing or stopping current therapy
based on gestational age (<14 weeks) If therapy is stopped, stop and restart all ARV
simultaneously Resistance testing for suboptimal viral suppression
or failure
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Clinical Scenario 3: Women with HIV infection who present in labor with no
previous treatment Discuss benefits of treatment during intrapartum and
neonatal period Four treatment options
Intrapartum IV ZDV followed by six weeks ZDV for the newborn
Oral ZDV/3TC for mother during labor followed by one week oral ZDV/3TC to the newborn
Single dose nevirapine for mother at onset of labor followed by single dose of nevirapine for the newborn at age 48–72 hrs
The two-dose nevirapine regimen as above combined with intrapartum IV ZDV and six week ZDV for the newborn
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Cesarean Section to Reduce Perinatal HIV Transmission
Scheduled C/S offers potential benefit to reduce perinatal transmission for women with VL 1000
Unknown whether scheduled C/S offers any benefit to women on HAART with low or undetectable VL given the low transmission rate
Complications of C/S similar to HIV uninfected women
Patient’s decision should be respected and honored
No known benefit of C/S if labor has begun
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Counseling During Labor
Not a great time but it is possible!
Other opportunities: ER visits for false labor, antenatal admissions, premature labor
Materials for patient education/informed consent
Policy and procedure in place with a counseling “script” for providers
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Which pregnant women will need rapid HIV testing in labor?
Women with no or limited prenatal care
Women who were not offered testing
Women whose results are unavailable
Women who declined testing previously
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Formula for HIV Counseling and Testing in Labor*
Confidentiality
Comfort
Consent
Reasons to test
Results
Rx to decrease risk
R3C3
* Concept developed by Carolyn Burr and Elaine Gross, FXB Center
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Confidentiality
Who is in the room with the patient? How can you assure confidentiality
during History taking Giving test results Giving medication for treatment?
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HIV Counseling and Testing During Labor: Case Studies
Lucy is admitted with contractions 7 minutes apart. She is 17, scared and asking to be given something to stop the pain. This is her first baby. Her parents are with her. She recently moved back home, and had only one visit with her present OB. You don’t have a prenatal chart for Lucy.
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HIV Counseling and Testing During Labor: Case Studies
Ms. R is admitted from the ER fully dilated and pushing. This is her third baby and, according to her chart, she had two prenatal visits for care. Her history leads you to believe she is at risk for HIV.
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Informed Consent Who is responsible for obtaining informed consent? How much information is “informed?”
HIV is the virus that causes AIDS A woman could be at risk for HIV and not know it Effective interventions can protect the infant from
HIV and improve mother’s health HIV testing is recommended for all pregnant women Services are available to help women reduce their
HIV risk and provide medical care to women with HIV Women who decline testing won’t be denied care
Centers for Disease Control & Prevention, Nov. 2001
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HIV Counseling and Testing During Labor: Case Studies
Ms. G. has just been admitted to L&D. No HIV test results are on her chart. A partner/ husband and her mother are with her. The family only speaks a little English.
You need to take an admission history including asking about HIV testing in labor.
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HIV Counseling and Testing During Labor: Case Studies
Ms. B. was just admitted in active labor. She has no record of prenatal care and no information about her HIV status. She “might have had an HIV test” in the past but isn’t sure if it was during this pregnancy.
This is the OB resident’s first week.
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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
A pregnant woman with HIV has a 1 in 4 chance of passing HIV to her baby if she is not treated
If a woman with HIV takes antiretroviral medicine during labor and delivery and her baby takes the medicine after birth, only 1 in 10 babies will get HIV
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HIV Counseling and Testing During Labor: Case Studies
You begin to explain toMs. Q that her prenatal record does not indicate that she has had an HIV test during this pregnancy and that it is recommended for every pregnant woman. Ms. Q becomes angry and says “What kind of woman do you think I am?”
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Giving Results of Rapid Testing in Labor
When and how should results be given? Post-test counseling for positive results
What does a preliminary positive test mean? What do you say?
Post-test counseling for negative results What treatment is available if the preliminary
test is positive Consent for prophylactic treatment based on
preliminary test results
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Results of a Rapid Test During Labor
The results of Ms. L’s rapid HIV test are positive. Her labor is progressing and she is at 7 cm. Her family is in the room with her. The L & D nurse accompanies the Obstetrician to the room to tell Ms. L the results. When the doctor leaves, Ms. L asks for clarification of what she’s been told.
What are the issues? What do you tell her?
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HIV Counseling and Testing During Labor: Case Studies
Ms. M was not offered an HIV test during her prenatal care. She consented to have a rapid test during labor. The result of the test is negative. She asks the nurse if she can be certain that she doesn’t have HIV.
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The Postpartum Woman with a Negative HIV Test
Counseling regarding risk reduction
Assessment of on-going risk
Referral for intensive counseling if high risk
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Rx: Treatment to Reduce Perinatal HIV Transmission
Antiretroviral treatment to mother during labor and delivery and to the baby after birth decrease the risk of transmission to 1 in 10
National guidelines offer 4 choices of treatment
Woman with a preliminary positive HIV test should delay breastfeeding until the results of the confirmatory test are known
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HIV Counseling and Testing During Labor Case Studies
Ms. P is in early labor. She refused testing during prenatal care. After consenting to the test, the preliminary result is positive. The physician and nurse explain to her the treatment options they recommend and the follow-up that will occur.
What are the treatment options for Ms P — for her baby?
What follow-up should be done?
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Clinical Scenario 4: Infant whose mother did not receive prenatal or
intrapartum ZDV
Offer the six-week neonatal ZDV component
Initiate therapy as soon as possible after maternal consent (preferably within 6 – 12 hours of birth)
Begin diagnostic testing of the infant
Refer to pediatric HIV specialist for long-term care
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Rapid HIV-1 Antibody Tests
OraQuick One step test that uses whole blood (finger stick) Can be done in the laboratory or at the point of care Very high sensitivity (99.6%) and specificity (100%)
Reveal Multi-step process that uses serum or plasma High sensitivity (98.6), specificity (99.1%) in plasma
Rapid tests should be confirmed with WB
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Labor & Delivery Versus the Laboratory: Where to
Do Rapid Testing
Factors to consider: Logistics in the L & D unit
Availability of trained staff
Training and continuing supervision
Lab – can it consistently give STAT results (in <60 minutes), 24 hours a day?
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Point of Care Testing
Requirements Quality control Clear concise procedures Training and education of personnel Verification of personnel competence Proper performance of quality control
procedures Record keeping