HIV Counseling and Rapid Testing in Labor

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

11/033

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

11/034

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

11/035

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

11/036

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.

11/037

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

11/038

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

11/039

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.

11/0310

(Add local laws/regulations)

11/0311

“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

11/0312

“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

11/0313

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

11/0314

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

What We Know About Perinatal HIV Transmission

11/0316

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

11/0317

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

11/0318

Breastfeeding and HIV Infection

Women with HIV infection in the U.S. should not breastfeed

Women considering breastfeeding should know their HIV status

11/0319

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

11/0320

Influences on Perinatal Transmission: Obstetric and Infant Factors

Obstetrical Factors Length of ruptured membranes/

chorioamnionitis Vaginal delivery Invasive procedures

Infant Factors Prematurity

11/0321

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

What have we learned?

Interrupting Perinatal HIV Transmission: Study Results

11/0323

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

11/0324

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

11/0325

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

11/0326

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

11/0327

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

11/0328

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

Treating Women with HIV Infection in Pregnancy

11/0330

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

11/0331

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)

11/0332

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

11/0333

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

11/0334

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

11/0335

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

11/0336

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

The Woman who Presents in Labor with Unknown

HIV Status

11/0338

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

11/0339

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

11/0340

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

11/0341

Confidentiality

Who is in the room with the patient? How can you assure confidentiality

during History taking Giving test results Giving medication for treatment?

11/0342

Comfort

What is her level of discomfort?

How is her pain being managed?

Is she anxious?

11/0343

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.

11/0344

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.

11/0345

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

11/0346

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.

11/0347

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.

11/0348

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

11/0349

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?”

11/0350

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

11/0351

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?

11/0352

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.

11/0353

The Postpartum Woman with a Negative HIV Test

Counseling regarding risk reduction

Assessment of on-going risk

Referral for intensive counseling if high risk

11/0354

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

11/0355

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?

11/0356

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

11/0357

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

11/0358

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?

11/0359

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

11/0360

Resources and Follow-up for the Family

Add your local resources