April 2003

Current Knowledge

Since the first pediatric case of HIV infection was documented in 1984, tremendous medical and public health achievements have been made in preventing mother-to-child transmission of HIV. A key step toward ensuring that the perinatal HIV interventions offered are effective is to make sure that care providers know the HIV status of the pregnant women in their care. When a woman is identified as HIV infected during pregnancy, antiretroviral and obstetrical interventions can reduce the risk of having an infected baby to <2%. When preventive anti-retroviral treatment is not initiated until labor or birth of the newborn, the risk of for transmission is 9% to 13%.^1-3 Without intervention, the risk for transmission is approximately 25% in the United States.⁴

Maximal reduction of perinatal HIV transmission in the United States depends on ensuring

• Pregnant women receive prenatal care
• Routine HIV screening of all pregnant women
• Recommended antiretroviral regimens are used during the prenatal, intrapartum and postpartum periods for HIV-infected women and their infants, as well as obstetrical interventions for women during labor and delivery
• Routine screening of women during labor and delivery or of the newborn when the mother’s HIV status has not been determined previously⁵

Approximately 6,000 to 7,000 HIV-infected women gave birth in the United States in 2000, resulting in an estimated 280 to 370 HIV-infected infants. In about 40% of the perinatal transmissions, health care providers were unaware of the mother’s HIV status before delivery. Additionally, in the November 15, 2002, issue of the Morbidity and Mortality Weekly Report, CDC published information on the most recently available prenatal HIV testing rates for the United States and Canada.6 The report includes a comparison of the HIV prenatal testing rates associated with different testing approaches. In opt-out, pregnant women are notified that an HIV test will be included in the standard battery of prenatal tests and procedures and that they may decline testing. In the more commonly used opt-in approach, pregnant women are given pretest counseling and must specifically consent, usually in writing, to an HIV test.

Among states using the opt-in approach and in which data were collected from medical records during 1998-1999, testing rates ranged from 25% to 69%. Population-based data from Canada showed testing rates in three opt-in provinces of 54% to 83%. In contrast, medical record data from Tennessee, which uses the opt-out approach, revealed a testing rate of 85%. Data from Canadian provinces using opt-out approaches showed a 98% testing rate in Alberta and a 94% testing rate in Newfoundland and Labrador. At the University of Alabama’s 8 prenatal clinics, HIV testing rates rose from 75% to 88% after the opt-out approach was implemented.⁷

In an April 22, 2003 Dear Colleague letter to health departments, community-based organizations, and health care providers, CDC recommended that clinicians routinely screen all pregnant women for HIV infection, using an opt-out approach, and that jurisdictions with statutory barriers to such routine prenatal screening consider revising them.8 For women whose HIV status is unknown when labor begins, CDC recommended routine rapid testing.9 CDC also encouraged clinicians to test any newborn for HIV whose mother’s HIV status is unknown.

Objectives
The purpose of this document is to provide guidance for state health departments to achieve

• Universal routine prenatal HIV testing in order to minimize perinatal HIV transmission in the United States
• Routine rapid HIV testing during labor and delivery for women whose HIV status is still unknown
• Rapid HIV testing post partum for women of unknown HIV status or their neonates, when rapid testing at labor and delivery is not possible or has been previously declined
• Appropriate antiretroviral treatment and comprehensive follow-up care for HIV-infected pregnant women and their infants

Procedures

During prenatal care

1. Health departments in collaboration with the AIDS Education and Training Centers (AETC) of the Health Resources and Services Administration’s (HRSA), medical organizations, and other partners, should facilitate the training of prenatal care providers in use of the opt-out approach, including documenting in a woman’s medical chart her HIV test results or that she declined testing.
2. Training should include the following key elements of the opt-out approach:
   1. At the first prenatal visit, women should be given information, which can be written (such as a brochure or pamphlet) or shown in a video, about perinatal HIV transmission, testing, and prevention.
   2. Women should be told that HIV testing will be included in the standard battery of prenatal tests and procedures. This information may be included in a consent form that women sign for all prenatal care and services. Specific procedures regarding consent will depend on state and local laws, regulations, and policies.
   3. Women should be told that they have the right to decline testing.
   4. HIV test results or the refusal to be tested should be documented in the woman’s medical chart.
3. Health departments should distribute materials, which are being or have been developed by the American College of Obstetricians and Gynecologists (ACOG), including a fact sheet on HIV testing for providers, an information sheet for women on HIV and other prenatal tests, and forms for documenting HIV test results or decline of testing.
4. Health departments should encourage prenatal care providers who work in areas of high HIV prevalence to rescreen women for HIV during the third trimester.
5. For pregnant women who test positive for HIV, health departments should facilitate access to appropriate obstetric, medical, and social services for prevention, care, and treatment.

During labor and delivery

Health departments should work with AETCs, medical organizations and other partners to provide training to hospital staffs on procedures for offering rapid testing during labor and delivery to pregnant women whose HIV status is unknown. Training should emphasize the need to document test results or refusals. The following are additional key points:

1. Women in labor whose HIV status is unknown should be informed that rapid HIV testing will be done routinely to help protect her baby’s health unless she declines testing.
2. Women should be informed that a negative rapid test result means that she is not HIV infected; a preliminary positive rapid test result means that she probably is HIV infected.
3. If a woman tests positive, she should be informed that medicines can be given to her during labor and to her newborn based on the preliminary test result to reduce the chance that the baby will become HIV infected.
4. Confirmatory testing will need to be done if she has a positive rapid HIV test result.

After birth

Health departments should work with medical organizations and other partners to train hospital staff to screen the mother or the infant or both with a rapid HIV test as soon as possible if the mother’s HIV status remains unknown. Some states mandate newborn screening in this circumstance.

Working with Partners and Integration into Existing Services

1. State AIDS directors should arrange training in the opt-out approach and in rapid testing with

• State and local medical organizations
• Maternal and child health (MCH) programs
• AIDS Education and Training Centers
• Hospitals offering obstetrical services
• Other venues such as family planning clinics and drug treatment centers serving pregnant women.

They should ensure that training is provided in prenatal clinics funded by MCH programs.

2. Working with ACOG and other partners, CDC has developed a model protocol for implementing rapid HIV testing in labor and delivery settings. The protocol should be disseminated to providers of obstetric services.

Programmatic Considerations

1. Implementing the opt-out approach into HIV screening of pregnant women may require changes in state laws to streamline pretest counseling and consent requirements and documentation of test results or decline of testing.
2. State health departments should provide information about the expected public health benefits of the opt-out approach to local representatives of national health care provider organizations, community groups that focus on maternal and child health issues, and state and local government officials.

Vignette

In 1995, the state of Texas passed a law to permit the opt-out approach to prenatal HIV testing. Prenatal care providers in Texas distribute to pregnant women brochures obtained from the state health department describing prenatal tests, including those for HIV. Most providers obtain a general written consent for the standard battery of prenatal tests, which includes a test for HIV. Refusal of the HIV test must be documented in the medical record.

Monitoring Implementation

CDC grantees receiving HIV prevention funds will be required to routinely report the following indicators to monitor their HIV testing of pregnant women.

CDC’s HIV Prevention Program Performance Indicators*:

1. Proportion of women who receive an HIV test during pregnancy (D.1)
2. Proportion of HIV-infected pregnant women who receive appropriate interventions to prevent perinatal transmission (D.2)
3. Proportion of HIV-infected pregnant women whose infants are perinatally infected (D.3)

Other program measures:

4. Statewide perinatal testing rates, possibly using PRAMS data (see Resources for the PRAMS website)
5. Hospital specific perinatal testing rates
6. States with low prevalence of HIV among women of childbearing age or who have low cumulative numbers of perinatal HIV infection, and who adopt the chart review method to obtain this indicator, may choose to sample only among hospital(s) with the largest proportion of deliveries in the state
7. Description of state laws related to perinatal HIV testing, including prenatal HIV testing and documentation, testing at labor and delivery, testing of the newborn and the use of rapid HIV testing.
8. Description of state efforts to monitor perinatal HIV testing rates.
9. Description of state efforts to promote routine prenatal HIV testing, including, for example:
   1. Number and location of provider trainings.
   2. Number and occupation of participants attending provider trainings
   3. Topics covered during training (e.g., the number, type, and destination of materials distributed)

* The CDC Technical Assistance Guidelines for Health Department HIV Prevention Program Performance Indicators provides information on setting baseline, target, and indicator specification including appropriate data sources, calculations and reporting issues. Note: Performance indicators may have been modified to reflect specific population or setting characteristics.

References

1. Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission: A randomized trial. JAMA 2002;288:189-198.
2. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 1999;354:795--802.
3. Wade NA, Birkhead GS, Warren BL et al. Abbreviated regimen of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med 1998;339:1409-1414.
4. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med 1994; 331:1173-1180.
5. Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV screening of pregnant women. MMWR 2001; 50 (RR 19: 50-86).
6. CDC. HIV testing among pregnant women – United States and Canada, 1998-2001. MMWR 2003;51:1013-1016.
7. Stringer EM, Stringer JS, Cliver SP, Goldenberg RL, Goepfert AR. Evaluation of a new testing policy for human immunodeficiency virus to improve screening rates. Obstetrics & Gynecology 2001;98(6):1104-1108.
8. CDC. Dear Colleague letter. April 22, 2003.
9. Cohen M et al., Rapid point-of-care testing for HIV-1 in labor and delivery: Chicago, 2002. In preparation for MMWR.

Resources

ACOG

AIDS Education and Training Centers

CDC perinatal HIV prevention website

PRAMS website

Rapid testing

CDC. Technical Assistance Guidelines for CDC’s HIV Prevention Program Performance Indicators.