00-27870. Draft Guidelines for Revised U.S. Public Health Service Recommendations for Human Immunodeficiency Virus (HIV) Screening of Pregnant Women

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice and Request for Comments.

SUMMARY:

This notice announces the availability for public comment of a document entitled “Revised U.S. Public Health Service Recommendations for Human Immunodeficiency Virus (HIV) Screening of Pregnant Women.”

DATES:

Comments must be submitted in writing on or before November 30, 2000. Comments should be submitted to the Technical Information and Communications Branch, Mailstop E-49, Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Atlanta, Georgia 30333; Fax: [phone]; E-mail: [e-mail].

FOR FURTHER INFORMATION CONTACT:

Requests for copies of the draft “Revised U.S. Public Health Service Recommendations for Human Immunodeficiency Virus (HIV) Screening of Pregnant Women” should be submitted to the CDC National Prevention Information Network, P.O. Box 6003, Rockville, Maryland 20849-6003; telephone [phone]; or copies can be downloaded from the Division of HIV/AIDS Prevention website at www.cdc.gov/​hiv.

SUPPLEMENTARY INFORMATION:

In 1994, the U.S. Public Health Service (USPHS) published guidelines for use of zidovudine (ZDV) to reduce perinatal HIV transmission. In 1995, the USPHS issued guidelines recommending universal counseling and voluntary HIV testing of all pregnant women and treatment for those found to be infected. Publication of these recommendations was followed by rapid implementation by health care providers, widespread acceptance of chemoprophylaxis by HIV-infected women, and a steep and sustained decline in perinatal HIV transmission. Observational studies have confirmed the effectiveness of ZDV in reducing the risk of perinatal transmission that has resulted in a greater than 75% decline in pediatric AIDS cases diagnosed in 1998. Despite this progress, children are still becoming infected, with 300-400 babies being born with HIV each year in the United States. Studies show that many women, especially those who use illicit drugs, are not being tested for HIV during pregnancy because of lack of prenatal care.

In 1998, the Institute of Medicine (IOM) completed a study to assess the impact of current approaches for reducing perinatal HIV transmission, identify barriers to further reductions, and determine ways to overcome these barriers. They concluded that continued transmission is mainly due to a lack of awareness of HIV status among some pregnant women and that HIV testing should be simplified and routinized. IOM recommended that testing should be offered to all pregnant women as part of the standard battery of prenatal tests, regardless of risk factors and the HIV prevalence rates in the community. They also recommended that women should be informed that the HIV test is being done and of their right to refuse to be tested.

To address these and other issues, the USPHS convened an expert consultation in April 1999 and sought widespread public comment in revising the 1995 guidelines for HIV counseling and testing for pregnant women. The resulting guidelines presented in the draft “Revised U.S. Public Health Service Recommendations for Human Immunodeficiency Virus (HIV) Screening of Pregnant Women” differ from the 1995 guidelines in the following ways: (1) Emphasize HIV testing as a routine part of prenatal care and strengthen the recommendation that all pregnant women be voluntarily tested for HIV; (2) recommend a simplification of the testing process so that previously required pretest counseling is not a barrier to the provision of testing; (3) make the consent process more flexible to allow for various types of informed consent; (4) recommend that providers explore and address reasons for refusal of testing; and (5) place more emphasis on HIV testing and treatment at the time of delivery for women who have not received prenatal testing and chemoprophylaxis.

Dated: October 25, 2000.

Joseph R. Carter,

Associate Director for Management and Operations, Centers for Disease Control and Prevention.