CDC Recommends Routine HIV Testing for U.S. Residents Ages 13 to 64, Dropping Written Consent, Pretest Counseling RequirementsCDC on Thursday released revised recommendations on HIV testing in the U.S. that say HIV tests should become a routine part of medical care for residents ages 13 to 64 and requirements for written consent and pretest counseling be dropped, the Washington Post reports (Brown, Washington Post, 9/22). CDC estimates that about 25% of HIV-positive people in the U.S. do not know their status. Many physicians believe that routine testing could lead to an earlier diagnosis and earlier treatment (Kaiser Daily HIV/AIDS Report, 5/8). According to an agency release, the recommendations, published in the Sept. 22 edition of CDC's Morbidity and Mortality Weekly Report, were designed to "simplify the HIV testing process" and "overcome several barriers that hindered implementation" of the agency's previous guidelines -- released in 1993 -- calling for tests to be given to "high-risk individuals" and to all patients "in health care settings" with HIV prevalence of more than 1% (CDC release, 9/21). According to the revised guidelines, health care providers should continue routine HIV testing unless they establish that less than one of every 1,000 patients tested is HIV-positive, "at which point such screening is no longer warranted" (Branson et al., MMWR, 9/22). States can choose to adopt and modify the guidelines, the New York Times reports (McNeil, New York Times, 9/22). CDC has been working on the revised guidelines for about three years, receiving feedback from more than 100 groups, including HIV/AIDS patient advocacy groups and physician associations (Stobbe, AP/Forbes, 9/21). According to the Los Angeles Times, the recommendations "carry no legal force," but now insurance companies are more likely to cover the cost of the tests (Maugh, Los Angeles Times, 9/21). If health care providers follow the guidelines, the number of HIV-positive people who are unaware of their status might be reduced by two-thirds, the Post reports (Washington Post, 9/22). Lawrence Gostin, associate dean at the Georgetown University Law Center, said that a physician might incur legal issues if he or she does not at least tell a patient about the value of HIV testing and that patient has contracted HIV (Hendrick, Atlanta Journal-Constitution, 9/22). CDC in the release said it will issue additional guidelines for physicians by early next year and provide "model approaches and practical tools" for implementing HIV testing (CDC release, 9/21).
Consent and Counseling Recommendations
Under current testing regulations, many states require individuals to participate in a 20-minute counseling session before obtaining an HIV test. In addition, people in some states must sign a separate informed-consent form, which details the risks and benefits of the test (Kaiser Daily HIV/AIDS Report, 5/8). The revised CDC guidelines say providers do not have to require patients to sign written consent forms or undergo counseling before receiving an HIV test, but physicians must allow patients to opt out of the test, USA Today reports (Sternberg, USA Today, 9/22). "[P]atients should be informed orally or in writing that HIV testing will be performed unless they decline," the recommendations say, adding, "Information should include an explanation of HIV infection and the meanings of positive and negative test results, and the patient should be offered an opportunity to ask questions and to decline testing." The recommendations also say that it is "essential" that physicians make "[a]ctive efforts ... to ensure that HIV-infected patients receive their positive test results and linkage to clinical care, counseling, support and prevention services" (Washington Post, 9/22). In addition, the agency "continues to encourage prevention counseling for all patients where feasible" and "intensive HIV prevention counseling for high-risk populations will remain a vital component of community-based HIV prevention interventions" (CDC fact sheet, 9/21).
Testing Pregnant Women
The guidelines say that all pregnant women should be tested for the virus unless they opt out and that women who inject drugs, are commercial sex workers or who live in a higher prevalence region should be tested again in the third trimester of pregnancy, the New York Times reports (New York Times, 9/22). The guidelines also recommend that women in labor whose HIV status is unknown should be administered a rapid HIV test, and if a test cannot be administered before delivery, both the woman and the infant should immediately be given a rapid test postpartum (CDC fact sheet, 9/21). According to the Houston Chronicle, the recommendations for expanded testing of pregnant women aim to reduce the number of mother-to-child HIV transmissions in the U.S. There were 240 cases of vertical HIV transmission in 2005, the Chronicle reports (Hopper, Houston Chronicle, 9/22).
"We urgently need new approaches to reach the quarter-million Americans with HIV who do not realize they are infected," CDC Director Julie Gerberding, said, adding, "People with HIV have a right to know that they are infected so they can seek treatment and take steps to protect themselves and their partners" (Atlanta Journal-Constitution, 9/22). The American Medical Association said it supports the changes, and many physicians are expected to endorse the recommendations. "These recommendations are important for early diagnosis and to reduce the stigma still associated with HIV testing," Nancy Nielsen, an AMA board member, said (New York Times, 9/22). Sen. Tom Coburn (R-Okla.) added that the recommendations will "greatly enhance our ability to control the spread of this disease and improve the lives of those living with it" (AIDS Healthcare Foundation release, 9/21). More than 12 HIV/AIDS advocacy groups released a statement critical of the recommendation to remove the requirement for pretest counseling. "We fear that some health care settings will interpret today's announcement as a call for universal screening and test patients without informing them or arming them with the information they need to avoid putting others at risk," David Munar, associate director of AIDS Foundation Chicago, said. Peter Staley, founder of ACT UP, said that while "abandoning written informed consent raises issues" such as privacy and stigma, he supports the recommendations because "the bottom line is that this would probably save lives" (USA Today, 9/22). AIDS Project Los Angeles in a release said that while it supports the new guidelines, the group is unsure about who will pay for increased testing costs and whether it will deplete "already inadequate HIV/AIDS funding." APLA Executive Director Craig Thompson said, "This mandate would require at least an additional $6 billion, yet the federal government has cut domestic funding for care, treatment and services over the past five years," adding, "Conducting millions of HIV tests without appropriating the money for follow-up care is an empty promise" (APLA release, 9/21). Timothy Mastro, acting director of CDC's Division of HIV/AIDS Prevention, said that while there is not a "direct link" between the recommendations and coverage of the test costs, "[w]e think this will contribute to insurers and Medicare, Medicaid covering it, but it's not an automatic" (Atlanta Journal Constitution, 9/22). "It's all in the implementation," Munar said, adding, "I am concerned that in some settings that patients will be shortchanged" (Washington Post, 9/22).
NBC's "Nightly News" on Thursday reported on CDC's recommendations. The segment includes comments from Thomas Frieden, New York City health commissioner, and Greg Payne, director of the Washington, D.C., Department of Health (Bazell, "Nightly News," NBC, 9/21). The complete segment is available online in Windows Media. In addition, NPR's "All Things Considered" on Thursday reported on the recommendations. The segment includes comments from Brandon Armani, an administrator with Unity Health Care; Jean McGuire, former assistant commissioner of the Massachusetts Department of Public Health; Mastro; and U.S. residents (Shapiro, "All Things Considered," NPR, 9/21). The complete segment is available online in RealPlayer.