Medical Device Daily

The Centers for Disease Control and Prevention (CDC; Atlanta) late last week rolled out its revised recommendations for HIV testing in healthcare settings, calling for healthcare providers to make voluntary HIV screening a routine part of medical care for all patients aged 13 to 64.

The recommendations replace CDC's 1993 recommendations on testing in acute-care hospitals and update the portions of CDC's 2001 recommendations on HIV counseling, testing and referral that apply to healthcare settings. The new recommendations do not apply to non-clinical settings such as community centers or outreach programs.

CDC Director Julie Gerberding, MD, said in a teleconference Thursday that HIV has become a “pandemic,” and the new recommendations represents “a milestone for CDC and national health protection.”

“We urgently need new approaches to reach the quarter-million Americans with HIV who do not realize they are infected,” Gerberding said. “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.”

The recommendations call for simplified procedures, including eliminating the need for prevention counseling before being tested for HIV. According to the CDC, requiring this type of counseling, particularly in settings such as emergency rooms, has proven to be a barrier for broader testing.

The new recommendations call for HIV testing to be conducted much like any other blood test, although once informed that HIV testing would be included, patients have the choice of refusing it.

The report on the recommendations states that the declines in HIV seen in the early 1990s have not only leveled off, but “might even have reversed in certain populations in recent years.”

The CDC said that since 1998, the estimated number of new infections has “remained stable” at about 40,000 per year. As of December 2004, the CDC report says nearly 1 million people have been diagnosed with AIDS and, of those, 56% have died.

Since 1994, the report says, the annual number of cases among “blacks, members of other racial/ethnic minority populations and persons exposed through heterosexual contact has increased.”

Gerberding said people who don't know their HIV status account for “between 50% and 70% of all new sexually transmitted infections in the U.S.”

The CDC's director of the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Kevin Fenton, MD, who also spoke during the teleconference, called AIDS “one of today's most urgent public health challenges.”

Gerberding said that HIV infection is “increasingly characterized by health disparities, both internationally and domestically,” but that it also is a disease for which both treatments with drug therapies and diagnostic methods have increased and improved. And those advances have brought the U.S. to “a point in our country where there are some things that never should happen.”

She added: “No child in the United States should be HIV infected from birth. No person in the United States should not have access to treatment or diagnosis. And ultimately, no person in the U.S. should acquire HIV infection. In other words, we ought to be able to eliminate HIV transmission in the future.”

Further strengthening the reasoning for early diagnosis is that today almost 40% of “those diagnosed with HIV are diagnosed within one year of developing their AIDS diagnosis,” she said.

The changes in the recommendations actually began in 2003, when the CDC issued interim guidance for state and local efforts to develop programs for routine testing and implemented “several demonstration projects to evaluate potential approaches for expanding HIV screening,” the report states.

Timothy Mastro, MD, acting director of the Division of HIV/AIDS Prevention, said during the teleconference that in 2004 and 2005 the CDC convened three events to allow for consultations with healthcare providers, public health experts, community-based organizations and advocates to ask for their input.

Mastro said that “studies have shown that when HIV testing is presented as routine, more patients accept testing and learn their HIV infection status.”

The recommendations want to make it routine for all patients in the 13 to 64-year-old age group to get testing, and research conducted by the CDC suggests that two-thirds of Americans, according to Mastro, “agree that separate procedures for HIV testing are unnecessary.”

Asked if he expected any resistance from the public from such recommendations for routine HIV testing, Bernard Branson, MD, associate director of laboratory diagnostics at the CDC and a co-author of the policy recommendations, told Medical Device Daily that research suggests that the public is likely to be accepting of the new testing recommendations.

He said, however, that he could not predict if there will be resistance from physicians to implement the policy, noting however that physician groups have come out in support of the recommended policy.

For example, the American Medical Association (AMA; Chicago) issued a statement Thursday from board member Nancy Nielsen, MD, voicing AMA support for the policy.

“The recommendations released today by the CDC to make HIV screening a routine part of medical care will greatly help in the diagnosis of HIV infection,” Nielsen said. “These recommendations are important for early diagnosis and to reduce the stigma still associated with HIV testing. This is an important public health strategy to stop the spread of HIV.”

Nielsen went on to say that the AMA would be working with the CDC and other organizations “to devise tools and offer guidance to enable physicians” to work to control new infections.

On the other side of the fence, the American Civil Liberties Union (ACLU; New York) said it was “concerned” that the rights of those newly diagnosed with HIV may be harmed under the new recommendations.

“The CDC should be commended for trying to increase the number of people tested for HIV, but eliminating the only safeguards that guarantee that testing is voluntary and informed does little to ensure that people will receive the care they need,” said Rose Saxe, a staff attorney with the ACLU AIDS Project.

Saxe went on to note that “receiving an HIV diagnosis is a significant life-changing event. In addition to having to learn to live with a life-threatening disease, people with HIV deal with the continuing stigma that comes from having HIV.”

The ACLU said the recommendations also “raise serious privacy concerns,” because according to that organization, “many states also require doctors to report private information, such as drug use and sexual history about those who test positive.”

OraSure Technologies (Bethlehem, Pennsylvania), maker of the OraQuick Advance Rapid HIV-1/2 Antibody Test, not surprisingly issued a statement of support for the CDC's policy.

“We believe the implementation of routine testing in healthcare settings is an important step toward stopping the spread of HIV in America. We applaud the CDC for issuing this clear call to action, which will reduce barriers in both the public and private sector to HIV testing as a regular part of medical care,” said Douglas Michels, president/CEO of OraSure.

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