Bay Area Reporter - September 28, 2006
Bob Roehr

The changes have been under discussion for more than three years. They apply only to health care settings (including public health and community clinics) not to non-clinical outreach programs or community centers.

Major components of the recommendations are to screen all patients for HIV, regardless of risk; retention of a voluntary "opt-out" option for those who object to being tested; the elimination of special consent and its incorporation into general medical consent; and a recommendation - but not a requirement - for pre- and post-test counseling on HIV.

"Our goal is to ensure that everyone who receives medical care also has the opportunity to learn if they are infected with HIV," said Dr. Kevin Fenton, director of the CDC's National Center for HIV, STD, and TB Prevention. "Making the HIV test a normal part of care for all Americans is also an important step toward removing the stigma still associated with testing."

The previous guidelines had been issued in 1993, prior to the introduction of highly active antiretroviral therapy, which radically altered the treatment and course of disease of persons infected with HIV. Most people are living longer, healthier lives on therapy, and stigma and discrimination associated with the disease have declined markedly.

An estimated 250,000 Americans infected with HIV are not aware of their infection. The CDC's recommended changes aim to reduce the paperwork burden associated with obtaining special consent to conduct a test for HIV, which many physicians see as a barrier to increased testing.

The American Medical Association endorsed the new recommendations.

The American Academy of HIV Medicine also endorsed the new guidelines but expressed "concerns about successful linkages into medical care and prevention services for the newly diagnosed, patient privacy, informed consent, and funding to support both increased testing and care."

"Patients who get treatment while they're still healthy live longer than those who get it when they're already sick. Only those people who start with a CD4 count above 200 are gaining the full benefit" of the drugs, said Dr. Michael S. Saag, director of the HIV clinic at the University of Alabama at Birmingham.

Three-quarters of patients have less than 200 CD4 T-cells when they first appear at Saag's clinic. "The one exception is pregnant women; their median CD4 count is 400." That is because state law has long required that opt-out testing for HIV be offered to all pregnant women as part of standard medical care. The experience has made Saag a supporter of the guideline changes.

Reaction

Some community groups have embraced the changes. The National Association of People With AIDS supports increased voluntary testing for HIV, noting that people who elect testing appear to be more actively engaged in their own healthcare.

NAPWA offered guarded support for the new recommendations. But it also expressed concern that "expanded testing without corresponding increases in available HIV care and treatment services will mean that many people learn their HIV-positive status but have no way to obtain the healthcare and services that could save their lives."

San Francisco AIDS Foundation Executive Director Mark Cloutier said, "The current testing paradigm has failed to identify the 250,000 Americans who need to be in care for HIV infection from getting care." He added that many of the estimated 40,000 new HIV infections in the U.S. each year might be avoided if people learn their status.

But 16 organizations warn that the changes gut consent and counseling. They say CDC's "expanded focus on testing without counseling and written, informed consent will put people at risk for testing without their prior knowledge or approval - a clear violation of medical ethics and human rights."

Among those signing on to the statement are the AIDS Foundation of Chicago; amFAR, the Foundation for AIDS Research; the Gay Mens' Health Crisis; Housing Works; Lambda Legal Defense and Education Fund; and San Francisco-based Project Inform.

The American Civil Liberties Union criticized elimination of the requirements of pre-and post-test counseling, and obtaining written consent prior to administering the test as eliminating the only safeguards that guarantee that testing is voluntary.

"Receiving an HIV diagnosis is a significant life-changing event," said Rose Saxe, a staff attorney with the ACLU AIDS Project. "Without pre- and post-test counseling requirements, we risk losing a critical opportunity to educate people about HIV and how to prevent the spread of it."

Some organizations are considering whether there is a legal basis to challenge the recommendations in court.

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The CDC's revised recommendations are available at www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.

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