New HIV testing guidelines meet with praise, criticism
Opponents say it violates privacy
Major revisions to the Centers for Disease Control and Prevention (CDC) guidelines for HIV screening are either a boon to the task of identifying the 250,000 Americans who carry the virus but don't know it or a blow to patient autonomy and privacy.
The CDC in September issued a new recommendation for across-the-board HIV testing for anyone age 13 to 64 as part of regular medical care. It removes requirements for written consent in states where consent is now mandatory and eliminates the requirement for pre-test counseling.
"These recommendations come at a time when approximately 25% of the more than 1 million persons infected with HIV in this country are unaware of their infection," CDC Director Julie Gerberding, MD, stated in announcing the revised guidelines. "People who are infected but not aware of their condition are unable to take advantage of the therapies that can keep them healthy and extend their lives, or have the knowledge to protect their sex or drug-use partners from becoming infected. Knowing if one is HIV-infected or HIV-negative confers great benefits in healthy decision making."
Kevin Fenton, MD, director of the CDC's National Center for HIV, STD, and TB Prevention, says the new guidelines go a step further.
"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," Fenton suggests.
But a coalition of HIV and health care interests has issued objections to the new guidelines.
"An expanded focus on testing without counseling and written, informed consent will put people at risk for testing without their prior knowledge or approval," states an open letter issued by the coalition, which includes 33 AIDS–related groups, gay activists, and civil liberties organizations. The new guidelines, the coalition says, are "a clear violation of medical ethics and human rights."
The coalition's letter expresses support for expanded testing, but strongly urges that counseling and written consent prior to testing be kept intact.
Revisions broaden testing, but keep it voluntary
The guideline changes are the result of study and debate over the last three years and apply only to health care settings. They do not apply to outreach programs or community centers.
The major features of the recommendations include:
- screening of all patients for HIV regardless of risk;
- screening of high-risk persons at least once a year;
- retention of a voluntary "opt-out" option for anyone who objects to being tested;
- elimination of special consent; general medical consent will be considered sufficient to cover consent for HIV screening;
- HIV screening should be included in routine prenatal screening tests for all pregnant women, with repeat testing in the third trimester for women in certain areas where rates of HIV infection among pregnant women are high;
- pre-test counseling and post-results counseling are not recommended, but not required.
The guidelines ask that everyone age 13 to 64 be tested at least once. The government estimates that one-quarter of people in the United States with HIV, about 250,000, do not know they are infected and so do not seek treatment or ensure that they engage in safer-sex practices.
While many health care organizations, including the American Medical Association (AMA), have indicated support for the guideline changes as a prevention tool and means of eliminating some of the stigma associated with HIV testing, other groups are concerned by the change.
"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," says Rose Saxe, JD, a staff attorney with the American Civil Liberties Union (ACLU) AIDS Project. "Studies have shown that patients who are tested without consent are less likely to get the follow-up care that is critical to maintaining good health."
The ACLU further cautions that the change could lead to people being tested without their consent, especially in urgent care or emergency department settings. The ACLU is one of the groups that opposes not requiring pre- and post-screen counseling.
"Receiving an HIV diagnosis is a significant, life-changing event," Saxe says. "In addition to having to learn to live with a life-threatening disease, people with HIV deal with the continuing stigma that comes with having HIV. 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."
The previous HIV testing guidelines had been issued in 1993, before HAART (highly active antiretroviral therapy) altered the treatment and course of disease in HIV patients. According to the CDC, by prolonging lives and preserving health in HIV-infected people, HAART has helped eliminate some of the stigma associated with infection.
Another feature that influences stigma is opt-out vs. opt-in screening, the CDC guidelines explain. Opt-out screening means performing an HIV test after notifying the patient that the test will be performed and that the patient may elect to decline or defer testing. Opt-in screening means testing is offered and the patient is required to actively give permission for testing.
Areas that have opt-out testing policies for pregnant women and for recipients of treatment for sexually transmitted diseases have higher HIV testing rates than those that use opt-in policies or those that require specific counseling for testing.
Patients prefer when testing is routine and offered to everyone rather than being singled out for testing because they are perceived to be "at-risk," Gerberding stated in her announcement, and the CDC thinks the opt-out approach will make testing more routine.
Applying guidelines to your patients
Though the CDC recommends its guidelines for all health care settings, state laws on informed consent and pre-screening counseling vary from state to state. Some states do not allow opt-out screening, or may have other requirements that conflict with the CDC guidelines.
"Where policies exist that are in conflict with the new recommendations, jurisdictions should examine strategies to best implement these recommendations within current parameters, and initiate steps to resolve conflicts with these recommendations," Fenton advises.
AMA board member Nancy Nielsen, spokeswoman for the AMA on the new guidelines, says the association is asking states to re-examine their legislation "to allow physicians to carry out the new CDC recommendations."
"The AMA will work with the CDC and other organizations to devise tools and offer guidance to enable physicians to move toward the control of HIV infection in the U.S. [and] urges physicians to begin implementing the recommendations as soon as possible," Nielsen says.
The new CDC guidelines do not change recommendations for testing and post-exposure prophylaxis for occupational exposures. Unless recent HIV test results are immediately available, any person whose blood or body fluid is the source of an occupational exposure for a health care provider should be informed of the incident and tested for HIV infection at the time the exposure occurs, the CDC advises.
If a patient a physician believes is at high risk for infection declines HIV testing, the provider should attempt to identify and discuss the patient's reasons for declining the test — lack of perceived risk; fear of disease; concerns about partner violence, stigma, etc. If the patient still ultimately decides against testing, the physician should encourage him or her to consider being tested at a later date; the patient's decision should be respected and documented in the medical file.
The full report of the CDC's recommended HIV guidelines is available at www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.
Major revisions to the Centers for Disease Control and Prevention (CDC) guidelines for HIV screening are either a boon to the task of identifying the 250,000 Americans who carry the virus but don't know it or a blow to patient autonomy and privacy.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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