PEP may become easier with 'opt-out' testing

CDC wants more people to know their HIV status

HIV testing would become a routine part of health care under a proposed recommendation by the Centers for Disease Control and Prevention. If adopted by hospitals, that policy could indirectly benefit health care workers seeking post-exposure treatment after a needlestick incident by making HIV status more widely identified.

The first hours after a bloodborne pathogen exposure are a time of high anxiety for health care workers. The CDC recommends that health care workers exposed to HIV-positive blood or body fluids start post-exposure prophylaxis as soon as possible. But if the patient is unconscious or under anesthesia, it may be impossible to get prompt consent. Health care workers often begin taking the medications while the hospital seeks the patient's HIV status.

The CDC now is looking to standardize the process of HIV testing. Routine testing would eliminate the sense of stigma patients may feel when asked if they have any risk factors and whether they want to be tested for HIV, says Tim Maestro, MD, deputy director for science in the CDC's Division of HIV/AIDS Prevention.

"The goal of this is to provide better care for the people currently living with HIV and to reduce transmission," he says. "We think the best way to do that is for everybody to know their status."

The CDC estimates that about 25% of Americans who are HIV-infected, or 250,000 to 300,000 people, do not know their HIV status and are not receiving treatment. That includes young women who do not realize they're at risk and who are reluctant to report multiple sexual partners, says Maestro. "If you just make it a routine test, it's very well accepted."

The CDC proposal calls for every person ages 13-64 to receive at least one baseline HIV test. People with identified risk factors, such as those with multiple sexual partners, intravenous drug users, or men having sexual relations with men, should be tested at least annually, the CDC says.

Health care providers, including hospitals, could provide the testing as a routine part of blood tests, with an option for patients to "opt out" if they don't want to be tested. Testing has become even easier with rapid tests that can be conducted with oral swabs, Maestro notes. The opt-out proposal is under review.

Timing is everything

An opt-out policy presents different possible scenarios for health care workers facing post-exposure evaluation. It may be reassuring for health care workers to learn that the source patient involved in their needlestick was at low risk for HIV — and had previously tested negative. More HIV-positive patients would be identified and placed on treatment, which would make their status known as well.

But what about the patient who is at high risk for HIV but tested negative within the past year? "When are you going to be satisfied with a negative?" wonders Jim Garb, MD, director of occupational health and safety at Baystate Health System in Springfield, MA. "If it was done last month, that's great. If it was done a year ago, what were they doing since then? A lot might happen in a year."

In some cases, such as emergency department admissions, the patient's full medical record may not be available. If the patient was unable to consent to testing, then the health care worker still would need to begin prophylaxis while awaiting further information.

"In the event that there would still be exposures to patients whose status is unknown, it wouldn't change our recommendations," says Elise Beltrami, MD, MPH, a medical epidemiologist in the CDC's Division of Healthcare Quality Promotion.

In its 2001 guidelines on the management of occupational exposures, the CDC recommends testing source patients as soon as possible after an exposure, maintaining the confidentiality of the source patient, and following state and local laws regarding obtaining consent. All initial tests, including rapid tests, must be followed by a confirmatory test.1

If the source is unknown, the CDC offers advice about assessing risk and determining whether to start post-exposure prophylaxis. Sometimes, that risk is difficult or impossible to ascertain.

"The most common situation where it's an unknown exposure is when the source of the blood or needle is unknown," says Beltrami.

Some states require prior consent

Meanwhile, hospitals must work within state laws that vary widely related to the post-exposure testing of source patients. Many of them were drafted in the early 1990s when HIV/AIDS was imbued with stigma and controversy.

For example, Massachusetts has one of the stricter laws regarding HIV testing of source patients, requiring patient consent or a judge's order. Efforts to change the state's law have failed.

It's not uncommon for patients to refuse to be tested, Garb says, though "it's usually in the situation where we don't find out about it until the patient's been discharged and they don't want to come in to have their blood tested."

JoAnn Shea, MSN, ARNP, director of employee health and wellness at Tampa (FL) General Hospital, would like to see a change in the Florida law, to allow for a "blanket consent" that patients would sign when they're admitted. Currently, the hospital can test source patients if consent can't be obtained after a "reasonable attempt" and blood has already been drawn and is available in the lab.

"I believe that the stigma related to HIV is not as great as it was when the laws were developed," says Shea. "Our law has been around since the early '90s when HIV was at its peak. It hasn't been changed or revised. We have to look at protecting our health care workers and not starting them on drugs that are toxic. I think we can still protect [patients'] confidentiality."

A compilation of state laws as they relate to HIV testing is available from the National HIV/AIDS Clinicians' Consultation Center (NCCC) at the University of California at San Francisco (www.ucsf.edu/hivcntr/PDFs/State_HIV_Testing_Laws.pdf).

If opt-out testing becomes the norm, hospitals will need to address issues of patient counseling and confidentiality, as well as the rare false positive, says Ronald H. Goldschmidt, MD, director of the NCCC, which runs a post-exposure prophylaxis hotline (PEPLine) for clinicians, and vice chair of the department of family and community medicine at the University of California at San Francisco.

"I think most people would agree that there's a greater need than is presently met in terms of testing people routinely, but we need to make sure that when it happens, people's lives don't get upset unnecessarily," he says.

Reference

1. Centers for Disease Control and Prevention. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR 2001; 50(RR11):1-42.