Next weapon in war on AIDS: universal HIV screening
From the December ACP Observer, copyright © 2006 by the American College of Physicians.
By Bonnie Darves
When the CDC issued new guidelines in late September, the U.S. became the only Western nation—the only country outside of the African continent, in fact—to call for universal HIV testing.
The bold recommendation to test all Americans between the ages of 13 and 64 (see sidebar) regardless of risk, and dispensing with separate written consent and counseling, was accompanied by surprisingly little fanfare. Yet it clearly is an aggressive step toward tackling a problem that numerous education, awareness and public health campaigns have failed to resolve: relatively high infection rates among individuals who don't know their status. According to the CDC, an estimated 250,000 to 300,000 Americans have HIV and don't know it.
More compelling, perhaps, are estimates about transmission patterns, said Bernard Branson, MD, associate director for laboratory diagnostics in the CDC's Division of HIV/AIDS Prevention. Individuals unaware of their infection "account for an estimated 50%-70% of all new HIV infections," he said, "and the meta-analyses data show that people reduce risky behavior by 68% when they know that are infected."
What makes the CDC's recommendations and their rationale hard to dispute, proponents say, is the fact that so many individuals are diagnosed years after initial infection. Nearly 40% of patients are within a year of developing AIDS at the time of their HIV diagnosis. That disturbing statistic translates into fewer treatment options and increased likelihood that those people have transmitted the virus.
"Universal screening is a very good idea whose time has come," said Donna Sweet, FACP, a general internist in Wichita, Kan., who was among those who advised the CDC on the new recommendations. "I'm tired of seeing the 52-year-old man who comes in with full-blown pneumocystis pneumonia and has to be on a ventilator—yet he has been seen by very good physicians."
The new guidelines attempt to address the social stigma of HIV testing by making screening universal rather than risk-based, and to limit the number of missed diagnoses.
"There is very compelling evidence that the past approach for identifying people who have HIV just doesn't work," said Douglas K. Owens, senior investigator at the VA Palo Alto Health Care System, professor of medicine at Stanford University School of Medicine and chair of the College's Clinical Efficacy Assessment Subcommittee. "If you're testing based on risk-based targeting, you miss a substantial portion of people because they either don't know their risks or don't disclose them."
Barriers to implementation
The recommendations, while medically compelling, face many practical barriers. For example, 14 states have laws that require written consent, pre-test counseling, or both before an HIV test is conducted. In addition, reimbursement for the test historically has been based on physicians' reporting of symptoms or risks, and counseling may not be covered unless results are positive.
Concern over privacy is another potential roadblock. The CDC's Dr. Branson acknowledged that such concerns were raised by several individuals and organizations as the guidelines were being developed, but that actual incidents of disclosure have been rare. He noted that the practice of keeping HIV test records separate from patients' main health records "may actually increase disclosure."
Another potential source of confusion is that the CDC recommendations differ slightly from those of the U.S. Preventive Services Task Force (USPSTF). The latter body's guidelines call for testing high-risk individuals, pregnant women and other adults in settings where HIV prevalence is 1% or higher. Testing is also called for those in high-risk settings, such as sexually transmitted disease clinics, tuberculosis clinics and homeless shelters, but other testing is left to the discretion of providers.
The USPSTF gives universal testing a "C" recommendation—neither for nor against—citing small net benefits in low-risk patients, uncertain effects on reducing transmission rates, and the additional burden on practices of adding more disease screening. That may affect how both physicians and insurers view the new CDC guidelines.
"The CDC is looking at potential public health benefits that are very hard to prove. There is no direct study showing that HIV screening reduces transmission, which to the Task Force would be the strongest kind of evidence," said Roger Chou, MD, a principal investigator at the Oregon Evidence-Based Practice Center at Oregon Health and Science University in Portland and a consultant on the American College of Physician's PIER HIV screening module. In prioritizing screening recommendations the USPSTF also "considers all of the other things primary care providers (PCPs) have to do," including screening for other diseases such as colon cancer, breast cancer and diabetes.
However, said Dr. Chou, the lead investigator of the evidence review for the USPSTF effort in Oregon, the Task Force is reviewing its own guidelines based on the CDC's new recommendations. "It's also clear that we need to do a better job of testing high-risk patients and getting HIV-positive persons linked to appropriate care."
Overall, the CDC projects that universal screening could reduce HIV sexual transmission rates by 30% provided those who test positive refrain from risky behaviors—a challenge in itself. "It's possible that the highest-risk people are never going to come in to the clinic or may not consent to testing, so those kinds of estimates are best-case ones," said Dr. Chou.
How will it affect practice?
The CDC sought input on the recommendations from physician organizations such as the College, the American Medical Association and the American Academy of Family Physicians, but it may take longer to gauge the reaction of community practicing physicians. As of mid-November, Vincenza Snow, FACP, ACP's director of clinical programs and quality of care, reported "very little activity in terms of members writing or calling about the recommendations."
Yet, incorporating HIV screening and counseling into the already overloaded office visit could be a challenge for many internists. Based on data from its demonstration projects the CDC has projected that testing will take an additional 10 minutes. If the results are positive, an additional hour or more would be needed for confirmatory testing, counseling and referrals, at a cost of $80.
Those who already screen regularly have tended to focus on patients who identify risk factors, bypassing patients who reportedly are in longtime monogamous relationships or have no history of injection drug use. But relying on patients to report risk factors is problematic, said Dr. Sweet. "For women, the great unknown [HIV] risk is unprotected heterosexual intercourse—but they still are not perceiving themselves at risk even though 75% of women with HIV get it through unprotected intercourse."
Misconceptions about the time required for screening may also slow adoption of the new guidelines, said Robert Weinstein, MD, professor of medicine at Rush Medical College in Chicago and chief operating officer of the Ruth M. Rothstein CORE Center, a large HIV treatment center. "This would be a relatively easy change from a mechanical standpoint for most internists," he said, "but there's a mindset that pre-test counseling must be extensive."
That doesn't have to be the case, in part because HIV is no longer a "terminal" diagnosis, he said. "Early on, pre-test counseling was important and useful but now that we're 25 years into the epidemic, baseline knowledge has changed."
Time and cost are the main concerns for Essex, Conn., general internist Rodney Hornbake, FACP. "I'm not sure it makes sense everywhere—and I have so many things to do that spending time explaining the recommendations and the consent would be an impossible burden," he said.
For now, Dr. Hornbake uses a new-patient written questionnaire that includes a section about HIV and hepatitis C testing. It asks patients to indicate whether they've been tested, lists the major risks, and notes the CDC's new testing recommendations.
Some physicians worry about using resources for HIV testing, when treatment availability and funding remain problematic.
"We know who is at risk and why—and it does not make sense to test people who are not at risk," said William Aronstein, FACP, a general internist who formerly practiced at Emory Clinic in Atlanta and now conducts clinical researcher in Cincinnati. "How does the CDC justify diverting resources from at-risk to no-risk populations?"
HIV specialist Jeffrey Schouten, MD, who chairs the American Academy of HIV Medicine's board of directors and practices at the University of Washington in Seattle, also worried that focusing on the general population will shift resources away from high-risk populations and those already infected.
"What else won't be done in prevention and screening if this [universal testing] gets done?" Dr. Schouten said. "You have to look at the opportunity costs."
While the academy supports the CDC's opt-out approach, physicians are concerned about the "de-linking" of counseling and testing, said Dr. Schouten. The elements of informed consent are similar to pre-test counseling requirements—what a reasonable person would want to know before consenting to an HIV test. Also, the CDC recommends annual testing of individuals with high risk activities, he explained.
Physicians should have some discussion about risky behaviors with the patient, and that information should generate a discussion of risk-reduction strategies. Testing should not occur in a vacuum, Dr. Schouten said.
Cost is a concern even among those who support the recommendations. "It's got to be do-able and billable, so internists don't lose money," noted Dr. Sweet.
Susan Pisano, vice president of communications for America's Health Insurance Plans in Washington, D.C., said that AHIP "is looking at the implications of the CDC recommendations" but has not yet made a formal statement to its members.
The actual costs of the new recommendations are difficult to project, but certain fixed costs and some ranges have been identified.
According to the CDC, a conventional HIV test is about $8, or $20 to $30 for the rapid test. Neither figure takes into account counseling for patients who test positive—that may cost up to $80. If HIV prevalence is the estimated 1 in 1,000 that CDC officials suggest, screening is "as cost effective as other screenings, such as breast cancer or hypertension," said Dr. Branson.
HIV testing is cost effective "if you have a prevalence of about 1 in 2,000 or greater—and most health care settings will be above that," said Dr. Owens, who co-authored a study on HIV screening and testing that appeared in the Feb. 10, 2006, issue of the New England Journal of Medicine. The study also estimated that an HIV screening strategy could reduce annual transmission by 21% compared with no screening.
While those numbers may not apply to all community-based practices, supporters of the guidelines contend that it's the best defense currently available against spread of the disease.
It's worth the effort, said Dr. Sweet, if "universal testing actually reduces the stigma that has prevented many people from undergoing testing, and ultimately, transmitting the disease."
By recommending screening and voluntary testing for all individuals between the ages of 13 and 64, the CDC hopes to stem transmission of the virus that results in 40,000 new infections annually, many caused by people who are unaware of their HIV-positive status. The new recommendations differ substantially from the CDC's original 1993 Recommendations for HIV Testing Services for Inpatients and Outpatients in Acute-Care Hospital Settings, and represent important changes to the most recent 2001 update, which targeted screening, counseling and testing of pregnant women.
Following are the key recommendations:
|Screening in health care settings, including physician practices, for all individuals ages 13 to 64, regardless of perceived or reported risk.|
|OLD: Routine HIV testing only of individuals with recognized risk factors or in settings where prevalence exceeded 1%.||NEW: Screening frequency is not addressed. Repeat annual testing is encouraged for individuals injection drug users, those with either an infected sex partner or who have had multiple partners, and for those seeking treatment for tuberculosis or sexually transmitted diseases.|
|Voluntary opt-out approach to testing, to "normalize" screening and testing as part of routine care.|
|OLD: Separate informed consent specific to HIV testing, and pre- and post-test counseling||NEW: Destigmatize testing through voluntary testing and only with the patient's knowledge. Patients should receive information about HIV and the meaning of positive or negative test results, and be encouraged to ask questions.|
|Streamlined, simplified testing procedures to reduce barriers to test acceptance.|
|OLD: Pre-test counseling and written consent.||NEW: Incorporate HIV testing into the general consent for care and stress provision of prevention counseling for all patients-especially those seeking care for substance abuse, sexual health or family planning, or comprehensive health assessment. Encourage onsite counseling for those who test positive and provide a direct link to ongoing care.|
|Expanded testing and screening for pregnant women.|
|Opt-out approach to test pregnant women. The opt-out approach dramatically reduced the number of infants born with HIV from 1,650 annually in 1991 to approximately 240 in 2005.||The CDC now calls for rapid testing during labor for women of unknown status, repeat HIV screening in the third trimester for women with know risk factors. Emerging evidence suggests that an increasing number of mother-to-child transmissions occur in women who tested negative earlier in their pregnancy.|
Click here to obtain a copy of the new recommendations, titled Revised Recommendations for HIV Testing of Adults, Adolescents and Pregnant Women in Health Care Settings.
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