Jeffrey T. Kirchner, DO, AAHIVS Medical Director Comprehensive Care Center for HIV Lancaster General Hospital, Pa

It has been 1 year since the Centers for Disease Control and Prevention (CDC) issued updated guidelines on HIV testing in the United States. These guidelines were groundbreaking in that, for the first time, they recommended routine HIV screening for all persons, regardless of whether or not they had any of the traditional risk factors for the disease. Although it is still too early to assess the impact of these new guidelines, my hope and personal mission has been to continually disseminate this information to practicing physicians, residents, medical students, and the lay public.

To summarize, the CDC recommends routine one-time HIV screening of all persons between the ages of 13 and 64 years and repeat screening at least annually of those at high risk.¹ Screening should be performed wherever patients receive medical care, including physicians' offices, ambulatory clinics, emergency departments, and in-patient settings (Table). HIV screening should be incorporated into routine healthcare visits. However, the guidelines emphasize that testing should be voluntary, that is, individuals may "opt-out" of testing: they have the option to refuse testing after being informed that it will be performed. Prevention counseling, including pre- and posttest counseling, has been traditionally recommended or, in many cases, legally mandated. The new guidelines recommend that counseling may be performed if requested or for high-risk patients, but it is not required as part of routine HIV screening. Finally, the CDC notes that separate written consent (historically a barrier to testing) is no longer required, but that general consent for medical care is sufficient to proceed with testing.

There were several reasons for the move from risk-based to routine screening. It has been estimated, based on surveillance studies, that of the 1 million persons in the United States living with an HIV/AIDS diagnosis, about 25% are unaware of their status.² It is this "unaware group" that is thought to account for between 50% and 70% of new infections. One meta-analysis showed that after people learn they are infected with HIV, they significantly reduce high-risk behaviors that place others at risk.² Evidence from this study suggests new infections could be reduced by more than 50% if self-imposed behavioral changes occurred by those aware of their HIV status. This could potentially decrease the annual number of new infections from 40,000 to between 15,000 and 20,000.

HIV screening in several studies has been shown to be cost-effective, based on the standard of quality-adjusted life-year (QALY) gained typically used to measure the benefits of many other screening tests. A recent study demonstrated that routine one-time HIV screening had cost-effectiveness ratios of $30,800/QALY if the prevalence was 1% and about $60,000/QALY, even when the prevalence was only 0.10%.³

These numbers are comparable to those with screening for breast and colon cancer. Although risk-based screening makes sense, many studies have shown that persons who test positive often do not report any of the traditional risk factors for HIV infection. Moreover, a large number of patients who are tested continue to present with late-stage disease. Approximately 40% of all patients diagnosed with HIV infection in 2003 had an AIDS diagnosis at the time of testing or within 1 year after HIV infection was diagnosed.⁴ Routine opt-out HIV screening has been a part of prenatal care since 1994, when it was determined that using zidovudine (AZT; Retrovir) monotherapy in pregnant women markedly reduced mother-to-child transmission. Newborn infections declined from more than 1000 annually to fewer than 100 annually today. And we now have more than 20 antiretroviral drugs to effectively treat patients with HIV/AID—therapies that for the past 10 years have saved more than 3 million life-years.⁵

Rapid Testing

Implementing screening programs does present challenges for physicians. One way to overcome logistical and follow-up problems with standard testing is to move toward the use of rapid tests. There are now 6 rapid HIV tests approved for use by the Food and Drug Administration, including the OraQuick Advance. This CLIA (Clinical Laboratory Improvements Amendments Act of 1988)-waived HIV test produces results in about 20 minutes. It can be performed with either blood or saliva and has a sensitivity of 99.7% with whole blood and 99.1% with saliva; specificities are 99.9% with whole blood and 99.6% with saliva.⁶

Rapid testing has proven highly effective in emergency department settings and obviates the need for a follow-up visit, as was required with traditional testing. Moreover, the available tests are inexpensive ($12-$15) and may eventually be made available over the counter. Rapid test results should be confirmed with serologic testing, but patients can be referred for HIV-specific medical care based on the rapid test results and thus not be "lost" to follow-up until they become clinically ill.

Legal Issues

Legal issues remain a barrier to HIV screening. In deference to the new CDC guidelines, at least 31 states and the District of Columbia currently require written consent for HIV testing. Most of these legal statutes, including those in my own state of Pennsylvania, were put into place in the early years of the epidemic as a means of protecting patients from the loss of jobs, housing, and health insurance.⁷ Effective treatments have changed the course of this disease. Consequently, state laws should be changed to protect the civil liberties of those who test positive, while respecting the public health risks that HIV, like other infectious contagious diseases, represents.

One argument against routine screening has been the lack of access to medical care. As a physician I find this argument counterintuitive in that it appears to say, "Let's not look for this fatal, treatable disease, because we don't have the resources to treat it." Would we put forth the same argument if we were addressing diabetes, breast cancer, or neonatal screening? I think not. This point raises the access issue, something our legislature, as well as we, must address, as the number of uninsured Americans continues to grow. Unfortunately, some experts believe that between 40% and 60% of HIV-infected individuals identified by expanded testing do not have health insurance.

The CDC is doing its part to help advance the new guidelines. They have been working with Medicare and Medicaid policymakers to ensure reimbursement for testing and have requested a new CPT code for routine HIV testing. The CDC has also reallocated $45 million dollars to support the implementation of HIV testing in the 26 US jurisdictions with the highest incidence of HIV disease.⁸

Preventive Healthcare

My expectation is that the current generation of physicians in training, including my own residents and students, will work with the new CDC guidelines to destigmatize HIV testing. Preventive healthcare, unfortunately is still ignored by many policymakers and clinicians, but this is what early identification of HIV is now a part of. We can keep people who are infected healthy for many years, and we can prevent new infections by working with our patients to educate them regarding effective prevention. To do otherwise, in my mind, makes no sense.

References

1. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17.
2. Marks G, Crepaz N, Senterfitt JW, et al. Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States. JAIDS. 2005;39:446-453.
3. Paltiel AD, Walensky RP, Shackman BR, et al. Expanded HIV screening in the United States: effect on clinical outcomes, HIV transmission, and costs. Ann Intern Med. 2006;145:797-806.
4. Centers for Disease Control and Prevention. Cases of HIV infection and AIDS in the United States, 2004. HIV/AIDS Surveill Rep. 2005; 16:16-45.
5. Walensky RF, Paltiel AD, Losin E, et al. The survival benefits of AIDS treatment in the United States. J Infect Dis. 2006;194:11-19.
6. Delaney KP, Branson BM, Uniyal A, et al. Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies. AIDS. 2006;20:1655-1660.
7. Gostin LO. HIV screening in health care settings: public health and civil liberties in conflict? JAMA. 2006;296:2023-2025.
8. Ask the Experts: HIV Testing [transcript]. Kaiser Family Foundation Broadcast Studio. June 26, 2007. Available at: www.kaisernetwork.org/health_cast... (pdf).