Medical Device Daily
The Centers for Disease Control and Prevention (CDC; Atlanta) is proposing changes to its recommended guidelines for HIV infection testing to include everyone ages 13 to 64, regardless of their risk of contracting the disease, which still remains – along with acquired immune deficiency syndrome (AIDS) – a leading cause of illness and death in the U.S.
The recommendations, which are not yet finalized, are expected to be published by the CDC this summer and are expected to replace recommendations as set forth in CDC's 1993 Recommendations for HIV Testing Services for Inpatients and Outpatients in Acute-Care Hospital Settings. The agency also will suggest revisions to the its 2001 Revised Guidelines for HIV Counseling, Testing and Referral, and Revised Recommendations for HIV Screening of Pregnant Women.
“Current HIV testing recommendations call for routine testing for those at high-risk and for everyone, regardless of risk, in areas with an HIV prevalence of more than 1%,” said Tammy Nunnally, a CDC spokesperson. “However, this process is not leading to adequate diagnosis of infection.”
She continued: “A quarter of HIV positive Americans do not know that they are infected, and data shows that when people learn they are infected, they take steps to protect their partners. Knowledge of status can also mean earlier access to treatment that results in a longer, healthier life span.”
The CDC estimates that about 1 million Americans are HIV-infected, and about 250,000 of those people are unaware of their HIV status.
According to the proposed guidelines, HIV screening is recommended in all healthcare settings; however, after being informed that testing would be done, an individual would have the opportunity to decline the test.
But should the patient give consent to medical care, separate consent for HIV testing would not be required. Also, there would be no requirement for prevention counseling and actually is not recommended as part of routine HIV screenings.
The guidelines propose that people at high risk for HIV infection should be screened for HIV at least annually.
For pregnant women, the guidelines would call for HIV screening in the routine panel of prenatal screening tests for all pregnant women. Repeat screening during the third trimester of pregnancy would be recommended in “certain jurisdictions with high rates of HIV infection among pregnant women.”
“CDC's potential changes will make HIV testing a standard part of medical care,” Nunnally said. “The changes call for the screening of every person ages 13-64, regardless of risk or prevalence. At this point, however, repeat testing would only be recommended for those at high risk [annual testing].”
She continued: “Testing should be part of a general battery of tests, and there would be no need for separate consent. And while HIV counseling remains a critical part of HIV testing, counseling services in medical settings should be focused on those who test positive - pretest counseling is not a requirement.”
The recommendations were most recently presented in February at the Conference on Retroviruses and Opportunistic Infections in Denver. They were presented by Timothy Mastro, MD, of the Divisions of HIV/AIDS Prevention of the CDC.
Nunnally said that “the purpose of these changes [is] to eliminate the complexities around HIV testing; instead of having to do risk screening or determine the local HIV prevalence, HIV testing will be standard. This will also help to reduce the stigma that still surrounds testing and diagnosis.”
She added: “As always, however, HIV testing should be voluntary.”
The expectation is that with the new guidelines, the CDC will gain more opportunities for HIV testing and enable those who are unknowingly infected gain access to treatment more quickly.
For example, the CDC has achieved what Nunnally termed “remarkable success” in perinatal HIV prevention, or prevention of transmission from mother to child. Those numbers peaked in the early to mid-'80s at about 1,750 HIV-infected children born in the U.S., compared to from 280 to 370 today.
It is well-known that treatment has significantly improved survival rates of those with HIV infection – particularly since the introduction of protease inhibitors and antiretroviral therapy in 1995.
“HIV testing has become a standard part of the general care for pregnant women, without the need for a separate notification,” she said. “Through this, we have seen success in using these strategies among pregnant women and hope to extend that success to other adults.”
The CDC has been working on the recommendations for some time, with a presentation last August at the HIV Prevention Leadership Summit and at community consultations last fall, as well as through a peer review that took place in November.