An estimated one-fourth of the roughly one million Americans believed to be living with HIV remain unaware of their infection. New approaches are urgently needed to reach these individuals with information on their HIV infection, and are essential to the success of HIV prevention and care efforts in the United States. Early diagnosis is critical in order for people with HIV to receive life-extending therapy. Today, nearly 40 percent of individuals diagnosed with HIV are diagnosed within one year of developing AIDS, when it may be too late for them to fully benefit from treatment. Additionally, studies show that most people who learn they are infected take steps to protect their partners, while people who are unaware of their infection are estimated to account for between 50 and 70 percent of new sexually transmitted HIV infections.

In order to increase the proportion of HIV-infected Americans who know they are infected early in the course of infection, the U.S. Centers for Disease Control and Prevention (CDC) has published revised recommendations for HIV testing in health care settings. The recommendations are designed to make HIV screening a routine part of medical care for all patients between the ages of 13 and 64, and to improve diagnosis of HIV infection among pregnant women.

The revised recommendations address HIV testing in health care settings only. They replace CDC's 1993 Recommendations for HIV Testing Services for Inpatients and Outpatients in Acute-Care Hospital Settings. They also update portions of CDC's 2001 Revised Guidelines for HIV Counseling, Testing and Referral and Revised Recommendations for HIV Screening of Pregnant Women. The new recommendations do not alter current recommendations on HIV counseling and testing in non-clinical settings, such as community centers or outreach programs.

Removing Barriers to HIV Screening in Health Care Settings

Health care settings represent a major opportunity for early diagnosis of HIV infection. Yet HIV screening rates remain low in many of these facilities. In one study of people who had reasonable access to medical care, more than 60 percent of those newly diagnosed with HIV had already progressed to an advanced stage of disease, suggesting that many had missed key opportunities for diagnosis at prior medical visits.

CDC's previous HIV testing recommendations for health care settings called for routine testing for people at high risk, and for everyone (regardless of risk) in settings with HIV prevalence above 1 percent. However, several key barriers hindered the implementation of those recommendations in health care settings. Many providers report that they do not have information about HIV prevalence in their facilities, or do not have sufficient time to conduct risk assessments. Physicians also report that the processes related to separate, written consent and pre-test counseling have posed significant barriers. For example, one recent study found that even for patients presenting with other sexually transmitted diseases (STDs), HIV testing is rarely provided. In that study, 76 percent of emergency department professionals said they never or rarely encouraged HIV testing for these patients, primarily because the HIV testing process is too time-consuming or because they are not certified to provide counseling. CDC's revised recommendations are designed to help remove these barriers by simplifying the testing process and making HIV testing a routine part of care for all patients aged 13-64.

Key Recommendations for Adults and Adolescents

• Provide HIV screening for all individuals ages 13 to 64 in health care settings: To normalize HIV screening as a routine part of medical care, the revised recommendations advise that all patients aged 13-64 be screened. Screening that is universal, and not tied to risk behaviors, will help maximize opportunities for early diagnosis in medical settings and reduce the stigma still associated with HIV testing.

  The recommendations do not specify the frequency of screening for all patients, but do encourage repeat testing at least annually (or more frequently if risk behavior dictates) for patients with recognized risk factors. This includes individuals with HIV-positive sex partners, injection drug users and their sex partners, individuals who exchange sex for money or drugs, and individuals who have had, or whose sex partners have had, more than one sex partner since their most recent HIV test. In addition, all patients initiating treatment for tuberculosis or seeking treatment for STDs should be screened.

• Voluntary, "opt-out" approach: CDC's recommendations strongly emphasize that HIV testing must be voluntary and undertaken only with the patient's knowledge. The recommendations advise that patients be specifically informed that HIV testing is part of routine care and have the opportunity to decline testing. Before making this decision, patients should be provided basic information about HIV and the meaning of positive and negative test results, and should have the opportunity to ask questions.

• Simplified testing procedures: To overcome the most significant barriers to testing in health care settings, the recommendations advise that pre-test counseling and separate, written consent for HIV testing should no longer be required. Consent for HIV testing can be incorporated into general consent for medical care. In terms of counseling, the recommendations underscore the need to ensure that patients who test positive for HIV are provided prevention counseling and linked to ongoing care. CDC also continues to encourage prevention counseling for all patients where feasible, especially when the health care visit is related to substance abuse, sexual health, family planning, or comprehensive health assessments. In addition, intensive HIV prevention counseling for high-risk populations will remain a vital component of community-based HIV prevention interventions.

Key Recommendations for Pregnant Women

Existing recommendations for routine prenatal HIV screening have already contributed to remarkable success in preventing mother-to-child HIV transmission in the U.S. The estimated number of infants born with HIV declined from a peak of approximately 1,650 in 1991 to fewer than 240 each year today. The revised recommendations include measures to further that progress.

• Rapid testing during labor for women of unknown status: A large proportion of perinatal HIV transmission occurs among women who lack prenatal care or who are not tested for HIV during pregnancy. Existing CDC recommendations advise that HIV testing should be provided during labor for women whose HIV infection status remains unknown. To more quickly diagnose HIV and initiate antiretroviral prophylaxis to women who test positive, the revised recommendations advise that a rapid HIV test should be used for testing during labor. If the rapid test is positive, prophylaxis can be administered before results of a confirmatory test.

  If HIV status cannot be determined prior to delivery, the recommendations advise that women should be voluntarily screened with a rapid HIV test immediately post-partum. Rapid HIV testing is recommended for newborns when the mother's status remains unknown.

• Expanded repeat HIV screening in the third trimester: Available data suggest that an increasing portion of mother-to-child transmission may result from HIV infection that occurs among pregnant women after they test HIV-negative earlier in their pregnancy. CDC's existing recommendations advise that women with known risk factors receive a second HIV test during the third trimester. To further increase diagnosis, the revised recommendations also advise repeat testing in the third trimester for all women in areas with high HIV prevalence among women of childbearing age (15 to 45) or in facilities with at least one HIV diagnosis per 1,000 pregnant women screened. Providers should consider repeat testing in the third trimester for other women on a case-by-case basis.

Process for Developing and Finalizing the Recommendations

The revised recommendations represent the culmination of an extensive process that began in 2003, as part of broader efforts to increase early HIV diagnosis. One of the key strategies was to make voluntary HIV testing a routine part of medical care.

For the past three years, CDC has been working with national, state, and local partners to identify the most effective ways to achieve this goal. CDC issued interim guidance in 2003 to guide state and local efforts to develop programs for routine testing, and implemented multiple demonstration projects to evaluate potential approaches for overcoming barriers to testing.

In 2004 and 2005, the agency convened two consultations with health care providers, public health experts, insurers, community-based organizations, and advocates to solicit further input. Based on the lessons learned from these efforts, CDC developed draft national recommendations and distributed them in early 2006 to diverse professional, scientific, and community-based organizations around the country for review and comment. The draft recommendations were also submitted for scientific peer review.

In response to comments on the draft recommendations, CDC strengthened guidance on several key issues. The final recommendations include stronger language on informed consent to ensure that no one is tested without his or her knowledge. They emphasize the need to provide basic information about HIV and the meaning of positive and negative test results, with the opportunity for patients to ask questions, prior to consent. The final recommendations also indicate that informational materials should be made available in multiple languages whenever appropriate, and that interpreter assistance should be provided for those with limited English proficiency. Finally, CDC stressed strong continued support for prevention counseling in health care settings, where feasible, and in community-based HIV prevention programs for high-risk populations.

Next Steps for Implementing the Recommendations

CDC's revised recommendations are one of the many steps that CDC, in conjunction with multiple private and public sector partners, is taking to ensure that individuals in health care settings have the opportunity to learn whether they are infected with HIV. To support health care providers, CDC will issue additional guidance in early 2007, which will provide examples of model approaches and practical tools for implementing the recommendations in various types of health care settings. CDC will also continue working with public and private insurers to encourage coverage for routine HIV screening, which studies have shown to be as cost-effective as other routine health screening programs, such as Pap smears and mammograms.

It is important to recognize that while knowledge of HIV infection status is critical, testing efforts must be part of a comprehensive program of prevention and care. CDC is working with the Health Resources and Services Administration and the National Association of Community Health Centers to ensure that newly diagnosed individuals have access to necessary treatment and ongoing prevention services. CDC is also conducting demonstration projects in several states to improve linkages from emergency departments to primary care for people newly diagnosed with HIV.

In addition to efforts to expand HIV testing in health care and community settings, CDC continues to support the full range of HIV prevention interventions needed to reduce HIV infections in the U.S., including comprehensive interventions for both high-risk and HIV-infected individuals.