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H H S Department of Health and Human Services
Health Resources and Services Administration
Primary Care: The Health Center Program

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HIV Testing in Health-Care Settings

Program Assistance Letter 2010-13

I. Purpose

The purpose of this Program Assistance Letter (PAL) is to provide grantees information regarding the Centers for Disease Control and Prevention’s (CDC) “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings.” The Health Resources and Services Administration (HRSA) and Bureau of Primary Health Care continue to support reducing the number of people who become infected with HIV, increasing access to care and optimizing health outcomes for people living with HIV, and reducing HIV-related health disparities. This PAL also identifies resources for training and technical assistance to help Health Centers follow the Revised Recommendations.

II. Background
Approximately 25 percent of people living with HIV/AIDS (PLWHA) in the United States do not know their HIV status,1 partly because many underestimate their risk and do not seek testing.2 Unaware of their HIV status, PLWHA forego needed care and risk poor health outcomes and increased morbidity and mortality.3 

The National HIV/AIDS Strategy4 (NHAS) released on July 13, 2010, outlines the commitment to reduce HIV incidence in the United States by 25% by 2015. The NHAS calls for refocused and intensified activities towards reducing HIV incidence; increasing access to high quality care; reducing health disparities; and improving federal coordination and collaboration. 

Health Centers are a critical partner in meeting the Strategy’s goals. For more than 40 years, health centers have delivered comprehensive, high-quality preventive and primary health care to patients regardless of their insurance status or ability to pay. During that time health centers have become the essential primary care medical home for America’s most vulnerable populations: the poor, uninsured, and homeless; minorities; migrant and seasonal farmworkers; public housing residents; geographically isolated communities and inner cities; and people with limited English proficiency. Today, more than 1,100 health centers operate 7,900 service delivery sites that provide care to nearly 19 million patients in every U.S. state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. About half of all health center grantees serve a critical need in rural America; the remainder are found in urban areas.

The HIV/AIDS epidemic has profoundly and disproportionately affected these communities and the populations served by health centers. With appropriate care, HIV/AIDS can be managed as a chronic condition in primary care and outpatient specialty settings. Early detection and care is essential however, to reduce HIV/AIDS-related morbidity and mortality and improve quality of life. 

Many PLWHA who are unaware of their disease status seek health care services at a variety of clinical settings including health centers, providing opportunities for conventional or rapid HIV testing. Routinely providing rapid HIV testing at these points of entry can increase the number of people who learn their HIV status,5 although conventional testing remains appropriate in many circumstances.

III. Summary of Revised Testing Recommendations
In September 2006, the CDC updated its recommendations for HIV testing in health care settings and for HIV screening of pregnant women. The objectives of the updated recommendations were as follows: 1) to increase the number of individuals receiving HIV screening in health care settings, including pregnant women; 2) to facilitate earlier detection of HIV infection; 3) to identify individuals with unrecognized HIV infection, provide them with counseling services and referrals to clinical and prevention HIV services; and 4) to further reduce perinatal transmission of HIV in the United States.

Excerpts of major revisions from previously published guidelines include the following:

For Adults and Adolescents

  • Screening after notifying the patient that an HIV test will be performed unless the patient declines (opt-out screening) is recommended in all health-care settings. Specific signed consent for HIV testing should not be required. General informed consent for medical care should be considered sufficient to encompass informed consent for HIV testing. 
  • Persons at high risk for HIV should be screened for HIV at least annually. 
  • HIV test results should be provided in the same manner as results of other diagnostic or screening tests.
  • Prevention counseling should not be required as a part of HIV screening programs in health-care settings. Prevention counseling is strongly encouraged for persons at high risk for HIV in settings in which risk behaviors are assessed routinely (e.g., STD clinics) but should not have to be linked to HIV testing.
  • HIV diagnostic testing or screening to detect HIV infection earlier should be considered distinct from HIV counseling and testing conducted primarily as a prevention intervention for uninfected persons at high risk.

For Pregnant Women 

  • HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women. Patients should be informed that HIV screening is recommended for all pregnant women and that it will be performed unless they decline (opt-out screening). 
  • Repeat HIV testing in the third trimester is recommended for all women in jurisdictions with elevated HIV or AIDS incidence and for women receiving health care in facilities with at least one diagnosed HIV case per 1,000 pregnant women per year. 
  • Rapid HIV testing should be performed for all women in labor who do not have documentation of results from an HIV test during pregnancy. Patients should be informed that HIV testing is recommended for all pregnant women and will be performed unless they decline (opt-out screening). Immediate initiation of appropriate antiretroviral prophylaxis should be recommended on the basis of a reactive rapid HIV test result, without awaiting the result of confirmatory testing. 

The full text of the Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings were published in Morbidity and Mortality Weekly Report (MMWR), September 22, 2006, Volume 55, Number RR-14; available online at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm

IV. Additional Resources 

There are numerous technical assistance and training resources to assist Health Centers in following the CDC HIV testing recommendations. The HRSA’s HIV/AIDS Bureau (HAB) administers the AIDS Education and Training Centers (AETCs) Program. The AETC Program is a network of regional and national centers that provide multidisciplinary training for health care providers treating PLWHA, including Health Centers and other safety net providers. The AETC National Resource Center maintains a central repository of training materials developed by regional and national AETCs and can provide technical assistance and training addressing HIV testing. Additional resources are available through the National Minority AETC and the National HIV/AIDS Clinicians’ Consultation Center. For more information, see http://www.aids-ed.org/, http://www.nmaetc.org/, and http://www.nccc.ucsf.edu/.  

The CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) supports HIV programs across the country and funds a variety of entities, include state and local health departments, that can provide technical assistance and other resources to providers, administrative staff, and PLWHA. The NCHHSTP is responsible for public health surveillance, prevention research, and programs to prevent and control human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS), other sexually transmitted diseases (STDs), viral hepatitis, and tuberculosis (TB). Center staff work in collaboration with governmental and nongovernmental partners at community, State, national, and international levels, applying well-integrated multidisciplinary programs of research, surveillance, technical assistance, and evaluation. For more information, see
http://www.cdc.gov/nchhstp/ or http://www.cdc.gov/hiv/topics/testing/healthcare/index.htm

The National Association of Community Health Centers (NACHC) (see http://www.nachc.com/) has a standing committee on HIV/Substance Abuse Prevention and Treatment. The committee engages in the following: 1) encourages and supports Health Centers in the provision of primary HIV and substance abuse care: 2) tracks funding and develops partnerships with Federal Agencies (i.e., SAMSHA, CDC, HRSA); and 3) develops and provides relevant training and technical assistance to Federally Qualified Health Center (FQHCs). In addition, NACHC provides technical assistance to individual Health Centers on-site regarding the development of programmatic, administrative, and clinical policies and protocols addressing HIV testing and HIV/AIDS care and treatment. For more information, see http://www.nachc.com/.

Finally, many State and Local Health Departments help providers navigate testing barriers through the provision of rapid test kits, laboratory services, and training on how to administer tests.6 Health Departments also can help providers establish screening algorithms for confirmatory HIV testing, which is required when rapid HIV testing produces a reactive, or HIV-positive, result.7  

Early detection and treatment of HIV/AIDS increases longevity and quality of life for PLWHA and reduces the likelihood of new HIV infections. As the HIV/AIDS epidemic in the United States moves toward a 30 year history, Health Centers continue to play a vital role in caring for PLWHA and in eliminating new infections. HRSA remains a committed partner in your efforts to help PLWHA, their families, and communities live longer, healthier, and more fulfilling lives.

Sincerely,
James Macrae
Associate Administrator

REFERENCES 

1 Centers for Disease Control and Prevention (CDC). Estimates of new HIV infection in the United States. 2008. Available at: http://www.cdc.gov/nchhstp/Newsroom/docs/Fact-Sheet-on-HIV-Estimates.pdf.

2 Knox R. Many Americans with HIV don’t know they have it. National Public Radio. November 24, 2008. Available at: http://www.npr.org/templates/story/story.php?storyId=97315837.

3 Peck P. HIV testing often comes late in course of infection. Medpage Today. June 25, 2009. Available at: http://www.medpagetoday.com/HIVAIDS/HIVAIDS/14863.

4 The National HIV/AIDS Strategy for the United States and the accompanying Federal Implementation Plan may be accessed at: http://www.whitehouse.gov/ONAP

5 Branson B, Handsfield H, Lampe M, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR. 2006;55(RR14):1-17. 

6 NASTAD. HIV testing in emergency departments: a primer on issues and strategies for health departments. 2007. Available at: http://www.nastad.org/Docs/highlight/2007103_NASTAD_ED_Primer_FINAL.pdf.

7 CDC. Notice to readers: protocols for confirmation of rapid reactive HIVtest. MMWR.2004;53(10):221-222.

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