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SAMHSA News - November/December 2004, Volume 12, Number 6

SAMHSA Launches Rapid HIV Testing Initiative

SAMHSA has launched a Rapid HIV Testing Initiative, which will make available a "rapid results" HIV test and related support services to thousands of people who receive help from SAMHSA's programs.

In August 2004, the U.S. Department of Health and Human Services provided $4.8 million to SAMHSA to purchase rapid HIV test kits and to train eligible service providers on the fundamentals of rapid HIV testing, HIV prevention counseling, and related data collection activities. Preliminary efforts are now underway.

With this Initiative, SAMHSA has the potential to revolutionize prevention and treatment services for HIV/AIDS—and ultimately reduce the incidence of the disease.

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The Test

The Food and Drug Administration (FDA) recently approved the OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test, which provides results in just 20 minutes, for use in non-clinical settings. (For more on the test, see Facts about Rapid HIV Testing.) These settings may include a doctor’s office, a local clinic, or a community-based outreach organization, among others. However, each testing site must receive a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). To qualify for a CLIA waiver, a facility must establish quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results.

Traditional HIV testing requires two visits: one visit to take the test sample and then a second visit—often 2 weeks later—to receive the results. According to the Centers for Disease Control and Prevention (CDC), however, many people do not complete this sequence. Nearly one-third (31 percent) of those who test positive for HIV at CDC-funded sites never return to receive these results—and so do not access counseling, treatment, and other supportive services. Nationwide, CDC estimates that between 180,000 and 280,000 people do not know that they are HIV positive.

In contrast, rapid HIV testing provides results in one visit. An added benefit is that clients with a confirmed HIV-positive result can be referred immediately to appropriate treatment, counseling, and other vital assistance.

"People need to know that . . . if they test positive for HIV, we can connect them to treatment and other supportive care services to maintain their health . . ."
—Beverly Watts Davis, Director
Center for Substance Abuse Prevention and
SAMHSA's HIV/AIDS & Hepatitis Matrix Lead

Furthermore, because rapid HIV testing can be conducted in both clinical and non-clinical settings, access to people served through SAMHSA’s program site venues—especially outreach programs—is expected to increase.

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Currently, SAMHSA is supporting many mental health, substance abuse, and community-related HIV programs across the Nation. "The relationship between substance abuse and the transmission of HIV/AIDS has been well established since the beginning of the HIV/AIDS epidemic," said SAMHSA Administrator Charles G. Curie, M.A., A.C.S.W. "Injection drug use alone has accounted for 36 percent of AIDS cases in the United States."

Impaired judgment and lack of inhibitions associated with alcohol and drug use, as well as with some serious mental illnesses, can also lead to behaviors that put people at risk of contracting or transmitting HIV.

"The capacity to provide referral and access to treatment immediately is as important as the new testing technology," said Beverly Watts Davis, Director of SAMHSA’s Center for Substance Abuse Prevention, who also serves as SAMHSA’s HIV/AIDS & Hepatitis Matrix Lead. "People need to know that treatment for substance abuse and mental illness is an integral part of reducing their HIV risk, and that, if they test positive for HIV, we can connect them to treatment and other supportive care services to maintain their health and prolong their lives."

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How the Program Works

To provide rapid HIV testing, an eligible service provider must have the capacity to provide rapid HIV tests and counseling, make referrals, and collect required data.

SAMHSA has developed four criteria to determine site eligibility. A site must:

  • Be located in metropolitan and rural areas with high HIV prevalence that are currently interested in providing traditional HIV/AIDS counseling, testing, and referrals.

  • Serve high-risk clients (e.g., injection drug users, persons with co-occurring substance use and/or mental disorders, men who have sex with men, college students, previously incarcerated reentry populations).

  • Have a rapid HIV testing infrastructure that will expedite CLIA waiver certification, and have few state or local barriers to rapid HIV testing.

  • Have established linkages to HIV/AIDS treatment, counseling, and other supportive services.

Eligible sites must also meet SAMHSA’s mandatory readiness requirements, including the completion of required trainings; a CLIA waiver; an established referral network for clients who need counseling, treatment, and support services; copies of rapid HIV testing policies and procedures; and data collection capabilities.

Currently, SAMHSA is collaborating with CDC to finalize the Initiative’s data collection activities. Sites are required to collect and report on client- and site-level data, and other data specific to the use of the OraQuick® ADVANCE test.

The Initiative has two phases. The first phase will include SAMHSA’s current Substance Abuse Prevention, Treatment, and Mental Health Minority AIDS Initiative grantees, SAMHSA’s Opioid Treatment pilot sites, and grantees from states and territories with Substance Abuse Prevention and Treatment Block Grants that include HIV set-asides.

The second phase is open to service providers from other programs funded by SAMHSA discretionary and Block Grants, and other Federal agencies that fund HIV/AIDS-related services. Physicians who are providing buprenorphine treatment for opioid addiction are also eligible to participate during phase 2 (see SAMHSA News, March/April 2004).

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SAMHSA has been working extensively with CDC on training activities for this Initiative.

In July, SAMHSA identified 22 trainers instructed by CDC on the fundamentals of rapid HIV testing. In September, these trainers trained more than 40 service providers from SAMHSA’s regulated opioid treatment centers and more than 90 grantees from SAMHSA’s Minority AIDS Initiative.

For more information about SAMHSA’s Rapid HIV Testing Initiative, contact 1 (877) 219-6953 or e-mail For a fact sheet on SAMHSA’s Rapid HIV Testing Initiative, visit

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