SAMHSA Launches Rapid HIV Testing Initiative
By Melissa Capers
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 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,
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,
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®
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
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
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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
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 www.samhsa.gov/Matrix/matrix_HIV.aspx.
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