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Overview
The Substance Abuse and Mental Health Services Administration (SAMHSA) will be implementing a Rapid HIV Testing Initiative (RHTI) during fiscal year 2005. In view of the disproportionate HIV/AIDS incidence and prevalence rates across minority communities, the RHTI is designed to reduce HIV incidence rates among minority populations who may be at an even greater risk for acquiring or transmitting HIV associated with substance abuse and/or a mental health disorder.
Since the epidemic began in 1981, minority populations account for 57 percent of the reported AIDS cases. Injection drug use (IDU) continues to play a major role in HIV transmission among minority populations; the Centers for Disease Control and Prevention (CDC) reported that IDU among African Americans and Hispanics accounts for over one-third (36 percent) of all AIDS cases.
Notwithstanding, between 1981-2002, CDC estimated 850,000 to 950,000 U.S. residents were infected with HIV. It was estimated that one-quarter of them are unaware of their HIV status (CDC, 2002). CDC further reported that 9,300 individuals out of an estimated 30,000 who test positive for HIV each year at publicly funded sites do not return for their results.
In response, the Department of Health and Human Services (DHHS) recently directed $4.8 million to SAMHSA to make a bulk purchase of rapid HIV test kits and train SAMHSA's eligible service providers.
SAMHSA has since secured a federal contract with OraSure Technologies to supply rapid HIV test kits at no cost to eligible service providers. These rapid HIV test kits were recently approved by the Food and Drug Administration and waived under the Clinical Laboratory Improvement Amendment of 1988 (CLIA) for use in non-clinical settings.
To ensure proficiency in the rapid HIV testing methodology, SAMHSA will provide access to training, including travel, to eligible service providers. The fundamentals of rapid HIV testing, prevention counseling, and related data collection activities will be covered.
With increased access to SAMHSA's new rapid HIV testing methodology through its program sites, more high-risk minority populations can be identified and screened. These populations will subsequently benefit from effective counseling, treatment, and other supportive services.
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Goals
The goals of SAMHSA's RHTI are:
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To incorporate the new rapid HIV testing methodology in SAMHSA's qualified program sites as a strategic intervention:
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To facilitate early diagnosis of HIV among at-risk minority populations involved in substance abuse (SA) and/or living with a mental health (MH) disorder, and
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To increase referrals to sustained quality counseling, treatment, and other supportive care services for such persons diagnosed with HIV;
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To provide effective counseling to persons who previously tested negative to decrease their risk of acquiring HIV;
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To identify an increased number of evidence-based prevention and treatment programs and practices in the area of HIV/AIDS associated with SA and/or MH.
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Target Populations
Targeted populations include persons with a substance use (e.g., injection drug users) and/or mental health disorder, men who have sex with men, at-risk college students, sex workers, at-risk pregnant women, reentry populations, and transgender populations.
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Eligibility Criteria
Phase I/II Sites MUST:
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Be located in metropolitan and rural areas with high prevalence of HIV, which are currently interested in providing traditional HIV/AIDS counseling, testing, and referrals;
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Serving high-risk clients;
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Have a rapid testing infrastructure that will expedite CLIA Waiver certification, and have few state or local barriers to rapid testing; and
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Have established linkages to HIV/AIDS treatment, counseling, and other supportive services.
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Eligible Sites
SAMHSA will implement the RHTI in two sequential phases.
Phase I is comprised of SAMHSA's service providers who are equipped to meet SAMHSA's readiness requirements in Year 1:
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SAMHSA's substance abuse prevention, treatment, and mental health HIV discretionary grantees (SAMHSA's Minority AIDS Initiative)
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SAMHSA-regulated Opioid Treatment Programs (pilot sites)
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Substance Abuse Prevention and Treatment (SAPT) Block Grant HIV Set Aside States and Territories
Phase II is comprised of SAMHSA's service providers and service providers from other federal grant programs who will be equipped to meet SAMHSA's readiness requirements in Year 2:
- SAMHSA Block Grant States and Territories
- SAMHSA Drug Addiction Treatment Act (DATA) Waived Physicians
- SAMHSA-regulated Opioid Treatment Programs (non-pilot sites)
- Other SAMHSA funded discretionary grants (e.g., Criminal Justice, Women's Programs)
- Other Federal grant programs that provide substance abuse prevention, treatment, and mental health services (e.g., Department of Justice, Serious and Violent Offender Reentry Initiative (SVORI); National Institute on Drug Abuse (NIDA) HIV Clinical Sites)
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SAMHSA’s Readiness Requirements (Mandatory)
To obtain SAMHSA's free rapid HIV test kits, control kits, confirmatory kits, and confirmation laboratory services, eligible service providers are required to meet the following readiness requirements:
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Required Training
Eligible service providers must complete the following trainings:
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Basic fundamentals of HIV/AIDS training, as recognized by the State.
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State-certified HIV counseling and testing reporting (CTR) Services.
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“Fundamentals of Rapid HIV Testing and Prevention Counseling with the OraQuick® Rapid HIV-1 Antibody Test” (provided by SAMHSA or CDC, and States, as required).
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CLIA Certificate Of Waiver
Trained service providers must obtain a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver. Instructions on how to obtain this waiver are available on the Centers for Medicare & Medicaid Services website.
For additional information on the CLIA certificate of waiver, see the CDC's CLIA Certificate of Waiver Fact Sheet.
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State Regulations
Trained service providers must adhere to their State HIV testing regulatory requirements and provide a copy of State compliance documentation on rapid HIV testing (i.e., HIV Prevention Counseling, Partner Notification, Disease Reporting protocol).
The Centers for Medicare & Medicaid Services website provides a CLIA Contact List of State Survey Agencies.
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Linkages To Care
Trained service providers must provide signed Memoranda of Understanding or Agreement demonstrating established referral networks for clients needing appropriate counseling, treatment, and support services.
Linkages to care must consist of, but are not limited to, partnership(s) with:
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Local health departments and AIDS service organizations to secure appropriate HIV/AIDS support resources, including laboratory services;
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HIV/AIDS primary and behavioral health care services;
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Hepatitis services, and
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Other necessary support services (e.g., insurance, housing, food, transportation).
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Rapid HIV Testing Quality Assurance Plan
Trained service providers must provide a copy of their site's rapid HIV testing policies, procedures, and quality assurance (QA) plan (i.e., records management, self-monitoring protocol, test reliability and validity, and use of control kits).
CDC's National Center for HIV, STD, and TB Prevention, Divisions of HIV/AIDS Prevention, is responsible for quality assurance guidelines. See more at Quality Assurance Guidelines for Testing Using the OraQuick® Rapid HIV-1 Antibody Test.
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Participating sites must provide a copy of the following policies and procedures before initiating the RHTI project:
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Informed Consent form – Organizations must have an informed consent form for clients to give consent for confidential or anonymous testing and HIV prevention and risk-reduction counseling.
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Legal/Ethical Policies – Organizations must know their state laws regarding who may implement CTR procedures and disclosure of an individual's HIV status (whether positive or negative) to partners and other parties. Organizations are also obligated to inform clients about state laws regarding the reporting of child abuse, sexual abuse of minors, and elder abuse.
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HIPAA Compliance/Participant Protection and Confidentiality – Organizations must maintain the confidentiality of client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II. For information on HIPAA compliance, visit http://hipaa.samhsa.gov/.
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Safety – Organizations must have guidelines for personal safety and security in non-traditional settings, for assuring minimal safety standards (including biohazard waste disposal) as outlined by the Occupational Safety and Health Administration.
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Volunteers – Organizations using volunteers must follow State requirements.
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Data Security – Organizations must collect and report data consistent with SAMHSA/CDC requirements to ensure data security and confidentiality. This includes written protocols on how to collect and analyze HIV CTR data according to State and local policies.
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Cultural Competence – Throughout the life of the RHTI project, organizations must address cultural competency in relation to the RHTI project's target population, staffing, and materials.
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Participating sites are required to collect and report on several key measures of the RHTI. Written assurances agreeing to provide such data must be submitted to SAMHSA.
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RHTI Partners
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Contact Information
For more information, call 1-877-219-6953, or email us at rhti@samhsa.hhs.gov.
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