Description
Core Elements, Key Characteristics, and Procedures
Resource requirements
Recruitment
Policies and Standards
Quality Assurance
Monitoring and Evaluation
Key Articles and Resources
References

Description

Background
CDC now estimates that approximately 1.1 million adults and adolescents in the United States are living with HIV and many are unaware of their infection. Evidence suggests that many of the new HIV infections each year occur through transmission from persons who are unaware of their HIV status.

CDC is revising its HIV counseling and testing recommendations. Separate recommendations are being developed for HIV counseling, testing and referral in non-healthcare settings.  The guidance provided in this document may change, depending on the results of the revision process; however, until that time, the guidelines in this document should be adhered to.

Specifically, Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings was published in September, 2006. These recommendations have replaced CDC’s 1993 Recommendations for HIV Testing Services for Inpatients and Outpatients in Acute-Care Hospital Settings; and they have updated aspects of CDC’s 2001 Revised Guidelines for HIV Counseling, Testing, and Referrals that apply to health care settings and the 2001 Revised Recommendations for HIV Screening of Pregnant Women. In addition, the process for updating recommendations for HIV testing in non-healthcare settings is under way, with publication expected in 2010.

Goals
HIV Counseling, Testing, and Referral (CTR)^1,2 is a collection of activities designed to increase clients’ knowledge of their HIV status; encourage and support risk reduction; and secure needed referrals for appropriate services (medical, social, prevention, and partner services).

How It Works
Clients can receive CTR at clinics, dedicated sites, and through outreach or other services. CTR can be delivered anonymously or confidentially, but it should be undertaken voluntarily and only with informed consent. Several HIV test technologies have been approved by the Food and Drug Administration; they vary by fluid tested (whole blood, serum, plasma, oral fluids, and urine) and time required to run the test (conventional vs. rapid tests). Testing options facilitate access to testing and increase acceptability of testing.

HIV CTR may be anonymous or confidential. Anonymous means the client’s name is neither known nor solicited and is not recorded. Confidential means the client provides his or her name and may or may not provide additional contact information.

HIV CTR may be provided by self-referrals or by referrals from other related services. Self-referrals means the client initiated the services. Referrals from other related services come from medical or mental health care providers, substance abuse treatment facilities, homeless shelters, and partner services.

HIV CTR can be conducted using rapid or conventional HIV tests. (Please see Rapid HIV Testing in Non-clinical Settings in this document for more information about the rapid HIV test.)

Research Findings
Research demonstrates that after receiving a positive HIV test result, persons generally decrease their risk behavior.³

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Core Elements, Key characteristics, and Procedures

Core Elements
Core elements are those parts of an intervention that must be done and cannot be changed. Core elements are essential and cannot be ignored, added to, or changed.

CTR has the following 8 core elements.  HIV CTR Providers must:

• Ensure that CTR is a voluntary service that can only be delivered after informed consent is obtained.  
• Provide information and education to the client about
• the HIV test and its benefits and consequences
• risk for HIV transmission and how HIV can be prevented
• the type of HIV antibody test available/used
• the meaning of the test result, including the window period for HIV sero-conversion (the time after infection, before antibodies are produced by the body, during which an antibody test might be negative despite the presence of HIV)
• the importance of obtaining test results and explicit procedures for doing so
• where to obtain more information, counseling, or other services (medical, mental health, or substance abuse care, etc)
• Provide client-focused HIV prevention counseling to address the client’s
• readiness for testing
• personal risk assessment
• steps taken to reduce risk
• goals for reducing risk
• realistic plans for achieving those goals
• support systems
• referral needs
• plans for obtaining results, if necessary (if testing is done and the CBO is not using rapid testing)
• Work with the health departments (state, local, or both) and community mental health providers, establish clear and easy guidelines and sobriety standards to help counselors determine when clients are not competent to provide consent.
• Use an HIV testing technology approved by the Food and Drug Administration.
• Deliver test results in a manner that is supportive and understandable to the client.
• Assess referrals in support of risk reduction or medical care, provide appropriate referrals, and help link clients with referral services. A system must be in place for emergency medical or mental health referrals, if needed.
• Track referrals made and completed.

Key Characteristics
Key characteristics are crucial activities that may be tailored for different agencies and at-risk populations.  These are the parts of an intervention (activities and delivery methods) that can be adapted to meet the needs of the organization or target population.

CTR has the following key 5 characteristics.  HIV CTR Providers may:

• Provide information and education about testing in 1 of 3 ways.
• Individual face-to-face sessions
• Small or large group sessions
• Brochures, handouts, videos, or audiotape, or other non-personalized information
• Deliver client-focused counseling and test results in an individual, face-to-face session. Although some providers have given negative test results over the telephone when a face-to-face session was not feasible, it is recommended that positive results be given in person to ensure that the client has the necessary support and completes referrals for care and prevention services.
• Use a variety of specimen types and test types for HIV antibody testing, depending on the setting in which testing is conducted and the needs of the organization and the client.
• Provide service referrals to client’s self-identified priority needs (increases likelihood that referrals will be completed), if possible.
• For clients whose test results are positive, place priority on referrals for medical care, partner counseling and referrals services, and prevention and support services. 

Procedures
Procedures are detailed descriptions of some of the above-listed elements and characteristics.

Although HIV CTR may be conducted in a clinic or dedicated setting or in less conventional places as a part of outreach or other services (Comprehensive Risk Counseling and Services or other prevention interventions), each instance of CTR must follow a similar set of procedures, as follows.

Giving information simply
The client is first given information about HIV and the HIV antibody test. This information must include

• a discussion of the risk factors for HIV and how HIV can be prevented
• the type of test to be used and the manner in which the specimen will be collected
• the difference between anonymous and confidential testing
• the timeframe for testing, including when the results will be available and the importance of obtaining the results
• the meaning of positive and of negative test results
• the window period for HIV sero-conversion (so that the client can determine whether testing at a later time might provide more information)
• the need for partner services if the test result is positive
• the jurisdiction’s requirements for reporting positive test results to the health department

Client-focused counseling. Client-focused counseling techniques should be used to help clients determine their readiness for testing and to provide support systems to access while waiting for and after receiving the test results. Client-focused counseling also assesses the client’s ability to cope with a positive test result.

An individualized risk assessment should be conducted to determine the client’s risk behaviors. This information should be used to help the client better understand his or her risk and to enable the client and the counselor to identify, acknowledge, and understand the details and context of the client’s risk. Keeping the focus of the assessment personal helps the client identify concrete, acceptable protective measures to reduce personal risk for HIV. Factors associated with continued risk behavior that might be important to explore include

• using drugs or alcohol before sexual activity
• underestimating personal risk
• perceiving that taking precautions to reduce risk (e.g., using condoms) are not an accepted peer norm
• perceiving limited ability to change behavior
• perceiving reinforcement for frequent unsafe practices (e.g., receiving a negative HIV test result despite risk behaviors)
• perceiving that vulnerability is associated with luck or fate

The counselor should first acknowledge and provide support for positive steps that the client has already made toward risk reduction. At this point, the counselor should focus more on reducing the client’s current risk and less on general education about HIV transmission modes and the meaning of HIV test results.

Next, the counselor should negotiate a concrete and achievable behavior-change step to further reduce HIV risk. Although the ultimate goal is to eliminate HIV risk behaviors, small behavior changes can reduce the probability of acquiring or transmitting HIV.

Behavioral risk-reduction steps should be

• acceptable to the client and appropriate for the client’s situation
• relevant to reducing the client’s own HIV risk
• focused on reducing the most critical risk the client is willing to commit to changing (for the client with several high-risk behaviors)
• focused on a small, explicit, and achievable goal, not a global goal

Identifying (using interactive discussion, role-playing, recognizing social support, or other methods) the barriers and supports to achieving a step will increase the likelihood of success. In addition, the counselor should help the client build skills for achieving the goal, such as having the client demonstrate proper condom use on a penile model or cleaning of drug paraphernalia (with feedback) or role-playing negotiation of abstinence or safer sex.

Clients with ongoing risk behaviors should be referred to additional prevention and related support services. A structured protocol outlining session goals can help keep the counselor focused on risk reduction and can ensure consistent counseling delivery for all clients. See an example of client-focused counseling.

After all aspects of the HIV antibody test have been disclosed, the client can make an informed decision about whether to be tested. The client should then provide consent (oral or written, as required by state and local policy), indicating his or her willingness to be tested for the presence of HIV antibodies. If testing is anonymous, the client should be informed that providing a sample for testing implies consent.

Testing
A specimen is obtained and a conventional or rapid HIV antibody test is conducted according to the procedures outlined by the test’s manufacturer. A follow-up appointment is scheduled, if necessary or desirable. The counselor should schedule the appointment at the time and place that is most likely to result in the client returning for results.

If conventional HIV antibody testing is used, results are given at a second appointment.

If rapid HIV antibody testing is used, a follow-up appointment may not be needed to deliver test results but may be desirable for additional prevention counseling.

Results should be provided at the beginning of the results-giving session, using explicit language. Counselors should never ask the client to guess the test results. Counselors should, however, clarify test results. (For an explanation of test results, please refer to the Revised Guidelines for HIV Counseling, Testing, and Referrals.¹) Counselors should also discuss the importance of continued commitment to risk reduction.

For clients whose test results are negative, counselors should address personal HIV risk reduction, including reviewing progress on goals set at the previous counseling session.

For clients whose test results are positive, counselors should:

• provide psychological support, refer the client for additional counseling (if needed), or both
• ensure that the client knows where and how to obtain more information and services
• refer the client for medical evaluation, care, and treatment (including screening or care for sexually transmitted diseases, vaccination or treatment for viral hepatitis, and referrals to reproductive health services)
• assess the need for and provide, or make referrals for, other prevention services (individual- or group-level interventions or comprehensive risk counseling and services)
• ensure that the client has accurate information about steps necessary to prevent transmission
• elicit and correct misperceptions about HIV transmission risk and address strategies for prevention of other sexually transmitted diseases or bloodborne infections
• counsel the client about who to notify of his or her positive test result
• discuss and provide or refer the client to partner services

Referrals
Referrals for additional services may be made at any point in the CTR process.

Services could include:

• screening and care for sexually transmitted diseases
• viral hepatitis screening, vaccination, and treatment
• housing
• food
• transportation
• domestic violence services
• reproductive health services
• chemical dependency prevention and treatment
• mental health services
• legal services
• other support services

CTR sites should:

• develop and maintain a referral resource guide
• nurture strong working relationships with the agencies providing the services
• identify key contacts from these agencies
• have formal, written agreements to delineate the roles and responsibilities of each agency
• review referral agreements periodically and modify them as appropriate
• track referrals made and completed
• address barriers to successful referrals, initially and on an ongoing basis

Counselors must consider the most appropriate service provider for each client, considering such things as the client’s culture, language, gender or gender expression, sexual orientation, age, and developmental level. The counselor should work with the client to identify barriers to completing the referral and find ways to overcome those barriers. Referrals are most likely to be completed if they match the priority needs identified by the client and if the counselor is able to provide some personalized information about the agency, including a contact name, eligibility requirements, location, hours of operation, and the telephone number. More than one referral option should be provided, if possible. The referral may be also facilitated if the counselor can phone the service provider for the client; however, the counselor must first have a signed informed consent form to share private information from the client.

Information obtained through follow-up of referrals can identify barriers to completing the referrals, responsiveness of referral services in addressing client needs, and gaps in the referral system. All referrals should be documented and tracked to determine if they were completed.

• If not completed, barriers should be addressed.
• If completed, satisfaction should be assessed and recorded in the referral resource guide.
• If unsatisfactory, new referrals should be made, if possible.

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Resource Requirements

Staff
CTR needs paid or volunteer staff members who are trained in HIV CTR. If rapid HIV testing will be used, involved staff members must also be trained to perform rapid HIV tests. All polices, quality assurance requirements, and local and state requirements related to rapid HIV testing must be followed. The number of staff needed depends on the number of tests to be done and the type of test used (rapid or conventional). The number of tests completed per hour depends on the needs of the clients, the abilities of the staff, and the type of test used.

Space
CTR can be implemented at any location where confidentiality of clients can be assured (e.g., private area or room) and where a specimen can be collected according to minimal standards as outlined by the Occupational Safety and Health Administration. Additionally, if rapid testing is used, the setting must have a flat surface, acceptable lighting, and ability to maintain temperature in the range recommended by the test manufacturer for performing the test.

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Recruitment

The following recruitment strategies can be used to reach clients for CTR:

• Recruit from HIV prevention counseling, Comprehensive Risk Counseling and Services, or other agency services.
• Recruit from other CBOs or agencies that serve populations at high risk for HIV (e.g., substance abuse treatment facilities, correctional facilities, shelters).
• Send press releases and public service announcements to radio stations and TV stations that serve specific populations at high risk for HIV.
• Advertise in local newspapers (e.g., neighborhood, gay, alternative).
• Post announcements on the Internet.

Review the Recruitment section of this document to choose a recruitment strategy that will work in the setting in which the organization plans to implement CTR.

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Policies and Standards

Before a CBO attempts to implement CTR, the following policies and standards should be in place to protect clients, CTR providers, and the CBO:

Confidentiality
A system (e.g., a written protocol) must be in place to ensure that confidentiality is maintained for all participants in the program. Before sharing any information with another agency to which a client is referred, signed informed consent from a client or his or her legal guardian must be obtained.

Cultural Competence
CBOs must strive to offer culturally competent services by being aware of the demographic, cultural, and epidemiologic profile of their communities. CBOs should hire and train all staff to be representative of or sensitive to these different cultures. In addition, they should offer materials and services in the preferred language of clients, if possible, or make translation available. CBOs should involve clients and the community in designing and implementing prevention services to ensure that important cultural issues are incorporated. The Office of Minority Health of the Department of Health and Human Services has published the National Standards for Culturally and Linguistically Appropriate Services in Health Care, which should be used as a guide for ensuring cultural competence in programs and services.

Data Security
To ensure data security and client confidentiality, data must be collected and reported according to CDC requirements.  CBOs should have written protocols on how to collect, document, analyze, and use CTR data according to state and local policies.

Informed Consent
CBOs must have a consent form that carefully and clearly explains (in appropriate language) the CBO’s responsibility and the clients’ rights. Client participation must always be voluntary, and documentation of this informed consent must be maintained in the CBO’s client records. Individual state laws apply to consent procedures for minors; if necessary, consent should be obtained from a legal guardian if the client is a minor or unable to give legal consent.

Legal and Ethical Policies
It is important to keep in mind that CTR deals with the provision of services that require specialized training and deals with private client medical information. CBOs must know their state laws regarding who may implement CTR procedures and about disclosure of a client’s HIV status (whether positive or negative) to sex partners and other third parties. CBOs must know and follow all applicable state and local laws, regulations, and policies related to reporting of HIV test results to the health department. CBOs must inform clients about state laws regarding the reporting of child abuse, sexual abuse of minors, and elder abuse or imminent danger or harm. 

Referrals
CBOs must be prepared to refer clients as needed. For clients who need additional help decreasing risk behavior, providers must know about referrals sources for prevention interventions and counseling, such as partner services and health department and CBO prevention programs for persons living with HIV.  Consent for release of information to other agencies must be obtained as well as any inter-agency referral forms must be completed.

Safety
CTR provided in nonconventional settings may pose potentially unsafe situations (e.g., the risk of transmitting bloodborne pathogens). CBOs should develop and maintain written detailed guidelines for personal safety and security; for assuring minimal safety standards (including biohazard waste disposal) as outlined by the Occupational Safety and Health Administration; and for safeguarding the security of the data collected, client confidentiality, and the chain of custody for testing supplies and collected client specimens. CBOs must ensure that CTR providers are aware of and comply with safety guidelines.

Volunteers
If the CBO uses volunteers to assist with or conduct CTR activities, then the CBO should know and disclose how their liability insurance and worker’s compensation applies to volunteers. CBOs must ensure that volunteers also receive the same training and are held to the same performance standards as employees. All training should be documented. CBOs must also ensure that volunteers sign and adhere to a confidentiality statement.

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Quality Assurance

The following quality assurance activities should be in place when implementing CTR:

Counselors
Qualifications
Providers of CTR should have the following skills and characteristics:

• Completion of standard training courses in client-focused HIV prevention counseling or other risk-reduction counseling models
• Belief that counseling can make a difference
• Understand and be skilled in the counseling process 
• Active listening skills
• Ability to use open-ended rather than closed-ended questions
• Ability and comfort with an interactive negotiating style rather than a persuasive approach
• Ability to engender a supportive atmosphere and build trust with the client
• Interest in learning new counseling and skill-building techniques
• Being informed regarding specific HIV transmission risks
• Comfort in discussing specific HIV risk behaviors (i.e., explicit sex or drug behaviors)
• Ability to remain focused on risk-reduction goals
• Support for routine, periodic, quality assurance measures
• Skilled in eliciting behavioral information and providing prevention messages

Training
A training program should be in place for all new employees, existing employees, and volunteers who will be providing CTR. This program should ensure that all CTR providers receive

• adequate training
• competency assessment
• annual training updates
• continuing education
• adequate supervision to implement CTR and, if performed, the rapid HIV test

The program should also ensure that CTR providers are skilled and competent in the provision of services (by using observed practice of CTR sessions with feedback to counselors and of rapid HIV test procedures, if needed).

Supervision
A review mechanism should be in place to assure that all testing protocols are followed as written. Quality assurance activities can include observation as well as role-playing demonstration of skills. The review should focus on ensuring that the protocol is delivered with consistency and responsiveness to expressed client needs and should help counselors develop skills for delivering the intervention.

Records
Selected record reviews should focus on assuring that consent was obtained or documented for all clients and that all process and outcome measures were completed as required. Records should be securely stored, periodically reviewed, and destroyed when outdated (how long test result records are kept as part of a medical record may be subject to state or other requirements).

Clients
Clients' satisfaction with the services and their comfort should be assessed periodically.

Setting
Supervisors should periodically review the setting to ensure that it is private and confidential and that the waiting time for a test at this setting does not create a barrier to testing.

Troubleshooting
The CBO should have a method to detect and resolve problems that occur.  This should specify how to document problems and actions taken (such as having a logbook where problems and corrective actions taken can be recorded) and how to verify that corrective actions taken addressed the problem.

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Monitoring and Evaluation

Specific guidance on the collection and reporting of program information, client-level data, and the program performance indicators will be distributed to agencies after notification of award.

General monitoring and evaluation reporting requirements for the programs listed in the procedural guidance will include the collection of standardized process and outcome measures.  Specific data reporting requirements will be provided to agencies after notification of award. For their convenience, grantees may utilize PEMS software for data management and reporting.  PEMS is a national data reporting system that includes a standardized set of HIV prevention data variables, web-based software for data entry and management. CDC will also provide data collection and evaluation guidance and training and PEMS implementation support services.

Funded agencies will be required to enter, manage, and submit data to CDC by using PEMS or other software that transmits data to CDC according to data requirements.  Furthermore, agencies may be requested to collaborate with CDC in the implementation of special studies designed to assess the effect of HIV prevention activities on at-risk populations.

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Key Articles and Resources

CDC. Draft CDC Technical Assistance Guidelines for CBO HIV Prevention Program Performance Indicators. Atlanta, GA: US Department of Health and Human Services, CDC; November 2003.

CDC. MMWR 2008, Vol. 57, #39, pp. 1073-1076.

CDC. Project RESPECT counseling, testing, and referral protocol.

CDC. Rapid HIV testing.

CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50 RR-19: 1–58.

US Department of Health and Human Services, Office of Minority Health. National Standards for Culturally and Linguistically Appropriate Services in Health Care. Washington, DC: US Department of Health and Human Services; 2001.

US Department of Labor, Occupational Safety and Health Administration. Occupational Safety and Health Standards. Toxic and Hazardous Substances. Bloodborne Pathogens. Part 1910.1030, Appendix A.

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References

1. CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR. 2001; 50(RR-19): 1–58. Available at: .
2. Powderly WG, Mayer KH. Centers for Disease Control and Prevention revised guidelines for human immunodeficiency virus (HIV) counseling, testing, and referral: targeting HIV specialists. Clinical Infectious Diseases. 2003; 37:813–819.
3. Marks G, Crepaz N, Senterfitt JW, Janssen RS. Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States: Implications for HIV prevention programs. Journal of Acquired Immune Deficiency Syndromes. 2005;39;446–453.
4. CDC. Advancing HIV prevention: new strategies for a changing epidemic. MMWR. 2003; 52;15:329–332.

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Incorporating HIV Prevention into the Medical Care of Persons Living with HIV