Revised Guidelines for HIV Counseling, Testing, and Referral

Technical Expert Panel Review of CDC HIV Counseling, Testing, and Referral Guidelines

February 18--19, 1999
Atlanta, Georgia

Terje J. Anderson
National Association of People with AIDS
Washington, D.C.

David Atkins, M.D., M.P.H.
Agency for Healthcare Research and Quality
Rockville, Maryland

Catherine Baker-Cirac
California Office of AIDS
Sacramento, California

Ronald Bayer, Ph.D.
Columbia University
New York, New York

Frank K. Beadle de Palomo, M.A.
Academy for Educational Development
Washington, D.C.

Gail A. Bolan, M.D.
California Department of Health
Berkeley, California

Carol A. Browning, M.S.
Rhode Island Department of Health
Providence, Rhode Island

Scott Burris, J.D.
Temple University
Philadelphia, Pennsylvania

Amy S. DeGroff, M.P.H.
Centers for Disease Control and Prevention (CDC)
Atlanta, Georgia

John M. Douglas, M.D.
Denver Public Health
Denver, Colorado

Martin Fishbein, Ph.D.
University of Pennsylvania
Philadelphia, Pennsylvania

Alice A. Gandelman, M.P.H.
California STD Control Branch
Berkeley, California

Cynthia A. Getty
CDC
Atlanta, Georgia

Lawrence O. Gostin, J.D., L.L.D.
Georgetown University
Washington, D.C.

Khurram S. Hassan, M.P.H.
United Way of Metro Atlanta
Atlanta, Georgia

Thomas L. Hearn, M.S., Ph.D.
CDC
Atlanta, Georgia

Michael P. Johnson, M.D., M.P.H.
Health Resources and Services Administration
Rockville, Maryland

William J. Kassler, M.D., M.P.H.
New Hampshire Department of Health & Human Services
Concord, New Hampshire

Marlene LaLota, M.P.H.
Florida Department of Health
Tallahassee, Florida

Michael K. Lindsay, M.D., M.P.H.
Emory University
Atlanta, Georgia

Michael H. Merson, M.D.
Yale University
New Haven, Connecticut

Stephen F. Morin, M.A., Ph.D.
University of California, San Francisco
San Francisco, California

James Pearson, M.P.H., Ph.D.
Division of Consolidated Laboratory Services
Richmond, Virginia

Beny J. Primm, M.D.
Urban Resources Institute
Brooklyn, New York 

Joel Rosenstock, M.D., M.P.H.
Infectious Disease Solutions, P.C.
Atlanta, Georgia

Peter Salovey, Ph.D.
Yale University
New Haven, Connecticut

Charles A. Schable, M.S.
CDC
Atlanta, Georgia

Kathleen J. Sikkema, Ph.D.
Yale University
New Haven, Connecticut

Edith Springer, M.S.W.
Edith Springer Associates
Brooklyn, New York

Janis Spurlock-McLendon, M.S.W.
Connecticut Department of Public Health
Hartford, Connecticut

Lee Trevithick, M.A.
Cocoon House
Everett, Washington

James Welch
Division of Public Health
Dover, Delaware 

The following CDC staff members prepared this report:
Beatrice T. Divine, M.A.
Stacie M. Greby, D.V.M., M.P.H.
Kenneth V. Hunt
Mary L. Kamb, M.D., M.P.H.
Richard W. Steketee, M.D., M.P.H.
Lee Warner, M.P.H.
Division of HIV/AIDS Prevention --- Surveillance and Epidemiology
National Center for HIV, STD, and TB Prevention

in consultation with
Liisa M. Randall, M.A.
National Alliance of State and Territorial AIDS Directors

Summary

• giving guidance to all providers of voluntary HIV CTR in the public and private sectors;
• using an evidence-based approach to provide specific recommendations for CTR;
• underscoring the importance of early knowledge of HIV status and making testing more accessible and available;
• acknowledging providers' need for flexibility in implementing the guidelines, given their particular client base, setting HIV prevalence level, and available resources;
• recommending that CTR be targeted efficiently through risk screening and other strategies; and
• addressing ways to improve the quality and provision of HIV CTR.

INTRODUCTION

Purpose of the Guidelines

These guidelines were developed for policy makers and service providers in the many settings that offer voluntary human immunodeficiency virus (HIV) counseling, testing, and referral (CTR) --- public and private, urban and rural, and those with high and low HIV prevalence. The guidelines are intended to be used to develop CTR services and policies in traditional clinical settings (e.g., sexually transmitted disease [STD] clinics, private physicians' offices) and nontraditional settings (e.g., community-based or outreach settings [homeless shelters, bars]), which can be important places to provide access to CTR to persons at increased HIV risk. The Public Health Service is responsible for ensuring the quality of services in publicly funded programs, and many aspects of these guidelines focus on such programs. The guidelines could also be useful for CTR in other settings (e.g., for insurance, military, and blood donation purposes). Recommendations should be tailored to fit the needs of clients, communities, and programs within local, state, and federal rules and regulations.

Evolution of the Guidelines

These guidelines revise and update several sets of CDC guidelines for HIV CTR. The first CDC guidelines, published in 1986, highlighted the importance of offering voluntary testing and counseling and maintaining confidential records (1). In 1987, new guidelines emphasized the need to decrease barriers to counseling and testing, especially disclosure of personal information (2). In 1993, an additional report described the model of HIV prevention counseling currently recommended --- an interactive rather than didactic model focusing on a personalized HIV risk-reduction plan (3). In 1994, HIV Counseling, Testing and Referral Standards and Guidelines focused on standard counseling and testing procedures and reiterated the importance of the HIV prevention counseling model and the need for confidentiality of counseling (4).

Because of recent advances in HIV treatment and prevention (5--32), CDC consulted with multiple partners to revise the 1994 guidelines using an evidence-based approach (33,34) and to expand the target audience to all providers of HIV CTR in the United States (33). Where scientific findings were lacking, recommendations were guided by "best practices" from specialists in the field. These guidelines were developed through the following five-step approach:

• Address user needs. A survey was conducted of publicly funded sites that offer HIV CTR to assess user satisfaction with the 1994 CDC guidelines for HIV CTR. Internal and external content specialists were consulted on key areas to address.
• Review scientific literature. Approximately 5,000 abstracts were screened and approximately 600 relevant publications were reviewed and synthesized where appropriate. Approximately 20 previously published CDC guidelines related to HIV CTR also were summarized.
• Obtain technical opinion. A panel of technical specialists from public and private sectors; governmental and nongovernmental agencies; and legal, ethics, and policy fields was convened to review the recommendations.
• Obtain user input. Internal CDC comments, public and private provider assessments, key consultant interviews, broad external reviews, and public comments through the Federal Register were obtained.
• Publish electronically and in hard copy. Single copies of this report are available from CDC's National Prevention Information Network (NPIN) website at http://www.cdcnpin.org or by calling (800) 458-5231. The guidelines are also available at the HIV Counseling, Testing, and Referral website at http://www.cdc.gov/hiv/ctr. They will be updated and posted periodically.

Similarities and Differences Between Current and Previous Guidelines

Aspects of previous CDC HIV guidelines that are unchanged include

• encouraging availability of anonymous as well as confidential HIV testing;
• ensuring that HIV testing is informed, voluntary, and consented;
• emphasizing access to testing and effective provision of test results;
• advocating routine recommendation of HIV CTR in settings (e.g., publicly funded clinics) serving clients at increased behavioral or clinical risk for HIV infection;
• recommending use of a prevention counseling approach aimed at personal risk reduction for HIV-infected persons and persons at increased risk for HIV; and
• stressing the need to provide information regarding the HIV test to all who take the test.

Differences in the new guidelines include

• giving guidance to all providers of voluntary HIV CTR in the public and private sectors;
• using an evidence-based approach to provide specific recommendations for CTR;
• underscoring the importance of early knowledge of HIV status and making HIV testing more accessible and available;
• acknowledging providers' need for flexibility in implementing the guidelines, given their particular client base, setting HIV prevalence level, and available resources;
• recommending that CTR be targeted efficiently through risk screening and other strategies; and
• addressing ways to improve the quality and provision of HIV CTR.

Advances in HIV/AIDS Prevention and Treatment Interventions

During the past 2 decades, HIV infection and severe HIV-related diseases (e.g., acquired immunodeficiency syndrome [AIDS]) have become a leading cause of illness and death in the United States. As of December 31, 2000, a total of 774,467 persons were reported with AIDS, and 448,060 of these persons had died; the number of persons living with AIDS (322,865) was the highest ever reported (35). Approximately 800,000--900,000 persons in the United States are infected with HIV, and approximately 275,000 of these persons might not know they are infected (36).

Since the last CTR guidelines were published, many advances have been made in HIV/AIDS prevention and treatment, including development of effective antiretroviral therapies that have reduced HIV-related illness and death. However, although medical treatment has improved the quality and length of life for HIV-infected persons, it cannot cure HIV disease. Furthermore, the successes of new medical therapies might have led to relaxed attitudes toward safer sex (e.g., increased incidence of unprotected anal sex by young men who have sex with men) by HIV-infected persons and uninfected persons at increased risk (36,37). Additional advances include improved understanding of HIV transmission; a wider array of HIV test technologies; effective prevention counseling approaches; and practical, beneficial referral strategies --- all of which could reduce the impact of the HIV epidemic in the United States.

Early knowledge of HIV infection is now recognized as a critical component in controlling the spread of HIV infection (38). Cohort studies have demonstrated that many infected persons decrease behaviors that transmit infection to sex or needle-sharing partners once they are aware of their positive HIV status (39--46). HIV-infected persons who are unaware of their infection do not reduce risk behaviors (42,47--49). Persons tested for HIV who do not return for test results might even increase their risk for transmitting HIV to partners (50). Because medical treatment that lowers HIV viral load might also reduce risk for transmission to others (51), early referral to medical care could prevent HIV transmission in communities while reducing a person's risk for HIV-related illness and death.

The array of HIV test technologies available has expanded, possibly enhancing a person's willingness to be tested and learn his or her HIV status. HIV tests can use specimens collected by less-invasive methods (e.g., oral fluid, urine, and finger-stick blood), in addition to serum specimens collected by venipuncture. Rapid HIV testing allows clients to receive results the same day, which is useful in urgent medical circumstances and settings where clients tend not to return for HIV test results (e.g., some STD clinics). HIV testing can also be conducted using commercially available home sample collection devices (52).

Also during the 1990s, randomized controlled trials demonstrated that, for persons at increased HIV risk, certain prevention counseling approaches can be effective in reducing high-risk behaviors and new sexually transmitted infections (5,18--21). The counseling approach used is critical to effectiveness; interactive counseling approaches directed at a client's personal risk and the situations in which risk occurs are more effective than didactic, informational approaches (5). Because personalized prevention counseling can require more provider time and training than traditional counseling approaches, providing it to everyone receiving HIV testing might not be feasible. This recognition has led to a new area of health services research --- developing strategies that effectively target CTR services to persons most likely to benefit from them.

The improved health of HIV-infected persons on antiretroviral therapy, along with new test technologies and effective counseling approaches, has contributed to an improved understanding of the importance of referral to needed services. In addition, new guidelines for partner counseling and referral services (PCRS) (27) and prevention case management (28) were developed specifically for publicly funded clinics and could also be useful to providers in other settings. Specialists in the field have also identified situations in which additional counseling or psychosocial support services might benefit HIV prevention efforts. Finally, advances in several areas have led to new guidelines for preventing mother-to-child transmission, treating opportunistic infections (23,53) and other sexually transmitted (29) and bloodborne diseases (30--32), and managing occupational and nonoccupational exposure and prophylaxis (54,55). These developments were considered in the formulation of the new CTR guidelines.

Despite these advances in HIV prevention and care, a substantial number of opportunities for HIV prevention through CTR are missed. At publicly funded sites, approximately 70% of persons tested received their results and information regarding the test, but fewer persons likely received HIV prevention counseling and referrals. In private settings, a lower proportion of all clients are tested, and few receive prevention counseling and referrals (56--59). In many potential testing settings (e.g., emergency departments), HIV prevention counseling and testing are not uniformly offered, and data regarding types, completion, and effectiveness of referrals are not routinely collected.

Goals of HIV CTR

• Ensure that HIV-infected persons and persons at increased risk for HIV
  • have access to HIV testing to promote early knowledge of their HIV status;
  • receive high-quality* HIV prevention counseling to reduce their risk for transmitting or acquiring HIV; and
  • have access to appropriate medical, preventive, and psychosocial support services.
• Promote early knowledge of HIV status through HIV testing and ensure that all persons either recommended or receiving HIV testing are provided information regarding transmission, prevention, and the meaning of HIV test results.

Principles of HIV CTR

Effective HIV CTR is based on the following principles:

• Protect confidentiality of clients who are recommended or receive HIV CTR services. Information regarding a client's use of HIV CTR services should remain private (i.e., confidential). Personal information should not be divulged to others in ways inconsistent with the client's original consent.
• Obtain informed consent before HIV testing. HIV testing should be voluntary and free of coercion. Informed consent before HIV testing is essential. Information regarding consent may be presented orally or in writing and should use language the client can understand. Accepting or refusing testing must not have detrimental consequences to the quality of care offered. Documentation of informed consent should be in writing, preferably with the client's signature. State or local laws and regulations governing HIV testing should be followed.
  Information regarding consent may be presented separately from or combined with other consent procedures for health services (e.g., as part of a package of tests or care for certain conditions). However, if consent for HIV testing is combined with consent for other tests or procedures, the inclusion of HIV testing should be specifically discussed with the client. For a discussion of HIV testing in pregnant women, consult the guidelines for HIV screening of pregnant women.
•  Provide clients the option of anonymous HIV testing. Anonymous testing (i.e., consented voluntary testing conducted without a client's identifying information being linked to testing or medical records, including the request for testing or test results) has been used widely and effectively. Anonymous testing can benefit the health of individual persons and the public by prompting earlier entry into medical care (60). Persons who would otherwise not be tested might seek anonymous HIV testing and learn their HIV status. Consistent with public health best practices, states in which anonymous testing is not available should reconsider their policy. When the client has no clear preference regarding testing type, confidential testing (i.e., information documented in client's record) should be recommended to promote receipt of test results and linkage to follow-up counseling and referral for needed services. Clients opting for anonymous testing should be informed that the provider cannot link the client's test result to the client by name. Therefore, if the client does not return for test results, the provider will not be able to contact the client with those results.
• Provide information regarding the HIV test to all who are recommended the test and to all who receive the test, regardless of whether prevention counseling is provided. The information should include a description of ways in which HIV is transmitted, the importance of obtaining test results, and the meaning of HIV test results.
• Adhere to local, state, and federal regulations and policies that govern provision of HIV services. Laws at the local, state, and federal levels might address aspects of HIV services or regulate how services are provided to particular persons (e.g., minors). In addition, policies, local ordinances, funding source requirements, and planning processes could also affect a provider's decisions regarding which services to provide and how to provide them.
• Provide services that are responsive to client and community needs and priorities. Providers should work to remove barriers to accessing services and tailor services to individual and community needs. To ensure that clients find services accessible and acceptable, services can be offered in nontraditional settings (i.e., community-based or outreach settings); hours of operation can be expanded or altered; unnecessary delays can be eliminated (e.g., integrating counseling and testing for STDs/HIV with counseling and testing for hepatitis); test results can be obtained more easily (e.g., with rapid testing or by telephone in certain situations); and less-invasive specimen collection can be used (e.g., oral fluid, urine, or finger-stick blood).
• Provide services that are appropriate to the client's culture, language, sex, sexual orientation, age, and developmental level. These factors could affect how the client seeks, accepts, and understands HIV services. Providers should consider these factors when designing and providing HIV services to increase the likelihood of return for test results and acceptance of counseling and referral services.
• Ensure high-quality services. To ensure ongoing, high-quality services that serve client and community needs, providers should develop and implement written protocols for CTR and written quality assurance and evaluation procedures. Many state and local health departments have substantial expertise in providing and monitoring the quality of HIV CTR services and can be a resource to private providers or community-based or outreach settings initiating these services.

TARGETED VERSUS ROUTINELY RECOMMENDED HIV CTR

Providers in all settings (traditional and nontraditional) should ideally recommend CTR to all clients on a routine basis to ensure that all clients who could benefit from CTR receive these services. However, resources might be insufficient to permit this practice. Therefore, these guidelines contain recommendations aimed at ensuring that as many persons as possible who are HIV-infected or at risk for HIV who do not know their HIV status have access to testing, prevention counseling, and referrals.

Routinely Recommending CTR to All Clients Versus Targeting CTR to Selected Clients

Studies have documented that, in settings serving clients at increased behavioral and clinical risk for HIV infection, targeting HIV testing based on reported risk factors will miss many HIV-infected clients (61--69). However, in low prevalence settings, where most clients have minimal risk, targeting clients for HIV testing based on risk screening might be more feasible for identifying small numbers of HIV-infected persons (70). Providers should consider three factors in determining whether to recommend HIV CTR to all clients or to target only selected clients.

• Type of setting.
• HIV prevalence of the setting.
• Behavioral and clinical HIV risk of the individual clients in the setting.

Although certain types of settings serve populations at increased risk (e.g., STD clinics), others might serve individual clients at increased risk (e.g., private physicians' offices in areas of low prevalence). Individual risk can be ascertained through risk screening. Under certain circumstances --- perinatal transmission, acute occupational exposure, and acute nonoccupational (i.e., high-risk sexual or needle-sharing) exposure --- providers should recommend HIV CTR regardless of setting prevalence or behavioral or clinical risk, based on the respective guidelines (54,55).

Using Prevalence Data to Establish Service Priorities

Few data exist to define "high" and "low" HIV prevalence and describe how these definitions could help develop and prioritize HIV CTR services. A study conducted in the early 1990s for acute care hospitals with >1% HIV prevalence reported that routine voluntary HIV testing of all patients within a specific age range could be a feasible way to identify a large proportion of HIV-infected patients (71). This 1% prevalence can be used as general guidance for whether to routinely recommend or target HIV counseling and testing in other settings.

The threshold of HIV prevalence that should lead to routine recommendations for HIV testing of all clients within a setting can vary within and across settings and should be set in consideration of available resources. Services could be routinely recommended in settings with HIV prevalence rates <1% but higher than other settings in the community, according to U.S. prevalence data (72). If HIV prevalence data are outdated or unknown, providers should consult their local or state health department for assistance in determining appropriate HIV CTR strategies. Alternatively, providers could employ routine voluntary testing to obtain information on prevalence in their particular settings.

Because of the availability of antiretroviral therapy to reduce the risk for perinatal HIV transmission, all pregnant women should be recommended HIV testing regardless of setting prevalence or behavioral or clinical risk .

Determining Individual HIV Risk Through Risk Screening**

A client's individual HIV risk can be determined through risk screening based on self-reported behavioral risk and clinical signs or symptoms. Behavioral risks include injection-drug use or unprotected intercourse with a person at increased risk for HIV. Clinical signs and symptoms include STDs, which indicate increased risk for HIV infection, or other signs or symptoms (e.g., of acute retroviral or opportunistic infections), which might suggest the presence of HIV infection. Insufficient data exist to support the efficacy of any one risk-screening approach over others (e.g., face-to-face discussion or interviews, self-administered questionnaires, computer-assisted interviews, or simple open-ended questions asked by providers) (61,70).

Recommendations for Routinely Recommended and Targeted CTR by Setting and Circumstance

Decisions regarding whether to recommend routine or targeted services are based on the behavioral and clinical HIV risk of the client population in the setting, the level of HIV prevalence of the setting, and the behavioral and clinical HIV risk of individual clients.  These factors should not be used to determine recommendations for CTR in circumstances in which treatment potential exists (i.e., perinatal transmission and acute occupational or nonoccupational exposure).

Settings Serving Populations at Increased Behavioral or Clinical Risk

HIV CTR should be routinely recommended for all clients in settings where the client population is at increased behavioral or clinical risk for acquiring or transmitting HIV infection, regardless of setting prevalence.  These services should be provided on-site. In these settings, clients with ongoing risk behaviors should be linked to additional HIV prevention and support services (e.g., PCRS, drug or alcohol prevention and treatment), as appropriate. HIV-infected clients should receive ongoing HIV prevention counseling applicable to their personal situation.

Low Prevalence Settings

In low prevalence settings (e.g., <1%, see Using Prevalence Data to Establish Service Priorities) where the client population is generally not at increased behavioral or clinical HIV risk, CTR should be targeted to clients based on risk screening.  Prevention counseling and referral are recommended for persons at increased risk even if HIV testing is declined. Any client who requests HIV testing should receive it, regardless of risk. These settings likely represent most health-care settings.

High Prevalence Settings

In high prevalence settings (e.g., >1%), all clients should be routinely recommended HIV testing.  Risk screening should be used to determine if HIV prevention counseling and referral should also be recommended. CTR should be provided on-site. In these settings, clients with ongoing risk behaviors identified during risk screening should be linked to additional HIV prevention and support services (e.g., PCRS and drug or alcohol prevention and treatment), as appropriate.

Circumstances For Which HIV Preventive Treatment Exists

Prophylaxis exists for a limited number of situations: perinatal transmission, acute occupational exposure, and acute nonoccupational (i.e., high-risk sexual or needle-sharing) exposure. Regardless of population risk, setting prevalence, or individual behavioral or clinical risk, voluntary HIV testing should be routinely recommended to a) all pregnant women, b) clients with acute occupational exposure, and c) clients with acute nonoccupational (e.g., high-risk sexual or needle-sharing) exposure. Regardless of whether a client receives an HIV test, HIV prevention counseling and referral should target pregnant women based on risk screening and be routinely recommended to clients with either acute occupational or nonoccupational exposures. For further information, consult the respective guidelines on perinatal transmission, acute occupational exposure, and acute nonoccupational exposure (Revised Recommendations for HIV Screening of Pregnant Women,54,55).

A Framework for Implementing HIV CTR

CTR are interrelated interventions that ideally should be integrated and offered in all settings. However, these guidelines acknowledge public and private providers' needs for flexibility. Certain providers might be able to offer prevention counseling but not an HIV test, whereas others might be able to offer an HIV test but not prevention counseling. Although all providers in settings serving populations at increased behavioral or clinical risk for HIV (e.g., STD clinics) should provide HIV CTR on-site, not all can. These providers should maintain clear and appropriate methods of referral to providers of prevention counseling or testing elsewhere. To ensure client referral, providers who offer HIV counseling and testing should collaborate with providers serving populations at increased risk for HIV who might not provide these services.

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HIV COUNSELING

HIV counseling seeks to reduce HIV acquisition and transmission through the following:

• Information. Clients should receive information regarding HIV transmission and prevention and the meaning of HIV test results. Provision of information is different from informed consent.
• HIV prevention counseling. Clients should receive help to identify the specific behaviors putting them at risk for acquiring or transmitting HIV and commit to steps to reduce this risk. Prevention counseling can involve >1 sessions.

Information

All clients who are recommended or who request HIV testing should receive the following information, even if the test is declined:

• Information regarding the HIV test and its benefits and consequences.
• Risks for transmission and how HIV can be prevented.
• The importance of obtaining test results and explicit procedures for doing so.
• The meaning of the test results in explicit, understandable language.***
• Where to obtain further information or, if applicable, HIV prevention counseling.
• Where to obtain other services (see Typical Referral Needs).

In certain settings where HIV testing is offered, other useful information includes a) descriptions or demonstrations of how to use condoms correctly; b) information regarding risk-free and safer sex options (73); c) information regarding other sexually transmitted and bloodborne diseases; d) descriptions regarding the effectiveness of using clean needles, syringes, cotton, water, and other drug paraphernalia; e) information regarding drug treatment; and f) information regarding the possible effect of HIV vaccines on test results for persons participating in HIV vaccine trials (see Additional Counseling Considerations for Special Situations and Positive HIV Test Results).

For efficiency, information can be provided in a pamphlet, brochure, or video rather than a face-to-face encounter with a counselor. This approach allows the provider to focus face-to-face interactions on prevention counseling approaches proven effective with persons at increased risk for HIV infection. Information should be provided in a manner appropriate to the client's culture, language, sex, sexual orientation, age, and developmental level. Certain informational videos and large-group presentations that provide explicit information regarding correct use of condoms have proven effective in reducing new STDs (19--21,74) and could be effective in reducing HIV.

HIV Prevention Counseling

HIV prevention counseling should focus on the client's own unique circumstances and risk and should help the client set and reach an explicit behavior-change goal to reduce the chance of acquiring or transmitting HIV. HIV prevention counseling is usually, but not always, conducted in the context of HIV testing. The client-centered**** HIV prevention counseling model involves two brief sessions (4,5,75), whereas other effective models are longer or involve more sessions (5--8,10,11,13--18,76--79). Regardless of the model used, in HIV prevention counseling, the counselor or provider focuses on assessing the client's personal risk or circumstances and helping the client set and reach a specific, realistic, risk-reduction goal. These guidelines avoid using the terms "pretest" and "posttest" counseling to underscore that prevention counseling is a risk-reduction process that might involve only one or >1 session.

Several models for HIV prevention counseling in conjunction with HIV testing have been developed, evaluated in controlled studies, and documented to be efficacious in changing behavior or reducing sexually transmitted infections, including individual face-to-face counseling (5,12), large- and small-group counseling with a facilitator (6,16,18,79), and video-based counseling (19). For more information regarding interventions, see The Compendium of HIV Prevention Interventions with Evidence of Effectiveness at http://www.cdc.gov/hiv/pubs/hivcompendium.pdf.

Client-Centered HIV Prevention Counseling

Since 1993, CDC has recommended one interactive counseling model, called client-centered HIV prevention counseling (3,4), which involves two face-to-face sessions with a provider or counselor (3--5,75,80). This model has traditionally used a two-step HIV testing approach in which clients are physically present at a setting for the HIV test (initial session) and then return for HIV test results (follow-up session). Each session might require 15--20 minutes (including testing and referral) for clients at increased risk for HIV, but could take only a few minutes for those at lower risk. In the first session, a personalized risk assessment***** encourages clients to identify, understand, and acknowledge the behaviors and circumstances that put them at increased risk for acquiring HIV. The session explores previous attempts to reduce risk and identifies successes and challenges in these efforts. This in-depth exploration of risk allows the counselor to help the client consider ways to reduce personal risk and commit to a single, explicit step to do so. In the second session, when HIV test results are provided, the counselor discusses the test results, asks the client to describe the risk-reduction step attempted (and acknowledges positive steps made), helps the client identify and commit to additional behavioral steps, and provides appropriate referrals (e.g., to PCRS).

In one large, randomized, controlled trial, this model was reported to be

• effective at reducing high-risk sexual behaviors and new STDs (5);
• feasible to use even in busy publicly funded clinics;
• acceptable to clients, counselors, and health-care providers (80); and
• cost-effective at preventing STDs in persons at increased risk for HIV (81--83).

The model was reported to be especially effective among adolescents and persons with ongoing sexual risk behaviors (e.g., newly diagnosed STDs) (5). Although the benefits of client-centered HIV prevention counseling in reducing high-risk drug behaviors are unknown, studies have indicated that similar counseling approaches that help clients explore risks and set specific risk-reduction goals reduce risky drug use behaviors (39--41,84).

Observational studies and reviews of programs in various settings have indicated that many counselors are still unfamiliar with the specific goals of the client-centered HIV prevention counseling model (75,85) (Amy S. DeGroff, M.P.H., written communication, 2000). Because "client-centered" is sometimes misinterpreted as "face-to-face," providers in many HIV test sites deliver face-to-face informational messages in response to a generic checklist risk assessment. This type of counseling provides advice rather than encouraging client participation or discussion of personal risk; it seldom focuses on personal goal setting. "Client-centered" can also be misinterpreted to mean that the counselor should avoid directing the session. Although attentive listening and respect for clients' concerns are important elements of effective counseling, the primary goal of client-centered HIV prevention counseling is risk reduction. HIV prevention counseling usually requires provider training and support and ongoing quality assurance to achieve optimal benefit. Providers can contact their state health department's HIV/AIDS program office for information on local training opportunities. For information on client-centered counseling with rapid testing, see Addressing Barriers to HIV Prevention Counseling.

Elements of HIV Prevention Counseling

Regardless of the HIV prevention counseling model used, some counseling elements have been used repeatedly in effective interventions and are recognized by many specialists as critical in counseling success (Technical Expert Panel Review of CDC HIV Counseling, Testing, and Referral Guidelines; February 18--19, 1999; Atlanta, Georgia).

The following elements should be part of all HIV prevention counseling sessions:

• Keep the session focused on HIV risk reduction. Each counseling session should be tailored to address the personal HIV risk of the client rather than providing a predetermined set of information. Although counselors must be willing to address problems that pose barriers to HIV risk reduction (e.g., alcohol use in certain situations), counselors should not allow the session to be distracted by the client's additional problems unrelated to HIV. Certain counseling techniques (e.g., open-ended questions, role-play scenarios, attentive listening, and a nonjudgmental and supportive approach) can encourage the client to remain focused on personal HIV risk reduction.
• Include an in-depth, personalized risk assessment. Sometimes called "enhancing self-perception of risk," risk assessment allows the counselor and client to identify, acknowledge, and understand the details and context of the client's HIV risk (17,86,87). Keeping the assessment personal, instead of global, will help the client identify concrete, acceptable protective measures to reduce personal HIV risk. The risk assessment should explore previous risk-reduction efforts and identify successes and challenges in those efforts. 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 precautionary changes are not an accepted peer norm, perceiving limited self-efficacy for successful change efforts, receiving reinforcement for frequent unsafe practices (e.g., a negative HIV test result after risk behaviors), and perceiving that vulnerability is associated with "luck" or "fate" (86--89).
• Acknowledge and provide support for positive steps already made. Exploring previous risk-reduction efforts is essential for understanding the strengths and challenges faced by the client in reducing risk. Support for positive steps already taken increases the clients' beliefs that they can successfully take further HIV risk-reduction steps. For some clients, simply agreeing to an HIV test is an important step in reducing risk (5,75).
• Clarify critical rather than general misconceptions. In most situations, counselors should focus on reducing the client's current risk and avoid discussions regarding HIV transmission modes and the meaning of HIV test results. However, when clients believe they have minimal HIV risk but describe more substantial risk, the counselor should discuss the HIV transmission risk associated with specific behaviors or activities the clients describe and then discuss lower-risk alternatives (73). For example, if clients indicate that they believe oral sex with a risky sex partner poses little or no HIV risk, the counselor can clarify that, although oral sex with an infected partner might result in lower HIV transmission risk than anal sex, oral sex is not a risk-free behavior, particularly when commonly practiced. If clients indicate that they do not need to be concerned about HIV transmission among needle-sharing partners if they use clean needles, the counselor can clarify that HIV can be transmitted through the cooker, cotton, or water used by several persons sharing drugs. With newly identified or uninformed HIV-infected clients, the counselor should discuss HIV transmission risks associated with specific sexual or drug-use activities, including those in which the client might not be currently engaged.
• Negotiate a concrete, achievable behavior-change step that will reduce HIV risk. Although the optimal goal might be 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 to the client's situation. For clients with several high-risk behaviors, the counselor should help clients focus on reducing the most critical risk they are willing to commit to changing. The step does not need to be a personal behavior change. For many clients, knowledge of a partner's recent HIV status (and talking with the partner about getting an HIV test) might be more critical than personal behavior changes. The step should be relevant to reducing the client's own HIV risk and should be a small, explicit, and achievable goal, not a global goal. Identifying the barriers and supports to achieving a step, through interactive discussion, role-play modeling, recognizing positive social supports, or other methods will enhance the likelihood of success (90). Writing down the goal might be useful. For clients with ongoing risk behaviors, referral to additional prevention and support services is encouraged.
• Seek flexibility in the prevention approach and counseling process. Counselors should avoid a "one-size-fits-all" prevention message (e.g., "always use condoms"). Behaviors that are safe for one person might be risky for another (91). For example, unprotected vaginal intercourse might be unsafe with anonymous partners whose HIV status is unknown, but safe for uninfected persons in a mutually monogamous relationship. The length of counseling sessions will vary depending on client risk and comfort (e.g., adolescents might require more time than adults).
• Provide skill-building opportunities. Depending on client needs, the counselor can demonstrate or ask the client to demonstrate problem-solving strategies such as a) communicating safer sex commitments to new or continuing sex partners; b) using male latex condoms properly; c) trying alternative preventive methods (e.g., female condoms); d) cleaning drug-injection equipment if clean syringes are unavailable; or e) communicating safer drug-injection commitments to persons with whom the client shares drug paraphernalia (86,92--94).
• Use explicit language when providing test results. Test results should be provided at the beginning of the follow-up session. Counselors should never ask the client to guess the test results. Technical information regarding the test can be provided through a brochure or other means so the session can focus on personal HIV risk reduction for clients with negative tests and other considerations for clients with positive or indeterminate test results (see Additional Counseling Considerations for Special Situations). In-depth, technical discussions of the "window period (i.e., the time from when a person is infected until they develop detectable HIV antibody) should be avoided because they could confuse the client and diffuse the importance of the HIV prevention message. Counselors should clarify that negative test results do not mean the client has no HIV risk and work with the client to reconsider ongoing HIV risk behaviors and the benefits of taking steps to reduce those risks. A client with ongoing risk behaviors should not be given a false sense of the safety of those behaviors (i.e., avoid statements like "whatever you were doing seems to be safe" or "continue to do whatever you are doing now").

These counseling elements are considered necessary for high-quality counseling. Specialists in the field (Technical Expert Panel Review of CDC HIV Counseling, Testing, and Referral Guidelines; February 18--19, 1999; Atlanta, Georgia) also suggested adoption of the following:

• Ensure that the client returns to the same counselor. Consistency of the client and counselor relationship helps the client feel secure, reduces misunderstanding, and promotes the likelihood of effective risk reduction. Effective counseling models tended to use the same counselor for all sessions. When follow-up prevention counseling sessions must be provided by a different counselor, careful record-keeping is recommended to ensure high-quality counseling. See The Compendium of HIV Prevention Interventions with Evidence of Effectiveness at http://www.cdc.gov/hiv/pubs/hivcompendium.pdf.
• Use a written protocol to help counselors conduct effective sessions. A structured protocol outlining session goals can help keep the counselor focused on risk reduction. The protocol can include examples of open-ended questions (to help a new counselor avoid closed-ended questions) and a list of explicit risk-reduction steps (to help a new counselor avoid accepting a client's suggestion of global risk-reduction steps) (95).
• Ensure ongoing support by supervisors and administrators. Supervisory support is essential for effective counseling. Training in HIV counseling approaches that focus on personal risk reduction is recommended for persons supervising counselors. Staff appraisals should acknowledge that completion of critical counseling elements has higher priority than completion of paperwork.
• Avoid using counseling sessions for data collection. If required, paperwork should be completed at the end of the counseling session or by staff members who are not counseling. Checklist risk assessments driven by data collection forms are detrimental to effective counseling because they can encourage even skilled counselors to use closed-ended questions, limit eye contact, and miss critical verbal and nonverbal cues. The relevance of any routinely collected data should be periodically assessed.
• Avoid providing unnecessary information. An emphasis on providing information might prompt counselors to miss critical HIV prevention opportunities and cause clients to lose interest. Discussion of theoretical HIV risks (e.g., sex with a person with hemophilia or needle exposures through tattoos) tends to shift the focus away from the client's actual HIV risk situations to topics that are more "comfortable" or easy to discuss but irrelevant to the client's risk.

Who Should Deliver Prevention Counseling

In any setting where HIV testing is provided, existing personnel can be effective counselors if they have the desire and appropriate training and employ the essential counseling elements (5,80). Advanced degrees or extensive experience are not necessary for effective HIV prevention counseling, though training is (80). Training in counseling is available (see Ensuring High-Quality HIV Prevention Counseling). In situations where primary health-care providers (e.g., physicians) might not be able to provide prevention counseling, auxiliary health professionals trained in HIV prevention counseling models can provide this service. Although peer counseling has been successful in certain situations (18), research does not support an explicit risk-reduction need or benefit to matching clients with counselors based on same or similar backgrounds, sex, ethnicity, age, or peer group for intervention efficacy (96--98). The following skills and counselor characteristics were identified by specialists in the field as important for effective HIV prevention counseling (Technical Expert Panel Review of CDC HIV Counseling, Testing, and Referral Guidelines; February 18--19, 1999; Atlanta, Georgia):

• Completion of standard training courses in client-centered HIV prevention counseling or other risk-reduction counseling models.
• Belief that counseling can make a difference.
• Genuine interest 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 skills-building techniques.
• Being informed regarding specific HIV transmission risks (73).
• 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.

Additional Counseling Considerations for Special Situations

• Persons with newly identified HIV infection. Clients with newly identified HIV infection have immediate and long-term needs. Some clients might be better prepared to receive positive test results than others. The emotional impact of hearing an HIV-positive test result might prevent clients from clearly understanding information during the session in which they receive their results. Providers should provide appropriate referrals (see Typical Referral Needs) and, when necessary, additional sessions. 
  When a client receives the test result, the provider should ensure that the client understands it. As part of HIV prevention counseling, providers should explicitly discuss and clarify any misconceptions regarding HIV transmission risk to partners associated with specific sexual or needle-sharing activities. Clients should be advised to refrain from donating blood, plasma, or organs. For sexually active clients who are not in mutually monogamous partnerships, providers should also address strategies to prevent other sexually transmitted or bloodborne infections (e.g, gonorrhea, syphilis, chlamydia, herpes simplex virus, human herpes virus type 8 [the virus linked to Kaposi sarcoma], hepatitis B virus, hepatitis C virus, and cytomegalovirus).
  The first few months after persons learn they are HIV infected are important for accessing medical and other support services to help them obtain treatment and establish and maintain behavior changes that reduce the likelihood of transmitting the virus to others. For example, persons with ongoing risks might be referred for prevention counseling to prevent transmission to others or for prevention case management. For all newly identified clients, a follow-up appointment 3--6 months after diagnosis is recommended by some specialists (99) to assess whether clients were able to initiate medical care, minimize transmission risk to uninfected partners, and access other needed services (e.g., partner counseling and referral services). See guidance on partner counseling and referral services (27) and prevention case management (28).
• Persons with a single, recent nonoccupational HIV exposure. After a reported sexual, injection-drug use, or other nonoccupational exposure to HIV (55), providers should refer clients for prompt initiation of evaluation, counseling, and follow-up services. Early postexposure prophylaxis could reduce the likelihood of becoming infected with HIV, although the degree to which early treatment can prevent new infection after acute nonoccupational HIV exposure is unclear. Further guidance on nonoccupational HIV exposure is available (55).
• Persons with indeterminate HIV test results. Until follow-up test results are available, persons with an indeterminate result should receive information regarding the meaning of test results. HIV prevention counseling should be the same as for a person with newly identified HIV infection. Behaviors that minimize the risk for HIV transmission to sex and needle-sharing partners should be emphasized, even if the client reports no risk behaviors. Clients with repeated indeterminate test results >1 month apart are unlikely to be HIV-infected and can be provided test results in the same way as clients with negative test results, unless recent HIV exposure is suspected (see Indeterminate Test Results).
• Persons seeking repeat HIV testing. In addition to brief prevention counseling sessions, ongoing HIV prevention counseling aimed at personal risk reduction might be useful for persons seeking repeated HIV testing who have continued HIV risk. Counselors should encourage clients to explore alternative prevention strategies and to identify and commit to additional risk-reduction steps. Clients with ongoing risk behaviors might benefit from referral to other HIV prevention and support services because their current risk behavior might be reinforced by repeated negative HIV test results or they might view HIV testing as protective (100). More information on prevention case management is available (28) (see Ongoing Exposure).
• Persons who use drugs. Persons who inject drugs might also be at increased risk for acquiring HIV through unprotected sex with an HIV-infected partner (101--103). For injection-drug users (IDUs), intervention studies indicate that personalized, interactive prevention counseling models using goal-setting strategies might be effective in reducing injection-drug and sexual-risk behaviors (39--41,84). Evidence also supports the efficacy of community strategies (e.g., methadone maintenance programs or other drug treatment programs, outreach programs, and syringe exchange) to reduce new HIV infections among IDUs (104--108). Specialists in the field advocate recommending such strategies, along with individual HIV prevention counseling, to persons who inject drugs.
• Sex or needle-sharing partners of HIV-infected persons. Sex or needle-sharing partners of HIV-infected persons should be encouraged to have HIV prevention counseling and testing. Partners who are HIV discordant (i.e., one person is HIV-infected and the other is uninfected) should receive counseling aimed at preventing HIV transmission from the infected to the uninfected partner, including explicit discussion and clarification of any misconceptions regarding HIV transmission risk associated with specific sexual or needle-sharing activities. In addition, many HIV-discordant couples benefit from ongoing HIV prevention counseling aimed at personal risk reduction or from couples counseling that teaches safe sexual practices and proper condom use (27,109--111). Little evidence exists to conclusively support or refute whether simultaneous infection with >2 subtypes of HIV is likely to occur or, if it does, whether it is associated with more aggressive or resistant disease (112). Researchers are divided on the value of recommending consistent condom use to prevent HIV sequelae for mutually monogamous, HIV-infected partners.
• Health-care workers after an occupational exposure. After an occupational exposure, health-care workers should use measures to prevent transmission during the follow-up period (54). HIV-exposed health-care workers should be advised that, although HIV is infrequently transmitted through an occupational exposure, they should abstain from sex or use condoms and avoid pregnancy until they receive a negative follow-up test result. In addition, they should not donate blood, plasma, organs, tissue, or semen; if a woman is breast-feeding, she should consider discontinuing (54). Health-care workers should also be advised of the rationale for postexposure prophylaxis, the risk for occupationally acquired HIV infection from the exposure, the limitations of current knowledge of the efficacy of antiretroviral therapy when used as postexposure prophylaxis, the toxicity of the drugs involved, and the need for postexposure follow-up (including HIV testing), regardless of whether antiretroviral therapy is taken. Further guidance on occupational HIV exposure is available (54).
• Participants in HIV vaccine trials. HIV-vaccine--induced antibodies may be detected by current HIV tests and may cause a false-positive result. Trial participants should be advised that HIV CTR is best provided at the vaccine trial sites, the vaccine is of unknown efficacy, and HIV risk behavior can result in their becoming HIV-infected (see Positive Test Results).

Addressing Barriers to HIV Prevention Counseling

Several factors can prevent provision of high-quality HIV prevention counseling, including unavailability of trained prevention counselors at the setting in which the HIV test was conducted, client reluctance, and low rates of client return for test results. Recommended strategies for addressing these common barriers include a) providing counseling on-site, b) enhancing client acceptance of counseling by examining and improving the counseling provided, and c) considering alternate counseling methods.

Provide On-Site Counseling

Cost, lack, or turnover of trained staff members and space constraints are barriers to providing HIV prevention counseling (113). However, given the proven efficacy of prevention counseling models, in settings where HIV prevalence is high or the population served is at increased risk, the ability to provide such counseling on-site is a high priority, and efforts should be made to address and remove barriers to providing HIV prevention counseling on-site. Health educators or other auxiliary staff members trained to discuss preventive activities such as healthy eating, prenatal education, or smoking cessation could, if adequately trained, be effective HIV prevention counselors. In the interim, alternative resources should be identified, and clearly defined referrals should be made to settings that can provide high-quality prevention counseling for clients at increased HIV risk. Systems to ensure that referrals are completed should be established (see HIV Referral).

Enhance Client Acceptance of HIV Prevention Counseling

Clients who agree to HIV testing but decline HIV prevention counseling often report they lack time or already are aware of HIV transmission modes. However, experienced counselors report that clients mainly refuse counseling because they do not perceive the service to be personally beneficial (Technical Expert Panel Review of CDC HIV Counseling, Testing, and Referral Guidelines; February 18--19, 1999; Atlanta, Georgia). These counselors believe that most of these clients are concerned about a specific risk, which they would be willing to explore if the counseling seemed useful. Three of the most commonly reported barriers to the perceived usefulness of counseling are the type of counseling provided, how it is recommended, and the setting of the counseling. In settings where many clients are declining counseling, these barriers and others should be examined. The counseling might be providing information only rather than addressing personal risks. Counselors might not be offering counseling in ways appropriate to the client's culture, language, sex, sexual orientation, age, or developmental level. The setting might inhibit open discussion of risk (e.g., some outreach settings are not private). Counseling skills (e.g., attentive listening, use of open-ended questions) that allow clients to participate might have been overlooked. Even when clients at increased risk refuse counseling, use of 1--2 open-ended questions that urge clients to examine their personal situations could prompt personal exploration of risk (e.g, "What were your concerns that led you to decide to get tested today?").

Consider Alternative Methods for HIV Prevention Counseling

HIV prevention counseling models proven effective have all used face-to-face (individual or group) encounters between counselor and client and involved >2 brief sessions. Thus, face-to-face prevention counseling is preferred for clients at increased HIV risk. Most HIV test sites use an enzyme immunoassay (EIA) and confirmatory test algorithm that requires several days for final results. The return visit for test result offers an opportunity to continue prevention counseling in a second, face-to-face meeting. However, in some settings (e.g., STD clinics, managed care organizations, and other private settings), many clients do not return for their results (50,114--116). In such settings, providers can adopt strategies that increase clients' receipt of test results, and counseling strategies might need to be adapted (117).

Telephone Counseling. Limited studies among STD clinic clients at lower risk indicated that substantially more clients learned their HIV infection status when negative test results were provided by telephone rather than in person (12,117,118). Although home sample collection provides a precedent for providing counseling by telephone to persons with either negative or positive HIV test results, the efficacy of telephone counseling in reducing HIV risk behaviors or the number of new HIV infections has not been studied. One study indicated that telephone notification of positive results was associated with delay in linkage to care (119). However, not learning positive test results at all guarantees a delay in linkage to care. Many specialists recommend that provision of HIV test results and prevention counseling by telephone be limited to clients whose results are negative (Technical Expert Panel Review of CDC HIV Counseling, Testing, and Referral Guidelines; February 18--19, 1999; Atlanta, Georgia). Also, given the known risk-reduction benefits of face-to-face counseling, lack of efficacy data on telephone counseling, and concerns regarding disinhibition (e.g., "since my test result is negative, whatever risks I am taking now may be okay"), telephone counseling should be limited to clients without known ongoing HIV risk behaviors (e.g., unprotected sex or needle-sharing with an HIV-infected [or status unknown] partner).

Single-Session Prevention Counseling with Rapid Testing. Rapid tests allow clients to receive their HIV test results the same day. This process could reduce the number of clients receiving two prevention counseling sessions. Studies of the efficacy of single HIV prevention counseling sessions for use with a rapid test are under way. Although some single-session counseling protocols have been successfully implemented in busy clinics and are well-accepted by most clients, how well a single counseling session reduces risk behaviors or the number of new HIV infections is unknown. A counseling protocol for use with a rapid test is being studied; information is available at http://www.cdc.gov/hiv/projects/respect-2. For clients with identified risk behaviors, referral or rescheduling for ongoing counseling should be considered.

Ensuring High-Quality HIV Prevention Counseling

All CTR providers should conduct routine, periodic assessments for quality assurance to ensure that the counseling being provided includes the recommended, essential counseling elements.

Supervisors must be aware of HIV prevention counseling goals and necessary counselor skills. Supervisor and administrator support of HIV counseling models that focus on personal risk reduction (distinct from provision of information) is critical to effective counseling. Quality assurance for counseling should contain the following elements:

• Training and continuing education. Basic training in the use of >1 of the interactive HIV prevention counseling models aimed at personal risk reduction is recommended for counselors and supervisors. Counselors should know the communities they serve and the available referral opportunities. They also might benefit from formal training on a) transmission and prevention of HIV and other sexually transmitted and bloodborne diseases, b) the natural history of HIV, c) recognition and treatment of opportunistic infections, d) new therapeutic agents used to treat HIV and AIDS, e) PCRS, f) prevention case management, and g) other HIV prevention and support services available in the community (e.g., services related to substance abuse assessment, cultural competence, adolescent concerns, domestic abuse, and health concerns for gay or lesbian clients). Additional training in specific counseling skills is also warranted (e.g., training on how to facilitate groups for counselors conducting group sessions). For training opportunities, providers or supervisors can contact their state health department's HIV/AIDS program office.
• Supervisor observation and immediate feedback to counselors. Direct observation of counseling sessions can help ensure that objectives are being met (80). Supervisors can perform this task periodically (with client consent). Sessions might also be audiotaped (with client consent), or counseling can be demonstrated through role-play scenarios between the counselor and supervisor. Observation and feedback should be structured, and the outcome should be constructive, not punitive. Supervisors should support positive elements of the prevention counseling session and provide specific, constructive comments regarding content areas needing improvement. Observation and feedback should be conducted regularly for routine counseling. Staff discomfort with observation typically wanes over time; many counselors report that the sessions are useful in enhancing skills. When observation is offered routinely, clients seldom refuse to participate. A suggested time frame for routine, direct observation of an HIV prevention counselor by the supervisor is twice monthly for the first 6 months, monthly for the second 6 months, and quarterly for counselors with >1 year of experience. After observation, supervisors should provide feedback to counselors quickly, preferably the same week. Observation and feedback forms used in research studies of client-centered HIV prevention counseling are available at http://www.cdc.gov/hiv/projects/RESPECT/default.htm.
• Periodic evaluation of physical space, client flow, and time concerns. Counseling sessions should be conducted in a private space where discussion cannot be overheard. Clients should not wait for long periods between testing and counseling, and information could be provided during waiting times (e.g., through videos). Periodic time-flow analyses or client surveys can be used to evaluate adequacy of space, client flow, and length of waiting period.
• Periodic counselor or client satisfaction evaluations. Evaluations of client satisfaction can ensure that counseling meets client needs. These evaluations also can provide important feedback to counselors who otherwise might not see the benefits of what they do. Evaluations can be brief. Surveys should address whether specific counseling goals were met, the type of interaction (e.g.,"who talked more, the counselor or the client?"), and, when applicable, specifics of development of the risk-reduction plan (e.g, "what was the behavior change step that you agreed to work on?"). Linking client and counselor descriptions of a particular session might be useful. Conducting such evaluations only occasionally (e.g., for 1--2 weeks once or twice a year) decreases the programmatic burden and is probably sufficient to identify problems. For more information, see Quality Assurance and Evaluation of HIV CTR Services.
• Case conferences. Regularly scheduled meetings of counselors allow supervisors to understand counselors' skills and areas that need improvement and can help counselors learn techniques from their colleagues. Case conferences are an opportunity for counselors to discuss specific or problematic questions asked by clients, allowing providers to better understand the concerns facing clients who are HIV-infected or at increased risk for HIV. Case conferences can help offset counselor fatigue and "burn out" by providing a positive outlet for dealing with difficult situations. Discussion might focus on a hard-to-address client or specific elements (e.g., developing acceptable and practical risk-reduction plans with clients who deny the magnitude of their HIV risk). Frequency of case conferences should be balanced with client volume, with efforts made to meet at least monthly.

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HIV TESTING

Characteristics and Applications of HIV Test Technologies

Only FDA-approved HIV tests should be used for diagnostic purposes. Routine screening in the United States for HIV-2 and HIV-1 group O infections is not generally recommended unless geographic, behavioral, or clinical information indicates that infection with these strains might be present. Several HIV test technologies have been approved by FDA for diagnostic use in the United States. These tests enable testing of different fluids (i.e., whole blood, serum, plasma, oral fluid, and urine) (Table). The available technologies

• enable specimen collection procedures that are less invasive and more acceptable than venipuncture, thus helping expand HIV testing into nontraditional settings (with home sample collection tests, oral fluid tests, and urine-based tests) (25);
• enable provision of HIV test results during a single visit at the time of testing (with rapid tests) (120); and
• increase the convenience of HIV testing (with home sample collection tests) (52).

The decision to adopt a particular test technology in a clinical or nontraditional setting should be based on several factors, including

• accuracy of the test,
• client preferences and acceptability,
• likelihood of client returning for results,
• cost and mechanism for provider reimbursement,
• ease of sample collection,
• complexity of laboratory services required for the test,
• availability of trained personnel, and
• FDA approval of the test.

Home Testing Versus Home Sample Collection

FDA has not approved home-use HIV test kits, which allow consumers to purchase a test kit, collect a sample in private, and interpret their own HIV test results in a few minutes. The Federal Trade Commission has warned that some home-use HIV test kits, many of which are available on the Internet and in the "gray" market (i.e., unauthorized imports), supply inaccurate results (121). These tests are different from FDA-approved home sample collection kits (52), which allow consumers to purchase test kits, collect a sample in private, send the sample to a laboratory for testing, and telephone for their HIV test result, counseling, and referral.

HIV-2 and HIV-1 Group O Infections

Although most HIV infections in the United States are of HIV-1 group B subtype, current EIAs can accurately identify infections with nearly all non-B subtypes and many infections with group O HIV subtypes (122). Infections with HIV-2 and HIV-1 group O are rare in the United States (123,124), and routine screening for these subtypes is not generally recommended as part of diagnostic testing except in areas where several such infections have been identified. Routine screening for HIV-2 might be appropriate in certain populations where potential risk for HIV-2 infection is higher (e.g., in areas where West African immigrants have settled) (125). Since June 1992, FDA has recommended routine screening for antibody to HIV-2 (in addition to HIV-1) for all blood and plasma donations (125). Clients with clinical, epidemiologic, or laboratory history that suggests HIV infection and negative or indeterminate HIV-1 screening tests should receive further diagnostic testing to rule out HIV infection, potentially including testing for HIV-1 non-B subtypes (122) and HIV-2 (125).

Other Test Uses

Viral load and HIV-1 p24 antigen assays are not intended for routine diagnosis but could be used in clinical management of HIV-infected persons in conjunction with clinical signs and symptoms and ot