CDC MMWR - 2001Important note: Information in this article was accurate in November 2001. The state of the art may have changed since the publication date.
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Revised Guidelines for HIV Counseling, Testing, and Referral

Morbidity and Mortality Weekly Report, November 9, 2001 / 50(RR19);1-58
Centers for Disease Control and Prevention

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

These guidelines replace CDC's 1994 guidelines, HIV Counseling, Testing, and Referral Standards and Guidelines, and contain recommendations for public- and private-sector policy makers and service providers of human immunodeficiency virus (HIV) counseling, testing, and referral (CTR). To develop these guidelines, CDC used an evidence-based approach advocated by the U.S. Preventive Services Task Force and public health practice guidelines. The recommendations are based on evidence from all available scientific sources; where evidence is lacking, opinion of "best practices" by specialists in the field has been used.

This revision was prompted by scientific and programmatic advances in HIV CTR, as well as advances in prevention and the treatment and care of HIV-infected persons. These advances include a) demonstrated efficacy of HIV prevention counseling models aimed at behavioral risk reduction; b) effective treatments for HIV infection and opportunistic infections; c) effective treatment regimens for preventing perinatal transmission; and d) new test technologies.

Although the new guidelines include many aspects of the previous ones (e.g., encouragement of confidential and anonymous voluntary HIV testing, need for informed consent, and provision of HIV prevention counseling that focuses on the client's own risk), the new guidelines differ in several respects, including

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 (Box 1). 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, Revised Recommendations for HIV Screening of Pregnant Women), 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:

Similarities and Differences Between Current and Previous Guidelines

Aspects of previous CDC HIV guidelines that are unchanged include

Differences in the new guidelines include

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 (36,37). 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 (see Revised Recommendations for HIV Screening of Pregnant Women), 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

Principles of HIV CTR

Effective HIV CTR is based on the following principles:

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.

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 (Revised Recommendations for HIV Screening of Pregnant Women,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 (see Revised Recommendations for HIV Screening of Pregnant Women).

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 (Box 2) 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) (Box 2) (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 (Box 3). 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 (Box 4 and Figure 1). 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 (Figure 2). 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 (Figure 3). 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.

HIV COUNSELING

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

Information

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

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

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:

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:

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):

Additional Counseling Considerations for Special Situations

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:

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

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

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 other laboratory markers of disease progression. Although HIV-1 p24 antigen assays are used for routine screening in blood and plasma centers, routine use for diagnosing HIV infection has been discouraged because the estimated average time from detection of p24 antigen to detection of HIV antibody by standard EIA is 6 days, and not all recently infected persons have detectable levels of p24 antigen (126).

Interpreting HIV Test Results

Standard Testing Algorithm

HIV-1 testing consists of initial screening with an EIA to detect antibodies to HIV-1. Specimens with a nonreactive result from the initial EIA are considered HIV-negative unless new exposure to an infected partner or partner of unknown HIV status has occurred. Specimens with a reactive EIA result are retested in duplicate. If the result of either duplicate test is reactive, the specimen is reported as repeatedly reactive and undergoes confirmatory testing with a more specific supplemental test (e.g., Western blot or, less commonly, an immunofluorescence assay [IFA]). Only specimens that are repeatedly reactive by EIA and positive by IFA or reactive by Western blot are considered HIV-positive and indicative of HIV infection. Specimens that are repeatedly EIA-reactive occasionally provide an indeterminate Western blot result, which might represent either an incomplete antibody response to HIV in specimens from infected persons or nonspecific reactions in specimens from uninfected persons (127). Although IFA can be used to resolve an indeterminate Western blot sample, this assay is not widely used. Generally, a second specimen should be collected >1 month later and retested for persons with indeterminate Western blot results. Although much less commonly available, nucleic acid testing (e.g., viral RNA or proviral DNA amplification method) could also help resolve an initial indeterminate Western blot in certain situations. A small number of tested specimens might provide inconclusive results because of insufficient quantity of specimen for the screening or confirmatory tests. In these situations, a second specimen should be collected and tested for HIV infection.

Modified Testing Algorithms

FDA has licensed only one rapid test, but modified testing algorithms are anticipated when additional rapid HIV tests are approved. If >2 sensitive and specific rapid HIV tests became available, one positive rapid test could be confirmed with a different rapid test. This combination has provided positive predictive value compared with the EIA/Western blot or IFA algorithm (128). However, no such algorithms have been adequately assessed or approved for diagnostic use in the United States.

Positive HIV Test Results

An HIV test should be considered positive only after screening and confirmatory tests are reactive. A confirmed positive test result indicates that a person has been infected with HIV. False-positive results when both screening and confirmatory tests are reactive are rare. However, the possibility of a mislabeled sample or laboratory error must be considered, especially for a client with no identifiable risk for HIV infection. HIV-vaccine--induced antibodies may be detected by current tests and may cause a false-positive result. Persons whose test results are HIV-positive and who are identified as vaccine trial participants should be encouraged to contact or return to their trial site or an associated trial site for HIV CTR services.

Negative HIV Test Results

Because a negative test result likely indicates absence of HIV infection (i.e., high negative predictive value), a negative test need not be repeated in clients with no new exposure in settings with low HIV prevalence. For clients with a recent history of known or possible exposure to HIV who are tested before they could develop detectable antibodies (129,130), the possibility of HIV infection cannot be excluded without follow-up testing (29). A false negative result also should be considered in persons with a negative HIV-1 test who have clinical symptoms suggesting HIV-1 infection or AIDS. Additional testing for HIV-2 and HIV-1 group O infection might be appropriate for these persons.

Indeterminate HIV Test Results

Most persons with an initial indeterminate Western blot result who are infected with HIV-1 will develop detectable HIV antibody within 1 month (127,131,132). Thus, clients with an initial indeterminate Western blot result should be retested for HIV-1 infection >1 month later.****** Persons with continued indeterminate Western blot results after 1 month are unlikely to be HIV-infected and should be counseled as though they are not infected unless recent HIV exposure is suspected.

Nucleic acid tests for HIV DNA or RNA exist, but are not approved by FDA for diagnostic purposes and are not generally recommended for resolving indeterminate Western blot results. However, in consultation with clinical and laboratory specialists, nucleic acid testing (if available) might also be useful for determining infection status among persons with an initial indeterminate Western blot result.

Informing Clients of Test Results

Because low rates of return for test results occur in many settings offering HIV CTR (133), providers should work to ensure that clients tested for HIV infection receive their test results, particularly HIV-infected clients who might benefit from earlier entry into care and initiation of antiretroviral therapy. Reducing barriers to testing can maximize the number and proportion of persons tested for HIV who receive their test results in a timely manner (see Addressing Barriers to HIV Testing). Adoption of new HIV test technologies and alternative methods of providing HIV-negative test results should be considered when face-to-face rates of return for test results are low. Strict confidentiality of the receipt of the HIV test and the HIV test result must be maintained, regardless of the method used. Providers unable to locate clients who do not return for test results should seek support from their local or state health department.

Because knowledge of HIV status is a critical HIV prevention strategy and essential for entry into care, providers should stress to clients the importance of returning to receive their test results and establish a plan for doing so with the client. Reminder systems might be useful. Using alternate HIV test technologies might increase the percentage of tested persons who learn their HIV status.

Providing Test Results by Telephone

Many clinicians routinely notify clients of negative test results for various diseases and conditions by means other than face-to-face (e.g., by telephone). They also ask clients to return to discuss positive test results that might indicate potential life-threatening illnesses. This strategy can also be applied, under limited circumstances, to notifying clients of their HIV test results. Face-to-face provision of HIV test results is strongly encouraged for HIV-infected clients and HIV-uninfected clients at increased risk who might benefit from HIV prevention counseling and referral to medical, preventive, and support services. Providing uninfected clients who are not at increased risk the option of receiving HIV test results and counseling by telephone --- with the understanding that provider assurance of client confidentiality is of paramount importance --- might be appropriate. Limited research indicates that offering clients the option of contacting the provider by telephone to receive negative HIV results might increase rates of receipt of results, satisfy client preferences for options, and preserve setting resources without apparent adverse consequences (52,117,118). Although no published research exists regarding use of telephones for providing positive HIV test results with most HIV test technologies, limited experience exists on using this method to provide HIV-positive test results for home sample collection testing (52).

Providing Test Results During the Initial Visit Through Rapid Tests

More clients receive their HIV test results with rapid tests because results can be provided at the testing visit (120). Rapid test technology could be useful in urgent medical circumstances (e.g., when decisions must be made regarding postexposure prophylaxis) and in nontraditional settings with low return rates (e.g., community-based or outreach settings).

During the initial visit, the provider can definitively tell clients who have had a single rapid HIV test with negative results that they are not infected (120), except when retesting might be indicated because of recent known or possible exposure to HIV. A reactive rapid HIV test result should be considered preliminary until the completion of confirmatory testing, and results should be carefully communicated to the client because of the possibility of a false-positive result.

The likelihood that a positive screening test truly indicates the presence of HIV infection decreases as HIV prevalence in the tested population becomes lower. Therefore, false-positive HIV test results are more likely in settings where the tested population prevalence is lower than in settings where the tested population prevalence is higher. When a preliminary, positive rapid test is explained to clients, phrases like "a good chance of being infected" or "very likely infected" can be used to indicate the likelihood of HIV infection and qualified based on the HIV prevalence in the setting and the client's individual risk (120). Further testing is always required to confirm a reactive screening test result.

Follow-up Testing in Clients with Negative HIV Test Results

A negative HIV test usually indicates the absence of HIV infection (29). Because recent infection cannot be excluded without follow-up testing (see Negative HIV Test Results), the appropriate timing and frequency for follow-up testing among clients with negative HIV test results has not been firmly established. Providers should consider the following factors related to individual client needs when recommending the timing and frequency for follow-up HIV testing:

Recent Exposure

Follow-up testing might be appropriate for clients who have negative test results but who have not had time to develop detectable antibody after a recent documented occupational (54) or nonoccupational (sexual or needle-sharing) (55) exposure to HIV-infected persons or persons at increased risk for HIV with unknown HIV status. The timing of follow-up testing should provide assurance that the exposure did not lead to infection. Follow-up testing should be conducted in a timely manner so clients identified as HIV-infected can receive appropriate antiretroviral treatment and prevention and support services as soon as possible.

Single Possible or Known Exposure

Most infected persons will develop detectable HIV antibody within 3 months of exposure (126). If the initial negative HIV test was conducted within the first 3 months after exposure, repeat testing should be considered >3 months after the exposure occurred to account for the possibility of a false-negative result. If the follow-up test is nonreactive, the client is likely not HIV-infected. However, if the client was exposed to a known HIV-infected person or if provider or client concern remains, a second repeat test might be considered >6 months from the exposure. Rare cases of seroconversion 6--12 months after known exposure have been reported (134). Extended follow-up testing beyond 6 months after exposure to account for possible delayed seroconversion is not generally recommended and should be based on clinical judgment and individual clients needs (54).

Ongoing Exposure

Persons with continued HIV risk behavior pose a special challenge for follow-up testing. In some settings, clients with ongoing risk represent a substantial proportion of those receiving HIV CTR. In most circumstances, follow-up HIV testing should be recommended periodically for clients with ongoing risk behavior. Follow-up testing would monitor the client's HIV status, but also promote continued client contact, opportunities for HIV prevention counseling (see Additional Counseling Considerations for Special Situations), and referral to additional preventive and support services.

No Identifiable Risk

In general, persons with no recent identifiable risk for HIV infection should receive additional HIV prevention counseling and follow-up testing when requested. Efforts should be made to understand why these clients repeatedly seek follow-up testing. These clients should be considered for in-depth prevention counseling and referral to support services, where appropriate.

Special Considerations

General recommendations for follow-up testing might not be applicable in all circumstances. In certain circumstances (e.g., when persons are simultaneously exposed to hepatitis C virus and HIV [54] and when persons have received HIV vaccines), guidance should be provided only after consultation with specialists.

Addressing Barriers to HIV Testing

Knowledge of HIV infection status can benefit the health of individual persons and the community. Thus, HIV testing should be as convenient as possible to promote client knowledge of HIV infection status. Efforts should be made to remove or lower barriers to HIV testing by ensuring that

Acceptance of HIV testing is reportedly lower when clients have been tested previously and are fearful of their ability to cope with their test results (112,113). Testing is more likely to be accepted when

Ensuring High-Quality Testing

Testing activities should be coordinated with state and local laboratories to ensure high-quality HIV testing through proper specimen collection, storage, and transport. Laboratory errors most often occur in the preanalytic (i.e., specimen collection, labeling, transporting, processing, and storing) and postanalytic steps of testing (i.e., results validation and reporting) (142--144) rather than during the test itself. Laboratories performing HIV testing must be enrolled in proficiency testing programs and conduct activities in accordance with regulatory standards outlined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (145). Many states have additional licensing requirements for laboratories conducting diagnostic HIV testing.

HIV REFERRAL

Definition of Referral

In the context of HIV prevention counseling and testing, referral is the process by which immediate client needs for care and supportive services are assessed and prioritized and clients are provided with assistance (e.g., setting up appointments, providing transportation) in accessing services. Referral should also include follow-up efforts necessary to facilitate initial contact with care and support service providers.

In this context, referral does not include ongoing support or management of the referral or case management. Case management is generally characterized by an ongoing relationship with a client that includes comprehensive assessment of medical and psychosocial support needs, development of a formal plan to address needs, substantial assistance in accessing referral services, and monitoring of service delivery.

Typical Referral Needs

Clients should be referred to services that are responsive to their priority needs and appropriate to their culture, language, sex, sexual orientation, age, and developmental level. Examples of these services include

Implement and Manage Referral Services

Clients should receive help accessing and completing referrals, and completion of referrals should be verified. In the context of HIV prevention counseling and testing, the following elements should be considered essential to the development and delivery of referral services (99).

Assess Client Referral Needs

Providers should consult with the client to identify essential factors that a) are likely to influence the client's ability to adopt or sustain behaviors to reduce risk for HIV transmission or acquisition or b) promote health and prevent disease progression. Assessment should include examination of the client's willingness and ability to accept and complete a referral. Service referrals that match the client's self-identified priority needs are more likely to be successfully completed than those that do not (147). Priority should be placed on ensuring that HIV-infected clients are assessed for referral needs related to medical care, PCRS, and prevention and support services aimed at reducing the risk for further transmission of HIV. When a provider cannot make appropriate referrals or when client needs are complex, clients should be referred to a case management system.

Plan the Referral

Referral services should be responsive to clients' needs and priorities and appropriate to their culture, language, sex, sexual orientation, age, and developmental level. In consultation with clients, providers should assess and address any factors that make completing the referral difficult (e.g., lack of transportation or child care, work schedule, cost). Research has indicated that referrals are more likely to be completed if services are easily accessible to clients (147).

Help Clients Access Referral Services

Clients should receive information necessary to successfully access the referral service (e.g., contact name, eligibility requirements, location, hours of operation, telephone number). Research has indicated that providing assistance (e.g., setting an appointment, addressing transportation needs) for some clients promotes completion of referrals (148). Clients must give consent before identifying information to help complete the referral can be shared. Outreach workers and peer counselors/educators can be an important and effective resource to help clients identify needs and plan successful referrals (149). Referrals are more likely to be completed after multiple contacts with outreach workers (147).

Document Referral and Follow-Up

Providers should assess and document whether the client accessed the referral services. If the client did not, the provider should determine why; if the client did, the provider should determine the client's degree of satisfaction. If the services were unsatisfactory, the provider should offer additional or different referrals. Documentation of referrals made, the status of those referrals, and client satisfaction with referrals should help providers better meet the needs of clients. Information obtained through follow-up of referrals can identify barriers to completing the referral, responsiveness of referral services in addressing client needs, and gaps in the referral system.

Ensure High-Quality Referral Services

Providers of referral services should know and understand the service needs of their clients, be aware of available community resources, and be able to provide services in a manner appropriate to the clients' culture, language, sex, sexual orientation, age, and developmental level, given local service system limitations.

Education and Support of Staff Members

Staff members providing referral services must understand client needs, have skills and resources to address these needs, have authority to help the client procure services, and be able to advocate for clients.

Training and Education. Providers should ensure that staff members receive adequate training and continuing education to implement and manage referrals. Training and education should address resources available and methods for managing referrals, as well as promote understanding of factors likely to influence the client's ability and willingness to use a referral service (e.g., readiness to accept the service, competing priorities, financial resources). Referrals are more likely to be completed when a provider is able to correctly evaluate a client's readiness to adopt risk-reducing behaviors (147). Research has indicated that cross-training increases knowledge and understanding of community resources among providers and can indicate gaps in services (148).

Authority. Staff members providing referrals must have the authority necessary to accomplish a referral. Supervisors must ensure that staff members understand referral policy and protocol and have the necessary support to provide referrals. This requires the authority of one provider to refer to another (e.g., through memoranda of agreement) or to obtain client consent for release of medical or other personal information.

Advocacy. Staff members who negotiate referrals must possess knowledge and skills to advocate for clients. Such advocacy can help clients obtain services by mediating barriers to access to services and promoting an environment in which providers are better informed regarding the needs and priorities of their clients.

Provider Coordination and Collaboration

Providers should develop and maintain strong working relationships with other providers and agencies that might be able to provide needed services. Providers who offer HIV prevention counseling and testing but not a full range of medical and psychosocial support services should develop direct, clearly delineated arrangements with other providers who can offer needed services. Coordination and collaboration promotes a shared understanding of the specific medical and psychosocial needs of clients requiring services, current resources available to address these needs, and gaps in resources.

Memoranda of agreement or other forms of formal agreement are useful in outlining provider/agency relationships and delineating roles and responsibilities of collaborating providers in managing referrals. When confidential client information is shared between coordinating providers, such formal agreements are essential. These agreements should be reviewed periodically and modified as appropriate.

Referral Resources

Knowledge of available support services is essential for successful referrals. When referral resources are not available locally, providers should identify appropriate resources and link clients with them. A resource guide should be developed and maintained to help staff members make appropriate referrals (Box 7). Information regarding community resources can be obtained from local health planning councils, consortia, and community planning groups. Local, state, and national HIV/AIDS information hotlines or websites (e.g., NPIN), community-based health and human service providers, and state and local public health departments can also provide information.

HIV CTR SERVICES IN NONTRADITIONAL SETTINGS

CTR should be provided in community-based and outreach settings as well as clinical settings. Data from publicly supported CTR programs have indicated that doing so could promote use of these services by persons at increased risk for HIV. When HIV CTR are not readily available, accessible, or acceptable, persons at increased risk might not take advantage of them. Expanding CTR into nontraditional settings can be accomplished through partnership with community-based service providers and use of new, FDA-approved HIV test technologies that offer portability, less-invasive sample collection, less-complex sample collection and processing, and reduced biohazard. To ensure effective CTR that is responsive to client needs, providers should develop and implement written quality assurance protocols and procedures specifically for services provided in nontraditional settings.

Privacy and Confidentiality

Ensuring clients' privacy and confidentiality during CTR is essential, but could present unique challenges in some nontraditional settings. Confidentiality can more easily be breached in settings where clients and providers can be seen or heard by others. Suggested strategies for maintaining privacy and confidentiality in nontraditional settings include the following:

Informed Consent

Staff members providing CTR services should be sensitive to barriers that can interfere with obtaining true informed consent, including alcohol and drug use, mental illness, and peer pressure in venues where persons congregate or socialize. Suggested strategies for obtaining informed consent in nontraditional settings include the following:

Counseling

Staff members working in community-based and other nontraditional settings should know and use risk-screening strategies to determine whether HIV prevention counseling should be recommended. Staff members should be trained in HIV prevention counseling or other approaches aimed at personal HIV risk reduction. When appropriate (e.g., among IDUs), information regarding other STDs and bloodborne diseases should be incorporated into the counseling sessions (29,30).

Testing

The decision to offer HIV testing in nontraditional settings should be based on several factors, including availability of resources and feasibility of providing test results and follow-up. In some cases, referral to other providers is appropriate. The selection of a specific HIV test technology should be based on logistical issues (e.g., field conditions related to collection, transport, and storage of specimens; worker safety; and the likelihood that clients will receive HIV test results). Providers must understand the extent to which field conditions can affect specimens (e.g., extreme temperatures or time lapse from collection to processing). Test specimens should be collected, stored, and transported according to manufacturer instructions.

Provision of Test Results

Clear protocols for provision of test results and prevention counseling should be developed. The following strategies might be useful in ensuring the provision of results in nontraditional settings:

Referral

Staff members working in community-based and outreach settings should be trained to implement and manage referrals. Providers should establish appropriate collaborative relationships for referrals. Arranging for PCRS staff members or case managers to be available to clients at the time test results are provided might help promote referral.

Record Keeping

Maintaining the confidentiality of client records is critical. Providers should develop written protocols for record keeping that address transport of client records to and from outreach venues. Strategies to maintain confidentiality of client records in nontraditional settings include the following:

Where allowed by state/local statute, clients can choose anonymous HIV testing. Procedures to ensure client anonymity (i.e., no indication of testing in the client's record and no recording of personal identifying information on laboratory requests) should be developed. Even when staff members providing CTR services know the client (including name and locating information) from other activities, the client's right to be tested anonymously should be protected.

Staff Safety

Providing services in outreach settings (e.g., bars, parks) might compromise staff safety, which must be considered in development of outreach protocols. Appropriate training and precautions (e.g., working in teams) should be developed in planning services in nontraditional settings.

QUALITY ASSURANCE AND EVALUATION OF HIV CTR SERVICES

Quality Assurance

Written quality assurance protocols should be developed, made available to all staff members providing CTR services, and routinely implemented. All staff members should receive training and orientation regarding quality assurance. For information specific to ensuring high-quality CTR services, see Ensuring High-Quality HIV Prevention Counseling, Ensuring High-Quality Testing, and Ensuring High-Quality Referral Services. Quality assurance activities should address the following:

Evaluation

CTR services should be continually evaluated to improve services to clients and provide accountability to stakeholders (150,151). Evaluation should be interactive, involving individual persons and organizations affected by the services (150). In public health settings, the community goals outlined in community health planning processes and other relevant local planning processes could be incorporated.

Providers should identify the key, relevant program goals and objectives that reflect services to the program, community, and client, and then determine what data are needed to evaluate those goals and objectives. Information obtained from the evaluation should be used to plan and prioritize provision of CTR services within a setting. For example, information from the HIV Counseling and Testing System (133) or locally available sources could be used during local community planning (e.g., HIV prevention community planning) to help develop or revise an HIV/AIDS prevention plan or describe who needs services. If resources for evaluation are limited, comprehensive evaluations (e.g., examining outcome or impact) might not be possible. However, even with limited resources, providers can conduct meaningful evaluations by focusing on relevant local outcomes (82).

Data

Data collected should have a clear, anticipated use and should not be the focus of or interfere with provision of CTR services. Data should be used to evaluate the extent to which the goals of CTR and locally defined service outcomes (e.g., targeted return rates, knowledge of HIV infection status, proportion of successful referrals) are met. Although sound data are essential for evaluation of services, the primary purpose of each visit should be to provide the best possible service to the client. Data should be recorded outside the time reserved for CTR discussions between the provider and the client. Clients could complete a questionnaire or intake information form on admission, providers could complete the forms immediately after meeting with a client, or a combination of the two approaches could be used.

Data collection methods should be compatible with the evaluation needs and priorities of the CTR setting and locally defined service outcomes. Data should be collected with a standard collection instrument throughout the program. Simple data collection instruments (e.g., intake forms, medical record reviews) should be developed so data can be collected unobtrusively as part of the provision of services.

Publicly funded CTR sites collect data on client demographic characteristics, risk behavior/exposure category, test acceptance, and type of site where service is provided (133). Most sites record the date of visit, anonymous or confidential test status, previous test result, current test result, and return for current test result for each client encounter. Additional data can be useful for evaluation of services, including date of previous test, type of current test (e.g., standard, rapid, oral fluid), risk-reduction plan summary, information relevant to any referrals made (e.g., provider and service description, information and materials provided, whether an appointment was made), whether the referral was received, type of service provided, dates when services were provided, and other relevant information (e.g., follow-up required, additional service needs).

Confidentiality

Any data collected or recorded must be collected or recorded in a manner that ensures the confidentiality of the client. Clear procedures and protocol manuals must be developed and used.

Ensuring High-Quality Evaluation

CONCLUSION

Advances in HIV prevention and medical treatment increase the importance of HIV CTR services. Prevention counseling and knowledge of HIV status can help persons who are HIV-infected or at increased risk for HIV infection reduce their risk for transmitting or acquiring HIV infection. Referral can help persons access relevant medical, preventive, and psychosocial support services to reduce their risk for transmitting or acquiring HIV infection. These guidelines recommend how CTR can be provided to clients who could most benefit from these services across various settings and client populations.

ADDITIONAL RESOURCES

Additional information on HIV CTR can be obtained from the following sources:

Acknowledgments

We are grateful for the contributions of health professionals within CDC and elsewhere (e.g., Health Resources and Services Administration, National Alliance of State and Territorial AIDS Directors, academic institutions, health departments, health-care organizations). We also thank graduate students/research assistants Jennifer Chapman, M.P.H., Steven J. Connor, M.P.H., and Parag R. Sanghvi, M.S.P.H., National Center for HIV, STD, and TB Prevention, CDC.

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* Delivered according to recommended protocols (for counseling, referral, and evaluation) or regulatory standards (for testing).

** Risk screening differs from risk assessment, which is a part of HIV prevention counseling (see HIV Prevention Counseling).

*** For example, "A negative test means no HIV was found. But if you were exposed to HIV recently --- in the last 1--2 months --- this test may not be able to pick that up." See Negative HIV Test Results.

**** Client-centered is used here to mean that the counseling sessions focus on the client's own risk circumstances, risk behaviors, and prevention needs. This term should not be confused with the more intensive, client-centered approach advocated by psychologist Carl R. Rogers, although some skills and strategies that involve the client in the prevention counseling process might be similar (Rogers CR. Client-centered therapy: its current practice, implications, and theory. Boston, MA: Houghton Mifflin, 1951).

***** Personal risk assessment is an essential element of HIV prevention counseling in which the client and counselor work to understand and acknowledge the client's personal risk for HIV. Risk assessment is not synonymous with risk screening (see Determining Individual Client Risk Through Risk Screening and Box 2), which helps determine which clients should be recommended HIV CTR.

****** Studies on repeat testing for persons with indeterminate Western blot results have not included pregnant women (see Revised Recommendations for HIV Screening of Pregnant Women).

Glossary

AIDS:
Acquired immunodeficiency syndrome. AIDS can affect the immune and central nervous systems and can result in neurological problems, infections, or cancers. It is caused by human immunodeficiency virus (HIV).
Anal sex:
A type of sexual intercourse in which a man inserts his penis in his partner's anus. Anal sex can be insertive or receptive.
Anonymous:
In anonymous testing, client identifying information is not linked to testing information, including the request for tests or test results.
Antiretroviral therapy:
Treatment with drugs designed to prevent HIV from replicating in HIV-infected persons. Highly active antiretroviral therapy (HAART) is an antiretroviral regimen that includes multiple classifications of antiretroviral drugs.
Client-centered HIV prevention counseling:
An interactive risk-reduction counseling model usually conducted with HIV testing, in which the counselor helps the client identify and acknowledge personal HIV risk behaviors and commit to a single, achievable behavior change step that could reduce the client's HIV risk.
Confidentiality:
Pertains to the disclosure of personal information in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the original disclosure. Confidentiality must be maintained for persons who are recommended and/or who receive HIV counseling, testing, and referral (CTR) services.
Confidential HIV test:
An HIV test for which a record of the test and the test results are recorded in the client's chart.
Confirmatory test:
A highly specific test designed to confirm the results of an earlier (screening) test. For HIV testing, a Western blot or, less commonly, an immunofluorescence assay (IFA) is used as a confirmatory test.
EIA:
Enzyme immunoassay. Sometimes referred to as ELISA (see next definition). A commonly used screening test to detect antibodies to HIV.
ELISA:
Enzyme-linked immunosorbent assay. A type of EIA (see previous definition). A commonly used screening test to detect antibodies to HIV.
Evaluation:
A process for determining how well health systems, either public or private, deliver or improve services and for demonstrating the results of resource investments.
False negative:
A negative test result for a person who is actually infected.
False positive:
A positive test result for a person who is actually not infected.
Freestanding HIV test site:
A site that provides only HIV services. Sometimes referred to as alternate test site or anonymous test site.
HIV:
Human immunodeficiency virus, which causes AIDS. Several types of HIV exist, with HIV-1 being the most common in the United States.
HIV test:
More correctly referred to as an HIV antibody test, the HIV test is a laboratory procedure that detects antibodies to HIV, rather than the virus itself.
HIV prevention counseling:
An interactive process between client and counselor aimed at reducing risky sex and needle-sharing behaviors related to HIV acquisition (for HIV-uninfected clients) or transmission (for HIV-infected clients). See also client-centered HIV prevention counseling.
Home sample collection test:
A test that a consumer purchases and uses to collect blood (or other bodily fluid) and then send it out for testing. Counseling and test results are typically provided by telephone using user-generated codes to ensure confidentiality and anonymity.
Incidence:
In epidemiology, the number of new cases of infection or disease that occur in a defined population within a specified time.
Indeterminate test result:
A possible result of a Western blot, which might represent a recent HIV infection or a false-positive.
Information:
In the context of HIV counseling, information encompasses the topics HIV transmission and prevention and the meaning of HIV test results.
Informed consent:
The legally effective permission of a client or legally authorized representative (e.g., parent or legal guardian of a minor child) to undergo a medical test or procedure.
Negative predictive value:
A negative predictive value estimates the probability that a person with a negative diagnostic test result will actually not be infected.
Nonoccupational HIV exposure:
A reported sexual, injection-drug--use, or other non-occupational HIV exposure that might put a patient at high risk for acquiring HIV infection.
Nucleic acid amplification testing:
A type of testing that identifies viral genes (e.g., specific sequences of nucleic acids) using gene amplification technologies such as polymerase chain reaction (PCR).
Occupational HIV exposure:
An occupational exposure to HIV that occurs during the performance of job duties. Defined as a percutaneous injury (e.g., a needlestick or cut with a sharp object), contact of mucous membranes, or contact of skin (especially when the exposed skin is chapped, abraded, or afflicted with dermatitis or the contact is prolonged or involving an extensive area) with blood, tissues, or other body fluids to which universal precautions apply.
Oral fluid test:
A test using oral mucosal transudate, a serous fluid. To differentiate this fluid from saliva, an absorbent material is left in the mouth for several minutes. In an HIV-infected person, oral mucosal transudate is likely to contain HIV antibodies.
Oral sex:
A type of sexual intercourse in which the partner's genitals are stimulated by mouth and tongue.
Partner counseling and referral services (PCRS):
A prevention activity that aims to a) provide services to HIV-infected persons and their sex and needle-sharing partners so they can reduce their risk for infection or, if already infected, can prevent transmission to others and b) help partners gain earlier access to individualized counseling, HIV testing, medical evaluation, treatment, and other prevention and support services.
Perinatal HIV transmission:
Transmission of HIV from the mother to the fetus or infant during pregnancy, delivery, or breast-feeding.
Positive predictive value:
A positive predictive value estimates the probability that a person with a positive diagnostic test result will actually be infected.
Positive test:
For HIV, a specimen sample that is reactive on an initial ELISA test, repeatedly reactive on a second ELISA run on the same specimen, and confirmed positive on Western blot or other supplemental test indicates that the client is infected.
Prevalence:
The number or percentage of persons in a given population with a disease or condition at a given point in time.
Prevention case management (PCM):
A client-centered HIV prevention activity that promotes adoption of HIV risk-reduction behaviors by clients with multiple, complex problems and risk-reduction needs. PCM is a hybrid of HIV prevention counseling and traditional case management that provides intensive, on-going, individualized prevention counseling, support, and referral to other needed services.
Prevention counseling:
An interactive process between client and counselor aimed at reducing risky sex and needle-sharing behaviors related to HIV acquisition (for HIV-uninfected clients) or transmission (for HIV-infected clients). See also client-centered HIV prevention counseling and HIV prevention counseling.
Quality assurance:
An ongoing process for ensuring that the CTR program effectively delivers a consistently high level of service to the clients.
Rapid HIV test:
A test to detect antibodies to HIV that can be collected and processed within a short interval of time (e.g., approximately 10--60 minutes).
Referral:
The process through which a client is connected with services to address prevention needs (medical, prevention, and psychosocial support).
Risk assessment:
Risk assessment is a fundamental part of a client-centered HIV prevention counseling session in which the client is encouraged to identify, acknowledge, and discuss in detail his or her personal risk for acquiring or transmitting HIV.
Risk screening:
A brief evaluation of HIV risk factors, both behavioral and clinical, used for decisions about who should be recommended HIV counseling and testing. Risk screening is different from risk assessment.
Screening test:
An initial test, usually designed to be sensitive, to identify all persons with a given condition or infection (e.g., enzyme immunoassay [EIA] or enzyme-linked immunosorbent assay [ELISA]).
Sensitivity:
The probability that a test will be positive when infection or condition is present.
Seroconversion:
Initial development of detectable antibodies specific to a particular antigen; the change of a serologic test result from negative to positive as a result of antibodies induced by the introduction of antigens or microorganisms into the host.
Specificity:
The probability that a test will be negative when the infection or condition is not present.
Tuberculosis (TB) disease:
Active disease caused by Mycobacterium tuberculosis, as evidenced by a confirmatory culture, or, in the absence of culture, suggestive clinical symptoms, including productive cough lasting >3 weeks, chest pain, hemoptysis, fever, night sweats, weight loss, and easy fatigability. Active TB is a communicable disease that is treatable, curable, and preventable, and persons with active TB disease should be under the care of a health-care provider. Active TB disease could indicate immune deficiency. For HIV-infected persons, active TB disease is considered an opportunistic infection and a qualifying condition for AIDS.
Tuberculosis (TB) infection:
Infection with the bacteria M. tuberculosis, as evidenced by a positive tuberculin skin test (TST) that screens for infection with this organism. Sometimes, TST is called a purified protein derivative (PPD) or Mantoux test. A positive skin test might or might not indicate active TB disease (see tuberculosis disease). Thus, any person with a positive TST should be screened for active TB and, once active TB is excluded, evaluated for treatment to prevent the development of TB disease. TB infection alone is not considered an opportunistic infection indicating possible immune deficiency.
Vaginal sex:
A type of sexual intercourse in which the man's penis enters the woman's vagina.
Voluntary HIV testing:
HIV testing that is offered free of coercion. With voluntary HIV testing, participants have the opportunity to accept or refuse HIV testing.
Western blot:
A laboratory test that detects specific antibodies to components of a virus. Chiefly used to confirm HIV antibodies in specimens found repeatedly reactive using ELISA.

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