April 2003

Current Knowledge

Outreach efforts for HIV prevention activities provide access to hard-to-reach populations at high risk for HIV. Numerous jurisdictions offer counseling and testing for HIV in non-clinical settings, often through the use of mobile vans. The U.S. Food and Drug Administration’s (FDA’s) approval of oral fluid HIV testing in 1994 greatly expanded opportunities for offering HIV testing in settings that were not suitable for drawing, handling, and storing blood specimens.

Testing programs in non-clinical venues are more likely to reach members of some racial and ethnic minorities and persons at increased risk for HIV. Compared with persons tested at conventional testing sites, those tested at non-clinical sites were twice as likely to report high-risk heterosexual contacts and 3 to 4 times as likely to report injection drug use or male-to-male sex.¹ A California outreach program called Neighborhood Interventions Geared to High-risk Testing (NIGHT) offers street outreach, HIV counseling and testing, and referrals through the use of mobile vans. NIGHT was the source of more than 104,000 tests during 1997 and 2001. Compared with other testing sources, NIGHT reached a higher proportion of African Americans (28% versus 13%), injection drug users (23% versus 11%), stimulant drug users (45% versus 25%), and commercial sex workers (12% versus 5%).²

The rate of HIV-positive tests in non-clinical settings is generally high and consistently higher than at conventional testing sites.1 In Wisconsin, persons tested in outreach were 23% more likely to test HIV-positive than those tested in clinics.³ Of the 597 persons tested in mobile vans and street outreach in a 1999 initiative to enhance prevention efforts in African American and Latino communities in 4 U.S. cities, 8.7% were HIV-positive.⁴ In South Carolina, 54% of men approached in a gay bar agreed to oral fluid testing; although 78% had been tested before, 6% were newly diagnosed with HIV.⁵ In CDC’s Young Men’s Survey in 7 cities, a total of 3,592 15-to-22-year-old men who have sex with men approached in 194 non-clinical testing settings (public venues) consented to HIV testing. Overall prevalence was 7.2%. Although 79% of the men had been tested previously, 203 (82%) of the 249 HIV-positive men did not know that they were currently HIV-positive.⁶

Unfortunately, many persons tested in non-clinical settings do not return for their test results. CDC’s national data from 2000 indicate that results from nearly half of the HIV-positive tests performed in non-clinical settings were never received. In California’s NIGHT program, mobile testing clients were three times less likely to receive their test results than clients tested at conventional sites. In contrast, limited experience to date with rapid testing in outreach programs is encouraging. In a Minnesota program, an outreach worker regularly visited community-based organizations (CBOs), homeless shelters, chemical dependency programs, and needle exchange programs to offer rapid HIV testing. When results were provided the same day, 99.9% of those tested received their HIV test results. ⁷

Interviews of persons at non-clinical settings reveal features important to the success of this type of testing. For high-risk persons at a needle exchange program and gay bath houses, 36% of those who had never been tested and 28% of those who had delayed testing gave “not wanting to go to a clinic” as their reason⁸. Participants in other testing initiatives cite a desire to receive HIV results immediately and a need for testing during expanded hours as important reasons to increase alternative testing opportunities⁹.

The recent FDA approval of the OraQuick Rapid HIV-1 Antibody Test, which can be suitable for use in selected non-clinical settings and can provide results in 20 minutes, offers an opportunity to take advantage of the benefits of outreach testing and ensure that tested persons receive their results.

Objectives

The purpose of this document is to provide guidance for state and local health departments* and collaborating CBOs to

• Select appropriate non-clinical settings where persons at risk for HIV infection can receive rapid HIV testing
• Build capacity in organizations serving high-risk populations in these settings to conduct HIV counseling, testing, and referral using rapid HIV tests
• Implement rapid HIV testing programs in these settings among populations at high risk to identify persons whose HIV infection has not been diagnosed

*Although the testing sites will be in CBOs or other non-clinical venues, the linkages and medical technology transfer to implement these programs will require facilitation by health departments or other medical and laboratory partners. Thus, the information presented here focuses both on health departments and non-clinical providers.

Procedures

Steps for health departments

1. Collaborate with community planning groups, community-based service-providers, and representatives of populations at high risk for HIV to develop an epidemiologic profile of populations in their communities in which HIV infection is likely to be under-diagnosed because people (a) do not recognize they are at risk for HIV infection and/or (b) do not use traditional HIV counseling, testing, and referral services.
2. Seek input to identify venues where high-risk persons who are likely to benefit from intervention programs are known to spend time and where rapid HIV testing could be provided without appointments, with little waiting time, and with no barriers such as transportation. In communities where the HIV Testing Survey (HITS) has been conducted, those data may be helpful in selecting appropriate venues (See Attachment).
3. Solicit suggestions from community groups and members of high-risk populations about organizations that have demonstrated access to and established trust among these populations. Health departments should identify CBOs and other non-clinical settings where these populations can receive HIV rapid testing, counseling, and referral.
4. Establish partnerships with other organizations that have contact with high-risk populations. An incremental approach will be important, beginning with a small group of identified organizations in a limited number of non-clinical venues to work on the initial development and implementation process (steps 5 and 6). Then, using an iterative process, successful programs can continue while lessons learned from successful and unsuccessful programs can improve procedures that will be used in initiating additional groups of programs.
5. Hold meetings with the first (or next) group of potential partner organizations to explain the need for rapid HIV testing in non-clinical settings and gain their support and suggestions on how to implement this activity.
6. Implement and evaluate testing programs, a few sites at a time, to learn what works, what is needed to support a successful program, and what other types of venues would support testing. As lessons are learned, begin a new wave of counseling and testing programs in non-clinical settings (step 4).

Steps for CBOs

1. Determine the feasibility of implementing rapid HIV testing by assessing the following: does the setting have acceptable lighting, temperature control, and private space for providing test results? Is a suitable location that is convenient to the venue available (e.g., if offering testing to clients of a needle exchange program)? Do members of the priority population remain at the venue long enough to receive counseling, testing, and results?
2. Establish a written agreement between the CBO and the health department and/or a laboratory to ensure compliance with the Clinical Laboratory Improvement Amendments (CLIA) and state and local regulations and policies. A clear supervisory structure should be delineated to ensure responsibility for training and guidance, oversight for testing procedures, and coordination.
3. Establish linkages with a laboratory for confirmatory testing of preliminary positive rapid test specimens. This relationship should be formalized with appropriate documentation.
4. Arrange linkages between organizations at different testing venues and appropriate medical and social referrals (e.g., housing, Medicaid, partner counseling and referral services) for comprehensive follow-up care of persons who have HIV infection.
5. Establish procedures and responsibilities for reporting HIV cases to the health department.
6. Collaborate with CDC to develop, implement, and monitor training programs to train non-clinical providers to perform rapid HIV testing. Essential training elements include how to
   1. Perform the test, including procedures performed before, during, and after testing
   2. Integrate testing into the overall counseling and testing program
   3. Develop and implement a quality assurance (QA) program
   4. Collect and transport specimens for confirmatory testing
   5. Document and deliver confirmatory testing results to persons whose rapid test results had been preliminary positive
   6. Comply with universal and biohazard safety precautions
   7. Ensure confidentiality and data security
   8. Ensure compliance with relevant state or local regulations
7. Evaluate readiness to perform rapid HIV testing.
8. Establish a system to document consent for testing and test results, and to track specimens sent for confirmatory testing. A central record keeping system could be established for multiple testing sites working under the umbrella of one health department or CBO.
9. Obtain detailed locating information on clients whose test results are preliminary positive so that they can be contacted and encouraged to come in for care if they fail to return for their follow-up appointment. The health department and the testing program should specify who is responsible for follow-up if clients fail to return for confirmatory test results.
10. Assemble the testing supplies for easy storage and transportation to each testing site. Individually packaged rapid test kits include all the supplies and materials necessary to facilitate single client testing in non-clinical settings.
11. Provide routine QA monitoring at non-clinical testing sites, especially the appropriate handling of infectious waste, compliance with the regulations of the Occupational Safety and Health Administration, and an exposure control plan for potential occupational exposures.

Working with Partners and Integration into Existing Services

1. Providing HIV testing in non-clinical settings such as bars, bathhouses, and needle exchange programs may pose risks to staff safety. Safety training should be included in the development of testing programs, and appropriate precautions (e.g., working in teams) should be specified. Agreements with law enforcement, owners of social venues such as bathhouses or sex clubs, neighborhood associations, and other key partners should be established before testing activities begin.
2. Clients offered HIV testing at non-clinical venues may be under the influence of alcohol or drugs or have chronic mental health conditions, any of which may interfere with their ability to provide informed consent for voluntary HIV testing, or to understand test results. The CBO and the health department should work with community mental health providers to establish guidelines and define sobriety standards for counselors to use to determine when clients are not competent to provide consent. These guidelines should be unambiguous and easy to implement.
3. After preliminary positive rapid test results have been provided, follow-up procedures should be in place to facilitate entry to care. For example, consideration should be given to scheduling a specific appointment at the referral medical center where confirmatory test results will be provided. HIV counselors from the non-clinical site may accompany clients to the medical center to provide support and ensure continuity of care.
4. After confirmed HIV-positive results have been delivered, it may be appropriate for counselors who have established good relationships with their clients to begin eliciting information about partners or to link clients to the partner, counseling, and referral services of their health department partner.

Programmatic Considerations

1. Legal and regulatory barriers, such as state prohibitions, health department policies, or state laboratory regulations against giving preliminary HIV test results may challenge the implementation of rapid HIV testing in non-clinical settings. Consideration should be given, where appropriate, to eliminating such barriers.
2. To provide accountability and continuity in collaborations, a key contact should be identified at the health department and at each testing site and community-based program conducting rapid HIV testing.
3. Linkages and resources for HIV care that are population specific must be identified and made available to non-clinical personnel who are providing HIV test results. These resources include treatment, prevention, and social services for persons who test HIV-positive and prevention services for high-risk persons who test HIV-negative.
4. For all HIV testing, specific written policies and procedures for ensuring confidentiality must be in place.

Vignette

In 2002, an HIV testing program using OraQuick HIV-1 test kits was implemented in Minneapolis, Minnesota. By working with various CBOs, the program was able to focus on specific geographic areas, ethnic groups, and persons who engaged in high-risk behaviors (e.g., injection drug users) and who had been identified as priority populations within the community. Before conducting testing at a given CBO, the testing team did an initial planning visit. They met with the staff and learned about their program. Asking: How can HIV counseling and testing best fit into their schedule? Are there times when they are already talking about HIV prevention, so that HIV testing might be more readily accepted? At this planning visit the CBO staff members learned about the testing program, including information about the OraQuick test, patterns of client referral, and the need for client confidentiality.

Also at this visit, the team evaluated the physical space of the facility. Most CBOs had an adequate meeting area that could be used as a pretest counseling room for groups. Finding rooms for individual testing and posttest counseling posed a greater challenge. The team asked about time constraints. What will the clients do while they are waiting to be tested and waiting for test results?

The CBOs determined how much client education was necessary. Some programs had a very structured HIV prevention class, where testing was planned immediately after the HIV prevention session. Other CBOs, such as homeless shelters, typically did not have structured health talks, so the HIV information provided had to be more complete.

After group pretest counseling, the team members adjourned to the space for individual testing. They enlisted a CBO staff member to direct and maintain a steady, efficient flow of clients through the process. They performed the OraQuick testing procedure as described in the package insert, using what is called the one-worker approach. After setting up the necessary supplies, the worker performed the test with Client A, set timer A for 20 minutes, and recorded the start time for Client A’s test. Client B came in as Client A left. The worker then set out the supplies for the next test and followed the same procedure as before. Just as Client B was leaving, the timer went off for Client A. The worker read and recorded the test results and then conducted posttest counseling with Client A. An advantage of the one-worker approach is that one person can be efficient. The continuity for the client is good because the same worker does pretest counseling, testing, and posttest counseling. A disadvantage of this approach is that workers can get “assembly line fatigue,” and special procedures may be needed if a test result is positive and more complex posttest counseling is necessary. Multitasking skills are needed. At large venues, as many as four workers have conducted testing at one time.

Monitoring Implementation

CDC grantees receiving HIV prevention funds will be required to routinely report the following indicators to monitor their HIV testing programs in non-clinical settings.

CDC’s HIV Prevention Program Performance Indicators*:

1. Number and percent of newly diagnosed HIV infections in non-clinical settings (B.1)
2. Percent of newly identified, confirmed HIV-positive test results returned to clients tested in non-clinical settings (B.2)
3. Percent of facilities reporting a prevalence of HIV-positive tests equal to or greater than the jurisdiction’s target set in B.1 (B.3)

Other program measures:

4. Percent of newly identified HIV-positive patients who enter care services and whose medical records contain documentation such as a CD4 count or a visit to an HIV care clinic, if feasible to ascertain
5. Summary data on the comparison between the performance indicators collected in non-clinical settings to the same performance indicators for all tests reported by CDC-funded HIV counseling, testing, and referral sites in the jurisdiction

* The CDC Technical Assistance Guidelines for Health Department HIV Prevention Program Performance Indicators provides information on setting baseline, target, and indicator specification including appropriate data sources, calculations and reporting issues. Note: Performance indicators may have been modified to reflect specific population or setting characteristics.

References

1. Greby S, Frey B, Royalty J, et al. Use of simple oral fluid HIV-tests in CDC-funded facilities. In: Program and abstracts of the XIV International Conference on AIDS; July 2002; Barcelona, Spain. Abstract TuPeD4991.
2. Rasmussen H, Chen M, Myrick R, Truax S. An evaluation of California’s neighborhood interventions geared to high-risk testing (NIGHT) outreach program. In: Program and abstracts of the XIV International Conference on AIDS; July 2002; Barcelona, Spain. Abstract ThOrD1401.
3. DiFrancesco W, Holtgrave DR, Hoxie N, et al. HIV seropositivity rates in outreach-based counseling and testing services: program evaluation. J Acquir Immune Defic Syndr 1998;19:282-288.
4. Dean HD, Gates CH. Conducting HIV counseling, testing and referral within the context of rapid assessment, response and evaluation in crisis response team cities. In: Program and abstracts of the XIV International Conference on AIDS; July 2002; Barcelona, Spain. Abstract MoPeF3980.
5. Sy FS, Rhodes SD, Choi ST, et al. The acceptability of oral fluid testing for HIV antibodies: a pilot study in gay bars in a predominantly rural state. Sex Transm Dis 1998; 25:211-215.
6. Valleroy LA, MacKellar DA, Karon JM, et al. HIV prevalence and associated risks in young men who have sex with men. JAMA 2000;284:198-204.
7. Keenan PA, Keenan JM. Rapid HIV testing in urban outreach: a strategy for improving posttest counseling rates. AIDS Educ Prev 2001;13:541-550.
8. Molitor F, Bell RA, Truax SR, et al. Predictors of failure to return for HIV test result and counseling by test site type. AIDS Educ Prev 1999;11:1-13.
9. Spielberg F, Branson BM, Goldbaum GM, et al. Overcoming barriers to HIV testing: preferences for new strategies among clients of a needle exchange, a sexually transmitted disease clinic, and sex venues for men who have sex with men. J Acquir Immune Defic Syndr 2003;32:318-328.

Resources

CDC. Revised Guidelines for HIV Counseling, Testing, and Referral.

CLIA application and requirements

NASTAD Primer on implementing rapid HIV testing 

Product information, OraQuick Rapid HIV-1 Antibody Test

Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988

Rapid HIV Testing

CDC. Technical Assistance Guidelines for CDC’s HIV Prevention Program Performance Indicators.

Attachment 1 – Rapid Testing in Non-Clinical Settings

HIV Testing Survey

Overview

The HIV Testing Survey (HITS) was funded by CDC in various sites from 1996-2002 through HIV/AIDS Surveillance cooperative agreement funds. HITS monitored HIV testing patterns by assessing reasons for seeking or avoiding testing, examining knowledge of state policies for HIV surveillance, and assessing HIV testing patterns among persons at high risk for HIV. In addition, HITS collected behavioral risk information from persons at high risk for infection.

HITS was anonymous and cross-sectional and surveyed populations at high risk for HIV infection. The core populations included men who have sex with men (MSM), injection drug users (IDUs), and heterosexual adults at high risk. Areas had the option of sampling a population of local interest. To recruit HITS participants, the study was conducted in several cities within a state (generally) at 3 venues: gay bars, street locations in areas of heavy drug use, and sexually transmitted disease (STD) clinics. At least 100 persons in each population group were interviewed. This number meant that each participating state had a minimum sample of 300 persons. Persons who had not been tested or who did not report that they had tested HIV-positive were interviewed. Persons who reported they were HIV-negative were interviewed as well.

Population

Regardless of the venue, persons who were at least 18 years of age, who were able to give informed consent, and had resided in the state for at least 1 year were eligible for an interview. In addition, the following behavioral criteria applied for each risk group: men at MSM venues (e.g., gay bars) if they had had sex with a man within the past 12 months; IDUs if they had injected drugs within the past 12 months; and heterosexual adults at high risk who had come to an STD clinic because of a suspected STD, had not been treated during the past 90 days, were not at the clinic because of referral or follow-up, and had not had homosexual sex within the past 12 months.

Location of HITS and year(s) of survey

HITS–1 (1996): Arizona, Colorado, Maryland, Missouri, Mississippi, New Mexico, North Carolina, Oregon, Texas. HITS–II (1998): Arizona, Colorado, Missouri, Mississippi, New Mexico, Oregon, Texas. HITS–2000: Florida, Illinois, Kansas, Nevada, New York, Texas, Washington, and New York City. HITS–2001: California, Louisiana, Vermont, and Philadelphia. HITS–2002: Florida, Illinois, Michigan, New Jersey, Washington, and Houston, Los Angeles County, New York City, and Philadelphia. Asian/Pacific Islander HITS (2002): Seattle/King County, Washington. Migrant Farm Worker HITS (2002): California. Native American HITS: Portland, Oregon (2001, 2002), and Houston (2002). Transgender HITS (2002): San Francisco.

Contact Person(s)

State or local health department, HIV/AIDS surveillance coordinator or HITS site coordinator. CDC, Division of HIV/AIDS Prevention, Behavioral and Clinical Surveillance Branch.