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HIV Testing: State of the Field and Current Research

Authors: Laura M. Bogart, PhD   Faculty and Disclosures


Overview: CDC Recommendations for HIV Testing

The Centers for Disease Control and Prevention's (CDC's) 2006 guidelines for HIV testing of adults, adolescents, and pregnant women recommend universal and routine HIV screening in all public and private healthcare settings, including community clinics, hospital emergency departments, urgent care clinics, inpatient services, occupational health exposures, and venues serving pregnant women.[1] The 2006 guidelines supplement existing guidelines from 2001 that recommend HIV testing of all at-risk individuals in healthcare settings, community-based organizations (CBOs), and outreach settings.[2] Repeat screening of pregnant women in the third trimester in jurisdictions with high rates of HIV-infected women is recommended.

Use of rapid HIV testing and simplified counseling and testing procedures, including opt-out screening (in which the patient can decline testing after being notified that it will be performed), optional prevention counseling, and optional written informed consent are recommended in the new guidelines. The goal of the recent testing recommendations is to increase the number of people in the United States who are aware of their HIV status. Awareness of HIV status increases the likelihood that seropositive individuals will reduce transmission risk behavior and allows providers to facilitate links to healthcare and antiretroviral treatment, thus increasing survival times among infected individuals.[1, 3-5] Routine and universal HIV testing therefore has substantial implications for public health.

Rapid HIV Testing Can Increase HIV Screening Rates

Standard HIV testing requires 2 sessions; clients must return 1-2 weeks after the test for results and counseling. This 2-part process has been shown to reduce risk behavior among those already infected.[6] Because approximately one third of clients do not return for results,[3,7] use of a single-session rapid HIV test has been recommended.[1,2] Rapid tests allow HIV-negative individuals to learn their status 20-40 minutes after the test. Rapid tests are ideal for community and outreach settings, as well as emergency departments, where clients may not have ongoing relationships with providers and may therefore be less likely to return for posttest counseling.

The Table shows the 4 rapid HIV tests approved by the US Food and Drug Administration (FDA) since 2002. All of these tests have high sensitivity and specificity.[4, 8-10] Two have been waived for point-of-care use under the 1998 Clinical Laboratory Improvement Amendments (CLIA) and can be used by trained staff in non-clinical settings: OraQuick ADVANCE (OraSure Technologies) for whole blood or oral fluid samples[11]; and Uni-Gold™ Recombigen (Trinity Biotech) for whole blood. Because rapid HIV tests are approved for use in multitest algorithms, all reactive rapid test results require confirmatory testing.[12]

Table. Sensitivity and Specificity of FDA-Approved Rapid HIV Tests

Rapid HIV Test Specimen Type Sensitivity
(95% CI)
(95% CI)
OraQuick ADVANCERapid HIV-1/2 antibody test (OraSure Technologies) Oral fluid 99.3% (98.4-99.7) 99.8% (99.6-99.9)
Whole blood 99.6% (98.5-99.9) 100% (99.7-100)
Plasma 99.6% (98.9-99.8) 99.9% (99.6-99.9)
RevealG2 RapidHIV-1 antibody test (MedMira) Serum 99.8% (99.2-100) 99.1 (98.8-99.4)
Plasma 99.8% (99.5-100) 98.6% (98.4-98.8)
Uni-Gold RecombigenHIV test (Trinity Biotech) Whole blood 100% (99.5-100) 99.7 (99.0-100)
Serum/plasma 100% (99.5-100) 99.8% (99.3-100)
Multispot HIV-1/HIV-2 Rapid test (Bio-Rad Laboratories) Serum/plasma 100% (99.9-100) 99.9 (99.8-100)

Research suggests that rapid HIV testing in such community and hospital settings could be instrumental in realizing the CDC's goal of widespread HIV screening. Rapid HIV tests have advantages over traditional HIV tests in community health and hospital settings, such as increased rates of posttest counseling, high feasibility and cost-effectiveness, and greater acceptability to clients and staff.[4, 13-35] Rapid testing may be especially useful in public health testing sites where substantially greater HIV rates have been found (2%-17%).[28,29]

Rapid testing of source patients in occupational exposure situations facilitates employee decisions about initiating postexposure prophylaxis.[25] Rapid testing of pregnant women during labor enables providers to take effective measures to prevent perinatal HIV transmission.[33, 36-38] Due to the need for expedience in labor situations, rapid testing may be more useful if test results are processed at the point-of-care during labor, vs in the hospital laboratory.[4,29,33]

Controversies: Universal and Routine HIV Screening

Despite the potential advantages of expanding HIV screening, the latest CDC recommendations have elicited some controversy. Some individuals are concerned that abbreviated pretest counseling will result in less effective prevention efforts.[39] However, no research has unequivocally shown that pretest counseling is effective and a necessary component of HIV testing.[40,41] Indeed, a meta-analysis showed that individuals who tested positive were more likely to reduce risk behavior, whereas individuals who tested negative were not.[6]

Although studies have not directly tested the effects of testing without vs with pretest counseling, findings of the meta-analysis suggest that the receipt of serostatus results and posttest counseling for individuals testing positive is the more critical component of the HIV testing session. In addition to concerns regarding pretest counseling, HIV activists worry that expansion of HIV screening and opt-out testing could threaten the rights of disenfranchised individuals, who may not feel that they have a choice in the testing decision.[41-43]

Review of Current and Ongoing HIV Testing Research: Presentations at the American Public Health Association Meeting

Use of Rapid HIV Tests Among Providers in the United States. The new CDC testing recommendations, as well as the streamlining of counseling, were widely discussed at the annual American Public Health Association (APHA) meeting. Despite CDC recommendations to screen individuals for HIV in hospital settings such as the emergency department and labor and delivery, research presented at the conference suggests that rapid HIV test use is low in US hospitals. At the conference, Laura Bogart, RAND Corporation, and colleagues from both RAND and the CDC, presented the results of their survey of a nationally representative probability sample of 584 US hospitals.[44,45] Results showed that only 52% of hospitals were currently using rapid HIV tests, and that an additional 21% had implementation plans for rapid testing. Half were using rapid tests in occupational health, 29% in labor and delivery, and 13% in the emergency department/urgent care. Furthermore, 45% of hospitals processed rapid tests in the laboratory, vs at point-of-service, despite the availability of CLIA-waived tests such as OraQuick ADVANCE, which can be processed by trained nonlaboratory staff.

Furthermore, healthcare settings' resources and need for HIV testing predicted use of rapid HIV tests. In multivariate models, rapid test use was more likely in hospitals serving more patients; and located in high poverty, high AIDS prevalence areas; in the South and Midwest (vs West); and in areas with lower proportions of blacks and Hispanics.

In summary, although rapid HIV test use is increasing in US hospitals, the penetration of rapid test use within hospitals is largely limited to occupational health to test index patients after employees experienced needle sticks. Although such use of rapid HIV testing is valuable in helping providers decide whether to initiate postexposure prophylaxis with antiretroviral treatment, hospitals need to expand use of rapid HIV tests to other patient care settings to reach the CDC's goal of routine screening across the US population. In particular, the low rate of test provision in emergency departments represents a missed opportunity to detect infections among high-risk individuals who may not otherwise be intending to test, and who may not have continuing relationships with providers.[29, 46-48]

Overcoming Staff and Organizational Barriers to Rapid HIV Test Use.Prior research has suggested that a number of staff-related and organizational barriers may inhibit rapid test use. Given recent publicity surrounding the high false-positive HIV rate in a San Francisco site,[9] staff may be concerned about the potential for false-positive results. Nonlaboratory staff may feel apprehensive about learning and implementing rapid testing procedures,[19] especially if they are already comfortable with traditional counseling and testing methods.

Compared with non-rapid HIV tests, rapid tests require larger blocks of time per client to perform counseling, testing, and test processing in 1 session that may increase the amount of time clients spend in the waiting room.[20] In addition, hospital staff have reported barriers such as time pressures, insufficient resources and staff for training, quality assurance, perceived lack of responsibility to provide HIV testing, and hospital infrastructures that inhibit changes in procedures.[28,29,48,49]

To overcome such barriers, hospital and community healthcare venues may need to revise and streamline counseling and testing procedures, as suggested by recent CDC recommendations. Such revisions may include opt-out screening (in which patients can decline testing after notification that it will be performed), optional prevention counseling, and optional written informed consent. For example, streamlined testing procedures, such as videotaped pretest and posttest counseling adopted by the New York State Department of Health, have helped to decrease the burden of HIV testing in the emergency department and at urgent care centers.[50] Streamlined opt-out testing protocols may also serve to reduce the stigma associated with HIV with normalized testing, which is similar to routine testing for other diseases.

Several presenters at APHA described innovative ways to streamline HIV testing in hospitals, community clinics, and CBOs to reduce the burden on healthcare settings and facilitate use of rapid tests.[51-55] In California, HIV test counselors are required by the State Office of AIDS to collect client-level risk data for each HIV test to receive state funding for testing. Shelley Facente, San Francisco Department of Health, California; Dale Gluth, Magnet, a gay community health center in San Francisco; and their colleagues, discussed use of handheld touchscreen computers to collect client data before the test session while clients are waiting to be tested.[52,53] Data are transmitted directly to local and state databases after the testing session. Staff found this system to be feasible and cost-effective. Both staff and clients are satisfied with this system, which allows staff to spend more time counseling with a client-centered, tailored approach, by focusing on issues brought up by the client. Site coordinators no longer need to enter client survey data and therefore have additional time to provide support, supervision, and training to site counselors. In this way, the streamlined data collection process has helped to improve the quality of care offered to clients.

Overcoming Clients' Attitudinal and Cultural Barriers to Rapid HIV Testing. Programs have worked to overcome cultural and attitudinal barriers to HIV testing by developing culturally tailored protocols for targeted populations. As evidenced by presentations at APHA, several community settings are at the forefront of implementing rapid HIV testing programs that are tailored to community needs. Antonio Torres, Benton County Health Department, Oregon, and colleagues[56] described the Promotores de Salud HIV Integration Program, that uses bilingual promoters to conduct rapid HIV testing and counseling, prevention education, and referral services to Hispanic immigrant farm workers in this rural county.

The HIV Integration Program is funded by the US Office of Population Affairs and US Office of Minority Health. Rapid HIV testing is critical for screening of Hispanic immigrant farm workers, who are mobile as they travel to different farm locations, making traditional HIV testing less feasible, with the need for a return visit for results receipt.

In Benton County's HIV Integration Program, rapid testing is conducted in outreach settings such as private rooms on farms and farm labor camps, as well as onsite in a community clinic. Moreover, promoters have sponsored several community events to raise awareness about HIV (including HIV testing): a program for women and girls that included a woman with HIV sharing her story; and a weekend soccer tournament for families, with informational tables of 20 community health agencies. The events have been well attended. Because immigrant farm workers may mistrust government entities such as public health workers, use of promoters in this context is essential for gaining the trust of the community and increasing HIV screening rates among Hispanic immigrants.

Another community outreach program for rapid HIV testing outreach effectively tailored for homeless youth in San Francisco by Larkin Street Youth Services was described by Chandra Sivakumar.[57] Rapid testing in this population is critical for increasing awareness of HIV status in this high-risk group because many of the youth may not be easily located for results receipt if tested by standard means. The Larkin Street HIV Prevention Program allows for testing of youth in outreach settings. Youth who test positive are linked into care at the Larkin Street medical clinic, which is operated in conjunction with the San Francisco Department of Public Health.

Rapid test use led to 100% of youth tested by Larkin Street staff learning their HIV status vs only an estimated 50% with standard nonrapid HIV testing. Social marketing, with materials created specifically for homeless youth, has been effectively used to educate youth about the test and address their misconceptions and concerns.


Rapid HIV testing gives healthcare settings great flexibility to provide testing to individuals who may not visit usual healthcare settings or who may not intend to be tested. Moreover, rapid HIV testing is cost-effective, feasible, and acceptable to staff and clients. Nevertheless, research indicates low rates of rapid HIV test use.

Healthcare settings should work with staff and clients to overcome barriers to providing rapid HIV testing in a way that is culturally tailored and feasible. In response to CDC recommendations to streamline HIV counseling and testing protocols, innovative programs are being developed for diverse populations of clients in hospitals, community clinics, and CBOs. By tailoring and simplifying counseling and testing, more venues may be able to provide rapid HIV testing to a greater number of clients. If barriers are overcome, increased rapid HIV testing in the United States will ultimately help to realize the CDC's goals of universal awareness of HIV status, and linking all those who test positive into care, in a way that is feasible and acceptable for both clients and providers.



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