Antonio-Gaddy, Mara San RN, MSN*; Richardson-Moore, April RN, MPH*; Burstein, Gale R MD, MPH, FAAP†; Newman, Daniel R MA†; Branson, Bernard M MD†; Birkhead, Guthrie S MD, MPH*
Identifying HIV-infected persons and linking them to medical care and prevention services is a national priority.1 Approximately 2.5 million HIV tests are conducted annually in publicly funded counseling, testing, and referral programs; however, in 2000, 31% of those tested did not receive their HIV test results.2 With conventional enzyme immunoassay (EIA) HIV testing, clients tested are typically asked to return to the HIV testing site in 1 to 2 weeks for laboratory test results.3 The additional burden of returning for test results may cause clients to be less likely to receive their test results or even to decide against getting tested.4,5
The use of rapid HIV tests is a new strategy in public health HIV prevention programs. Under the Clinical Laboratories Improvement Amendments (CLIAs), waived rapid HIV tests make it possible to provide a test result within 10 to 40 minutes in point-of-care and nonclinical settings.6-9
The New York State (NYS) Department of Health AIDS Institute's publicly funded statewide Anonymous HIV Counseling and Testing (ACT) Program offers HIV counseling and testing free of charge in a variety of community and correctional settings. Rapid HIV testing was integrated into existing HIV counseling and testing sites in 2003 after conducting a successful demonstration project at 10 pilot sites.
Initially, there was concern that individuals may not want to receive their test results with such immediacy, and would therefore not accept rapid testing as an option. In addition, there was the possibility that HIV test counselors may be apprehensive regarding their new role and responsibilities in conducting a rapid test. This evaluation project examined 3 aspects of implementing rapid HIV testing in a public health setting: (1) the number of clients testing for HIV, the number who tested positive, and the number who received their test results after introduction of point-of-care rapid HIV antibody tests; (2) clients' preferences for different types of HIV tests and satisfaction with the rapid test and their testing experience; and (3) counselors' proficiency and reported self-efficacy in performing rapid HIV antibody tests after training and 12 weeks of field experience.
The project protocol was granted a nonresearch determination by the Centers for Disease Control and Prevention (CDC) Institutional Review Board (IRB) and an exemption of consent from the NYS Department of Health IRB.
The rollout of rapid HIV testing began with a 2-day training session on rapid HIV testing for 40 ACT Program counselors. Training covered the HIV test product, performing a finger stick, performing the rapid test and reading the results, quality assurance practices, providing information about HIV and rapid testing during counseling, and delivering test results. Instructional tools included group discussion, demonstration, skill-building exercises, role plays, hands-on laboratory practice, and competency assessment for interpretation of results. Counselors tested external controls and blinded specimens of HIV.
After staff from each testing site were trained, rapid HIV testing was added to the existing options of conventional blood and oral fluid testing. Start-up was staggered so that ACT Program supervisors could devote individualized technical assistance to each testing site.
Use and Receipt of Results
The total number of HIV tests (rapid and conventional) and test results received during the first 6 months of rapid testing at each testing site in 2003 were compared with the number of conventional HIV tests and test results received at the same testing sites during the comparable time period in 2002. Data on confirmatory testing for clients with reactive rapid test results from a longer period, April 2003 through June 2004, were analyzed to examine acceptance of confirmatory HIV testing and receipt of test results.
At each site, clients could choose to have a rapid test on a finger-stick blood specimen or conventional testing with phlebotomy or oral fluid specimens. (Oral fluid rapid HIV antibody tests were not licensed at the time these data were collected.) Clients completed voluntary surveys during the first 30 days after the introduction of rapid HIV testing at each site. Six questions evaluated clients' opinions about rapid testing preferences for different test methods, the importance of test method choice, the reasons for choosing a test method, and satisfaction with the testing experience. Clients were also asked if they had known that rapid testing was available at the testing site before they arrived, and, if so, whether they would have come to that testing site if rapid testing were not available.
Responses from client surveys that were linked to counseling and testing scannable (CTS) data (including client demographics, risk behavior, and previous testing history) were analyzed to describe test method preferences and reasons for choosing a test method.
Counselors completed a 2-page survey to assess their self-efficacy in performing the tasks required for rapid HIV testing before and after training and 12 weeks after they began testing clients. The survey asked counselors to rate, on a 5-point Likert scale, their comfort with providing information to clients, offering a rapid HIV test with same-day results, performing the rapid test as part of a counseling session, interpreting the test, and delivering negative and reactive (preliminary positive) rapid HIV test results. The proportion of counselors who reported that they felt “very comfortable” with the tasks required to perform rapid HIV tests before the training period, immediately after training, and 12 weeks after starting to perform rapid tests on-site were compared. All counselors also tested 5 blinded samples 12 weeks after the initial training to evaluate their proficiency in performing the rapid HIV antibody test.
SAS statistical software version 8.2 (SAS Institute, Cary, NC) was used for statistical calculations comparing the total number of HIV tests performed and test results received during the surveillance period in 2003 compared with 2002, differences in client preferences for type of HIV test, and differences in the proportion of counselors who felt “very comfortable” before training and at the 12-week follow-up. Differences in the proportion who felt “very comfortable” before training and at the 12-week follow-up were assessed by using χ2 tests, where P ≤ 0.05 was considered to be statistically significant. The positive predictive value (PPV) was calculated as the proportion of reactive rapid test results with a confirmatory test performed that confirmed a positive result during the period from April 2003 through June 2004.10 We estimated 95% confidence limits (CL) for the PPV using exact binomial methods.11
Sixty-one anonymous testing sites, including community sites, state prisons, and county jails, were included in the project. Testing schedules at the sites ranged from 1 day every other week to 5 days per week. A total of 1321 clients were tested for HIV during the first 30 days after rapid testing was initiated at each clinic site.
HIV Testing in 2002 Versus 2003
In comparing test use for 6 months after the implementation of rapid testing with the same time periods and sites in 2002, an increase in HIV testing was observed in 2003. In 2003, 1667 more HIV tests were performed, a 36.9% increase (P < 0.001; Table 1). In 2002, there were 4520 conventional HIV tests reported compared with a total of 6187 HIV tests in 2003, of which 5771 (93.3%) were rapid tests (Table 1).
Overall, a substantial number of persons receiving an HIV test in 2003, when rapid HIV antibody tests were available, received their test results compared with the number receiving their test results in the same period in 2002, when rapid HIV tests were not yet available. During 2003, all 5771 persons testing with a rapid test received their test results at the end of the counseling session. In 2002 during the same time period, 3807 (84.2%) of 4520 persons received their test results. Of those persons testing negative in 2003, 6060 (99.0%) of 6122 persons (P < 0.0001) received test results and 49 (75.4%) of 65 persons (P < 0.7) confirmed to be positive received a test result (Table 2). In 2003, an increase in the receipt of test results was demonstrated in HIV-negative and HIV-positive clients. Of the 47 individuals who received a reactive rapid HIV test result, 38 (81.0%) returned for their confirmation test result. Of those testing positive with a conventional test in the 2002 observation period, 34 (72.3%) of 47 returned for a test result, and in the 2003 observation period, of those who had a conventional test, 10 (58.8%) of 17 returned for their test result (Table 2).
Reactive Rapid HIV Tests
From April 2003 through June 2004, 153 clients had reactive rapid test results. One hundred forty-one (92.2%) accepted confirmatory testing, and 113 (80%) returned for their confirmatory test result (Fig. 1). Among the 12 clients who refused to confirm their reactive rapid HIV test results, reasons for not accepting confirmatory testing included already knowing their HIV-positive status and the desire to seek confirmation with a private provider.
Of the 141 specimens submitted for confirmation by Western blot (WB) analysis, a total of 134 were confirmed as positive; the PPV of the rapid HIV test was 95% (134 of 141 specimens; 95% CL: 90 to 98). Of the 134 specimens that were confirmed to be HIV-positive, 133 (94.3%) were positive on the first confirmatory specimen collected at the time of the reactive rapid test; 1 (0.7%) had an initial indeterminate WB result but was positive by WB analysis at the second confirmation test (Fig. 1). There were 7 reactive rapid HIV tests that did not confirm HIV positive by WB analysis; 5 (3.6%) were negative and 2 (1.4%) were indeterminate by WB result (Fig. 1). Of the 134 confirmed HIV-positive tests, 109 (81.3%) clients received their test results and were referred to care.
During the first month of rapid HIV testing at each testing site, 1301 (98.5%) of the 1321 clients who received counseling and testing completed a client preference survey; a total of 1294 (99.5%) surveys were linked to CTS data. Almost all (1249 [96.5%]) clients selected rapid testing; 28 (2.2%) elected oral fluid collection and 17 (1.3%) elected phlebotomy for conventional testing. A similar proportion of clients who selected each method reported that it was “important” or “very important” to have a choice of test methods: 831 (67.8%) of 1225 who chose rapid testing, 19 (67.9%) of 28 who chose oral fluid collection, and 12 (70.6%) of 17 who chose phlebotomy for conventional testing (P > 0.3).
Among 1232 (95.2%) clients who responded to the question about the most important reason for choosing a specific test method, 855 (71.7%) of 1192 who chose rapid HIV testing reported that their most important reason was “I wanted the result today,” 11 (45.8%) of 24 of those who chose oral fluid testing reported “I don't like needles,” and 8 (50.0%) of 16 clients who selected phlebotomy for conventional testing said they did so because “I trust the accuracy of the results.” Five hundred twenty-two (40%) of the 1294 clients said they knew that rapid HIV testing was available at the site before presenting for an HIV test; 149 (28.5%) of these reported that they would not have tested if rapid testing were not available.
All 40 counselors who completed the training completed surveys before and after training and at 12 weeks of follow-up. Counselors' knowledge, comfort, and confidence levels increased in all skill categories after training and increased further at the 12-week follow-up (Table 3). During the pretraining survey, 50% or fewer reported feeling “very comfortable” about offering clients a rapid HIV test (n = 20 [50%]), correctly performing the rapid HIV test (n = 18 [45%]), or correctly interpreting test results (n = 19 [47.5%]). After receiving training and performing rapid HIV tests for 12 weeks, nearly all reported feeling very confident about performing these tasks (range: 39-40 [97.5%-100%]; P < 0.001; see Table 3). Of all tasks, the least number of counselors reported feeling comfortable with delivering a reactive rapid test result before training (14 [35%] of 40 counselors). This number, however, increased to 32 (80%; P < 0.001) after counselors had performed rapid testing for 12 weeks. Twelve weeks after test training, all 40 counselors correctly tested and interpreted results on all 5 blinded proficiency samples.
Clients tested in the NYS ACT Program overwhelmingly preferred finger-stick blood rapid tests (96.5%) over conventional HIV testing by oral fluid collection or phlebotomy. Their most important reason for choosing the rapid HIV test was the ability to receive same-day test results. Many clients said they would not have tested if rapid testing had not been available, probably accounting for at least part of the 37% increase in HIV testing noted after introduction of the rapid test. A few clients reported that they chose oral fluid collection for HIV testing because of their dislike for needles. At the time of this survey, only finger-stick rapid tests were available at the test sites. The US Food and Drug Administration (FDA) has since approved rapid testing using an oral fluid specimen; this availability may further increase the demand for rapid testing.
In addition to the increase in testing, the proportion of clients tested who learned their HIV status also increased substantially. All clients received their rapid test results, and more HIV-positive clients tested with rapid tests than with conventional testing received their confirmed positive test results. Because all testing was anonymous, it is not possible to tell how many clients with reactive tests may have sought confirmation elsewhere; some clients who refused confirmatory testing at the ACT Program sites indicated this as their intention.
Clients who fail to return for their confirmatory test results pose a challenge for anonymous testing sites. Approximately 20% of those clients with reactive rapid tests did not return for their confirmatory test results. In those testing sites with prevalence as high as 1%, there was a 95% chance that clients with a reactive rapid HIV test were seropositive. Although these clients received more information by learning that their rapid test was reactive compared with receiving no test result at all, counselors should encourage anonymously testing clients with reactive rapid HIV tests to provide some contact information to allow follow-up and to enhance the likelihood of the client's return.12 Validation of a confirmatory algorithm using a combination of point-of-care rapid HIV tests would enhance opportunities for individuals to get a confirmed HIV test result and be linked into care immediately after testing.
These data support the notion that point-of-care rapid HIV tests can play a key role in HIV prevention programs and increase opportunities for, and acceptance of, HIV testing as well as increasing the number of persons who learn their test results. Because many new HIV infections are transmitted by persons unaware that they are infected, reducing the number of HIV-infected persons unaware of their status and offering appropriate treatment and prevention services are important public health interventions.2,13-15
In NYS, counselors reported increased self-efficacy with rapid testing skills and counseling tasks after training and field experience. Although counseling staff initially reported apprehension about performing rapid HIV testing, most counselors reported feeling comfortable performing all the tasks required for rapid testing after they gained experience in performing the test in the field for 12 weeks. Even though most counselors had not yet disclosed a reactive test result after 12 weeks of rapid testing experience, 80% reported feeling comfortable with this prospect.
All the counselors correctly performed the rapid test and accurately interpreted the results on blinded proficiency samples 12 weeks after completing training. These results demonstrate that counseling staff with no previous laboratory experience can be trained to be competent rapid HIV test technicians in publicly funded HIV testing sites.
The generalizability of our findings may be limited because the NYS ACT Program is different from many other HIV testing programs. The NYS program routinely offers free and anonymous HIV testing with a choice of testing methods and is well established in a variety of community outreach and correctional sites. Programs that offer only confidential HIV testing, charge for testing, or do not offer choices for HIV testing methods may observe different results. Also, NYS established its rapid testing program with experienced counselors. Less experienced staff may not achieve the same level of comfort and proficiency with rapid testing and the associated counseling.
Training was an intensive 2-day program with information specifically tailored to local circumstances. After the training, management staff members were able to provide on-site technical assistance to each regional program as part of the staggered implementation during the roll-out period. Once rapid testing is established in multiple sites, it is likely to be difficult to offer this level of individual supervision and technical assistance.
Some of the increase in HIV testing may also have occurred because of the novelty and newsworthiness of rapid HIV tests at the time of these observations. Because many clients knew that the rapid test was available before they arrived at the test site, some may have sought testing at these sites when rapid testing was introduced instead of at sites that did not offer the rapid test.
Clients overwhelmingly preferred rapid HIV tests; some may not have tested if rapid testing were not available. With the introduction of rapid HIV testing, the number of HIV tests, positive test results, and receipt of test results all increased. An alternative strategy that would allow immediate confirmation of reactive rapid HIV tests would further reduce the number of individuals who do not receive confirmed test results and enhance opportunities to link newly diagnosed individuals into care. After training and field experience, counselors expressed confidence in their skills and demonstrated proficiency with rapid testing.
NYS Department of Health Wadsworth Center HIV Laboratory staff assisted in training ACT Program staff, developed samples for interpretation, and provided quality assurance guidance.
© 2006 Lippincott Williams & Wilkins, Inc.