CALDERON, YVETTE MS, MD*; HAUGHEY, MARIANNE MD*; LEIDER, JASON MD, PhD‡; BIJUR, POLLY E. PhD, MPH†; GENNIS, PAUL MD*; BAUMAN, LAURIE J. PhD§
THERE IS AN APPROPRIATE DRIVE to identify patients with human immunodeficiency virus (HIV) infection at earlier stages of disease. A primary goal of the Centers for Disease Control and Prevention (CDC) initiative, Advancing HIV Prevention: New Strategies for a Changing Epidemic, is to make HIV testing a routine part of medical care.1,2 The prevalence of unrecognized HIV infection among inner-city emergency department (ED) patients ranges from 1% to 14%.2–9 The CDC recommends voluntary HIV screening in medical sites with a prevalence of 1% or greater; however, few EDs offer HIV screening on a routine basis.1–2,4,6,10
There are many advantages to using EDs as sites for increasing the availability of HIV testing. EDs are open 24 hours a day, 7 days a week with no appointments required. Moreover, patients who are newly identified as HIV-positive demonstrate multiple visits within the health care facility before ultimately being tested and identified as HIV-positive.11 With appropriate arrangements the ED can provide an avenue to immediate care and referral to HIV services. Many patients who have sexually transmitted diseases present to the ED outside of usual working hours because many patients with sexually transmitted diseases are young and are employed during normal working hours when most doctors’ offices are open. Finally, EDs often provide health care to patients with limited or no access to traditional primary health care.
Recent reports in the literature find a substantial cost benefit to universal HIV testing of all adults in the United States.3,12,14 There are many advantages to identifying patients who are HIV positive at earlier stages. Now that there are effective treatments for HIV, individuals who are identified at earlier stages of disease can benefit from immediate referral for medical care, mental health counseling, and social services.15 Society as a whole benefits as patients who learn they are HIV positive have been demonstrated to reduce their behavioral risks (Yvette’s behavior reference).
A significant barrier to testing in a setting such as the ED is that few EDs are staffed to provide informed HIV testing services, and providing testing can be perceived as an additional burden by providers.16 ED-based HIV counseling and testing (C&T) is in its early stages of development.2 Pursuing “opt-out” testing for HIV is one way to address this barrier, but it can be argued that the time of HIV testing is a prime opportunity for education of patients that could then be lost in the bustle of ED activity. Additionally, New York State, among other states, currently requires a test-specific informed consent form to be signed by the patient after the patient has received adequate information and education to agree to such consent. One option for practitioners in those states is to refer patients to the HIV counselors available during the day, but such referrals have proven to be disappointing as patient compliance with these referrals has been poor.4,17
Because videos are an effective means of imparting health information, we developed a video to provide the information regarding HIV testing typically provided by a counselor.18–24 In a previous study, we found that a video was as effective as face-to-face counseling in conveying the information needed for inner-city ED patients to consent to HIV testing.18 This study was designed to estimate the willingness of an inner-city population to be tested for HIV in the ED during hours not usually covered by an HIV counselor, with the support of a specifically designed video.
We conducted a prospective randomized controlled trial comparing the rate of HIV testing in 2 groups of patients: those offered video-assisted informed consent with immediate blood sampling (video group), and those offered in-person C&T the next business day (standard referral group). The primary outcomes were 1) proportion of patients willing to receive HIV testing and 2) if the route of the testing will change, the proportion of patients tested. The institutional review board at the Albert Einstein College of Medicine and the Health and Hospital Corporation approved the research protocol.
Study Participants and Setting
This study was conducted at the Jacobi Medical Center, an urban tertiary care public hospital located in the Bronx, New York. We recruited a convenience sample of stable patients aged 18 and over who presented to the adult ED between 4:00 pm and midnight from October 2003 through July 2004.
Patients who were clinically unstable, unable to understand the consent process, had been HIV tested within 6 months and were informed of the result, or had a confirmed diagnosis of HIV were excluded from the study. Informed consent to participate in the research was obtained from each participant. Patients who refused to participate in the trial were asked to complete an anonymous refusal form that listed possible reasons for refusal and nonidentifying demographic questions.
Standard referral group for HIV C&T consists of pretest and posttest counseling sessions with a trained HIV counselor. This study occurred before rapid testing was available at our institution and this was the standard before and during the period of our study. During the pretest counseling session, patients are given information recommended by the New York State Department of Health and CDC to make an informed decision on whether to be tested.26 The essential elements covered in a pretest counseling session are the following: HIV transmission, definition of acquired immunodeficiency syndrome and HIV infection, nature and meaning of the HIV test, benefits of testing, reporting, partner notification, and the definition of voluntary and mandatory testing. If patients agreed to be HIV tested, they were then asked to return on a separate date for their test results after posttest counseling. If patients present during off hours, they are referred to counseling sessions the next day.
The video group received our pretest educational and counseling video that covered the essential elements described above.18 Before developing the script for the pretest counseling video, 2 of the coinvestigators took a 2-day training course for HIV counselors sponsored by the New York State Department of Health. The script for the video was based on the information from the training manual and the standard material covered in a pretest C&T session. The information covered in this video mirrored that which was supposed to be covered in the pretest counseling session and included: HIV transmission, definition of acquired immunodeficiency syndrome and HIV infection, nature and meaning of the HIV test, benefits of testing, reporting, partner notification, and the definition of voluntary and mandatory testing. Versions of the video were taped in English and Spanish, and dubbed in French and Albanian. The video showed a provider speaking directly to the viewer. Patients randomized to the video group viewed the pretest counseling video after consenting to participate in the research and before being asked to consent for HIV testing.
Bilingual research assistants recruited patients from the Adult ED waiting area who presented between 4:00 pm and midnight from October 2003 through July 2004 using a prescripted approach and obtained consent in Spanish or English. The study was described to each patient in a private examining room. Written consent to participate was then solicited. Those who refused to participate were asked to provide their reasons for refusal anonymously.
A computer program, randominzation.com, was used to generate a randomization list with blocks of 10 patients. The group assignments were placed in opaque envelopes that were sequentially opened by the research assistants. Those assigned to the video group were asked to select a video in 1 of 4 languages, English, Spanish, French, and Albanian. After viewing the 10-minute video in private, participants were given an opportunity to ask questions about HIV testing from a clinician, with an interpreter present if necessary. Those who agreed to be HIV tested provided written informed consent for the test and then had a blood sample drawn for what was the standard serum HIV enzyme-linked immunosorbent assay test. After a blood sample was drawn, participants completed a questionnaire that included demographic information and self-reported risk factors. They were also given Department of Health HIV literature and an appointment to return for test results and posttest counseling within 2 weeks.
Those randomized to the standard referral group received the same HIV Department of Health literature and had the same questionnaire administered as the video group. They were given an appointment to return for in-person C&T the next business day that was convenient for the patient. They too would need to return in 2 weeks for their results.
Return visits for both groups were tracked using the hospital’s computerized information system, which was cross-referenced with the HIV counselors’ logs for accuracy. Patients were considered failures to return if they did not return within 30 days from either the time of their C&T appointment or their appointment to return for results.
We aimed to recruit a sample of n = 200 that was determined assuming power of 85%, an effect size of a 10% difference in the rate of testing in the 2 groups, and an α of 0.05. The proportion of patients who were tested for HIV and the proportion who returned for their test results were calculated, as well as the 95% confidence intervals (CI) around the difference between proportions in the 2 groups. We assessed the success of the random assignment by comparing the point estimates of the demographic characteristics of participants in the 2 groups. A logistic regression analysis was also performed to create a predictive model for the rate of return for lab results in the video group. SPSS for Windows 98.95/NT running on Windows XP was used in the analysis of these data.
The research assistants screened 961 patients for recruitment into the study. Of those, 805 (83.8%) were eligible. Four hundred and one (49.8%) of the 805 eligible patients refused to participate (Fig. 1). Reasons for refusal to participate included “felt not at risk” 140 of 401 (34.9%), “not interested” 124 of 401 (30.9%), “had no time” 64 of 401(16.0%), and “afraid to get tested” 20 of 401 (5.0%). Of those enrolled, 202 were randomized to each group. Demographic characteristics, experience with prior HIV testing, and prevalence of behavioral risk factors were similar in the 2 groups (Table 1).
First we compared the proportion of patients who agreed to HIV testing in the 2 groups. In the video group 92.6% (187 of 202) agreed to be tested compared with 4.5% (9 of 202) of those in the standard referral group (difference = 88.1%, 95% CI: 83.5%–92.7%). Of the 187 patients who agreed to be tested in the video group, 57 (30.5%) returned for test results. Of the 9 patients willing to return for testing in the standard referral group, 8 (88.9%) returned for their test results (difference = −58.4%, 95% CI: −80.0% to −36.8%) (Table 2). Overall, patients in the video group (57 of 202) were more likely to be tested and receive their results than those in the standard referral group (8 of 202) (28.2% vs. 4.0%, difference = 24.3%, 95% CI: 17.5%–31.0%). All who tested positive were linked to care though our HIV clinic. Nearly all (98.0% 196 of 200; 95% CI: 95.0%–99.4%) patients in the video group told that they found it helpful to have HIV testing available in the ED.
The logistic regression analysis did not identify any demographic characteristics or risk factors for HIV that were significant predictors of returning for test results.
Patient receptivity to HIV testing in the ED is a critical component of expanding testing to EDs. This is especially important as the United States moves toward universal testing and less counseling. We found that 50% of eligible patients were willing to participate in the study, which implies willingness to consider being tested for HIV in the ED. However, at least a third of the patients who did not participate specifically indicated that they did not feel themselves to be at risk for HIV, and another 5% were afraid to be tested. Our finding that 50% of eligible patients who present during off hours are receptive to testing strongly suggests that if HIV testing were available, the rate of testing could be substantially increased.
In our study, only 9 of 202 (4.5%) of patients in the standard referral arm agreed to be tested. Similarly, Haukoos et al. found a 6% rate of return for screening that only increased to 21% if patients were given a $25 incentive to return.17 Next day referral for HIV testing from the ED does not work.
The model of video-assisted education and consent, however, is very effective. Patients who watched the pretest video overwhelmingly agreed to being tested. We found that 187 of 202 (92.6%) of ED patients receiving pretest video counseling with an opportunity to have blood drawn immediately for HIV testing agreed to the test.
We also tracked the number of patients who returned for their results. The overall rate of return to obtain results was low, consistent with the findings of others.17 In the group that viewed the pretest counseling video and agreed to be tested, 30% (57 of 187) returned for results. Of those referred for next-day outpatient C&T, 9 of 202 returned to be tested. These results were not surprising because for complete testing in the standard referral group the patients would have to return for 2 additional visits beyond the initial ED contact. Prior studies have demonstrated failure rates in the range of 24% to 50% for patients scheduled to return for HIV results and even higher failure rates in special populations like teenagers.
C&T practices have changed substantially with the introduction of rapid testing, which allows immediate testing after counseling. The current study was conducted before rapid screening was being used at the study site. We note, however, that with the use of rapid testing it becomes even more significant to develop a system that patients find approachable to have their questions regarding HIV testing answered and that does not overly burden the health care practitioners in the ED. Although some states still require informed consent for HIV testing, there is clearly a move away from requiring it. Whether informed consent is required or not, education about HIV testing and risk behavior is clearly beneficial to the patient. The video system allows patients to test for HIV comfortably, with appropriate knowledge of what the test means. As the United States moves toward universal testing, patients will still have questions regarding that testing that must be addressed and answered.
This study showed that it is possible to offer HIV pretest counseling and serum testing available in the ED without the need for a designated counselor, and still provide adequate education in a manner that makes patients comfortable and allows their questions to be addressed. It also provides preliminary evidence that patients in the ED are receptive to HIV testing with the aid of video instruction for education or informed consent when no counselor is available. Additionally, our study supports that if we are to use the ED as a site of HIV testing to capture a greater percentage of completed testing encounters, we need to give patients their results within the same visit.
There are several limitations to this study. The first limitation is that this study was done before rapid testing was available in our institution. Although as the study measures desire to be tested, one could argue it is even more applicable now with rapid testing more available.
The initial data form concerned receptivity to testing; it did not include results of the test. As the study was anonymous, and results not linked to the survey, we do not have data representing how many patients actually tested positive for HIV.
Third, we were unable to ascertain whether patients in the standard of care referral group might have sought testing at another site. If patients went to other sites for testing, this would falsely reduce the return rate for the standard of care referral group, which only had 9 patients.
Other limitations include that we used a convenience sample, that unstable patients were excluded, that adolescents were excluded, and that there may have been a selection bias as patients were generally healthy enough to wait in the waiting area and were willing to be HIV tested. Therefore, the evidence about the effectiveness of this experimental model can be generalized only to patients presenting to inner-city EDs who feel that they may be at risk of contracting HIV and want to be tested. A large number of patients declined to participate who felt that they were not at risk for HIV. Many individuals who believe they are not at risk for infection in fact would benefit from HIV C&T. We are currently working on strategies that would increase the awareness of patients so we can reduce refusal for testing.
We conclude that there are a substantial number of patients presenting off hours to the ED who are willing to consider HIV testing. Currently, in many states, however, testing can be offered only when pretest counseling is available. Data from this study indicate that a pretest counseling and education video offered off hours in an urban ED provides an effective means of improving access to informed HIV testing.
1. Advancing HIV prevention: New strategies for a changing epidemic—United States, 2003. MMWR Morbid Mortal Weekly Rep 2003; 52:329–332.
2. Rothman R. Current Centers for Disease Control and Prevention guidelines for HIV counseling, testing, and referral: Critical role of and a call to action for emergency physicians. Ann Emerg Med 2004; 44:31–42.
3. Rothman R, Ketlogetswe K, Dolan T, et al. Preventive care in the emergency department: Should emergency departments conduct routine HIV screening? A systematic review. Acad Emerg Med 2003; 10:278–285.
4. Coil C, Haukoos J, Witt M, et al. Evaluation of an emergency department referral system for outpatient HIV testing. J Acquir Immun Defic Syndr 2004; 35:52–55.
5. Schoenbaum E, Webber M. The underrecognition of HIV infection in women in an inner-city emergency room. Am J Public Health 1993; 83:363–368.
6. Hutchinson A, Corbie-Smith G, Thomas S, et al. Understanding the patient’s perspective on rapid and routine HIV testing in an inner-city urgent care center. AIDS Educ Prev 2004; 16: 101–114.
7. Goggin M, Davidson A, Cantril S, et al. The extent of undiagnosed HIV infection among emergency department patients: Results of a blinded seroprevalence survey and a pilot HIV testing program. J Emerg Med 2000; 19:13–19.
8. Alpert P, Shuter J, DeShaw M, et al. Factors associated with unrecognized HIV-1 infection in an inner-city emergency department. Ann Emerg Med 1996; 28:159–164.
9. Baraff L, Talan D, Torres M. Prevalence of HIV antibody in a noninner-city university hospital emergency department. Ann Emerg Med 1991; 20:782–786.
10. Kelen G, Hexter D, Hansen K, et al. Trends in human immunodeficiency virus (HIV) infection among a patient population of an inner-city emergency department: Implications for emergency department-based screening programs for HIV infection. Clin Infect Dis 1995; 21:867–875.
11. Duffus W, Kettinger L, Stephens T, et al. Missed opportunities for earlier diagnosis of HIV infection—South Carolina, 1997–2005. MMWR Morbid Mortal Weekly Rep 2006; 55:1269–1272.
12. Paltiel A, Weinstein M, Kimmel A, et al. Expanded screening for HIV in the United States—An analysis of cost-effectiveness. N Engl J Med 2005; 352:586–595.
13. Sanders G, Bayoumi A, Sundaram V, et al. Cost-effectiveness of screening for HIV in the era of highly active antiretroviral therapy. N Engl J Med 2005; 352:570–585.
14. Walensky RP, Weinstein MC, Kimmel AD, et al. Routine human immunodeficiency virus testing: An economic evaluation of current guidelines. JAMA 2005; 118:292–300.
15. Doll LS, Kennedy MB. HIV counseling: What is it and how well does it work? In: Schochetman G, George JR, eds. AIDS Testing: A Comprehensive Guide to Technical, Medical, Social, Legal and Management Issues. New York: Springer-Verlag, 1994:302–319.
16. Gift TL, Hogben M. Emergency department sexually transmitted disease and human immunodeficiency virus screening: Findings from a national survey. AEM 2006; 13:993–996.
17. Haukoos J, Witt M, Lewis R. The effect of a financial incentive on outpatient HIV testing referrals from the emergency department. Acad Emerg Med 2005; 12:617–621.
18. Calderon Y, Haughey M, Leider J, et al. The evaluation of an educational video program for HIV testing: A comparative analysis. Ann Emerg Med. In press.
19. Oermann MH, Webb SA, Ashare JA. Outcomes of videotape instruction in clinic waiting area. Orthop Nurs 2003; 22:102–105.
20. Oermann MH. Effects of educational intervention in waiting room on patient satisfaction. J Ambul Care Manage 2003; 26:150–158.
21. May S, West R, Hajek P, et al. The use of videos to inform smokers about different nicotine replacement products. Patient Educ Couns 2003; 51:143–147.
22. Roth-Isigkeit A, Ocklitz E, Bruckner S, et al. Development and evaluation of a video program for presentation prior to elective cardiac surgery. Acta Anaesthesiol Scand 2002; 46:415–423.
23. Reznik M, Sharif I, Ozuah PO. Use of interactive videoconferencing to deliver asthma education to inner-city immigrants. J Telemed Telecare 2004; 10:118–120.
24. Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns 1997; 30:239–245.
25. Sweat M, O’Donnell C, O’Donnell L. Cost-effectiveness of a brief video-based HIV intervention for African American and Latino sexually transmitted disease clinic clients. AIDS 2001; 15: 781–787.
26. Molitor F, Bell R, Truax S, et al. Predictors of failure to return for HIV test result and counseling by test site type. AIDS Educ Prev 1999; 11:1–13.