Patient Acceptance of Rapid HIV Testing Practices in an Urban Emergency Department: Assessment of the 2006 CDC Recommendations for HIV Screening in Health Care Settings

Article Outline

• Abstract
• Introduction
• Materials and Methods
  • Study Design and Setting
  • Data Collection and Processing
• Results
• Limitations
• Discussion
• Acknowledgment
• Appendix
• References
• Copyright

Study objective

The Centers for Disease Control and Prevention (CDC) recently released revised recommendations for HIV testing in health care settings, calling for the performance of nontargeted opt-out HIV screening, the integration of informed consent for HIV testing into the general consent for medical care, and the uncoupling of prevention counseling and testing. It is unclear, however, whether patients will understand opt-out screening or be satisfied with integration of the consent for HIV testing into the general medical consent or the uncoupling of counseling from testing. The objective of this study is to evaluate patients’ acceptance of the CDC’s revised recommendations in an urban emergency department (ED).

Methods

This was a cross-sectional survey study performed in the ED of an urban, public safety net hospital. The approximate annual ED census is 55,000 patients, and an approximate undiagnosed HIV seroprevalence ranges from 0.7% to 2.2%. A standardized survey instrument was developed and piloted and was then implemented with trained research assistants. Adult patients who were awake, alert, and agreed to participate in the study were included.

Results

During the 3-month study period, 529 patients were enrolled. The median age was 38 years (interquartile range 27 to 49 years; range 18 to 87 years), 57% were men, 48% were white, 28% were Hispanic, 18% were black, and 6% represented another race or ethnicity. When patients were asked whether they would have been tested had opt-out methodology been used, 81% (95% confidence interval [CI] 77% to 84%) would have agreed to be tested. When asked whether they would have been tested had opt-in methodology been used, there was no difference (absolute difference 0%; 95% CI –5% to 4%). However, explanation of opt-out screening was required for 11% (95% CI 8% to 14%), whereas explanation of opt-in screening was required for only 2% (95% CI 1% to 4%) (absolute difference 9%; 95% CI 5% to 11%). When asked whether the patient’s physician recommended an HIV test during the ED visit, 93% (95% CI 91% to 95%) would have agreed to be tested. When asked whether consent for HIV testing should be separate from consent for general emergency medical care, 50% (95% CI 46% to 54%) agreed. When asked whether counseling was necessary before performing an HIV test, 34% (95% CI 30% to 38%) agreed, and when asked whether counseling was necessary after receiving a negative HIV test result, 35% (95% CI 31% to 40%) agreed.

Conclusion

A large proportion of ED patients appear willing to be screened for HIV infection in accordance with the CDC’s revised recommendations for HIV testing in health care settings. Similar proportions were willing to be tested when opt-out or opt-in screening strategies were used; however, a significantly greater proportion required explanation of opt-out screening.

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Introduction 

It is estimated that 250,000 people in the United States are unaware of their HIV infections.¹, ² Additionally, each year approximately 50,000 people acquire HIV.² Because these statistics have not changed dramatically during the past decade despite substantial public health initiatives aimed at HIV prevention, the Centers for Disease Control and Prevention (CDC) recently revised their recommendations for performing HIV testing in health care settings.³, ⁴ This document specifically called for performing nontargeted opt-out HIV screening in medical care settings where the prevalence is greater than or equal to 0.1%, incorporating informed consent for HIV testing into the general consent for medical care using opt-out methodology, and uncoupling prevention counseling from diagnostic testing.

Emergency departments (EDs) provide care for more than 110 million patient visits per year in the United States, and a substantial proportion of these patients do not have the availability of routine primary care.⁵ In addition to commonly serving as patients’ primary source of medical care, the unselected seroprevalence of HIV infection in urban EDs ranges from approximately 1% to 4%.⁶, ⁷, ⁸, ⁹, ¹⁰ EDs, therefore, provide potentially an ideal setting to dramatically affect the HIV epidemic in the United States.¹¹

Unfortunately, the sweeping recommendations provided by the CDC remain untested, and it remains unclear how best to approach the identification of undiagnosed HIV infection in the ED.¹¹ It is also unclear how patients will perceive or accept testing strategies recommended by the CDC or alternative approaches. The objective of this study was to evaluate patient acceptance of several approaches to rapid HIV testing in the ED, including (1) nontargeted opt-out rapid HIV screening; (2) nontargeted opt-in rapid HIV screening; (3) emergency physician–recommended rapid HIV testing; (4) incorporation of informed consent for rapid HIV testing into the consent for general emergency medical care; (5) the need for pretest counseling before ED-based rapid HIV testing; and (6) the need for posttest counseling after receiving a negative rapid HIV test result.

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Materials and Methods 

This study was approved by the Colorado Multiple Institutional Review Board with a waiver of written informed consent. However, all participants provided verbal informed consent before inclusion in this study.

Study Design and Setting 

This was a cross-sectional survey study performed in the ED at Denver Health Medical Center in Denver, CO. Denver Health Medical Center is a 500-bed, urban, public safety net hospital; a Level I trauma center, the Rocky Mountain regional trauma referral center; and an integrated health care system for the city and county of Denver.¹² The approximate annual ED census is 55,000 patients, which excludes the approximately 35,000 patients evaluated annually in the adult urgent care center or the approximately 25,000 patients evaluated annually in the pediatric urgent care center. The approximate HIV seroprevalence in the ED at Denver Health Medical Center ranges from 0.7% to 2.2%.¹⁰, ¹³

All adult (≥18 years) patients who presented to the ED during the study period were eligible for inclusion in this study. A convenience sample of patients was approached by trained research assistants and asked to participate if they were awake, alert, not intoxicated, and understood the premise of the survey. Patients who had altered levels of consciousness, were determined to be critically ill, were known to have preexisting HIV infection, or who were younger than 18 years were not approached to participate. Patients who agreed to participate were asked to verbally complete the survey instrument with the research assistant.

A closed-response survey instrument was developed using standardized methodology.¹⁴ Six specific content domains were identified a priori and included the evaluation of (1) nontargeted opt-out rapid HIV screening; (2) nontargeted opt-in rapid HIV screening; (3) physician-recommended rapid HIV testing; (4) incorporation of informed consent for HIV testing into the general consent for emergency medical care; (5) performance of pretest counseling before performance of ED-based rapid HIV testing; and (6) performance of posttest counseling for patients who had negative test results for HIV infection.

Multiple items were developed for each of the 6 domains, with the principal purpose of creating the most valid and comprehendible items for each. To create an instrument that was concise, easy to administer, and easy to understand, each set of items was ultimately reduced to a single item related to each of the 6 domains. Items were developed to include a discrete, closed response from the patient. A pilot instrument was developed and applied to a sample of patients to assess their comprehension of each question and to provide research assistants with an opportunity to refine their skills in the administration of the survey. One investigator supervised this process and participated in the assessment of comprehension by patients and the process of survey administration by the research assistants. The instrument was then modified by the investigative team based on this pilot evaluation and tested on another sample of patients before finalizing and formally implementing it. In addition to the 6 specific domain items, additional data were obtained during the administration of the survey. These data included the date and hour the instrument was completed; the patient’s age, sex, race/ethnicity, and primary language; and whether each question required specific additional explanation by the research assistant. Finally, in an effort to minimize response bias, the nontargeted opt-out item was included at the beginning of the survey and the nontargeted opt-in item was included at the end of the survey (Appendix E1, available online at http://www.annemergmed.com).

Data Collection and Processing 

All survey instruments were administered by trained research assistants. Research assistants are members of the Department of Emergency Medicine at Denver Health Medical Center, are certified by the Colorado Multiple Institutional ReviewBoard, and underwent specific protocol and survey administration training before enrolling patients. Each research assistant was trained specifically in the administration of the survey, including methods for asking each question in an effort to minimize response bias. Research assistants read each survey question verbatim and provided additional explanation only if the patient did not understand the question. If additional explanation was required, the research assistant was free to explain the concept of the question in any manner he or she chose. For those patients who spoke a language other than English as their primary language, a certified hospital-based medical interpreter was used during the administration of the survey.

According to unpublished pilot data, it was assumed that approximately 75% of patients would agree to be tested when offered nontargeted opt-out rapid HIV testing as part of their ED visits. A sample size of 500 patients was therefore estimated to provide 95% confidence intervals (CIs) around this point estimate of less than 10%.

All data were manually transferred from the closed-response data collection instruments to an electronic database (Microsoft Access; Microsoft Corporation, Redmond, WA) and subsequently transferred into native SAS (SAS Institute, Inc., Cary, NC) or Stata (StataCorp, College Station, TX) formats using translational software (dfPower DBMS/Copy; DataFlux Corporation, Cary, NC). All statistical analyses were performed using SAS version 9.1 or Stata version 9. Continuous data are reported as medians and interquartile ranges (IQRs) and categorical data are reported as percentages and 95% CIs. Bivariate statistical tests were performed to compare differences between the study sample and eligible population or while stratifying question responses by sample characteristics using the Wilcoxon rank sum test or Fisher’s exact test. Agreement was assessed with κ.¹⁵ P≤.05 was considered statistically significant, and no adjustments were made for multiple comparisons.

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Results 

During the study period (February 15, 2007, through May 10, 2007), a total of 6,965 adult patients presented to the ED. Of these, 529 (8%) patients were enrolled and completed the survey. The median age of the study sample was 38 years (IQR 27 to 49 years; range 18 to 87 years), 57% were men, 48% were white, 28% were Hispanic, 18% were black, 1% was Asian, and 5% represented another race or ethnicity. In addition, 92% of the study patients spoke English as their primary language. Age and sex were not different between the study sample and eligible population. However, more white patients and fewer Hispanic patients completed the survey (Table 1).

Table 1. Study sample and eligible population characteristics.

When asked whether the ED provided free rapid HIV testing to all patients who presented to the ED unless declined (ie, nontargeted opt-out screening), 417 (81%; 95% CI 77% to 84%) of the 517 who answered the question would have agreed to be tested (Table 2). When asked whether the ED offered free rapid HIV testing to all patients who agreed to be tested (ie, nontargeted opt-in screening), 412 (81%; 95% CI 77% to 84%) of the 508 who answered the question would have agreed to be tested (absolute difference 0%; 95% CI –5% to 4%). Explanation of the nontargeted opt-out screening process was required for 55 (11%; 95% CI 8% to 14%) of the patients, but explanation of the nontargeted opt-in screening process was required for only 11 (2%; 95% CI 1% to 4%) of the patients (absolute difference 9%; 95% CI 5% to 11%). Of the 506 total patients who provided answers to both questions, 29 (31%, 95% CI 22% to 41%) of the 95 patients who would have declined rapid HIV testing using opt-out consent methodology would have agreed to testing using opt-in consent methodology (Figure). Alternatively, 30 (31%; 95% CI 22% to 42%) of the 96 patients who would have declined rapid HIV testing using opt-in consent methodology would have agreed to testing using opt-out consent methodology. Moderate to substantial agreement occurred between the nontargeted opt-out and nontargeted opt-in domains (κ=0.62; 95% CI 0.53 to 0.71).¹⁵

Table 2. Responses in proportions to questions associated with each of the 6 survey domains.

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• Figure 1. 

  Distributions of patients’ acceptances of nontargeted opt-out rapid HIV screening, nontargeted opt-in rapid HIV screening, and physician-recommended rapid HIV testing in the ED.

When asked whether the patient’s emergency physician recommended a rapid HIV test during the ED visit, 481 (93%; 95% CI 91% to 95%) of the 515 patients who answered this question would have agreed to be tested. Of the 97 patients who would have declined rapid HIV testing using opt-out consent methodology, 74 (76%; 95% CI 67% to 84%) would have agreed to testing if their physicians had recommended it (Figure).

When asked whether consent for HIV testing should be separate from consent for general medical care, 254 (50%; 95% CI 46% to 54%) of 507 who answered the question agreed. When asked whether counseling was necessary before performing an HIV test in the ED setting, 173 (34%; 95% CI 30% to 38%) of the 508 patients who answered this question agreed, and when asked whether counseling was necessary after receiving a negative HIV test result in the ED, 180 (35%; 95% CI 31% to 40%) of the 509 patients who answered this question agreed. Only moderate agreement occurred between the pretest counseling and posttest counseling domains (κ=0.47; 95% CI 0.39 to 0.55).¹⁵

Each domain was stratified by age, sex, race/ethnicity, primary language, and time of day. No statistically significant differences were identified between each of the domains when stratified by these variables, except that men were less likely to indicate counseling was necessary before performance of a rapid HIV test in the ED (30% versus 40%; P=.03).

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Limitations 

This study has several limitations. First, although the survey was developed using standard methodology, survey items were constructed and refined by consensus and piloting. The survey was not self-administered, and variability in how the survey was administered by research assistants was not formally evaluated beyond specific training and oversight during the pilot evaluation and during the study period. Although several domain-related questions were piloted, to obtain high response levels, each final domain consisted of 1 specific item. Additionally, phrasing and ultimate comprehension and interpretation of the survey questions (eg, complete understanding of HIV testing using an opt-out methodology as represented by a single question) may have been ambiguous and therefore misinterpreted by study participants, thus resulting in biased estimates.

The study sample was a convenience sample of patients who presented to the ED during an approximate 3-month period. Although study patient demographics were similar to those seen in the ED at our institution, a significantly larger proportion of white patients completed the survey, which may have introduced a selection bias, although bivariate statistical testing did not demonstrate response differences between different race and ethnic categories. Also, although this study was performed at the only urban, inner-city hospital in a moderate-sized city, the results of this study may not be generalizable to other locations or practice settings.

Patients’ responses to questions asked during administration of the survey were theoretical; as such, patients did not actually undergo rapid HIV testing with any of the mechanisms described in the survey. This may have artificially improved the proportionate responses across patients, thus introducing response bias. Patients, however, were not told the basis or implications of this study, and we believe, therefore, that this form of bias was minimized.

Finally, item nonresponse may have contributed to biased estimates. However, only up to 4% of all items were not answered, thus likely minimizing this form of bias. Because of the small levels of missing data, we performed available-case analyses and elected not to impute missing data.¹⁶

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Discussion 

The prevalence of undiagnosed HIV infection is high in socioeconomically disadvantaged patients, the same patients who commonly seek care in urban, public EDs. Unfortunately, relatively little is known about how best to target these patients.⁹, ¹⁰, ¹¹ Previous efforts to improve identification of undiagnosed HIV infection in EDs has been relatively ineffective.¹⁰, ¹⁷, ¹⁸, ¹⁹, ²⁰, ²¹, ²² As a result, the CDC revised their recommendations for performing HIV testing in health care settings, calling for dramatic and more liberal changes in how patients should be targeted, tested, and counseled.⁴ The recommendations proposed by the CDC, however, remain untested and have been met with controversy.²³, ²⁴, ²⁵, ²⁶, ²⁷ One specific controversy centers on patients’ acceptance of such (and alternative) HIV testing practices in EDs, a relatively unknown construct.¹¹

Our study demonstrated that a large proportion of patients, when offered nontargeted opt-out rapid HIV testing as part of their emergency medical visits, would agree to such testing. However, the same proportion of patients would agree to be tested if offered nontargeted opt-in rapid HIV testing, and significantly fewer required additional explanation. The largest proportion of patients, however, would agree to be tested if their physician recommended it. Our study did not incorporate actual testing practices (eg, offering testing, consenting the patient, obtaining a specimen) and therefore only reflects patients’ perceptions removed from actual HIV testing practices. Although the CDC currently recommends opt-out consent methodology in an effort to reduce the potential barrier of obtaining opt-in consent, it is unclear whether this is in fact an actual or perceived barrier in the ED. In addition, our finding that a larger proportion of patients understood opt-in methodology suggests that opt-out strategies may prevent testing in some patients.

The results of our study also indicate that patients are more likely to be tested for HIV infection if their treating emergency physician recommends it. The effect of physician recommendation on HIV testing practices has been demonstrated in other medical care settings.²⁰, ²⁸ Approximately 74% and 29% of patients who would have declined testing with opt-out methodology would have agreed to be tested if their physician recommended it or if opt-in methodology were used, respectively (Figure). Unfortunately, physician-based, targeted rapid HIV testing in the ED has demonstrated relatively low targeting rates and likely misses a substantial proportion of patients who have undiagnosed HIV infection,¹³ which highlights that alternative methods may be useful in targeting patients for rapid HIV testing in the ED. The combined mechanisms of performing nontargeted opt-out or opt-in testing in conjunction with physician-based targeted testing for those patients who decline screening is likely to be the most effective strategy for testing the largest proportion of patients.

In an effort to reduce barriers associated with completing rapid HIV testing, the CDC also recommended integrating informed consent for HIV testing into the general consent for medical care and uncoupling preventive counseling from diagnostic testing. Although approximately two thirds of patients surveyed did not believe counseling was necessary before being tested in the ED for HIV infection or after receiving a negative HIV test result, only approximately half thought the consent for such testing should be incorporated into the consent for general emergency medical care. These relatively lower acceptance rates of methods recommended by the CDC may introduce barriers to testing as these recommendations are more widely adopted and implemented. In fact, a recent letter called into question rates of HIV testing in light of consent policy changes.²⁹ Although responses to each of the 6 domains did not vary statistically by specific demographic characteristics or the time of day, it is possible that responses varied by other unmeasured characteristics (eg, specific HIV-related risk behaviors).

An additional and potentially substantial barrier to performing widespread rapid HIV screening in EDs includes costs associated with program implementation.³⁰ We included the word “free” in our survey in an effort to remove the perception of whether the patient would have to pay for the test from his or her consideration of the question itself, which focused on the provision of nontargeted rapid HIV screening using opt-out or opt-in consent mechanisms. It is unknown whether our results would have differed had patients been told they would be charged for testing, although it is likely that a smaller proportion of patients would have accepted testing.

Widespread screening has been demonstrated to be cost-effective.³¹, ³² However, the CDC does not take a stance on this issue, and it remains to be seen whether and how such recommendations will be adopted without financial compensation.⁴ Unless streamlined methods are developed to integrate testing (and the payment for such testing) into routine medical care, expanded testing is unlikely to occur.

A large proportion of ED patients appear willing to be screened for HIV infection in accordance with the CDC’s revised recommendations for HIV testing in health care settings. Similar proportions were willing to be tested when opt-out or opt-in screening strategies were used; however, a significantly greater proportion required explanation of opt-out screening.

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The authors would like to thank the departmental research assistants for their tireless administration of the survey instruments and data collection.

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Appendix 

Denver Emergency Department HIV Testing Study Group (alphabetically): Bob Bongiovanni, RN, BSN (Colorado Department of Public Health and Environment, Denver, CO [CDPHE]); Eric Christensen, RN, BSN (Denver Health Medical Center, Denver, CO [DHMC]); Beth Dillon, MSW, MPH (CDPHE); Sheri Eisert, PhD (DHMC); Jessica Forsyth, MSW (The Children’s Hospital of Denver, Denver, CO); Steven Johnson, MD (University of Colorado at Denver and Health Sciences Center, Denver, CO); Jennifer Saltzsieder, RN (DHMC); Morgan Silverman, LCSW (DHMC); Mark Thrun, MD (Denver Public Health, Denver, CO); Shawn Ullrich, RN (DHMC); Melinda Whalen, RN, BSN, CEN (DHMC); Michael Wilson, MD (DHMC).

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• Appendix.

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