In 2006 the Centers for Disease Control and Prevention (CDC) published revised recommendations for HIV testing in health-care settings, which included emergency departments (EDs) [
The CDC recommends an opt-out approach for several reasons. By integrating opt-out screening into general consent, the screening process is streamlined and routinized. Patients may perceive the process to be less stigmatizing because they do not feel “singled out” for testing [
Despite the backing of the CDC and these initial clinical successes, some experts cite concerns with an opt-out approach to HIV screening [
Patient satisfaction and attitudes toward opt-out HIV screening compared with opt-in HIV screening have not been studied. Understanding the experience of patients with opt-out screening is important for the successful integration of the revised CDC guidelines. The goal of this study was to compare patient satisfaction with ED HIV screening using an opt-in versus an opt-out approach.
The study was conducted at an urban teaching hospital and regional trauma center in Oakland, California. In 2006, the annual ED census was approximately 75,000 visits; 47% of patients presenting to the ED were black, 32% were Hispanic, 21% were white, 44% were female, 98% were adults ≥15 years of age, and 80% did not have health insurance.
We conducted a survey study to compare ED patient satisfaction and patient attitudes toward opt-in and opt-out rapid HIV screening. This survey study was administered concurrently with a prospective observational study comparing the outcomes of two successive 6-month screening periods. During the first 6 months, nontargeted opt-in HIV screening was performed and during the second 6 months, nontargeted opt-out screening was performed [
A detailed description of the HIV screening protocol has previously been published [
Two full-time medical assistants were hired as HIV testers and worked during the entire study period. HIV testers were located in a testing station within the triage area on weekdays between 7 am and 10 pm. Only one HIV tester was on duty at any given time. During hours when the HIV tester was not on site, screening was not performed. During both study phases, HIV testing was performed at the testing station using the OraQuick ADVANCE Rapid HIV 1/2 Antibody Test (OraSure Technologies, Inc. Bethlehem, PA, USA) on oral fluid specimens. HIV test results were documented in special fields in the electronic medical record (Wellsoft Corporation, Somerset, NJ, USA) accessible by clinical staff. Results were interpreted as reactive, negative, or indeterminate.
Patients were eligible for HIV screening if they were ≥15 years of age, medically stable, and able to consent for HIV testing (opt-in phase) or able to complete the general consent for care (opt-out phase).
During this phase, all medically stable patients were referred by the triage nurse to the HIV tester. HIV testers determined eligibility and offered HIV screening using the following opt-in script: “Would you like to have a rapid HIV test today?” Patients opting-in completed a streamlined HIV consent form followed by immediate testing. No additional counseling was performed, and patients were directed to the waiting room after collection of an oral fluid sample.
During this phase, consent for HIV testing was integrated into the general consent form for medical care in accordance with CDC guidelines and California state law and completed during registration. The general ED consent form was modified to include both a statement that HIV testing may be performed during the ED visit unless the patient declined and an opt-out signature box next to the statement, “I do not want to be HIV tested.” Registration staff determined eligibility and offered HIV screening using the following opt-out script: “HIV testing may be performed during your emergency room visit, if you do not want to be HIV tested sign here.” Patients declined testing by signing in the opt-out signature box. Registration staff electronically flagged the charts of patients not opting-out and then referred these patients to the triage area where rapid testing was performed by the HIV testers.
In both study phases, HIV test results were documented and provided to patients using the same procedures and printed materials. After tests were completed, the HIV testers placed an electronic order instructing the nurse to disclose negative results once the patient was placed in the ED. Nursing staff verbally disclosed the negative results and provided patients with a postresult informational handout that documented the result, explained risk reduction strategies and indications for repeat testing, and provided a list of testing resources. A copy of the postresult handout was also added to the patient’s electronic discharge instructions.
Patients who had reactive HIV test results were placed immediately in a private room in the ED. HIV testers and ED physicians provided patients with a verbal explanation of the reactive test result, offered emotional support, and arranged direct linkage to follow-up care. A postresult informational handout was also provided that explained the preliminary nature of the test result, the importance of confirmatory testing and follow-up care, strategies to prevent transmission, and referral for mental health and other support services. Blood was drawn and sent for CD4 cell count, viral load, and Western blot testing. Drop-in follow-up appointments were available on select dates and times at the medical center’s HIV clinic.
The survey instrument was developed by one of the authors in collaboration with experts from the CDC and an emergency medicine physician with experience in ED-based rapid HIV testing (Appendix). The survey instrument was pilot tested on a convenience sample of patients (
The survey was administered to English and Spanish speaking patients with negative HIV screening tests during the last three months of the opt-in and opt-out screening phases (May 1, 2007–July 31, 2007 and November 1, 2007–January 31, 2008), respectively. The two survey administrators were college research volunteers who were trained in survey administration and who were not blinded to the study purpose. Working in three-hour shifts, survey administrators reviewed the ED electronic record and identified all patients who had completed HIV screening, received their test results, and had not been discharged. Patients were then approached, and eligible patients were provided an explanation of why the study was being performed and written informed consent was obtained. Patients were ineligible for survey administration according to prespecified criteria: unavailable, too ill, language spoken other than English/Spanish, or altered mental status/confusion. Determination of eligibility was at the discretion of the survey administrators. The survey was verbally administered face-to-face at the patient’s bedside. In order to evaluate the satisfaction and attitudes of patients with reactive HIV screening tests, these patients were asked to participate in the study as part of the result disclosure process. Surveys for this subset of patients were conducted by a single research coordinator.
The primary outcome measure was overall satisfaction with opt-in and opt-out screening. The global index of satisfaction was determined by asking the patient, “Overall, how would you rate the rapid HIV testing program in the emergency department?” Responses were graded on a 5-point Likert scale (poor, fair, good, very good, and excellent). Respondents were classified as satisfied with the HIV testing program if they rated the program good, very good, or excellent and dissatisfied if they rated the program poor or fair. Secondary outcome measures were the attitudes of patients toward each screening program. The attitudes of patients toward the screening program were evaluated by assessing their level of agreement (agree, disagree) with 13 potential indicators of satisfaction over 6 domains. The domains were designed to evaluate (1) patient satisfaction, (2) coercion to test, (3) impact of testing on care received, (4) confidentiality of screening, (5) information provided, and (6) patient beliefs regarding the role of HIV screening.
The research volunteers entered the survey responses into a spreadsheet (Microsoft Excel 2003, Microsoft Corporation, Redmond, WA, USA). The first 25 surveys by each research volunteer were reviewed to ensure accurate entry of responses, and inconsistent data were identified and reconciled. The study population and results of the satisfaction survey are reported in descriptive statistics. Categorical data are reported as percentages with 95% confidence intervals (CIs). Frequencies of survey responses and demographics were evaluated by screening program (opt-in versus opt-out) using Chi-square analysis and Fisher’s exact tests. We specified a logistic regression model to predict responses to questions about patient satisfaction and patient attitudes toward the opt-in and opt-out screening programs, based on consent arm allocation and adjusting for the variables age, gender, race/ethnicity, and HIV test result, which, because of each covariate’s theoretic importance in the model, were included regardless of significance in bivariate testing. A priori sample size calculation was performed and based on an opt-in satisfaction rate of 95% (pilot data), 159 patients per group were needed to determine an absolute difference in satisfaction of 10% between opt-in and opt-out screening, assuming a
The study flow is outlined in Figure
Study flow diagram.
During the opt-in phase, research volunteers approached 293 of the 4,053 patients that completed HIV screening to participate in the survey. Of these, 208 were eligible and 207 consented and completed the survey. During the opt-out phase, research volunteers approached 273 of the 4,679 patients that completed HIV screening to participate in the survey. Of these, 190 were eligible and 188 consented and completed the survey. Reasons patients were ineligible for survey administration were similar between both phases and included: patient unavailable (61%), language barrier (31%), too ill (7%), and altered mental status/confusion (2%). Of the 207 patients who completed surveys during the opt-in phase, 199 (96%) tested negative and 8 (4%) had reactive test results. Of the 188 patients who completed surveys during the opt-out phase, 160 (85%) tested negative and 28 (15%) had reactive test results.
Characteristics of patients accepting screening and characteristics of patients surveyed in both opt-in and opt-out HIV screening phases are shown in Table
Comparison of opt-in and opt-out patients.
Characteristic | Accepted opt-in screening | Accepted opt-out screening | Surveyed opt-in screening | Surveyed opt-out screening | ||
---|---|---|---|---|---|---|
Gender | ||||||
Male | 2,103 (52) | 3,319 (53) | 0.264 | 102 (49) | 119 (63) | 0.005 |
Female | 1,958 (48) | 2,954 (47) | 105 (51) | 69 (37) | ||
Age (years), mean SD | 38 ± 13 | 38 ± 13 | >0.999b | 37 ± 13 | 39 ± 13 | 0.128b |
Race/ethnicity | ||||||
Black | 1,625 (40) | 2,862 (46) | <0.001 | 77 (37) | 88 (47) | 0.883 |
White | 563 (14) | 859 (14) | 28 (14) | 29 (15) | ||
Hispanic | 1,262 (31) | 1,826 (29) | 77 (37) | 53 (28) | ||
Other | 611 (15) | 726 (12) | 25 (12) | 18 (10) | ||
Education level | ||||||
Some high school | na | na | 63 (30) | 49 (26) | 0.747 | |
High school graduate | na | na | 67 (32) | 67 (36) | ||
Some college | na | na | 52 (25) | 53 (28) | ||
College degree | na | na | 18 (9) | 15 (8) | ||
Unknown | na | na | 7 (3) | 4 (2) | ||
Health insurance | ||||||
No insurance | na | na | 141 (68) | 145 (77) | 0.076 | |
Public insurance | na | na | 45 (22) | 35 (19) | ||
Private insurance | na | na | 9 (4) | 2 (1) | ||
Unknown | na | na | 12 (6) | 6 (3) | ||
Relationship status | ||||||
Single | na | na | 97 (47) | 119 (63) | 0.009 | |
Married/partnered | na | na | 63 (30) | 37 (20) | ||
Divorced/separated | na | na | 46 (22) | 32 (17) | ||
Unknown | na | na | 1 (0.5) | 0 | ||
Reported risk past 12 months | ||||||
Heterosexual sex | na | na | 142 (69) | 126 (67) | 0.532 | |
MSM only | na | na | 5 (2) | 7 (4) | ||
IDU only | na | na | 2 (1) | 6 (3) | ||
MSM + IDU | na | na | 1 (0.5) | 1 (0.5) | ||
None | na | na | 57 (28) | 48 (26) | ||
Previous HIV test | ||||||
Yes | na | na | 120 (58) | 113 (60) | 0.667 | |
No | na | na | 87 (42) | 75 (40) |
aPearson Chi-square.
b
Abbreviations: na: not available; MSM: men sex with men; IDU: injection drug use.
Patient satisfaction ratings were available for 393 of the 395 surveyed patients and are shown in Table
Patient satisfaction with HIV screeninga,
Screening | Excellent | Very good | Good | Fair | Poor | |||||
% (95% CI) | % (95% CI) | % (95% CI) | % (95% CI) | % (95% CI) | ||||||
Opt-in | ||||||||||
All | 130/206 | 63.1 (56.5–69.7) | 30/206 | 14.6 (9.7–19.4) | 36/206 | 17.5 (12.3–22.7) | 9/206 | 4.37 (1.6–7.2) | 1/206 | 0.5 (0–1.4)b |
Negative | 129/198 | 65.2 (58.5–71.8) | 29/198 | 14.7 (9.7–19.6) | 31/198 | 15.7 (10.6–20.7) | 8/198 | 4.04 (1.3–6.8) | 1/198 | 0.5 (0–1.5)b |
Positive | 1/8 | 12.5 (0–35.4)a | 1/8 | 12.5 (0–35.4)a | 5/8 | 62.6 (29.0–96.1) | 1/8 | 12.50 (0–35.4)b | 0/8 | |
Opt-out | ||||||||||
All | 91/187 | 48.7 (41.5–55.8) | 54/187 | 28.9 (22.4–35.4) | 30/187 | 16.0 (10.8–21.3) | 11/187 | 5.9 (2.5–9.3) | 1/187 | 0.5 (0–1.6)b |
Negative | 83/159 | 52.2 (44.4–60.0) | 45/159 | 28.3 (21.3–35.3) | 21/159 | 13.2 (8.0–18.5) | 10/159 | 6.3 (2.5–10.1) | 0/159 | |
Positive | 8/28 | 28.6 (11.8–45.3) | 9/28 | 32.1 (14.8–49.4) | 9/28 | 32.1 (14.8–49.4) | 1/28 | 3.6 (0–10.4) | 1/28 | 3.6 (0–10.4)b |
aThe global index of satisfaction was determined by asking the patient, “Overall, how would you rate the rapid HIV testing program in the emergency department?”
b1-sided, 97.5% CI.
Abbreviation: CI: confidence interval.
Responses to questions assessing patient attitudes toward HIV screening are shown in Table
Patient attitudes towards opt-in and opt-out HIV screening,
Domain | Question | Screening phase | Agree | Disagree | OR | Adjusted ORa | ||
% (95% CI) | % (95% CI) | (95% CI) | (95% CI) | |||||
I would recommend the ER to others as a good place to get tested for HIV | Opt-in | 197/207 | 95.2 (92.3–98.1) | 7/207 | 3.4 (0.9–5.8) | — | — | |
Opt-out | 183/188 | 97.3 (95.0–99.6) | 0/188 | 0 | — | — | ||
I was satisfied with the HIV testing that I received today | Opt-in | 200/207 | 96.6 (94.2–99.1) | 6/207 | 2.9 (0.6–5.2) | ref | ref | |
Opt-out | 180/188 | 95.7 (92.9–98.6) | 4/188 | 2.1 (0.1–4.2) | 1.4 (0.4–4.9) | 2.0 (0.5–8.1) | ||
I felt pressured into getting an HIV test | Opt-in | 18/207 | 8.7 (4.9–12.5) | 181/207 | 87.4 (82.9–92.0) | ref | ref | |
Opt-out | 6/188 | 3.2 (0.7–5.7) | 180/188 | 95.7 (92.9–98.6) | 0.3 (0.1–0.9) | 0.3 (0.1–0.8) | ||
I felt like I had a choice about getting an HIV test | Opt-in | 194/207 | 93.7 (90.4–97.0) | 6/207 | 2.9 (0.6–5.2) | ref | ref | |
Opt-out | 183/188 | 97.3 (95.0–99.6) | 4/188 | 2.1 (0.1–4.2) | 1.4 (0.4–5.1) | 1.2 (0.3–4.4) | ||
I had to wait too long for my HIV test result | Opt-in | 27/207 | 13.0 (8.5–17.6) | 173/207 | 83.6 (78.5–88.6) | ref | ref | |
Opt-out | 17/188 | 9.0 (4.9–13.1) | 168/188 | 89.4 (85.0–93.8) | 0.6 (0.3–1.2) | 0.7 (0.4–1.4) | ||
HIV testing interfered with the overall care I received in the ER | Opt-in | 12/207 | 5.8 (2.6–9.0) | 189/207 | 91.3 (87.5–95.1) | ref | ref | |
Opt-out | 13/188 | 6.9 (3.3–10.5) | 173/188 | 92.0 (88.2–95.9) | 1.2 (0.5–2.7) | 0.9 (0.4–2.3) | ||
Overall, I felt that the HIV testing done today was private | Opt-in | 191/207 | 92.3 (88.6–95.9) | 6/207 | 2.9 (0.6–5.2) | ref | ref | |
Opt-out | 180/188 | 95.7 (92.9–98.6) | 5/188 | 2.7 (0.4–5.0) | 1.1 (0.3–3.8) | 1.9 (0.5–7.0) | ||
I felt that my HIV test was told to me in a private way | Opt-in | 196/207 | 94.7 (91.6–97.7) | 5/207 | 2.4 (0.3–4.5) | ref | ref | |
Opt-out | 179/188 | 95.2 (92.2–98.3) | 4/188 | 2.1 (0.1–4.2) | 1.1 (0.3–4.3) | 1.2 (0.3–4.8) | ||
HIV testing should be a regular part of health care | Opt-in | 200/207 | 96.6 (94.2–99.1) | 3/207 | 1.4 (0–3.1)b | ref | ref | |
Opt-out | 182/188 | 96.8 (94.3–99.3) | 3/188 | 1.6 (0–3.4)b | 0.9 (0.2–4.6) | 2.5 (0.4–16.5) | ||
Routine HIV testing should be performed in the ER | Opt-in | 188/207 | 90.8 (86.9–94.8) | 8/207 | 3.9 (1.2–6.5) | ref | ref | |
Opt-out | 182/188 | 96.8 (94.3–99.3) | 3/188 | 1.6 (0–3.4)b | 2.6 (0.7–9.9) | 3.2 (0.7–13.8) | ||
I understand the meaning of my HIV test result | Opt-in | 201/207 | 97.1 (94.8–99.4) | 3/207 | 1.4 (0–3.1)b | ref | ref | |
Opt-out | 179/188 | 95.2 (92.2–98.3) | 1/188 | 0.5 (0–1.6)b | 2.7 (0.3–26.0) | 2.6 (0.3–26.1) | ||
The information I was given about HIV testing was just about right | Opt-in | 192/207 | 92.7 (89.2–96.3) | 8/207 | 3.9 (1.2–6.5) | ref | ref | |
Opt-out | 172/188 | 91.4 (87.5–95.5) | 4/188 | 2.1 (0.07–4.2) | 1.8 (0.5–6.1) | 3.0 (0.8–11.3) | ||
I would like to have a more in-depth discussion about my risks of getting HIV and ways to prevent itc | Opt-in | 46/199 | 23.1 (17.3–29.0) | 135/199 | 67.8 (61.4–74.3) | ref | ref | |
Opt-out | 15/160 | 9.4 (4.9–13.9) | 134/160 | 83.8 (78.0–89.5) | 3.0 (1.6–5.7) | 3.2 (1.7–6.3)d |
aOdds ratio adjusted for age, gender, race/ethnicity, and HIV test result.
b1-sided, 97.5% CI.
cOnly asked of patients with negative test results,
dOdds ratio adjusted for age, gender, and race/ethnicity.
Frequencies were calculated as a fraction of the total data set and do not add up to 100% due to subjects choosing the response “prefer not to answer.”
Abbreviations: OR: odds ratio; ER: emergency room; CI: confidence interval; ref: reference category.
The CDC has called for “explicit and measurable indicators to measure the progress on the process and outcomes” of the revised recommendations [
We demonstrate that patient satisfaction is similar with opt-in and opt-out HIV screening protocols in an urban ED. Over 95% of patients surveyed reported being satisfied with HIV testing and would recommend the ED as a testing site. Brown et al. also assessed patient perceptions with routine opt-out HIV screening and similarly showed that over 90% of ED patients surveyed would “recommend to a friend to get an HIV test in the ER” and that over 3/4 of patients felt that “the ER is a good place to perform screening” [
Patients in both screening phases rated their overall experience with HIV screening favorably. However, individuals surveyed during the opt-in phase of the study were more likely to report their overall experience as excellent. The reason for this difference between the two phases is unknown, but it may be explained by the extra time the HIV testers spent with the patients reviewing the consent form during the opt-in testing phase or the manner in which patients were consented for testing.
We also demonstrate that patient attitudes over a wide variety of domains are similar between opt-in and opt-out HIV screening protocols. Importantly, patients did not report feeling coerced to test and maintained their autonomy in deciding whether to be tested, even with the opt-out methodology. Preserving patient perception of autonomy with opt-out HIV screening is important because this has been cited as a major concern with the revised CDC guidelines [
Additionally, this study provides more detailed data about patient satisfaction with streamlined ED screening than any prior study. The streamlined format eliminated pretest counseling (providing instead a pretest information brochure) and simplified negative posttest counseling. Despite the streamlined approach, patients were remarkably satisfied, and most patients felt the information provided to them was adequate. This is consistent with the results of another survey study that assessed ED patient acceptance and understanding of opt-in and opt-out HIV testing [
The generalizability of our results to other screening programs is not known. Our method of implementing opt-out HIV screening represents one of several methods. Because California state law requires documentation of patient refusal of HIV screening, we added an opt-out signature box to the general consent form—essentially creating an abbreviated written consent for patients to sign if they decline. Additionally, we chose to soften the opt-out language, instructing patients that HIV testing
This study has several limitations. Although the survey instrument was developed using standard methodology and pilot tested on a small convenience sample of subjects and refined with their feedback, the instrument has not been validated elsewhere. Additionally, content validity was not formally assessed, and participants may have misunderstood particular survey questions leading to biased results.
Convenience sampling and the relatively small surveyed population (approximately 5% of screened patients) may have resulted in selection bias. Furthermore, not including patients who declined HIV screening may have influenced the findings, probably toward higher satisfaction ratings [
Because we evaluated only those patients who completed HIV screening, the results may lack generalizability. We did not assess how nontesters felt about the testing method, and we were therefore unable to determine whether the testing methodology influenced a patient’s decision not to test.
We did not evaluate patient comprehension of the opt-in and opt-out screening protocols, and we are unable to report whether patients misunderstood the opt-out consent process. Because we utilized point-of-care rapid HIV testing using dedicated HIV testers and oral fluid sampling, it is unlikely that patients were tested unknowingly—even if some patients may have initially misunderstood the consent process. This may not hold true for programs, however, that link acceptance of opt-out HIV screening at registration with testing on blood samples later obtained as a part of ED care. Determining patient comprehension of opt-out HIV screening, specifically when HIV consent is integrated into the general consent for care, should be evaluated in future studies to ensure that patients are not tested unknowingly.
Our results suggest that, among the subset of ED patients surveyed, satisfaction with HIV screening is high, regardless of whether opt-in or opt-out screening is implemented. Furthermore, patients did not feel coerced into testing and patient autonomy was preserved even with opt-out methods and elimination of separate written consent. These results may encourage more widespread implementation of opt-out HIV screening in EDs.
The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the CDC.
The authors would like to thank Bradley W. Frazee, MD, for his editorial comments and Cara Olsen, PhD, MPH, for her assistance with statistical analysis. This study was funded by cooperative agreements from the CDC (U18 PS000314).