For the patient-based seroprevalence estimate, 1934 were eligible for enrollment. The initial approach could not be completed for 334 (17.3%), 112 (5.8%) were missed, and 454 (23.5%) declined. Of the 1034 who consented, 24 (2.3%) were already diagnosed with HIV and 37 (3.3%) would have been duplicate enrollments. There was insufficient sample to determine the serostatus in 45 (4.6%) who did not have a subsequent negative test documented in the medical record. Two were inadvertently assigned the same sample identification number and were excluded. For the sample-based seroprevalence estimate, there were 1083 samples collected for patients aged 18–64 years. Of these, 22 (2.0%) were previously diagnosed with HIV, 29 (2.7%) were duplicate enrollments, and 10 (0.9%) had insufficient sample and no subsequent record of negative HIV test result in the clinical record.
Among the 1911 patients tested on a universal basis, 6 were newly diagnosed (0.31%, 95% CI: 0.13% to 0.65%). For the 1451 tested on a targeted basis, 3 were newly diagnosed (0.22%, 95% CI: 0.06% to 0.55%). In the corresponding combined seroprevalence study, 7 of 1948 (0.36%, 95% CI: 0.16% to 0.70%) were found to be HIV antibody positive and not previously known to be diagnosed with HIV (4/926 in the patient-based component and 3/1022 in the remnant-based component).
Screening groups were of similar demographics and self-reported testing history. Patients in the targeted arm self-reported risk behavior with greater frequency. CD4 was available for 5 patients of the 9 new diagnoses identified by screening (154, 256, 493, 512, and 882 cells per cubic millimeter); 4 of these were obtained within 6 months of diagnosis (Table 2).
More patients consented when approached on a targeted basis than a universal basis [1454/3067 (47.4%) vs. 1915/4692 (40.8%); P < 0.002]. However, the proportion of all ED patients who were approached and tested was greater for the universal than the targeted arm [1911/4692 (40.7%) vs. 1454/3067 (29.7%); P < 0.002]. When compared with patients who declined testing in the universal arm, patients who declined testing in the targeted arm more often reported their reason as previous negative testing (59.8% vs. 48.9%; P < 0.001) and less often that they were not at risk (23.1% vs. 28.8%; P < 0.001) (Table 3).
Our study offers 2 primary advances. First, we applied sufficient resources to achieve comprehensive implementation. Previous studies have not delineated whether targeting was inadequately sensitive or inadequately applied. Second, we used a broad set of targeting criteria, whereby any indication more specific than simple presence in the ED led to an offer. Combined, these factors (1) gave targeting the best chance of detecting as many cases as universal screening while still avoiding testing where no indication of any risk was apparent, and (2) mimicked our existing screening program, which tries to balance the need for manageable testing volumes with the need to detect all cases.
We propose several explanations for the unexpected similarity between targeted and universal screening in our study. Although our environment has low HIV prevalence, risk for HIV was endemic throughout both study arms. We also posit that the lower risk population expected in the universal arm may have declined testing. In addition, targeting criteria were so broad that when fully implemented, the targeted group was not very different from the universal group. Of note, partial implementation of the same targeting criteria by our clinical screening program seems much more selective. The positivity rate of the clinical program was close to 1% immediately before and after this study (data not shown). This suggests that counselors naturally select higher risk patients when resources are insufficient to test all those with some identified risk, even when eligibility criteria are the same. If true, this finding highlights the potential for differences between efficacy and effectiveness studies.
Consent rate was higher in the targeted arm than the universal arm, despite the use of signed opt-in consent in both arms. This is most likely because targeted patients had higher behavioral risk,69,70 but it is possible that a lesser emphasis on the need for testing in the universal arm contributed to the lower consent rate. We think this is unlikely, counselors were encouraged to emphasize the need for testing in both arms, and using risk information to motivate testing has not been highly efficacious.71,72
The finding that consent varies by patient selection strategy demonstrates the importance of controlled comparisons. Outcomes from studies that alter or fail to control for such operational features will be difficult to interpret. Not only do multiple variables influence program outcomes, but these variables also interact with one another in unknown ways. Interactions between different aspects of a screening likely extend beyond consent and patient selection to include myriad factors such as assay method, which staff offer testing, and when in the course of care testing is offered.
Consent may be even more important when going beyond the number tested to consider the number of new infections detected. Extrapolation from our seroprevalence estimate of undiagnosed HIV (0.4%) would suggest 17 total cases among those eligible and approachable in the universal arm. Only 6 were identified by screening. Moreover, this extrapolation assumes an identical proportion with undiagnosed HIV among those who were and were not tested, whereas others have suggested positivity rates to be greater among those who decline testing than among those who consent.73,74
Our findings inform but do not resolve the tension between universal and targeted patient selection strategies. Methods to optimize the trade-off between missed cases and fewer tests when resources are insufficient remain largely unexplored. Recent reports have suggested the Denver HIV Risk Score to be a promising instrument to enhance targeting.75,76 This and other targeting approaches, including our baseline clinical program, should be compared individually with universal screening.
Our study should be considered in light of several limitations. Our results may not be generalizable to centers with different epidemiology; EDs differ in terms of disease prevalence even in the same region,77,78 and EDs are certain to differ from other healthcare venues.10,19 Our study was strengthened by controlling the overall screening methodology to isolate differences resulting from patient selection strategy. Nonetheless, overall results were necessarily influenced by our screening model, which is only one of many.18,79 A tiny proportion of those tested in the targeted screening arm were actually referred for diagnostic testing18 (ie, testing for signs and symptoms of HIV). The number of screened patients who may also have met the criteria for diagnostic testing is unknown. Our targeting criteria were not used as an instrument to systematically assess risk. Our analysis does not consider the relative costs of the 2 patient selection strategies. Prospective seroprevalence sampling was biased by the consent requirement but included patients who would not have had blood remnants available and used survey for health history. The remnant study was not biased by consent but only included individuals with adequate remnant samples, and health history was obtained by chart review. The study was stopped before the planned sample size was reached, although it is inconceivable that further testing could have led to a difference in proportion positive greater than ±0.5%.
The authors thank Josette Robinson-Eaton, Research Assistant and Virology Laboratory Manager of the University of Cincinnati Retrovirology Reference Laboratory for her assistance in processing the samples for the seroprevalence study component. The authors also express their appreciation to the patients who participated as subjects in the study.
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