Objective: Universal HIV screening is recommended but challenging to implement. Selectively targeting those at risk is thought to miss cases, but previous studies are limited by narrow risk criteria, incomplete implementation, and absence of direct comparisons. We hypothesized that targeted HIV screening, when fully implemented and using maximally broad risk criteria, could detect nearly as many cases as universal screening with many fewer tests.
Methods: This single-center cluster-randomized trial compared universal and targeted patient selection for HIV screening in a lower prevalence urban emergency department. Patients were excluded for age (<18 and >64 years), known HIV infection, or previous approach for HIV testing that day. Targeted screening was offered for any risk indicator identified from charts, staff referral, or self-disclosure. Universal screening was offered regardless of risk. Baseline seroprevalence was estimated from consecutive deidentified blood samples.
Results: There were 9572 eligible visits during which the patient was approached. For universal screening, 40.8% (1915/4692) consented with 6 being newly diagnosed [0.31%, 95% confidence interval (CI): 0.13% to 0.65%]. For targeted screening, 37% (1813/4880) had no testing indication. Of the 3067 remaining, 47.4% (1454) consented with 3 being newly diagnosed (0.22%, 95% CI: 0.06% to 0.55%). Estimated seroprevalence was 0.36% (95% CI: 0.16% to 0.70%). Targeted screening had a higher proportion consenting (47.4% vs. 40.8%, P < 0.002), but a lower proportion of ED encounters with testing (29.7% vs. 40.7%, P < 0.002).
Conclusions: Targeted screening, even when fully implemented with maximally permissive selection, offered no important increase in positivity rate or decrease in tests performed. Universal screening diagnosed more cases, because more were tested, despite a modestly lower consent rate.
*Department of Emergency Medicine; and
†Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, OH.
Correspondence to: Michael S. Lyons, MD, MPH, Department of Emergency Medicine, University of Cincinnati, 231 Albert Sabin Way, Cincinnati, OH 0769 (e-mail: email@example.com).
Presented at CROI, March 5, 2013, Atlanta, GA. Trial Registration: clinicaltrials.gov identifier: NCT00667186.
The counseling and testing program described in this report was supported by the Ohio Department of Health via the Cincinnati Health Department and also by Ryan White funding provided by the Cincinnati Health Network. The research component was supported in part by NIAID K23 AI068453, by an investigator-initiated research award from Gilead Sciences, Inc., and by an Institutional Clinical and Translational Science Award, NIH/NCRR Grant Number 5UL1RR026314-03. These funding organizations had no role in the design or conduct of the study; collection, management, analysis, or interpretation of the data; and preparation, review, or approval of the manuscript.
M.S.L. received investigator-initiated research funding from Gilead Sciences, Inc. There are no other potential conflicts of interest to disclose.
M.S.L. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: M.S.L., C.J.L., A.H.R., A.T.T., and C.J.F. Acquisition of data: A.H.R., D.B.W., and M.I.S. Analysis and interpretation of data: M.S.L., K.W.H, C.J.L., A.T.T., and C.J.F. Drafting of the manuscript: M.S.L., C.J.L., K.W.H., and C.J.F. Critical revision of the manuscript for important intellectual content: M.S.L., C.J.L., A.H.R., D.B.W., K.W.H., M.I.S., A.T.T., and C.J.F. Statistical analysis: K.W.H. and C.J.L. Obtained funding: M.S.L., C.J.L., A.T.T., and C.J.F. Administrative, technical, or material support: A.H.R., D.B.W., M.I.S., and K.W.H. Study supervision: M.I.S., C.J.L., A.T.T., and C.J.F.
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Received March 20, 2013
Accepted June 20, 2013