Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial

Jason S Haukoos, Michael S Lyons, Richard E Rothman, Douglas A E White, Emily Hopkins, Meggan Bucossi, Andrew H Ruffner, Rachel M Ancona, Yu-Hsiang Hsieh, Stephen C Peterson, Danielle Signer, Matthew F Toerper, Mustapha Saheed, Sarah K Pfeil, Tamara Todorovic, Alia A Al-Tayyib, Lucy Bradley-Springer, Jonathan D Campbell, Edward M Gardner, Sarah E Rowan, Allison L Sabel, Mark W Thrun, HIV TESTED Trial Investigators, Bryan Austin, Jacob Cohen, Jackie Easley, Somiya Haider, Peter Hill, Mauren Henley, Gabor Kelen, Maggie Leathers, Barbara Maliszewski, Paula Neira, Scott Newton, Lucas Spaeth, Tina Tolson, Valentina Viertel, Maddie Whalen, Lindsay Bohanske, Catherine Cronin, Frank Fernandez, Carl Fichtenbaum, Cortney Gaffney, Cathy Hamilton, Kim Hart, Dave Hoskins, Sharon Kohrs, Christopher Lindsell, Chris Miller, Brittany Punches, Geri Rowan, Kim Vance, Teresa Williams, Steve Cantrill, Angelica Chavez, Ann Comeau, Tracy Daugherty, Alex Delgado, Pamela Doyle, Roberto Esquivel, Maren Fassino, Kelly Finnegan, Greg Fliney, Theresa Freudig, Michael Fuhriman, Mary Gillman, Stacy Kahl-Geiger, Korina Keating, Jason Koerner, Karen Laber, Meghan Lang, Carolynn Lyle, Kim Makela, Mary Maltby, David Medina, Tanya Nielsen, Alice Ortiz, Angela Paolucci, Don Pate, Michael Pippins, Steven Roy, John Searcey, Jerry Solot, Kelly Stermer, Brian Stuart, Melissa Swanson, Lauren Timkovich, Zenia Toure, Lisa Vogel, Sommer Walker, Diane Weed, Julia Weise, Kerri Wenke, Courtney Wham, Michael Wilson, Jarrod Wright, Melody Zwakenberg, Harrison Alter, Erik Anderson, Brendan Campbell, Grace Chang, Connie Chao, Katie Ellis, Sarah Graffman, Brynn Kron, Rebecca Lucas, Kaitlin McCarthy, Valeria Ng, Christine O'Dell, Jim Peck, Mae Petti, Feuy Saechao, Barry Simon, Tonya Tyree, Jason S Haukoos, Michael S Lyons, Richard E Rothman, Douglas A E White, Emily Hopkins, Meggan Bucossi, Andrew H Ruffner, Rachel M Ancona, Yu-Hsiang Hsieh, Stephen C Peterson, Danielle Signer, Matthew F Toerper, Mustapha Saheed, Sarah K Pfeil, Tamara Todorovic, Alia A Al-Tayyib, Lucy Bradley-Springer, Jonathan D Campbell, Edward M Gardner, Sarah E Rowan, Allison L Sabel, Mark W Thrun, HIV TESTED Trial Investigators, Bryan Austin, Jacob Cohen, Jackie Easley, Somiya Haider, Peter Hill, Mauren Henley, Gabor Kelen, Maggie Leathers, Barbara Maliszewski, Paula Neira, Scott Newton, Lucas Spaeth, Tina Tolson, Valentina Viertel, Maddie Whalen, Lindsay Bohanske, Catherine Cronin, Frank Fernandez, Carl Fichtenbaum, Cortney Gaffney, Cathy Hamilton, Kim Hart, Dave Hoskins, Sharon Kohrs, Christopher Lindsell, Chris Miller, Brittany Punches, Geri Rowan, Kim Vance, Teresa Williams, Steve Cantrill, Angelica Chavez, Ann Comeau, Tracy Daugherty, Alex Delgado, Pamela Doyle, Roberto Esquivel, Maren Fassino, Kelly Finnegan, Greg Fliney, Theresa Freudig, Michael Fuhriman, Mary Gillman, Stacy Kahl-Geiger, Korina Keating, Jason Koerner, Karen Laber, Meghan Lang, Carolynn Lyle, Kim Makela, Mary Maltby, David Medina, Tanya Nielsen, Alice Ortiz, Angela Paolucci, Don Pate, Michael Pippins, Steven Roy, John Searcey, Jerry Solot, Kelly Stermer, Brian Stuart, Melissa Swanson, Lauren Timkovich, Zenia Toure, Lisa Vogel, Sommer Walker, Diane Weed, Julia Weise, Kerri Wenke, Courtney Wham, Michael Wilson, Jarrod Wright, Melody Zwakenberg, Harrison Alter, Erik Anderson, Brendan Campbell, Grace Chang, Connie Chao, Katie Ellis, Sarah Graffman, Brynn Kron, Rebecca Lucas, Kaitlin McCarthy, Valeria Ng, Christine O'Dell, Jim Peck, Mae Petti, Feuy Saechao, Barry Simon, Tonya Tyree

Abstract

Importance: The National HIV Strategic Plan for the US recommends HIV screening in emergency departments (EDs). The most effective approach to ED-based HIV screening remains unknown.

Objective: To compare strategies for HIV screening when integrated into usual ED practice.

Design, setting, and participants: This randomized clinical trial included patients visiting EDs at 4 US urban hospitals between April 2014 and January 2016. Patients included were ages 16 years or older, not critically ill or mentally altered, not known to have an HIV positive status, and with an anticipated length of stay 30 minutes or longer. Data were analyzed through March 2021.

Interventions: Consecutive patients underwent concealed randomization to either nontargeted screening, enhanced targeted screening using a quantitative HIV risk prediction tool, or traditional targeted screening as adapted from the Centers for Disease Control and Prevention. Screening was integrated into clinical practice using opt-out consent and fourth-generation antigen-antibody assays.

Main outcomes and measures: New HIV diagnoses using intention-to-treat analysis, absolute differences, and risk ratios (RRs).

Results: A total of 76 561 patient visits were randomized; median (interquartile range) age was 40 (28-54) years, 34 807 patients (51.2%) were women, and 26 776 (39.4%) were Black, 22 131 (32.6%) non-Hispanic White, and 14 542 (21.4%) Hispanic. A total of 25 469 were randomized to nontargeted screening; 25 453, enhanced targeted screening; and 25 639, traditional targeted screening. Of the nontargeted group, 6744 participants (26.5%) completed testing and 10 (0.15%) were newly diagnosed; of the enhanced targeted group, 13 883 participants (54.5%) met risk criteria, 4488 (32.3%) completed testing, and 7 (0.16%) were newly diagnosed; and of the traditional targeted group, 7099 participants (27.7%) met risk criteria, 3173 (44.7%) completed testing, and 7 (0.22%) were newly diagnosed. When compared with nontargeted screening, targeted strategies were not associated with a higher rate of new diagnoses (enhanced targeted and traditional targeted combined: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.7; 95% CI, 0.30 to 1.56; P = .38; and enhanced targeted only: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.70; 95% CI, 0.27 to 1.84; P = .47).

Conclusions and relevance: Targeted HIV screening was not superior to nontargeted HIV screening in the ED. Nontargeted screening resulted in significantly more tests performed, although all strategies identified relatively low numbers of new HIV diagnoses.

Trial registration: ClinicalTrials.gov Identifier: NCT01781949.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Haukoos reported receiving grant funding from the National Institute on Drug Abuse (NIDA) (No. R01DA042982) and the Agency for Healthcare Research and Quality (AHRQ) (No. K02HS017526 and R01HS021749) during the conduct of this study. Dr Lyons reported receiving grant funding from NIDA (R01DA049282), AHRQ (No. R01HS021749), the Cincinnati Health Network, and Hamilton County Public Health during the conduct of this work, and from Gilead Sciences, Inc outside the submitted work. Dr Rothman reported receiving grant funding from the National Institute on Drug Abuse (No. R01DA049282), AHRQ (No. R01HS021749), Gilead Sciences, Inc, and the Maryland Department of Health and Mental Hygiene during the conduct of the study. Dr White reported receiving grant funding from the National Institute on Drug Abuse (No. R01DA049282) during the conduct of this study, and from Gilead Sciences, Inc outside the submitted work. Dr Ancona reported receiving research support from Gilead Sciences outside the submitted work. Dr Pfeil reported receiving research funding from Gilead Sciences, Inc during the conduct of the study. Dr Al-Tayyib reported receiving grant funding from Denver Health during the conduct of the study. Dr Campbell reported receiving grant funding from Denver Health during the conduct of the study. Dr Rowan reported receiving grant funding from Gilead Sciences outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. CONSORT Flow Diagram
Figure 1.. CONSORT Flow Diagram
Enrollment occurred from April 8, 2014, through January 27, 2016, with longitudinal follow-up through January 27, 2017. Patients considered high risk for enhanced targeted screening had a Denver HIV Risk Score of 30 or higher; for traditional targeted screening, eligible patients had at least 1 risk behavior as adapted from the Centers for Disease Control and Prevention.
Figure 2.. Distribution of Patient Visits and…
Figure 2.. Distribution of Patient Visits and HIV Diagnoses Within Targeted Screening Arms
BRST indicates Behavioral Risk Screening Tool; DHRS, Denver HIV risk score.

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