The HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial
HIV TESTED
Effectiveness of Rapid HIV Screening Methods in Urban Emergency Departments
1 other identifier
interventional
76,235
1 country
4
Brief Summary
The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening methods, including a novel targeted strategy, in urban emergency department settings in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2013
CompletedFirst Posted
Study publicly available on registry
February 1, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedMarch 4, 2024
September 1, 2018
1.8 years
January 11, 2013
March 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Confirmed Newly-Diagnosed HIV Infection
Confirmed newly-diagnosed and previously-diagnosed HIV infection; classified as binary "yes" or "no"; assessed using structured medical record and laboratory data abstraction.
Day 1
Secondary Outcomes (10)
CD4 Count
Day 1
HIV Viral Load
Day 1
Linkage-to-Care
Expected average of 1 week, but may be up to 1 month
Development of AIDS
1 year after diagnosis
Initiation of Antiretroviral Therapy
1 year after diagnosis
- +5 more secondary outcomes
Study Arms (3)
A: Nontargeted rapid HIV screening
OTHEREligible patients randomized to this arm will be offered rapid HIV screening without assessment of risk. HIV testing will occur on a 24-hour basis as part of routine ED care.
B: Enhanced targeted rapid HIV screening
OTHEREligible patients randomized to this arm will be asked to answer questions regarding HIV risk using the Denver HIV Risk Score (DHRS), an empirically-developed clinical prediction instrument for assessing HIV risk, to identify patients at increased risk for HIV infection. Patients identified as being at increased risk for HIV infection will be offered rapid HIV testing. HIV testing will occur on a 24-hour basis as part of routine ED care.
C: Traditional targeted rapid HIV screening
OTHEREligible patients randomized to this arm will be asked to answer questions related to HIV risk using a traditional behavioral risk screening tool to identify patients at increased risk for HIV infection. Patients identified as being at increased risk for HIV infection will be offered rapid HIV testing. HIV testing will occur on a 24-hour basis as part of routine ED care.
Interventions
Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be offered voluntary, free, and confidential rapid HIV testing by nurses using opt-out consent during medical screening.
Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from the Denver HIV Risk Score (DHRS). Patients will be considered at increased risk for HIV infection if they have a DHRS score of 30 or more. These increased-risk patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients identified as low risk (DHRS \<30) will not be offered rapid HIV testing but will eligible for diagnostic HIV testing.
Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from a Behavioral Risk Screening Tool (BRST). The BRST was adopted from the 2001 Centers for Disease Control and Prevention's recommendations for targeted HIV screening, and includes 6 questions. An affirmative response to 1 or more questions identifies the person as being at increased risk for HIV infection. These patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients who do not respond affirmatively to any of the questions will not be offered rapid HIV testing but will eligible for diagnostic HIV testing.
Eligibility Criteria
You may qualify if:
- Greater than or equal to 16 years of age
- Clinically stable
- Capable of providing consent for medical care
You may not qualify if:
- \< 16 years old
- Unable to consent for medical care
- Prisoners or detainees
- Self-identified as infected with HIV
- Occupational exposure
- Sexual assault
- Fast-track patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Denver Health and Hospital Authoritylead
- Alameda County Medical Centercollaborator
- Johns Hopkins Universitycollaborator
- University of Cincinnaticollaborator
Study Sites (4)
Alameda County Medical Center
Oakland, California, 94602, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (2)
Haukoos JS, Lyons MS, Rothman RE, White DAE, Hopkins E, Bucossi M, Ruffner AH, Ancona RM, Hsieh YH, Peterson SC, Signer D, Toerper MF, Saheed M, Pfeil SK, Todorovic T, Al-Tayyib AA, Bradley-Springer L, Campbell JD, Gardner EM, Rowan SE, Sabel AL, Thrun MW; HIV TESTED Trial Investigators. Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2117763. doi: 10.1001/jamanetworkopen.2021.17763.
PMID: 34309668DERIVEDMohareb AM, Patel AV, Laeyendecker OB, Toerper MF, Signer D, Clarke WA, Kelen GD, Quinn TC, Haukoos JS, Rothman RE, Hsieh YH. The HIV Screening Cascade: Current Emergency Department-Based Screening Strategies Leave Many Patients With HIV Undiagnosed. J Acquir Immune Defic Syndr. 2021 May 1;87(1):e167-e169. doi: 10.1097/QAI.0000000000002609. No abstract available.
PMID: 33769768DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason S Haukoos, MD, MSc
Denver Health and Hospital Authority
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2013
First Posted
February 1, 2013
Study Start
April 1, 2014
Primary Completion
January 1, 2016
Study Completion
August 31, 2018
Last Updated
March 4, 2024
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available after the main trial results have been reported/published. They will be available for a period of 10 years.
- Access Criteria
- Individuals who wish to access deidentified IPD must email the PI (Jason Haukoos) or Project Manager (Emily Caruso) with a description of the proposed analysis, outcomes of interest, and how results will be reported.
The final research dataset resulting from this project will be made available to other investigators who wish to perform secondary analyses in this content area. The final dataset will include demographic and self-reported behavioral risk information as collected as a part of the Denver HIV Risk Score (DHRS) and the Behavioral Risk Screening Tool (BRST), as well as results of rapid HIV testing, if performed. Because HIV infection is a reportable disease, identifying information will be collected. While the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains a possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make data and associated documentation available to users only under a data-use agreement (DUA).