The HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial

NCT ID: NCT01781949

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-08-31

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.

Detailed Description

Early identification of undiagnosed HIV infection remains a critical public health priority. In the United States, approximately 250,000 HIV-infected individuals remain undiagnosed and 50,000 new infections occur annually, despite several substantial HIV-related public health initiatives. Although HIV testing is an important intervention, controversy still exists as to how it should be implemented.

In 2006, the Centers for Disease Control and Prevention (CDC) recommended nontargeted opt-out HIV screening in clinical settings where the undiagnosed prevalence was ≥0.1%. Emergency departments (EDs) have been a major focus of these recommendations, prompted by the fact that over 120 million ED visits occur annually in the United States, they serve large proportions of underserved patients, and are the most common site of missed diagnostic opportunities for HIV infection. In contrast, in 2007 the United States Preventive Services Task Force recommended targeted HIV screening (i.e., testing high-risk subpopulations) as the principal approach to HIV testing because insufficient evidence existed to support the CDC recommendations.

Led by Jason Haukoos, MD, MSc, the research team has pioneered investigations in this area since 2004, recently publishing the largest clinical trial to date, concluding that nontargeted opt-out rapid HIV screening in the ED was associated with a small increase in number of newly-identified HIV-infected patients when compared to diagnostic testing (i.e., testing based on clinical signs or symptoms) by physicians. The investigators also recently developed the Denver HIV Risk Score (DHRS), the first multivariable tool to estimate risk of HIV infection. The DHRS combines 3 demographic and 5 behavioral characteristics, and classifies patients into distinct strata with increasing HIV prevalence.

To build on this work, the investigators propose the following specific aims: (1) to evaluate and compare the effectiveness of 3 rapid HIV screening strategies when fully-integrated into ED care; (2) to measure and compare programmatic costs of each HIV screening strategy; and (3) to measure and compare ED operational processes of each HIV screening strategy. In doing so, the investigators will perform a multi-center prospective randomized control trial to test the following hypotheses: (1) targeted rapid HIV screening using the DHRS to identify high-risk patients is significantly associated with new HIV diagnoses when compared to traditional targeted rapid HIV screening and nontargeted rapid HIV screening; (2) enhanced and traditional targeted rapid HIV screening is more cost effective per newly-identified patient than nontargeted rapid HIV screening; and (3) enhanced targeted rapid HIV screening is associated with non-inferior ED process metrics and crowding when compared to traditional targeted screening or nontargeted screening.

To accomplish these aims, the investigative team will conduct: (1) a prospective randomized controlled "pragmatic" clinical effectiveness trial in the EDs at Denver Health Medical Center (Denver, CO), Alameda County Medical Center (Oakland, CA), Johns Hopkins Hospital (Baltimore, MD), and the University of Cincinnati Medical Center (Cincinnati, OH); and (2) nested observational studies to evaluate programmatic costs and operational metrics between the 3 rapid HIV screening strategies and using newly-diagnosed HIV infection as the primary outcome.

Conditions

Rapid HIV Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

A: Nontargeted rapid HIV screening

Eligible 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.

Group Type: OTHER

A: Nontargeted rapid HIV screening

Intervention Type: OTHER

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.

B: Enhanced targeted rapid HIV screening

Eligible 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.

Group Type: OTHER

B: Enhanced targeted rapid HIV screening

Intervention Type: OTHER

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.

C: Traditional targeted rapid HIV screening

Eligible 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.

Group Type: OTHER

C: Traditional targeted rapid HIV screening

Intervention Type: OTHER

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.

Interventions

A: Nontargeted rapid HIV screening

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.

Intervention Type: OTHER

B: Enhanced targeted rapid HIV 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.

Intervention Type: OTHER

C: Traditional targeted rapid HIV 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 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Greater than or equal to 16 years of age
• Clinically stable
• Capable of providing consent for medical care

Exclusion Criteria

• < 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alameda County Medical Center

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason S Haukoos, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Denver Health and Hospital Authority

Locations

Alameda County Medical Center

Oakland, California, United States

Denver Health and Hospital Authority

Denver, Colorado, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34309668 (View on PubMed)

Mohareb 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.

Reference Type: DERIVED

PMID: 33769768 (View on PubMed)

Other Identifiers

NIAID R01 AI106057

Identifier Type: -

Identifier Source: org_study_id